guide to the quality management system - world meteorological

2011 edition

www.wmo.int

Guide to the Quality Management System for the Provision of Meteorological Service for International Air Navigation

WMO-No. 1001

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Guide to the Quality Management System

for the Provision of Meteorological Service for

International Air Navigation

WMO-No. 1001

Approved by the Secretaries-General of WMO and ICAO and published under their authority

2011

Published jointly by the

WORLD METEOROLOGICAL ORGANIZATION7 bis, avenue de la Paix, P.O. Box 2300, CH-1211 Geneva 2, Switzerland

and the

INTERNATIONAL CIVIL AVIATION ORGANIZATION999 Univerisity Street, Montreal, Quebec, Canada H3C 5H7

WMO-No. 1001 ICAO Doc 9873

© World Meteorological Organization and International Civil Aviation Organization, 2010

The right of publication in print, electronic and any other form and in any language is reserved by WMO and ICAO. Short extracts from WMO publications may be reproduced without authorization, provided that the complete source is clearly indicated. Editorial correspondence and requests to publish, reproduce or translate this publication in part or in whole should be addressed to:

Chair, Publications BoardWorld Meteorological Organization (WMO)7 bis, avenue de la Paix Tel.: +41 (0) 22 730 84 03P.O. Box 2300 Fax: +41 (0) 22 730 80 40CH-1211 Geneva 2, Switzerland E-mail: [email protected]

WMO ISBN 978-92-63-11001-5 ICAO ISBN 978-92-9231-619-8

NOTE

The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariats of WMO and ICAO concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries.

Opinions expressed in WMO publications are those of the authors and do not necessarily reflect those of WMO. The mention of specific companies or products does not imply that they are endorsed or recommended by WMO in preference to others of a similar nature which are not mentioned or advertised.

iii

Foreword v

Chapter1–Policiesonqualitysystemsforaeronauticalmeteorologicalservices 1

1.1 Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 RelevantprovisionsinICAOAnnex3/WMOTechnicalRegulations[C.3.1]. . . . . . . . . . . 1

Chapter2–Conceptsandvocabulary 3

2.1 StandardsandISO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.2 BackgroundtoISO9000series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.3 Whatisquality?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.4 Qualitycontrol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.5 Qualityassurance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.6 Qualityimprovement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.7 Qualitymanagementsystem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.8 Quantifyingqualitycosts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.9 Qualitymanagementprinciples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.10 TheISO9000seriesofstandards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Chapter3–TheanatomyofISO9001:2008qualitymanagementsystems 7

3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.2 StructureofISO9001:2008. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.3 RequirementsofISO9001:2009. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.3.1 Clause1—Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.3.2 Clause2—Normativereferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.3.3 Clause3—Termsanddefinitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.3.4 Clause4—Qualitymanagementsystem . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.3.5 Clause5—Managementresponsibility . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.3.6 Clause6—Resourcemanagement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.3.7 Clause7—Productrealization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.3.8 Clause8—Measurement,analysisandimprovement. . . . . . . . . . . . . . . . . . . 15

Chapter4–Qualitymanagementsystemdocumentation 19

4.1 Structureofqualitymanagementsystemdocumentation. . . . . . . . . . . . . . . . . . . . . 19

4.2 Qualitymanual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4.3 Controlofdocuments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4.4 ISOguidance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Chapter5–Auditingprocesses 23

5.1 Auditobjectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.2 Audittypes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.3 Processauditingapproach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.4 Certification/registrationaudit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.5 Surveillance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.6 ISOguidance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

CONTENTS

iv

GuidetotheQualityManagementSystemfortheProvisionofMeteorologicalServiceforInternationalAirNavigation

Chapter6–Nonconformancereportsandcorrectiveaction 27

6.1 Typesofnonconformity–Majorandminornonconformities . . . . . . . . . . . . . . . . . . 27

6.2 Observationsandpotentialnonconformities. . . . . . . . . . . . . . . . . . . . . . . . . . . 27

6.3 Correctiveactionprocess. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Chapter7–Stepstocertificationandotherpracticalissues 29

7.1 Stepstocertification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

7.2 Timeandcostconsiderations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

7.3 Processanalysisforthemeteorologicalserviceprovider. . . . . . . . . . . . . . . . . . . . . . 30

7.4 Performanceindicatorsformeteorologicalproductsandservices. . . . . . . . . . . . . . . . . 30

7.5 Interfacingaspectswithexternalsystems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

7.6 ISOassistancefordevelopingcountries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Chapter8–HongKong,Chinacasestudy 33

8.1 Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

8.2 Qualitypolicy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

8.3 Stepsfollowedthatledtothecertificationofthequalitymanagementsystem. . . . . . . . . . 33

8.4 Documentationsystemputinplace. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

8.5 Specificmonitoringandmeasurementactivitiesemployed. . . . . . . . . . . . . . . . . . . . 35

8.6 QualitymanagementsystemcosttotheHongKongObservatory . . . . . . . . . . . . . . . . 35

8.7 Criticalsuccessfactors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

8.8 Qualitymanagementsystembenefitstotheorganization. . . . . . . . . . . . . . . . . . . . . 36

8.9 Experienceofanationalmeteorologicalserviceprovider. . . . . . . . . . . . . . . . . . . . . 36

Appendices

Appendix1–RecordsrequiredbyISO9001:2008. . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Appendix2–HongKong,Chinadocumentationsystem. . . . . . . . . . . . . . . . . . . . . . . . 39

A. Qualityobjectivesestablishedfortheairportmeteorologicaloffice. . . . . . . . . . . . . . . . 39

B. Outlineofthequalitymanualoftheairportmeteorologicaloffice. . . . . . . . . . . . . . . . 40

C. Qualitymanagementsystemproceduresmaintainedbytheairportmeteorologicaloffice. . . . 42

D. Exampleofaqualitymanagementsystemprocedure(controlofnonconformingproduct). . . 43

E. Exampleofworkinstructionsforweatherobservers. . . . . . . . . . . . . . . . . . . . . . . . 49

F. Exampleoftheformbeingusedintheairportmeteorologicaloffice. . . . . . . . . . . . . . . 50

Appendix3–Exampleofacertificationprocessundergonebyanationalmeteorological

serviceprovider. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

v

FOREWORD

TheICAOMeteorology(MET)DivisionalMeeting(2002),heldconjointlywiththeTwelfthSessionoftheWMOCommissionforAeronauticalMeteorology,formulatedRecommendation4/3—Guidancematerialonqualitymanagement systems, calling for ICAO and WMO todevelopguidancematerialconcerningtheprovisionofmeteorologicalservicesforinternationalairnavigation.

As a follow-up to Recommendation 4/3 approved bythe ICAO Council and the WMO Executive Counciland in accordance with the ICAO/WMO workingarrangements,thetwoorganizationsagreedtojointlydevelop and publish the present guidance material.TheICAOdocumentisbeingpublishedastheManual on the Quality Management System for the Provision of

Meteorological Service for International Air Navigationand the WMO document as the Guide to the Quality Management System for the Provision of Meteorological Service for International Air Navigation.Theresponsibil-ity for future amendments to these publications liesjointlywiththetwoorganizations.

The terms and definitions taken from the ISO 9000Compendium, Tenth Edition, are reproduced withthe permission of the International Organization forStandardization (ISO). The ISO 9000 CompendiumaswellastheISOStandardsreferredtohereincanbeobtained from any ISO member or from the websiteoftheISOCentralSecretariatatthefollowingaddress:www.iso.org.CopyrightremainswithISO.

1

CHAPTER 1

POLICIES ON QUALITY SYSTEMS FOR AERONAUTICAL

METEOROLOGICAL SERVICES

1.1 BACKGROUND

1.1.1 Quality assurance-related Standards andRecommended Practices were first introduced inICAOAnnex15totheConventiononInternationalCivil Aviation — Aeronautical Information Services,Chapter 3, 3.2.1, which became applicable on6November1997.TheStandardprovidesthat“EachContractingStateshalltakeallnecessarymeasurestointroduceaproperlyorganizedqualitysystemcontain-ingprocedures,processesand resourcesnecessary toimplement quality management at each functionstage...”intheaeronauticalinformationservice(AIS)field.Qualitymanagementhasalsobecome increas-inglyimportantinthefieldofmeteorologicalservicefor international air navigation. The setting up ofa properly organized quality system is to ensure acontinuedhighqualityofdataandproductsprovidedbytheaeronauticalmeteorologicalservices.

1.1.2 Amendment 72 to ICAO Annex 3 tothe Convention on International Civil Aviation —Meteorological Service for International Air Navigationand the WMO Technical Regulations (WMO-No. 49),Volume II — Meteorological Service for International Air Navigation [C.3.1],whichare identicalexcept fora fewminor editorialdifferences,becameapplicableon 1 November 2001. It introduced RecommendedPracticesconcerningqualitycontrolandmanagementofmeteorological information supplied tousersandin the trainingofmeteorologicalpersonnel.Alignedas far as possible with “quality system” provisionsin ICAO Annex 15, these provisions recommendconformitywiththeISO9000seriesofqualityassur-ancestandards.WhiletheISO9000seriesofqualityassurance standards provides a basic framework forthedevelopmentofaqualityassuranceprogramme,the details of such a programme have to be formu-latedbyeachICAOContractingState/WMOMember.

1.1.3 ThejointmeetingoftheICAOMeteorology(MET) Divisional Meeting (2002)/twelfth session oftheWMOCommission forAeronauticalMeteorology(CAeM-XII)discussedtheabovenewrequirementsandformulated Recommendation 4/3, which requestedthatICAOandWMOdevelopjointguidancematerialto assist Contracting States/Members in developingqualitymanagementsystemsoftheirown.Thepresentpublication thus provides guidance to facilitate thedesign, development and implementation of an ISO9000-compliant quality management system by the

aeronauticalmeteorologicalservicesintheprovisionofmeteorologicalservicesforinternationalairnavigation.

1.1.4 Amendment75 to ICAOAnnex3 intro-duced,asaStandard,therequirementtoestablishandimplement a quality system, which becomes appli-cableon15November2012.

1.2 RELEVANT PROVISIONS IN ICAO ANNEX 3/WMO TECHNICAL REGULATIONS [C.3.1]

1.2.1 Definitionsforqualityassurance,qualitycontrol,qualitymanagementandqualitysystemhavebeen introduced in ICAO Annex 3/WMO TechnicalRegulations [C.3.1] since Amendment 72. TheStandards and Recommended Practices related toqualityassurancearegiven in ICAOAnnex3/WMOTechnical Regulations [C.3.1], Chapter 2, 2.2.2 to2.2.7. In brief, the Standards and RecommendedPracticessetoutthefollowingrequirements:(a) The designated meteorological authority shall

establish and implement a properly organizedqualitysystem,comprisingprocedures,processesandresourcestoprovideforthequalitymanage-mentofthemeteorologicalinformationsuppliedto the users (ICAO Annex 3/WMO TechnicalRegulations[C.3.1],Chapter2,2.2.2);

(b) ThequalitysystemshouldbecompliantwithISO9000(ICAOAnnex3/WMOTechnicalRegulations[C.3.1],Chapter2,2.2.4);

(c) Thequalitysystemprovidestheuserswithassur-ancethatthemeteorologicalinformationsuppliedcomplies with the stated requirements (ICAOAnnex 3/WMO Technical Regulations [C.3.1],Chapter2,2.2.5);

(d) Thequalitysystemincludesverification/validationproceduresinregardtotheoperationalmeteoro-logical (OPMET) information exchange, as wellasresourcesformonitoringtheadherencetotheprescribedtransmissionschedules(ICAOAnnex3/WMO Technical Regulations [C.3.1], Chapter 2,2.2.6);and

(e) Audits should be conducted in order to demon-strate compliance of the quality system applied(ICAO Annex 3/WMO Technical Regulations[C.3.1],Chapter2,2.2.7).

1.2.2 It should be noted that all the statedrequirements(1.2.1(c)refers)havebeenlaiddownin

2


ICAO Annex 3/WMO Technical Regulations [C.3.1],theICAOregionalairnavigationplansandtheWMOregulatory documents. In particular, these includeproduct requirements concerning the geographicaland spatial coverage, format and content, time andfrequencyofissuanceandperiodofvalidityofmete-orologicalinformationtobesuppliedtoaeronauticalusers and requirements concerning the exchange ofOPMET information. In the case of qualificationsand training of meteorological personnel in aero-nauticalmeteorology, requirements are given in theWMOTechnical Regulations (WMO-No.49),VolumeI— General Meteorological Standards and Recommended Practices and also in the Guidelines for the education and training of personnel in meteorology and operational hydrology(WMO-No.258),VolumeI:Meteorology.

1.2.3 The designated meteorological authori-tiescouldachieveISO9000certificationforalloranypartoftheirservice,iftheysodecide.Thecertificationcouldbelimitedtoservicesprovidedforinternationalair navigation. This will be indicated in the ScopeattachedtotheCertificate.

NOTE:Itwillnotnecessarilybethemeteorologicalauthor-ityinaStatewhichseeksISO9000certification;itcouldbethe meteorological service provider that is providing theservicesundercontract to themeteorologicalauthority. Inthe present publication, the term “meteorological serviceprovider” will either refer to the meteorological authorityitselfor to anorganizationworkingunder contract to themeteorologicalauthorityfortheprovisionofmeteorologicalservicesforinternationalairnavigation.

3

2.1 STANDARDS AND ISO

2.1.1 Standardsprovidegreaterstructureintheworkenvironmentandtherebymakelifesimplerandeasier by bringing about advantages such as betterquality, more safety and prompter exchanges. Themorewidelycommunicated,acceptedandutilized,thebetterarethestandards.Somestandardsrelatetosometypeofmeasurementssuchasweightsanddimensions,while others relate to processes, that is, how thingsare done. Under the framework, ICAO ContractingStates/WMOMembersfollowthestandardsstipulatedin theAnnexes to theConventionon InternationalCivil Aviation/WMO Technical Regulations in ordertoensuresafety,regularityandefficiencyintheopera-tionofinternationalairnavigation.

2.1.2 The International Organization forStandardization, established in 1947 and based inGeneva, Switzerland, prescribes procedures control-ling the basic process whereby an ISO InternationalStandardisupdatedandreleased.ISOisaworldwidefederation of national standards bodies, which areresponsibleforstandardsofsome155countries,manyofwhicharegovernmentorganizations.Theobjectiveof ISO is to promote the development of standardi-zation and related activities globally with a view tofacilitatinginternationalexchangeofgoodsandserv-ices,andtodevelopingcooperationinthespheresofintellectual, scientific, technological and economicactivity.

2.2 BACKGROUND TO ISO 9000 SERIES

2.2.1 The work of preparing InternationalStandardsisnormallycarriedoutthroughISOspecial-izedtechnicalcommittees(TCs).ISO/TC176—Qualitymanagementandqualityassurance,theSecretariatofwhich is held by the Standards Council of Canada,istheISOtechnicalcommitteeresponsiblefordevel-opingandmaintainingauniversallyaccepted setofqualitymanagementstandards.

2.2.2 TheISO9000series,asitbecameknown,wasfirstpublishedin1987butitwasnotuntil1994thatthefirstrevisionswerepublished.Thereasonwasthatmanagementsystemswerenewtomanyof theorganizationsengagedinestablishingqualitysystemsonthebasisoftheISO9000standards.Inthissitua-tion,ISO/TC176believedthatmakingmajorchangesin the standards could run the risk of disruptingsuch efforts. Consequently, the 1994 revisions were

relativelyminorandmostlyrelatedtotheremovalofinternalinconsistencies.

2.2.3 There are many reasons why a newseries of the standards was published in 2000. First,ISO International Standards have a normal reviewcycle of five years. Secondly, the user communityrequested it. The year 2000 revisions representeda thorough overhaul of the standards to take intoaccount developments in the field of quality andthe considerable body of experience that had builtup as a result of implementing ISO 9000. The usersdemandedaprocess-orientedapproachandadefinedroute for performance improvement. The ISO 9000seriesofstandards,whichrepresentsamajorimprove-mentoverthetwoearlierversions,wassubsequentlypublishedinDecember2000.

2.2.4 A further updatable ISO 9000 series ofstandardswasintroducedby2008inordertoprovideclarification and to enhance compatibility with theISO 1400:2004 standards. This update included ISO9000:2005containingthefundamentalsandvocabu-laryandISO9001:2008providingtherequirements.

2.3 WHAT IS QUALITY?

2.3.1 The literature on quality managementprovides a broad range of definitions of quality. Inparticular,theliteraturenotesthatqualityisasubjec-tive term and that individuals and organizationshavetheirownperceptionsanddefinitions.However,thecommonthemeorfocusofeachofthesedefini-tionsreflectstheneedforthetotalcharacteristicsandfeaturesof aproductor service to satisfya specifiedneedoruse.Intermsofaviationweatherservicesandproducts, the word quality should communicate ahigh level of consistentperformance, reliability andoverallcredibilityinmeetingandsatisfyingtheavia-tionindustry’sidentifiedneeds.

2.3.2 As individuals and organizations holdtheirownperceptionofwhatdefinesquality,thereisobviouslyaneed fora commonunderstanding. ISOprovidesthisinitsdefinitionofquality:the“degreetowhichasetofinherentcharacteristicsfulfilsrequire-ments”(Clause3.1.1ofISO9000:2005).“Requirement”signifies“needorexpectationthatisstated,generallyimpliedorobligatory”;“inherent”signifies“qualityisrelativetowhatsomethingshouldbeandwhatitis,especiallyasapermanentcharacteristic”.Forexample,thepriceofaproductmaybedeterminedbythecost

CHAPTER 2

CONCEPTS AND VOCABULARY

4


andprofitmarginofthesupplier.Itisanassignedandtransientfeaturebutisnotnecessarilyrelatedtothequalityoftheproduct.Themostimportantaspectisthat,atminimum,itmeetsspecifiedrequirements.

2.3.3 Anyfeatureorcharacteristicofaproductorservicethatisneededtosatisfyuserneedsorachievefitnessforuseisaqualitycharacteristic.Whendealingwith products, the characteristics are mostly techni-cal, for example accessibility, availability, operabilityanddurability,whereasservicequalitycharacteristicshaveahumandimension,forexamplewaitingtime,delivery time, accuracy and accessibility. Thesecharacteristicsaremeasurableandconsequentlycanbeusedtomonitorthequalityoftheproductorservice.

2.4 QUALITY CONTROL

The quality control function of an organizationfirst evolved when inspectors were hired to inspectproducts to differentiate between the good and thebad. The 100 per cent inspection later evolved intosampling inspection. Quality control is a part ofquality management focused on fulfilling qualityrequirements (Clause 3.2.10 of ISO 9000:2005). Inother words, the operational techniques and activi-ties, such as sampling inspection mentioned above,are used to fulfil the requirements for quality. Thenatureof this approach remainsmoreor less detec-tion and that is considered a reactive downstreamapproach—correctiononlyafterproblemsoccur.

2.5 QUALITY ASSURANCE

Quality assurance is also a part of quality manage-mentbutitisfocusedonprovidingconfidencethatquality requirementswill be fulfilled (Clause3.2.11of ISO 9000:2005). In other words, it pertains toall those planned and systematic actions necessaryto provide adequate confidence that a product willsatisfytherequirementsforquality.Thisisafunda-mentalshiftinconceptfromthereactivedownstreamapproachofquality control bymeansofdetection,toaproactiveupstreamapproachthatcontrolsandmanagestheupstreamactivitiestopreventproblemsfromarising.

2.6 QUALITY IMPROVEMENT

2.6.1 Quality improvement is another part ofqualitymanagementthatisfocusedonincreasingtheability to fulfil quality requirements (Clause 3.2.12of ISO9000:2005). It isnotconcernedwithcorrect-ingerrorsbutconcernedwithdoingthingsbettertoimprovesystemefficiencyandeffectiveness.

2.6.2 ISOoffersthePlan–Do–Check–Act(PDCA)cycleasausefultoolforcontinualimprovement.Themethodologyappliestobothhigh-levelstrategicproc-essesand to simpleoperationalactivities. Figure2-1illustratesthePDCAcycle.

2.7 QUALITY MANAGEMENT SYSTEM

2.7.1 As defined in ISO 9000:2005, a qualitymanagement system is a management system thatdirects and controls an organization with regard toquality (Clause 3.2.3 of ISO 9000:2005). Activitiesgenerallyincludethefollowing:(a) Establishment of a quality policy and quality

objectives;(b) Qualityplanning;(c) Qualitycontrol;(d) Qualityassurance;and(e) Qualityimprovement.

2.7.2 TheintentoftheISO9000qualitymanage-ment system is to provide a management frameworkfortheorganizationtocomplywithapplicablerequire-ments,controlitsprocessesandminimizetheirrisk,andultimatelysatisfycustomerneedsandexpectations.

NOTE: The term “customer” is frequently referred to inISO9000.TheequivalenttermusedatICAO/WMOis“user”.Thecustomersofthemeteorologicalauthoritiesrefertotheusers listed in ICAOAnnex3/WMOTechnicalRegulations[C.3.1],Chapter2,2.1.2.

2.8 QUANTIFYING QUALITY COSTS

2.8.1 Thecostofquality,asameasureofqual-ity, is the ultimate test to evaluate the effectiveness

Plan Plan the improvement

Do Implement the improvement

Check Monitor and measure the results against policies, objectives and requirements

Act Take actions to continually improve the performance

Figure2-1 PDCAcycle

Plan

Do

Check

Act

5

Chapter2—Conceptsandvocabulary

of every quality initiative. It consists of four majorcomponents,asfollows:(a) Internal failure costs.Costsassociatedwithdefects

or nonconformance found before the customerreceivestheproductorservice,forexamplecorrect-ingawronglyencodedforecastwhencapturedbyautomaticcheckingprocedures.

(b) External failure costs.Costsassociatedwithdefectsor nonconformance found after the customerreceivestheproductorservice,forexampleinvesti-gatingcomplaintsfromapilotforthelateissuanceofanaerodromeforecastandlossofgoodwill.

(c) Appraisal costs. Costs incurred to determine thedegree of conformance to quality requirements,forexampleproceduresandresourcestoenabletheverificationofaerodromeforecasts,andmonitor-ingofthetransittimeofmeteorologicalbulletins.

(d) Prevention costs. Costs incurred to keep failureor nonconformance and appraisal costs to aminimum, for example training staff in qualitypracticesandprocedures,andperformingpreven-tivemaintenanceonananemometer.

2.8.2 The advancement in approach frominspection, quality control and quality assurance toqualitymanagementreducesthequalitycost.Atoneendofthespectruminspectioniseasytoimplement,involvingonlyasmallpartoftheorganizationwithsimplebuteffectivetoolsandskills.Attheotherend,qualitymanagementinvolvestheentireorganizationand is far more complex to implement effectively.Besidesthereductionofthequalitycosts,awell-imple-mentedqualitymanagementsystemmaybringmanyother benefits to the whole organization, includingstaffmotivation.

2.9 QUALITY MANAGEMENT PRINCIPLES

FromthecollectiveexperienceandknowledgeoftheinternationalexpertswhoparticipatedinISO/TC176,the Committee derived eight quality managementprinciplesonwhichthestandardsoftherevisedISO9000seriesarebased.Theseprinciplesreflectbestprac-ticeandaredesignedtoenablecontinualimprovementof the system. They can be used by senior manage-mentofmeteorologicalauthoritiesasaframeworktoguidetheirorganizationstowardsimprovedperform-ance.Theseprinciplesareasfollows:

(a) Customer focus. Organizations depend on theircustomers and therefore should understandcurrent and future customerneeds, shouldmeetcustomer requirements and strive to exceedcustomerrequirements.

ISO9001:2008placesmuchemphasisoncustomerfocus.Meteorologicalauthoritiesshoulddocumentcustomer requirements and monitor the quality

of services as perceived by the customers. Themeanstoachievethismayincludetheconductofregularcustomersatisfactionsurveys,liaisonmeet-ings with representatives of the customers andvisitstotheoperationfacilitiesofthecustomers.All customer feedback and complaints shouldbe formally recorded and followed up withoutdelay. Details of action taken and recommenda-tions for improvement should be documented.It is also important togivea formal response tothecustomerbeforethefeedbackorcomplaintisconsidered“closed”.

(b) Leadership.Leadersestablishunityofpurposeanddirectionoftheorganization.Theyshouldcreateandmaintaintheinternalenvironmentinwhichpeoplecanbecomefullyinvolvedinachievingtheorganization’sobjectives.

The implementation of a quality managementsystemwillhardlybesuccessful if there is lackofcommitmentfromtopmanagement.Assuch,itiscritical that top management has a sound appre-ciation and understanding of all facets of qualitymanagementand,inparticular,issuespertainingtoquality assurance. This understanding and appre-ciation should be obtained through appropriatetrainingandexperience.Itmustalsoberememberedthatleadershipcanbefoundatalllevelswithinanorganizationandidentifyingthisqualitymaybeofgreatbenefitinestablishingaqualityculturewithinaspecificsectionofanorganizationorthroughouttheorganizationasawhole.

(c) Involvement of people. People at all levels are theessenceofanorganizationandtheirfullinvolve-ment enables their abilities to be used for theorganization’sbenefit.

Staff must be suitably qualified and competentintheirjobs,asthequalityoftheirworkdirectlyaffectsthequalityofservice.Thiscanbeachievedthrough the provision of appropriate train-ing and evaluation. Quality awareness trainingshould also be provided to all relevant staff toheighten responsibility, accountability andqual-ity consciousness, that is, to assist in building aquality-focusedculture.Withtheimplementationofthequalitymanagementsystem,staffneedtotakeonadditionalresponsibilitiessuchastheday-to-dayconsistencychecksaspartof thedata forproductqualityassuranceandcontrolprocesses.

(d) Process approach.Adesiredresultisachievedmoreefficiently when activities and related resourcesaremanagedasaprocess.

A process is a set of interrelated or interactingactivities that transform inputs into outputs. Aquality management system can be thought ofasasinglelargeprocessthatusesmanyinputstogeneratemanyoutputs.Inturn,thislargeprocess

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ismadeupofmanysmallerprocesses.Allactivitiesandresourcesrelatedtoaviationweatherservices,includingoperationalandadministrative,havetobemanagedasprocesses.

(e) System approach to management.Identifying,under-standingandmanaginginterrelatedprocessesasasystemcontributestotheorganization’seffective-nessandefficiencyinachievingitsobjectives.

Meteorologicalserviceprovidersmayalreadyhavedocumentedmanyoftheoperationalandadmin-istrative processes for service provision. TheseprocessesshouldbereviewedandanydifferencesbetweentheISOrequirementsandexistingproc-essesidentified.Qualitysystemproceduresshouldthen be developed for these differences andappliedso that theprocesses toachieve thebestresultscanbealignedandintegrated.

(f) Continual improvement. Continual improvementof theorganization’soverallperformanceshouldbeapermanentobjectiveoftheorganization.

Specifically,theeffectivenessandsuitabilityofthequalitymanagementsystemhavetobeevaluatedandareasforimprovementidentifiedandrectified.Managementreviewshavetobeconductedregu-larlyusingthedatacollectedfromthemonitoringand measurement process to identify areas forfurther improvement. Channels may need to beestablishedtoallowallstaffintheorganizationtomakesuggestionsonwaystoimprovetheservice.

(g) Factual approach to decision-making. Effectivedecisions are based on the analysis of data andinformation.

Amongotherthings,aTAFverificationsystemhastobedevelopedinaccordancewiththeICAO/WMOrequirementstoensuretheaccuracyofeachoftheweatherelements.Otherperformancestatisticsorindicators,suchastimelinessandconformancetothe specification, user satisfaction survey resultsand supplier performance records should also becollectedinthedataandanalysisprocess.

(h) Mutually beneficial supplier relationships.Anorgani-zation and its suppliers are interdependent anda mutually beneficial relationship enhances theabilityofbothtocreatevalue.

Suppliers should be evaluated and selected onthe basis of their ability to meet purchase orderrequirementsandontheirpastperformance.

2.10 THE ISO 9000 SERIES OF STANDARDS

2.10.1 TheISO9000seriesofstandardshasbeendevelopedonthebasisoftheeightqualitymanagement

principles (see2.9)withanemphasisonsystemeffec-tiveness.Theentireserieshasbeenreducedfrommorethan20standardsinthe1994versiontoonly4stand-ardsinthe2000version,asfollows:

(a) ISO 9000:2005 Quality management systems —Fundamentalsandvocabulary

This standard is intended to provide the funda-mental background information of qualitymanagementsystemsandspecifiestheterminol-ogyphrasesusedinISO9000.Itfacilitatesamutualunderstanding of the terminology used in qual-ity management (i.e. between the organization,suppliers,customersandregulators).

(b) ISO 9001:2008 Quality management systems —Requirements

This standard specifies requirementsofaqualitymanagementsystemwheretheorganizationneedstodemonstrateitsabilitytoprovideproductsthatfulfil customer needs and applicable regulatoryrequirementsandaimstoenhancecustomersatis-faction through the effective application of thesystem.Clauses4through8containtherequiredelementsofthequalitymanagementsystem.ThedetailsoftheclausesandtheirmeaningsaregiveninChapter3.

(c) ISO9004:2009Managingforthesustainedsuccessof an organization — A quality managementapproach

This standard provides guidelines beyond therequirements given in ISO 9001 that considerboth theeffectivenessandefficiencyof thequal-itymanagementsystem.Theaimofthisstandardistoimprovetheperformanceoftheorganizationandsatisfactionofcustomersandotherinterestedparties.Thisinternationalstandardconsistsofguid-ance and recommendations and is not intendedforcertification,regulatoryorcontractualuse,norasaguidetotheimplementationofISO9001.

(d) ISO 19011:2002 Guidelines for quality and/orenvironmentalmanagementsystemsauditing

The standard provides guidance on the prin-ciples of auditing, managing audit programmes,conducting quality management system auditsand environmental management system audits,aswellasguidanceonthecompetenceofqualityandenvironmentalmanagementsystemauditors.

2.10.2 TheISO9000seriesofstandardsandotherISOpublicationscanbepurchasedfromISOmemberinstitutes.A listofexistingISOmember institutes isavailable on the ISO website at http://www.iso.org.ForcountrieswherethereisnoISOmemberinstitute,thesoftcopyofthestandardscanbepurchasedonlinefromtheISOwebsite.

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CHAPTER 3

THE ANATOMY OF ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS

3.1 INTRODUCTION

3.1.1 TheISO9001:2008InternationalStandardspecifiestherequirementsforaqualitymanagementsystem applicable to all organizations, products andservices.ItistheonlystandardintheISO9000:2005family of standards that can be used for certifi-cation of the system. The meteorological serviceprovider can only seek certification of the qualitymanagement system after validating that every ISO9001:2008requirementismet.Thischapterprovidesa detailed account of the requirements specified inthe international standard, supplemented with aninterpretationoftheirmeaninginthecontextoftheprovisionofmeteorologicalservicesforinternationalairnavigation.

NOTE:ISO9001:2008onlydefinesthefundamentalrequire-mentsandlaysdowntheframeworkforcertification.Eachmeteorologicalserviceproviderneedstoformulateitsownquality management system based on its own needs andcircumstances.Asoperatingservicesthathavebeenrunningsuccessfullyforalongtime,itislikelythatthemeteorologi-calserviceproviderswillalreadyhaveasystemorpracticesinplacetoaddresstheISOrequirements.Theywould,there-fore,quiteoftenbeabletoaddresstherequirementsofISO9001:2008inasimpleandcost-effectivemanner.

3.1.2 ISO 9001:2008 also requires that a“processapproach”, that is,oneof theeightqualitymanagement principles, be followed when develop-ingandmaintaininganeffectivequalitymanagementsystem. For a meteorological service provider tofunction effectively, it has to identify and managenumerouslinkedprocesses.Tonamebutafew,thesemayincludethefollowing:(a) Theprocessforreviewoftherequirementsrelated

totheproductssuchasaviationforecastsandwarn-ings,observationsandflightdocumentation;

(b) Theprocessforprovisionofsuchproducts;and(c) The process for monitoring the quality of the

products.

A“processapproach”canbedefinedastheapplicationof a system of processes, together with the identifi-cation and interaction of these processes, and theirmanagement.

3.2 STRUCTURE OF ISO 9001:2008

3.2.1 ISO 9001:2008 is organized into thefollowingeightclauses:

(a) Clause1–Scope(b) Clause2–Normativereferences(c) Clause3–Termsanddefinitions(d) Clause4–Qualitymanagementsystem(e) Clause5–Managementresponsibility(f) Clause6–Resourcemanagement(g) Clause7–Productrealization(h)Clause8–Measurement,analysisandimprovement.

3.2.2 Thefirstthreeclausesareintroductoryandset the stage for the requirements. The shall clausesthatsignifytheactualrequirementsarestipulatedinthelastfiveclauses.Thequalitymanagementsystemdescribed in Clause 4 encompasses the four majorgroupsofprocesses,withintheprocess-basedqualitymanagement system. These, which are described inClauses5to8,areasfollows:(a) Managementresponsibility;(b) Resourcemanagement;(c) Productrealizationandmeasurement;and(d) Analysisandimprovement.

3.2.3 Figure3-1illustratesthelinkagebetweenthese four groups of processes in the form of acontinuous loopandservesasagoodstartingpointfor developing the structure of the quality manage-ment system. Each of the four groups of processesin the loop contains specific tasks and processes, asdetailedinClauses5to8,thatmustbeaccomplished.Figure3-1highlightstheimportanceofthecustomerindefining requirementsas inputs, and theneed tomonitorcustomersatisfaction.Italsoshowshowtheimprovementprocesses,forexamplebymeansofthePlan–Do–Check–Act (PDCA) cycle (see Chapter 2,2.6.2)revolvearoundallaspectsofthesystem.

3.3 REQUIREMENTS OF ISO 9001:2008

3.3.1 CLAUSE1—SCOPE

Thisclauseemphasizestheaimtoenhancecustomersatisfaction through the effective application of thequality management system, continual improve-mentofthesystemandtheassuranceofconformitytocustomerandapplicable regulatory requirements.Where any requirement(s) cannot be applied owingtothenatureoftheorganizationanditsproducts,thiscanbeconsideredforexclusion.ExclusionsarelimitedtorequirementswithinClause7,andtheymustnotaffecttheabilityorresponsibilityoftheorganizationtoprovideproductsthatmeetbothcustomerrequire-mentsandapplicableregulatoryrequirements.

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3.3.2 CLAUSE2—NORMATIVEREFERENCES

ThisclausestatesthatcertainprovisionscontainedinISO9000:2005arereferredtoinISO9001:2008andassuch,theyalsoconstituteprovisionsofISO9001:2008.Inparticular,thereadershavetorefertoISO9000forthetermsanddefinitionswheninterpretingtheISO9001:2008requirements.

3.3.3 CLAUSE3—TERMSANDDEFINITIONS

Thisclauseclarifiesthattheword“product”usedinthe standard can also mean “service”. It also coversthespecificuseofterminologytodescribethesupplychainasfollows:

Supplier g Organization g Customer

Theorganizationindicatestheentityseekingcerti-fication to ISO9001:2008standard. In thepresentcontext, it indicates the meteorological serviceprovideritself,orthepartofitsservicesthatisseek-ingcertification.Asupplieristheproviderofaserviceorinformationtotheorganization.Itcanbeinternalorexternaltotheorganization.Forexample,aworld

areaforecastcentreisanexternalsupplierwhereastheinformationtechnologydivisioncanbeaninter-nalsupplierofthemeteorologicalserviceprovider.Customers of the meteorological service providerare the aviation users listed in ICAO Annex 3/WMO Technical Regulations [C.3.1], Chapter 2,2.1.2. These are operators, flight crew members,air traffic servicesunits, searchand rescue servicesunits, airport management and others concernedwith the conductordevelopmentof internationalairnavigationand themeteorological informationnecessary for the performance of their respectivefunctions.

3.3.4 CLAUSE4—QUALITYMANAGEMENTSYSTEM

3.3.4.1 Clause4 states thegeneral requirementsforISO9001andthedocumentationrequirementsofthequalitymanagementsystem.

Clause4 1—Generalrequirements

3.3.4.2 Clause4.1coverstherequirementsfortheorganizationtoestablish,document,implementandmaintainaqualitymanagement systemandcontin-ually improve its effectiveness in accordance with

Continual improvement

Managementresponsibility

Customers

Satisfaction

Customers

Requirements

Measurement,analysis andimprovement

Resourcemanagement

Productrealization

Input Output

Value-adding activities

Information flow

Clause 5

Clause 6

Clause 7

Clause 8

Product

Figure3-1 Modelofaprocess-basedqualitymanagementsystem(adaptedfromtheISO9001:2008standard)

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Chapter3—TheanatomyofISO9001:2000qualitymanagementsystems

ISO9001:2008.Thestepstobefollowedaredescribedinthefollowingtable:

Step Description

1 Determine the processes needed for the quality management system and their application throughout the organization

2 Determine the sequence and interaction of these processes

3 Determine criteria and methods needed to ensure that both the operation and the control of the processes are effective

4 Ensure the availability of resources necessary to support the operation and monitoring of these processes

5 Monitor, measure where applicable and analyse the processes

6 Implement actions necessary to achieve planned results and continual improvement of these processes

Clause4 2—Documentationrequirements

3.3.4.3 The quality management system docu-mentationmustinclude(Clause4.2.1):(a) Documented statements of a quality policy and

qualityobjective:— requirementsofwhicharefurtherelaborated

inClauses5.3and5.4.1respectively;(b) Aqualitymanual:

— whichincludesthescopeofthequalitymanage-mentsystem,justificationforanyexclusions,a description of the interaction between theprocessesandthedocumentedproceduresorreferencetothem(Clause4.2.2);

(c) A minimum of six documented proceduresrequiredbyISO9001:2008(seeChapter4,4.1.3),respectivelyon:— controlofdocuments(Clause4.2.3)— controlofrecords(Clause4.2.4)— internalaudit(Clause8.2.2)— controlofnonconformingproduct

(Clause8.3)— correctiveaction(Clause8.5.2)— preventiveaction(Clause8.5.3);

(d) RecordsrequiredbyISO9001:2008:— requiredtoprovideevidenceofconformityto

requirementsandoftheeffectiveoperationofthequalitymanagementsystem.Examplesofrecordsareresultsofcalibrationandverifica-tionofmeteorologicalsensorsandresultsofevaluationsofsuppliers.RequiredrecordsarelistedinAppendix1;and

(e) Other documents, for example operations manuals,required toensure theeffectiveplanning,opera-tionandcontroloftheprocesses.

Clause4 2 3—Controlofdocuments3.3.4.4 Proper controls are required of alldocuments of the quality management system. Adocumentedprocedurehastobeestablishedforthispurpose.Controlofdocumentsincludesthefollowing:(a) Approval,reviewandupdatingofdocuments;(b) Identification of changes and current revision

status;(c) Availability of documents at points of use, for

example a meteorological office, their legibilityandidentification;

(d) Identificationofexternaldocuments,forexampleICAO/WMO regulatory documents, States’Aeronautical Information Publications (AIP) andtheirdistribution;and

(e) Control of obsolete documents to prevent theirunintendeduse.

Clause4 2 4—Controlofrecords

3.3.4.5 Records are a special type of document.The controls needed for the identification, storage,protection,retrieval,retentiontimeanddispositionofrecordshavetobedefinedinadocumentedprocedure.

3.3.4.6 It shouldbenoted that thedocumenta-tionrequiredcanbeinanyformortypeofmedium.The extent of the documentation is dependent onthe size and type of the organization; complexityandinteractionoftheprocesses;andcompetencyofpersonnel.Moredetaileddescriptionsofdocumenta-tion required for a quality management system aregiveninChapter4.

3.3.5 CLAUSE5—MANAGEMENTRESPONSIBILITY

3.3.5.1 Agenuinecommitmentfromtopmanage-ment and strong leadership are instrumental in thesuccessful implementation of an effective qualitymanagement system. Appropriate resources have tobeallocatedandeverystaffmembermadeawarethatthis is a sign that topmanagement is committed totheprocess.Clause5discussestheroleandresponsi-bility of management in developing and improvingthequalitymanagementsystem.

Clause5 1—Managementcommitment

3.3.5.2 Topmanagementoftheorganization,forexample the General Manager or Officer-in-Chargeof themeteorological serviceprovider,mustprovideevidenceofitscommitmenttothedevelopmentandcontinual improvement of the quality managementsystemby:(a) Communicatingtotheemployeestheimportance

of meeting customer needs as well as statutoryand regulatory requirements, for example ICAOAnnex3/WMOTechnicalRegulations[C.3.1];

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(b) Establishing the quality policy (Clause 5.3) andqualityobjectives(Clause5.4.1);

(c) Conductingregularmanagementreviews(Clause5.6)toensurethecontinuingsuitability,adequacyand effectiveness of the quality managementsystem;and

(d) Ensuring the availability of resources needed bythequalitymanagementsystem(Clause6).

Clause5 2—Customerfocus

3.3.5.3 This clause focuses attention on theapplication of the quality management principle of“customerfocus”.Itemphasizesthattopmanagementmustensurethatcustomer(i.e.aviationuser)require-ments are determined and met, so as to enhancecustomersatisfaction(Clauses7.2.1and8.2.1).

Clause5 3—Qualitypolicy

3.3.5.4 The quality policy and quality objec-tives,asestablishedbytopmanagement,providethefocustodirecttheorganization.Togethertheydeter-mine the desired results and guide the organizationinallocatingitsresourcestoachievetheseresults.Thequalitypolicyprovidestheframeworkforestablishingandreviewingthequalityobjectives.Clause5.3statesthatthequalitypolicymust:(a) Bealignedwiththeoverallbusinesspolicyofthe

organization, that is, the provision of meteoro-logicalservicesforinternationalairnavigation;

(b) Includeacommitmenttomeetingrequirements,primarily the Standards and RecommendedPractices stipulated in ICAO Annex 3/WMOTechnicalRegulations[C.3.1]andtheairnaviga-tionplanrequirements,andcontinuallyimprovingthequalitymanagementsystem;

(c) Bewidelycommunicatedthroughouttheorgani-zation;and

(d) Be reviewedduring regularmanagement reviews(Clause5.6)forcontinuingsuitability.

Clause5 4—Planning

3.3.5.5 According to ISO 9000:2005, qualityplanningshouldbefocusedonsettingqualityobjec-tives, specifying necessary processes and relatedresourcestofulfiltheseobjectives.Clause5.4requiresthat top management must ensure proper qualityplanning.

Clause5 4 1—Qualityobjectives

3.3.5.6 Top management has to ensure theestablishmentofqualityobjectives,whicharequality-related goals aimed at relevant functions and levelswithintheorganization.Thisdoesnotimplythattopmanagement must define quality objectives one byone,butthattheachievementoftheseobjectivesisa

priority,whichshouldbemadecleartoallstaffoftheorganization.Qualityobjectivesincludethoseneededto meet the requirements for products and must bemeasurable and consistent with the quality policy.Typicalobjectivesfortheprovisionofaviationmete-orologicalservicesarediscussedinChapter7.

Clause5 4 2—Qualitymanagementsystemplanning

3.3.5.7 Topmanagementhastoensurethatqual-ity management planning is conducted so that thegeneral requirements given in Clause 4.1 and thequalityobjectives given inClause5.4.1 canbemet.Controlofchangestothesystemmustalsobeimple-mentedtopreservetheintegrityofthesystem.Withinthebroadercontextoftheorganization’soperations,top management should exercise its authority andcarefullyconsideranyproposalsforchanges,inordertoavoidanyunexpectednegativeconsequencespriortoimplementation.

Clause5 5—Responsibility,authorityandcommunication

3.3.5.8 Clause 5.5 covers the requirementsconcerninghowtopmanagementshouldadministerthequalitymanagementsystem,includingareassuchas responsibility and authority, management repre-sentationandinternalcommunications.

Clause5 5 1—Responsibilityandauthority

3.3.5.9 Top management needs to ensure thatresponsibilities and authority are properly defined,usually in the quality manual by means of organi-zational charts and job descriptions, and widelycommunicatedwithintheorganization.

Clause5 5 2—Managementrepresentative

3.3.5.10 A staff member, or a group of staffmembers, should be appointed as the managementrepresentativetohelptopmanagementadministerthequalitymanagementsystem.Thespecificresponsibili-tiesandauthorityofthemanagementrepresentativeincludethefollowing:(a) Ensuringthatallprocessesinthequalitymanage-

ment system are established, implemented andmaintained;

(b) Reportingtheperformanceofthequalitymanage-mentsystemtotopmanagement;and

(c) Promoting awareness of customer requirementsthroughouttheorganization.

Clause5 5 3—Internalcommunication

3.3.5.11 Top management must ensure that theeffectiveness of the quality management system

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(requirements, objectives and performance) is alsocommunicatedwidelywithintheorganization.

Clause5 6—Managementreview

3.3.5.12 Management review is the processconductedby topmanagement atplanned intervalsonaregularbasis, forexampleannually,toevaluatetheeffectivenessandefficiencyofthequalitymanage-mentsystem.Italsoassessestheneedforchangesandopportunitiesforimprovementtothesystem,includ-ingthequalitypolicyandqualityobjectives.Records,usually in the form of management review meetingminutes or summary reports of the meetings, fromsuchreviews,includingtheinputs,outputsanddeci-sionsandagreedactions,havetobemaintained.

3.3.5.13 TherequiredinputstoandoutputsfromthereviewsareshowninFigure3-2.

3.3.6 CLAUSE6—RESOURCEMANAGEMENT

3.3.6.1 Clause6coversrequirementsconcerningtheresourcesneededfortheeffectiveimplementationofthequalitymanagementsystem.

Clause6 1—Provisionofresources

3.3.6.2 The organization has to determine andmake available the resources, in particular human

resources, infrastructure and the work environ-ment, needed to meet customer requirements andto implement and continually improve the qualitymanagementsystem.

Clause6 2—Humanresources

3.3.6.3 Thestaffwhoseworkaffectsproductqual-ity must be competent, appropriately educated andtrained,skilledandexperienced(Clause6.2.1).

3.3.6.4 The organization has to determine thenecessarycompetenceforsuchstaff.High-levelguid-ance on the training needs of managers and keystaff in meteorological offices serving aviation canbe found in the Guide to Practices for Meteorological Offices Serving Aviation (WMO-No. 732). Detailedrequirements for the qualifications and training ofmeteorologicalpersonnelinaeronauticalmeteorologyaregiveninTechnical Regulations,VolumeI—General Meteorological Standards and Recommended Practices (WMO-No. 49) and the Guidelines for the education and training of personnel in meteorology and operational hydrology — Volume I, Meteorology (WMO-No. 258),complemented by Initial formation and specialisation of meteorological personnel: Detailed syllabus examples(WMO/TDNo.1101).Theorganizationmustprovideadequatetrainingtothestaff,ortakeotherappropri-ateactionstoensurethatallstaffaresuitablyqualifiedfortheworkassignedtothem.Theorganizationmustalso communicate to the staff their role and how

Figure3-2 Inputsandoutputsofamanagementreview

Managementreview

Recommendationsfor improvement

Process performance andproduct conformity

Customerfeedback

Audit results(see Chapter 5)

Status of preventive andcorrective actions

Changes that couldaffect the system

Follow-ups from previous reviews

Improvement of theeffectiveness of the system

and its processes

Improvement ofproducts and services

Resource needs

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they contribute to the achievement of the qualityobjectives.Recordsof education, training, skills andexperiencehavetobemaintained(Clause6.2.2).

Clause6 3—Infrastructure

3.3.6.5 Infrastructure, which includes the work-space,processequipment(bothhardwareandsoftware,for example computers and meteorological sensors)andsupportingservicessuchascommunicationsfacil-ities,hastobedeterminedandmaintainedtoachieveconformitytoproductrequirements.

Clause6 4—Workenvironment

3.3.6.6 Theworkenvironmentneededtoachieveconformitywithproductrequirementshastobedeter-mined and maintained. One particular issue in thecontextofthemeteorologicalserviceprovideristhata significant number of meteorological offices serv-ingaviationareoperating24hoursaday.Appropriateandreasonabledutyandshiftarrangementshavetobeorganizedtocoverallworkrequired.

3.3.7 CLAUSE7—PRODUCTREALIZATION

3.3.7.1 Clause7coversrequirementsconcerningthe entire production cycle, which involves deter-miningproductrequirements,designingtheproduct,acquiringtherawmaterials,manufacturingtheprod-uctanddeliveryofthefinishedproduct.

Clause7 1—Planningofproductrealization

3.3.7.2 Theorganizationhastoplananddeveloptheprocessesneededforproductrealization.Planningof product realization must be consistent with therequirements of the other processes of the qualitymanagement system specified in Clause 4.1. In theplanningprocess,theorganizationmustdetermine,asappropriate,thefollowing:(a) Qualityobjectivesandrequirementsrelatedtothe

product(Clause7.2.1);(b) The need to establish processes, documents and

provideresourcesspecifictotheproduct;(c) Required verification, validation, monitoring,

inspectionandtestactivitiesspecifictotheprod-uctandthecriteriaforproductacceptance;and

(d) Records required to prove that the realiza-tion processes and the resulting product meetrequirements.

3.3.7.3 Itshouldbenotedthatgiventheopera-tionalnatureofthemeteorologicalserviceproviders,it is most likely that the products provided andthe resources specific to the products have alreadybeen established.Additional resources, for example

keepingextrarecords,mayberequiredtomaintainan effective quality management system but theyshould not be prohibitive. Verification, validation,monitoring,inspection,testactivitiesandcriteriaforproductacceptancemayalsoalreadybe inplacesothatitmaynotbenecessarytoestablishadditionalprocesses or documents. The realization processescan be described concisely in the quality manual,augmented by procedures given in the operationsmanual.

Clause7 2—Customer-relatedprocesses

Clause7 2 1—Determinationofrequirementsrelatedtotheproduct

3.3.7.4 Theorganizationmustdeterminerequire-ments specified by the customer, including thefollowing:(a) Those for delivery and post-delivery activities,

suchasrequirementsforamendedTAForcorrec-tiontometeorologicalreports;

(b) Requirements not specified by the customer butnecessaryforspecifiedorintendeduse;

(c) Statutory and regulatory requirements related totheproduct;and

(d) Any additional requirements determined by theorganization.

Note that most of the product and service require-ments have already been determined and stated inICAOandWMOregulatorydocumentsandtherele-vantStates’AIP.

Clause7 2 2—Reviewofrequirementsrelatedtotheproduct

3.3.7.5 The organization has to review therequirements related to the product determined inClause 7.2.1 prior to committing to supply such aproducttothecustomer.Thereviewmustensurethat:(a) All requirements related to the product are

defined;(b) Anymisunderstandingsbetweentheorganization

andthecustomerareresolved;and(c) The organization has the ability to meet the

definedrequirements.

Recordsofthereviewresultsandactionarisingfromthereviewmustbekept.

3.3.7.6 The organization must confirm thecustomer requirements before acceptance, if thecustomer has not already provided a documentedstatementofrequirements.

3.3.7.7 When product requirements have beenchanged,forexampleamendmentstoAnnex3/WMOTechnicalRegulations[C.3.1],therelevantdocuments

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mustbeamendedandtherelevantpartiesmadeawareofthechanges.

Clause7 2 3—Customercommunication

3.3.7.8 Theorganizationhastoimplementeffec-tivechannelsofcommunicationwiththecustomerinrelationtoproduct information,enquiries,contractsor order handling, amendments and customer feed-backincludingcomplaints.

Clause7 3—Designanddevelopment

3.3.7.9 Designisrequiredintheproductionofanewproductorofavariationtoanexistingproduct.Clause7.3coverstherequirementsfortheorganizationtodevelopproceduresfordesignanddevelopmentofaproduct.

Clause7 3 1—Designanddevelopmentplanning

3.3.7.10 Theorganizationmustplanandcontrolthe design and development of the products andservicesitprovides.Intheplanningstage,theorgani-zationhas todeterminethevariousstages involved,thereview,verificationandvalidationappropriatetoeachstage,andtherelativeresponsibilitiesandauthor-ity. Effective communication and clear assignmentof responsibility must be ensured when managingthe interfaces between different groups involved inthe design and development process. The planningoutputhastobeappropriatelyupdatedasthedesignanddevelopmentprogresses.

Clause7 3 2—Designanddevelopmentinputs

3.3.7.11 Product requirements thatarecomplete,unambiguous and not in conflict with each otherarenecessaryforanydesign.Theorganizationhastodetermine and review these requirements as designanddevelopmentinputsandmustmaintainrecords.Theinputsincludethefollowing:(a) Functionalandperformancerequirements;(b) Applicablestatutoryandregulatoryrequirements;(c) Informationderivedfromprevioussimilardesigns,

ifapplicable;and(d) Other requirements essential to design and

development, for example cost and schedule forcompletion.

Clause7 3 3—Designanddevelopmentoutputs

3.3.7.12 Theoutputsmustgothroughanapprovalprocessbeforetheyarereleased.Theymust:(a) Meet the input requirements determined in

Clause7.3.2;(b) Provide appropriate information for the sub-

sequent product realization processes including

purchasing(Clause7.4),andproductionandserv-iceprovision(Clause7.5);

(c) Contain product acceptance criteria, or providereferencetothem;and

(d) Specifythecharacteristicsoftheproductthatareessentialforitssafeandproperuse.

Clause7 3 4—Designanddevelopmentreview

3.3.7.13 Theorganizationmust,inaccordancewiththe planned arrangements in Clause 7.3.1, performsystematicreviewstoevaluatetheabilityofthedesignanddevelopmentresults, identifyanyproblemsandproposeactions.Thereviewneedsto includeall thefunctionsaffected.Recordsof thereviewresultsandanynecessaryactionhavetobemaintained.

Clause7 3 5—Designanddevelopmentverification

3.3.7.14 The organization must, in accordancewiththeplannedarrangementsinClause7.3.1,verifythat the design and development outputs meet allthe input requirements determined in Clause 7.3.2.Recordsof theverificationresultsandanynecessaryactionhavetobemaintained.

Clause7 3 6—Designanddevelopmentvalidation

3.3.7.15 Theorganizationmust,inaccordancewiththe planned arrangements in Clause 7.3.1, performvalidationof thedesignanddevelopment toensurethat the product is capable of meeting the require-mentsforthespecifiedapplicationorintendeduse.Ifpossible,thevalidationmustbecompletedpriortothedeliveryorimplementationoftheproduct.Recordsofthevalidationresultsandanynecessaryactionshavetobemaintained.

Clause7 3 7—Controlofdesignanddevelopmentchanges

3.3.7.16 Theorganizationmustidentifyanydesignanddevelopmentchangesandhave themreviewed,verifiedandvalidated, as appropriate, andapprovedbeforeimplementation.Thereviewmustincludeeval-uationoftheeffectofthechangesontheconstituentpartsandproductalreadydelivered.Allrecordsofthedesignanddevelopmentchanges,reviewresultsandanynecessaryactionmustbemaintained.

Clause7 4—Purchasing

3.3.7.17 Clause 7.4 establishes control on thepurchasing phase during the product realizationprocesstoensuregoodqualityofpurchasedproducts.Note that the suppliers referred tounder this clauseincludebothexternalandinternalsuppliers.

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Clause7 4 1—Purchasingprocess3.3.7.18 The organization has to ensure that thepurchased product conforms to specified purchaserequirements. It must evaluate and select suppliersbased on their ability to supply product that meetsthepurchase requirements.Criteria for theselectionofsuppliershavetobeestablished.Inessence,tightercontrolmustbeappliedtothesupplieriftheeffectofthepurchasedproductonsubsequentproductrealiza-tionorfinalproductishigh.

3.3.7.19 Theorganizationhastokeeptherecordsoftheevaluationresultsandanynecessaryactionaris-ingfromtheevaluation.

Clause7 4 2—Purchasinginformation

3.3.7.20 The organization must ensure adequacyof the specified purchase requirements including,whereappropriate,thefollowing:(a) Requirements for approval of the product and

approvalofprocedures,processesandequipmentemployedbythesupplier;

(b) Requirementsforqualificationofsupplierperson-nel;and

(c) Requirementsforthesuppliertomaintainaqual-itymanagementsystem.

NOTE:While it isnot amandatory requirement for everysupplierofthemeteorologicalserviceprovidertomaintainaqualitymanagementsystem,ifthemeteorologicalserviceprovider has outsourced any of its core functions to thirdparties,itmaybeappropriateandnecessaryforthemeteoro-logicalserviceprovidertoapplythetightestcontroltothesuppliersandrequest themtomaintainaqualitymanage-mentsystem.

Clause7 4 3—Verificationofpurchasedproduct

3.3.7.21 The organization must establish andimplement the inspection or other verificationactivitiestoensurethepurchasedproductmeetsthespecifiedpurchaserequirements.

3.3.7.22 If verification is to be performed at thepremisesofthesupplier,theorganizationmuststatesuch a requirement in the purchasing information(Clause7.4.2)andthemethodofproductrelease.

Clause7 5—Productionandserviceprovision

Clause7 5 1—Controlofproductionandserviceprovision

3.3.7.23 Theorganizationhastocontroltheproc-essofplanningandcarryingoutproductandserviceprovision. The control must include, as applicable,thefollowing:

(a) Theavailabilityofinformationthatdescribesthecharacteristics of the product, for example tech-nical specifications in the appendices to ICAOAnnex3/WMOTechnicalRegulations[C.3.1];

(b) The availability of work instructions, i.e. opera-tionsproceduresandmanuals;

(c) Theuseofsuitableequipmentsuchascomputers,communicationandofficeequipment;

(d) The availability and use of monitoring andmeasuring devices such as pressure sensors andtransmissometers;

(e) Theimplementationofmonitoringandmeasure-ment;and

(f) Theimplementationofrelease,deliveryandpost-deliveryactivities.

Clause7 5 2—Validationofprocessesforproductionandserviceprovision

3.3.7.24 Deficienciesinaproductorservicesome-times do not become apparent until after delivery.Forexample, theaccuracyof forecastsandwarningscannotbeverifieduntiltheyhavebeendeliveredtothecustomer. This clause requires that the organizationmust validate the production and service provisionprocessesforsuchproductsandservices.Thevalida-tion must be able to demonstrate the ability of theprocessestoachievetheplannedresults.Regulareval-uationof thequalityof aerodrome forecasts againsttheoperationallydesirableaccuracyoftheStandardsascontainedinAttachmentBofICAOAnnex3/WMOTechnical Regulations [C.3.1] is an example of suchvalidation.

3.3.7.25 The organization has to make arrange-mentsfortheprocessesthatinclude,asapplicable,thefollowing:(a) Defined criteria for review and approval of the

processes;(b) Approvalofequipmentandqualificationofpersonnel;(c) Useofspecificmethodsandprocedures;(d) Requirementsforrecords;and(e) Revalidation.

Clause7 5 3—Identificationandtraceability

3.3.7.26 The organization must identify theproduct by suitable means throughout the productrealization. For example, aTAF, the identificationofthetypeofforecast(forexampleTAF AMD),locationindicatorof the aerodrome, and timeof issuanceofforecasts, must be provided. The organization mustalsoidentifytheproductstatuswithrespecttomoni-toring and measurement requirements, for examplesigninghardcopyreportsorchartsshowingthattheyhavebeeninspectedorverified.

3.3.7.27 Ifitisarequirementthataproductmustbetraceabletoitsorigin,theorganizationmustcontrol

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andrecordtheunique identificationof theproduct.Thistraceabilityrequirementisamustforvirtuallyalltheproductsprovidedby themeteorological serviceproviders, forexample the identificationof the typeofproduct(TAF,METAR,etc.), locationindicatorandtimeofissuance.

Clause7 5 4—Customerproperty

3.3.7.28 Duringthecourseofproductrealization,customer properties, which can include intellectualproperties such as specifications, computer softwareor proprietary information, may sometimes be usedbytheorganization.Theorganizationmustidentify,verify, protect and safeguard such properties. In theevent that customer properties are lost, damaged orotherwise unsuitable for use, the organization mustreporttothecustomersconcernedandkeeptherele-vantrecords.

Clause7 5 5—Preservationofproduct

3.3.7.29 The organization must preserve theconformity of product and constituent parts of theproductduringinternalprocessinganddeliverytothedestination.Thepreservationincludesidentification,handling,packaging,storageandprotection.

3.3.7.30 Itisimportantforaviationsafetythattheobservations,forecastsandwarningsshouldbeissuedto the customer in accordance with the appropriatetemplatesincludedinICAOAnnex3/WMOTechnicalRegulations[C.3.1].Theyshouldalsobeintheappro-priateWMOcodeformat,orinaformatagreedwithlocalcustomers.Itisalsoimportanttoensurethatthemessagereceivedisthesameasthatoriginallyissued.Where facilitiesareprovided toenablecustomers tointerrogateacentraldatabaseforobtainingproductsprovidedby themeteorological serviceprovider, theavailabilityofthelatestproductsinthecorrectformatshouldbeensured.WhereproductsareprovidedviatheInternet,itisimperativetoadvisecustomersthattheymustensurethattheyareaccessingcurrentprod-uctpages,andnotcachedproductpagesthatmaybeoutofdate.

Clause7 6—Controlofmonitoringandmeasuringequipment

3.3.7.31 Thisclauserequiresthattheorganizationdeterminethemonitoringandmeasurement,andtheassociatedequipment,neededtoprovideevidenceofconformity of product to the product requirementsdetermined in Clause 7.2.1. Meteorological instru-ments such as dry- and wet-bulb thermometers,barometers, anemometers, transmissometers andscatterometersrequiredfortakingobservationsattheaerodromeare examplesofmonitoringandmeasur-ingdevices.

3.3.7.32 The organization has to establish proc-esses to ensure that monitoring and measurementcanbecarriedoutasplannedandinamannerthatisconsistentwith themonitoringandmeasurementrequirements.

3.3.7.33 Themeasuringdevicesmustbe:(a) Calibratedorverifiedatspecifiedintervals,orprior

to use, against measurement standards traceableto internationalornationalmeasurementstand-ards;wherenosuchstandardsexist,thebasisusedforcalibrationorverificationmustberecorded;

(b) Adjusted or readjusted as necessary, but at thesame time safeguarded from adjustments thatwouldinvalidatethemeasurements;

(c) Identified, enabling the calibration status to bedetermined;and

(d) Protected fromdamageanddeteriorationduringhandling,maintenanceandstorage.

3.3.7.34 Theorganizationmust record andmain-taintheresultsofcalibrationandverification.Whentheequipment is foundnottoconformtorequirements,theorganizationhastoassessandrecordthevalidityofpreviousmeasuringresults,andtakeappropriateactionontheequipmentandtheproductsaffected.

3.3.7.35 Priortoinitialuseofanycomputersoft-wareinthemonitoringandmeasurementofspecifiedrequirements,theorganizationmustconfirmtheabil-ityof thecomputer software to satisfy the intendedapplication.AnexampleofsuchcomputersoftwareisaprogramusedbyameteorologicalserviceproviderforcheckingerrorsincodingTAFsbeforedispatch.

3.3.8 CLAUSE8–MEASUREMENT,ANALYSISANDIMPROVEMENT

3.3.8.1 Clause 8 addresses requirements formonitoring and measuring the effectiveness of thequalitymanagementsystemoftheorganization,andconformity of its products, and continual improve-mentofthequalitymanagementsystem.

Clause8 1—General

3.3.8.2 This clause requires the organization toplan and implement the monitoring, measurement,analysis and improvementprocesses todemonstrateconformity of its quality management system andproducts, and to continually improve the effective-nessofthesystem.

3.3.8.3 The organization has to determine theappropriatemethodstobeused,suchas:(a) Theconductandanalysisofcustomersatisfaction

surveys;(b) Countingthenumberofretardmessagesissued;and(c) Evaluationofsupplierperformancerecords.

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3.3.8.4 Suitablestatisticaltechniquessuchas:(a) Trendanalysis,and(b) Samplingandstatisticalprocesscontrol,can be applied to identify the variations, irregulari-tiesornonconformitiesintheprocesses,productsandservices.

Clause8 2—Monitoringandmeasurement

Clause8 2 1—Customersatisfaction

3.3.8.5 Itisaspecificrequirementthattheorganiza-tionmonitorcustomersatisfaction.Theorganizationhastodeterminehowthisinformationcanbecollected,suchas:(a) Throughtheconductofcustomersurveys;(b) Customercomplaintrecords;or(c) Regularliaisonmeetingswithcustomers.

Theinformationcollectedwillbeusedtoimprovethequalitymanagementsystem.

Clause8 2 2—Internalaudit

3.3.8.6 The organization is also required toconduct internal audits at planned intervals, typi-cally at 6- or 12-month intervals between visits byregisteredauditors,todeterminewhetherthequalitymanagement system conforms to various require-ments stipulated in ISO9001:2008andwhether thesystemhasbeeneffectivelyimplemented.

3.3.8.7 A documented procedure has to beestablishedtodefinetheresponsibilitiesandrequire-ments for planning and conducting the audits, inparticular:(a) Thescope;(b) Frequencyandmethodstobeused;and(c) Reportingtheresultsandmaintainingrecords.

Auditors selected must not be responsible for theproduct or processes being audited. For example, aforecastercouldnotbeassignedastheinternalaudi-tortoaudittheforecastprocess.

3.3.8.8 The manager responsible must ensurethat,followingeachaudit,promptactionistakensothat any nonconformities detected and their causesarerectified.Verificationoftheactiontakenmustbeconductedandtheresultsreported.

3.3.8.9 More information on the conduct ofinternalauditsisgiveninChapter5.

Clause8 2 3—Monitoringandmeasurementofprocesses

3.3.8.10 Thequalitymanagementsystemprocessesmustbemonitored,andwhereapplicable,measured

todemonstratetheabilityoftheprocessestoachievetheplannedresults, inparticular, theassurancethatnononconformingproductwillbeproduced.Internalauditisonewaytomonitorandmeasuretheprocesses.There aremanyothermethods that canbeapplied,such as the use of suitable statistical techniques, orregular verification against the prescribed objectivesoftheprocesses.

3.3.8.11 It is essential that, when the plannedresultsarenotachieved,appropriatecorrectiveactionistakentoensureconformityoftheproduct.

Clause8 2 4—Monitoringandmeasurementofproduct

3.3.8.12 By the same token, the quality of theproductshastobemonitoredandmeasured,atappro-priatestagesduringtheproductrealizationprocess,toverifythattheymeettheproductrequirements.Itisrequiredthatevidenceofconformitywiththeaccept-ancecriteriabemaintainedandthatrecordsindicatethepersonnelresponsibleforthereleaseoftheprod-uct. For example, implementation of automaticquality checking routines, along with the require-ment to sign the TAF issued by the duty forecastersafter a satisfactory product checking, are consideredevidenceofproductconformity.

NOTE:Intheeventthatthequalityofaproductcannotbemonitoredandmeasuredbeforedelivery,Clause7.5.2ofISO9001:2008 then applies, such that the process for produc-tionprovisionmustbevalidatedtodemonstrateitsabilitytoproducetheplannedresults(see3.3.7.23).

3.3.8.13 Aproductmustnotbereleasedtocustom-ersbeforethesatisfactorycompletionofallplannedarrangements from the planning of product realiza-tionprocess(Clause7.1).Exceptionisallowedunderextraordinary situations, that is, when the relevantauthority within the organization authorizes thereleaseoftheproductand,whereapplicable,upontheapprovalofthecustomers.

Clause8 3—Controlofnonconformingproduct

3.3.8.14 Nonconforming products have to beidentifiedandcontrolledtopreventthemfrombeinginadvertently released.Theorganizationmustestab-lish a documented procedure detailing the control,associated responsibilities and authority for dealingwiththosenonconformingproducts.

3.3.8.15 Nonconformingproductsmustbehandledinoneofthefollowingways:(a) Reworked to eliminate the nonconformity

detected, followed by reverification to demon-strateconformance;

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(b) Isolationorscrappingofthenonconformingprod-ucts;or

(c) Theirreleaseauthorizedbytherelevantauthorityand,whereapplicable,upontheapprovalof thecustomers.

3.3.8.16 In the event that nonconforming prod-uctsaredetectedafterdelivery, theorganizationhasto take appropriate action regarding the effects, orpotential effects,of thenonconformity, forexampleissuanceofcorrectionmessages.

3.3.8.17 Theorganizationhastomaintainrecordsofthenatureofthenonconformitiesandthesubse-quentactionstaken(3.3.8.15refers).

Clause8 4—Analysisofdata

3.3.8.18 Theorganizationmustdetermine,collectandanalyseappropriatedatatodemonstratethesuit-ability and effectivenessof thequalitymanagementsystem,andtoevaluatetheopportunitiesforcontin-ual improvement of system effectiveness. The datacanbegeneratedbythemonitoringandmeasurementprocessesconductedbytheorganization(Clause8.2)or from other relevant sources, both internal andexternal,forexampleevaluationofsupplierperform-anceandauditreports.

3.3.8.19 Information relating to the followingmustbeprovidedthroughtheanalysisofdata:(a) Customersatisfaction;(b) Conformitytoproductrequirements;(c) Characteristicsandtrendsofprocessesandprod-

uctsincludingopportunitiesforpreventiveaction;and

(d) Performanceofsuppliers.

Clause8 5—Improvement

Clause8 5 1—Continualimprovement

3.3.8.20 This requires the organization to seekcontinual improvement to the effectiveness of thequality management system through the use of thefollowing:(a) Qualitypolicy(Clause5.3);

(b) Qualityobjectives(Clause5.4.1);(c) Auditresults,includingthosefrombothinternal

(Clause8.2.2)andexternalaudits;(d) Analysisofdata(Clause8.4);(e) Corrective and preventive action (Clauses 8.5.2

and8.5.3);and(f) Managementreview(Clause5.6).

Clause8 5 2—Correctiveaction

3.3.8.21 The organization has to take correctiveaction to prevent recurrence of detected noncon-formities. ISOdefinescorrectiveactionas“actiontoeliminate the cause of a detected nonconformity orother undesirable situation” (ISO 9000:2005, Clause3.6.5).Theorganizationmustdevelopadocumentedproceduretodefinerequirementsforthefollowing:(a) Reviewingnonconformitiesanddeterminingtheir

cause;(b) Evaluatingtheneedforacorrectiveaction;(c) Determiningandimplementingactionneeded;(d) Recordingtheresultsofactiontaken;and(e) Reviewingcorrectiveactiontaken.

Clause8 5 3—Preventiveaction

3.3.8.22 The organization has to determine thepreventiveactionneededtopreventtheactualoccur-rence of potential nonconformities. ISO definespreventive action as “action to eliminate the causeof a potential nonconformity or other undesirablepotential situation” (ISO 9000:2005, Clause 3.6.4).Potential nonconformities can be revealed in vari-ousways,suchasoutputs frommanagementreview(Clause 5.6), outputs from analysis of data (Clause8.4),reviewofcustomerneedsandexpectations,andriskanalysis.

3.3.8.23 Again the organization must develop adocumentedproceduretodefinetherequirementsforthefollowing:(a) Identifying potential nonconformities and their

cause;(b) Evaluatingtheneedforapreventiveaction;(c) Determiningandimplementingactionneeded;(d) Recordingtheresultsofactiontaken;and(e) Reviewingpreventiveactiontaken.

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4.1 STRUCTURE OF QUALITY MANAGEMENT SYSTEM DOCUMENTATION

4.1.1 TheISO9000seriesofstandardsrequiresthat the quality management system be properlydocumented. In addition to describing the qual-ity management system, the documentation alsocommunicatestothestafftheirroleintheorganiza-tion,theexpectationsoftheirworkperformance,andat the same timeprovidesabasis for evaluating theeffectiveness and continuing suitability of the qual-ity management system. The documentation in thequalitymanagementsystemisconstructedinahierar-chicalformasshowninFigure4-1.

4.1.2 Level1documentationdefines theprin-ciples and approaches of the meteorological serviceprovider to quality-related issues. It consists of thequalitymanual, thequalitypolicyandobjectivesoftheorganization.

4.1.3 Level2documentationconsistsofproce-dures by which the meteorological service providermanagesthequalitymanagementsystem.Itcorrespondsto the processes described in Clauses 4 through 8of ISO 9001:2008. Note that while ISO 9001:2008

explicitly requires a minimum of six documentedproceduresrespectivelyonthefollowing:— controlofdocuments(Clause4.2.3)— controlofrecords(Clause4.2.4)— internalaudit(Clause8.2.2)— controlofnonconformingproduct(Clause8.3)— correctiveaction(Clause8.5.2)and— preventiveaction(Clause8.5.3),the meteorological service provider may need todocumentadditionalprocessestoensuretheeffectiveoperationandcontrolofsuchprocesses.

4.1.4 Level3documentationprovidesdetailedinstructions, in the form of work instructions orproceduremanuals,whichthestaffneedtofollowincarryingoutspecificoperationalactivities.

4.1.5 Level4documentationconsistsofallformsand records that serve as the objective evidence ofconformitytorequirementsandoftheeffectiveoperationof the quality management system. Records explicitlyrequiredbyISO9001:2008arelistedinAppendix1.

4.1.6 In essence, the quality managementsystemdocumentationusuallyincludesthefollowing:(a) Quality policy and objectives — an explicit

requirement;

CHAPTER 4

QUALITY MANAGEMENT SYSTEM DOCUMENTATION

Figure4-1 Hierarchyofqualitymanagementsystemdocumentation

Qualitymanual

Quality managementsystem procedures

Work instructions/operational procedures

Forms and records

Contents of documents

Level 1Description of the quality managementsystem in accordance with the statedquality policy and objectives

Level 2Descriptions of the interrelated processesand activities required to implement thesystem

Level 3Detailed descriptions of how to performand record specific tasks

Level 4The organization’s records

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(b) Qualitymanual—anexplicitrequirement;(c) Documentedprocedures—anexplicitrequirement;(d) Workinstructions/operationalprocedures–implic-

itlyrequiredbyClause4.2.1ofISO9001:2008;(e) External documents — documents which can

include specifications, statutory and regulatoryrequirements,standards,codes,etc.ICAOAnnex3/WMOTechnicalRegulations [C.3.1], States’AIPsand regionalairnavigationplansalso fallunderthiscategory; implicitlyrequiredbyClause4.2.1ofISO9001:2008;

(f) Formsandrecords—anexplicitrequirement;and(g) Qualityplans—usuallyusedincomplexprojects,

products,processesorcontracts,notamandatoryrequirementinISO9001:2008.

4.1.7 ISOdefinesaqualityplanasa“documentspecifyingwhichproceduresandassociatedresourcesshallbeappliedbywhomandwhentoaspecificproject,processorcontract”(Clause3.7.5ofISO9000:2005).Itisanoutputoftheprocessforplanningofproductrealization(Clause7.1ofISO9001:2008)andcoversallthequalitypracticesandresourcestobeappliedtoaspecificproduct.Itmakesthequalityrequirementsoftheproductmorereadilyunderstandableandcanbeused todemonstratehowsuch requirementswillbemet.Sometimes,acontractmayspecifyarequire-ment forqualityplansbutotherwise it isup to themeteorological service providers to decide if qualityplansshouldbepreparedfortheirproducts.TherearenorequirementsfromISO9001:2008.

4.1.8 WhileISO9001:2008explicitlyrequiresaminimum of six documented procedures, the mete-orological service provider may need to documentadditionalprocessestoensuretheeffectiveoperationandcontrolofsuchprocesses.Forexample,althoughnot explicitly required by ISO 9001:2008, it wouldbe useful to have a documented procedure for themanagement review (Clause 5.6 of ISO 9001:2008)process, taking into account the importance of thisprocess to the effective operation of the qualitymanagementsystemandthecomplexityandpossibil-ityofdeviationfromtherequirement.

4.1.9 Workinstructionsandoperationalproce-dures are developed to describe the performance ofspecific tasks.The extent and levelofdetail dependlargely on the complexity of the tasks concerned.Instructions will be essential, the absence of whichwill lead to inconsistency of outputs, and hence adegradationofqualityof thefinalproducts or serv-ices. However, with a team of highly skilled andcompetent personnel provided with adequate train-ingand informationnecessary toperformthe tasks,thelevelofdetailoftheinstructionscanbereduced.In the context of meteorological service providers,extensive work instructions and operational proce-duresshouldnaturallybeexpectedfortherealization

ofproductsand services (i.e.meteorological reports,forecasts, warnings and briefings and consultationstousers,etc.).Wheneverappropriate,referencetotherelevantexternaldocumentscontainingtheproductrequirements,suchasICAOAnnex3/WMOTechnicalRegulations [C.3.1], States’AIPsand the regional airnavigationplans,shouldbeincorporated.

4.1.10 Ithastobenoted,however,thatthemainreasonforestablishingawrittenprocedureistoensureconsistencyoftheoutputs,regardlessofwhoperformstheprocedure.Assuch,theprocedureshouldnotbeunnecessarily complex. It shouldbemadeas simpleandcomprehensibleaspossible,as if itwerewrittenforsomeonenewtotheprocess.

4.1.11 Forms and records provide evidenceof what the meteorological service provider hasperformed and, therefore, would indicate whetherornotthequalitymanagementsystemimplementedand maintained is in conformance with ISO 9000standards.Theyshouldbekept longenoughforthepurposesofbothinternalandexternalauditsduringwhichtheyarethesubjectsofscrutiny.Ingeneral,aretentionperiodofoneyearisadequatebutalongerperiod may be required for certain records such astraining records,which shouldbe retained through-outtheemploymenthistoryofthestaffconcerned.

4.2 QUALITY MANUAL

4.2.1 Clause 4.2.2 of ISO 9001:2008 requiresthe development of a quality manual for the mete-orologicalserviceprovider.Thequalitymanualisthehome for all qualitymanagement systemdocumen-tation of the meteorological service provider fromwhich the staff or auditors could easily locate thedocumentation. The manual must include or makereferencetothequalitypolicyanddocumentedqual-ityproceduresofthemeteorologicalserviceproviderandprovideadescriptionofinteractionbetweenthequalitymanagementsystemprocesses.

4.2.2 The manual has to address all applic-ableclausesofISO9001.OnewaytoembarkonthepreparationofthequalitymanualistoadapttheISOclauses by replacing every reference to phrases suchas“theorganizationshall...”with“wewill...”,andforclarification supplement them with additional textspecific to the meteorological service provider. Thecombinedstatements thenbecomethemeteorologi-cal serviceprovider’sownstatements tobe includedinitsqualitymanual.

4.2.3 Typical elements of a quality manualconsistofthefollowing:(a) Titleandscope—themanualshouldmakerefer-

ence to the specific quality management system

21

Chapter4—Qualitymanagementsystemdocumentation

standard (i.e. ISO 9001) on which the qualitymanagementsystemisbased;

(b) Tableofcontents;(c) Review,approvalandrevision—evidenceofthe

review, approval, revision status anddateof thequalitymanualshouldbeclearlystated;

(d) Qualitypolicyandobjectives—canbeseparatelydocumentedbut referenced in themanualorbeincludedinthequalitymanual;

(e) Organization, responsibility and authority — adescriptionofthestructureoftheorganizationisto be included. Organization charts, flow chartsand job descriptions may be included or refer-encedinthemanual;

(f) References—a listofdocumentsreferredtobutnotincludedinthemanual;

(g) Quality management system description —descriptions of the processes and their interac-tions, documented procedures or references tothemaretobeincluded;and

(h) Appendices—anysupportiveinformationsuchasflowchartsofprocessesandorganizationcharts.

4.3 CONTROL OF DOCUMENTS

4.3.1 ISO 9001:2008 describes what has to bedocumented in thequalitymanagement systembutit does not specify the format for the various docu-mentsorrecordsrequired.Themeteorologicalserviceprovidercanthusalignthequalitymanagementsystemdocumentationformatwiththatoftheorganization.Nevertheless, it is recommended that the meteoro-logical service providers use a consistent format forpreparing thedocumentation.Acontrol statusmustbeincludedsothatthedocumentinquestioncouldbereadilyidentifiableascurrentorobsolete,forexamplebywayofstampchopsuchas“CONTROLLEDCOPY”toproperlylabelthosecontrolledcopiesofdocumentsandtomark thoseobsoletedocuments thatneedtobe retained as “SUPERSEDED”. In general, written

documentation for the documented procedures,workinstructionsandoperationalproceduresshouldincludethefollowing:(a) Name and logo of the meteorological service

provider;(b) Title,purposeandscopeofdocument;(c) Document number, revision status and date of

issuance;(d) Reviewandapprovalsignatures;(e) Responsibilityandauthority;(f) Historyofpastamendments;and(g) Contentofdocument.

4.3.2 It should be remembered that the qual-ity management system documentation can existin any form — hard copy or electronic format. Theuseof electronicmedia, for example the intranetofthe meteorological service provider, is increasinglycommonandhasthefollowingadvantages:(a) Staff alwayshaveaccess to thecurrent copiesof

thedocuments;(b) Distributionismuchsimplifiedandefficient;(c) Access and changes can easily be made and

controlled;(d) Accessfromremotelocationsispossible,giventhe

staff have the necessary equipment to view thedocumentationatsuchlocations;and

(e) The possibility of unintended use of obsoletedocumentsiseliminated.

NOTE:Asrecordsbynaturedonotchange,normallytheyarenotunderrevisioncontrol,whichisrequiredforotherqualitymanagementsystemdocumentation.

4.4 ISO GUIDANCE

Acompletedescriptionandguidanceonhowtodocu-mentaqualitymanagementsystemcanbefoundinISO 10013:2001 – Guidelines for quality management system documentation.

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5.1 AUDIT OBJECTIVES

5.1.1 ISO defines an audit as a “systematic,independent and documented process for obtainingauditevidenceandevaluatingitobjectivelytodeter-minetheextenttowhichauditcriteriaarefulfilled”(Clause 3.9.1 of 9000:2005). The term “audit crite-ria”,accordingtothesamestandard,referstoa“setof policies, procedures or requirements” used as areference(Clause3.9.3).Ineffect,theyarethosemate-rials contained in the quality management systemdocumentation. The policies and procedures aredevelopedbythemeteorologicalserviceproviderandtherequirementsmayoriginatefromISO9001:2008,users,regulatoryandlegislativebodiesandthemete-orological service provider itself. During the audit,thecertificationbody/registrarwilltrytoverifyifthemeteorologicalserviceproviderisdoingwhatitsaysitwilldo(accordingtothequalitymanagementsystemdocumentation)andtoconfirmifthequalitymanage-mentsystemiseffectivelyimplemented.

5.1.2 While the obvious reason for the mete-orological serviceprovider toconductanaudit is toobtain or retain the ISO 9000 certification, the realimportanceofsuchauditsistoconfirmthatthequal-ity management system is effectively implementedand maintained as planned so that the benefits ofestablishingsuchasystemarerealized.

5.1.3 It is the responsibilityof theauditors toensurethattheauditsareconductedinanobjectiveandfairmanner.Themainobjectivesofanauditareasfollows:(a) To confirmconformanceof thequalitymanage-

mentsystemwithISO9001:2008;(b) Toconfirmthat thequalitymanagementsystem

hasbeenproperlyimplementedandmaintained;(c) Toconfirmthecommitmentandabilityofmanage-

menttoreviewthequalitymanagementsystemforcontinuingsuitability,adequacyandeffectiveness,andforcontinualimprovement;and

(d) To identifyopportunities to further improve thequalitymanagementsystem.

5.2 AUDIT TYPES

5.2.1 FIRST-PARTYAUDIT

First-partyauditreferstoaninternalauditconductedby,oronbehalfof,themeteorologicalserviceproviderfor compliance with the associated requirement of

ISO9001:2008 (seeChapter3,Clause8.2.2)and forother internal purposes such as staff development,preparationforcertificationauditandopportunitiesforimprovement.Itisimportanttonotethattheinternalauditorsselectedtoconducttheinternalauditsmustbeindependentofthefunctionbeingaudited.Formaltrainingonthefundamentalsofqualitymanagementsystemauditingshouldbeprovidedtotheseinternalauditorstoensurethattheyarecompetenttoperformthe audits. Results of the internal audits shouldindicate the readiness of the meteorological serviceproviderandthequalitymanagementsystemforthenextvisitofthecertificationbody/registrar.

5.2.2 SECOND-PARTYAUDIT

Second-partyauditreferstoanauditconductedbyaninterestedparty,suchasauserofthemeteorologicalservice provider or ICAO/WMO. The meteorologi-calserviceprovidermaybeauditedbyauserforthepurposeofawardingaservicecontract,orevaluatingtheperformanceofthemeteorologicalserviceprovider.

5.2.3 THIRD-PARTYAUDIT

5.2.3.1 Third-party audit refers to an auditconducted by an external, independent auditingorganization,suchasanaccreditedcertificationbody/registrar that provides certification of conformity tothe requirementsof ISO9001.The third-partyauditcould demonstrate the ability of the meteorologicalserviceprovidertoconsistentlyprovideservicesthatmeettheuserandapplicableregulatoryrequirements,thereby eliminating the need for repeating second-partyauditsconductedbyvariousinterestedparties.

5.2.3.2 Second-andthird-partyauditsarecollec-tivelyknownas“externalaudits”.

5.3 PROCESS AUDITING APPROACH

5.3.1 ISO 9000:2005 promotes the adoptionof “process approach” in implementing the qualitymanagementsystem.Consequently,incontrastwiththeauditsdescribedinpreviousversionsofISO9000that focused on procedure compliance and recordverification,theISO9000:2005auditemphasizesthepracticeofprocessauditingthatidentifiestheinputsandoutputsofthesubjectprocessanddeterminesiftheprocessiscapableofdeliveringthedesiredoutputconsistently.Ingeneral,theauditorswilllookatthefollowingaspectsoftheprocessbeingaudited:

CHAPTER 5

AUDITING PROCESSES

24


(a) Inputsandoutputsofthesubjectprocess;(b) Processactivities;(c) Processownership;(d) Qualityobjectives;(e) Continualimprovementoftheprocess;(f) Interrelationandinteractionwithotherprocesses;

and(g) Theriskstotheprocess.

5.3.2 Auditors will spend much time goingthroughtheprocessflowdiagramsandtheassociatedprocedureswhenauditingaprocess.Theywilltrytomakecertainthatthemeteorologicalserviceprovideris meticulous in following the published proceduresandincontrollingtheprocess.Thisiswhytheproce-dures should be designed and maintained as simpleas possible while still ensuring consistency of theoutputs.

5.4 CERTIFICATION/REGISTRATION AUDIT

5.4.1 The certification/registration audit is athird-party audit and is conducted by an accreditedcertification body/registrar engaged by the meteoro-logicalserviceprovider.Uponsatisfactorycompletionof the certification/registration audit, the qualitymanagement system of the meteorological serviceproviderbecomescertified/registeredtoISO9000.

5.4.2 Theauditteamofthecertificationbody/registrar is composed of a lead auditor, who takesthe leadingrole intheaudit teamtocoordinatetheaudit and to handle the main communication withthemeteorologicalserviceprovider,andoneormoreauditorsdependingonthesizeandscopeofthequal-ity management system being audited. Technicalexperts,andinparticularinthemeteorologicalfield,maybe employedby the certificationbody/registrartoassist indealingwithtechnicalmatters relatedtometeorologyduringtheaudit.

5.4.3 The certification/registration audit typi-cally consists of two phases. In the first phase, theauditors conduct an audit, usually off-site, of thequality management system documentation includ-ing, among others, the quality manual, externaldocumentsthatcontaininformationonusersofthemeteorological service provider, applicable statutoryand regulatory requirements, and records such asreports of internal audits and management reviews.By examining the documentation, the auditors willdetermine the adequacy of the documentation forthequalitymanagementsystem.Thisprocessiscalled“documentreview”or“adequacyaudit”.

5.4.4 The second phase of the certification/registrationauditreferstotheactualon-siteauditof

the quality management system. It will be arrangedafter the auditors are satisfied with the documentreview/adequacy audit process. The auditors willconduct the audit following the process auditingapproach (see 5.3). During the audit, the auditorswill collect objective evidence by interviewing theemployees of the meteorological service providerand observing their work. They will sometimes asktoinspectcertaindocuments,samplesofproductsortherecordsmaintainedbythemeteorologicalserviceprovider.

5.4.5 Attheendofthelastauditday,theaudi-tors will conduct a closed meeting and report theirfindings to the management of the meteorologicalservice provider. The auditors should advise of anynonconformityidentifiedinthequalitymanagementsystem during the audit. All such nonconformitiesmust be corrected within a certain time period asagreed between the certification body/registrar andthemeteorologicalserviceprovider.Thecertificationbody/registrar may again conduct a full or partialaudit to confirm that proper corrective action hasbeen taken before the certificate of registration canbe issued. An explanation of the types of differentnonconformitiesandthecorrectiveactionprocess isprovidedinChapter6.

5.4.6 Anoptionalpreliminaryassessmentvisitby the auditors may sometimes be arranged beforetheconductofthesecondphaseofthecertification/registration audit. The purpose of this preliminaryassessmentistoallowtheidentificationandclosingofany significant discrepancies in the implementationofthequalitymanagementsystembeforetheactualauditiscarriedout.ThispreliminaryassessmentcouldbeveryusefultothemeteorologicalserviceproviderespeciallyifithasnothadtheassistanceofconsultantsorexperiencedISO9000auditorsintheimplementa-tionprocessofthequalitymanagementsystem.

5.4.7 Theamountoftheauditor’stimerequiredontheinitialcertification/registration,thatis,theveryfirst formal on-site certification/registration audit,is largely dependent on the number of employeeswithinthescopeofthequalitymanagementsystem.Forexample,itwillnormallytakethreeauditordaystocompletetheinitialcertification/registrationauditofameteorologicalserviceproviderwith20employees.

5.4.8 The various steps of the certification/registrationauditaresummarizedinFigure5-1.

5.5 SURVEILLANCE

5.5.1 Certification/registration is only thebeginning.Aftercertification/registration,thecertifi-cationbody/registrarwillconductsurveillanceaudits

25

Chapter5—Auditingprocesses

Figure5-1 Stepsofcertification/registrationaudit

Engage certificationbody/registrar

Document review/adequacy audit by

auditors

Preliminary on-siteassessment by

auditors

Meteorologicalservice provider

correctsnonconformities

Yes

Yes

Yes

Formal on-sitecertification/

registration audit

Nonconformitiesidentified?

Majornonconformities

identified?

Meteorological serviceprovider ready for

certification/registration

Multiple minornonconformities

identified inhibitingcertification/registration?

No

Meteorological serviceprovider correctsnonconformities

No

No

Award ofcertification/registration

Optional

26


regularly to confirm the continued conformance ofthequalitymanagementsystemwithISO9000.Theauditors will follow the same general steps as thecertification/registrationaudittoconductthesurveil-lanceaudits.Theywillalsopayparticularattentiontothe effectivenessof thequalitymanagement systemwithregardtoachievingtheorganization’sobjectives,changesandimprovementsimplementedtothequal-itymanagementsystemsincethelastvisit,areasthathave generated nonconformities and results of thecorrective actions taken by the meteorological serv-iceprovider.Theminimumfrequencyofsurveillanceauditsisonceevery12months,butsomecertificationbodies/registrarswillauditonceevery6months.

5.5.2 Thecertificationexpiresafterthreeyears.A recertification audit is required at the end of the

third year after initial certification and the wholecyclebeginsagain.As thecertification itself isnotamandatoryrequirementoftheISO9001standard,theorganizationmustdecidewhethertheISO9001qual-itymanagementsystemshouldbeimplementedasaninternal improvement instrument or as an externalbusinesstoolinmostcasesinvolvingaviationservices.

5.6 ISO GUIDANCE

ISO has published ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing,toprovideguidanceonauditorqualificationand managing audit programmes for both internaland external auditing of the quality managementsystem.

27

6.1.2 Major nonconformities inhibit certifica-tion during the certification/registration audit andcontinued certification/registration during surveil-lance audits, but minor nonconformities do notnecessarily cause the certification body/registrar towithholdcertification.

6.2 OBSERVATIONS AND POTENTIAL NONCONFORMITIES

6.2.1 Inadditiontomajorandminornoncon-formities, potential nonconformities of the qualitymanagementsystem,oralternativelytermedas“obser-vations”bytheauditors,mayalsobeidentified.Thesepotential nonconformities or observations representanomalies, intheabsenceofevidencetosupportanactual nonconformity, in the quality managementsystemthatmayimpairtheeffectivenessorconform-anceofthesystem.

6.2.2 Observations or potential nonconformi-ties have a low impact on the effectiveness of thequality management system. However, they maydevelop into actual nonconformities if appropriateactionisnottakentocorrectthem.

6.3 CORRECTIVE ACTION PROCESS

6.3.1 Theauditorswillcompileanonconform-ance report when a major/minor nonconformityis discovered. A corrective action request form willalsohavetobecompletedtodocumentthenoncon-formity.Themeteorologicalserviceproviderandtheauditorsshouldagreetoaformalscheduletocompletethecorrectiveactionfortheidentifiednonconformi-ties.Acorrectiveactionrequestcannotbeconsideredcloseduntilthesatisfactorycompletionoftheplannedcorrective actionand the leadauditor (leaderof theaudit team)has signedoff to indicate thathasbeendone.

6.3.2 In general each nonconformity will gothroughthefollowingstages:(a) Anauditoridentifiesanonconformity;(b) Theauditorcompletesanonconformancereport

andacorrectiveactionrequestform;(c) Findings are presented to and agreed with the

auditee(themeteorologicalserviceprovider);(d) The target date for the nonconformity to be

addressedisagreed;

CHAPTER 6

NONCONFORMANCE REPORTS AND CORRECTIVE ACTION

1DifferencesbetweennationalpracticesofthemeteorologicalserviceproviderandtheStandardscontainedinICAOAnnex3/WMO Technical Regulations [C.3.1] will not be reported asnonconformitiesbytheauditorsprovidedthatthedifferencesaredulynotifiedto ICAO/WMOandnoairnavigationdefi-cienciesareraisedinconnectionwithsuchdifferencesbyusers.However,anairnavigationdeficiencyforanynon-compliancewithICAOAnnex3/WMOTechnicalRegulations[C.3.1]orairnavigationplansrepresentspersistentfailuresofthemeteoro-logicalserviceprovidertomeetcertainstatedrequirements.Itindicatestheexistenceofamajornonconformityinthequal-itymanagementsystem.

6.1 TYPES OF NONCONFORMITY — MAJOR AND MINOR NONCONFORMITIES

6.1.1 The monitoring and measuring of thesystem processes may reveal nonconformities1 ofthe quality management system (Clause 8.2 of ISO9001:2008).Theymayalsoberevealedduringthecerti-fication/registrationprocessbytheexternalauditors,orbysubsequentsurveillanceaudits.Nonconformitiesare material non-fulfilment of a quality manage-mentsystemrequirementthatincludestheISO9001requirements,standardssetoutinrelevantICAOandWMOregulatorydocuments,andanyotherapplica-blestatutoryandregulatoryrequirements.Twolevelsofnonconformitiesaredefined,asfollows:

(a) Minornonconformity; Asinglelapseinimplementingaqualitymanage-

ment system requirement is seenas ananomalyratherthanasystematicissue,forexamplethecopyof ICAO Annex 3/WMO Technical Regulations[C.3.1] kept at the forecaster’s bench has notbeen updated to the latest edition. This is non-compliantwithClause4.2.3(g)ofISO9001:2008concerningthecontrolofdocuments.

(b) Majornonconformity; AfailuretofulfilanyrequirementofISO9001or

theidentificationofmultipleminornonconform-ities sufficient for the auditors to conclude thatthequalitymanagementsystemisnoteffectivelyimplemented, for example management reviewsas required by Clause 5.6 of ISO 9001:2008 toensure the continuing suitability, adequacy andeffectiveness of the quality management systemhaveneverbeenperformed.

28


(e) The meteorological service provider determinesthe appropriate corrective action based on thecauseofthenonconformity;

(f) The meteorological service provider takes thecorrective action and verifies if it is effective.Repeatstep(e)ifitisnot;

(g) Theauditorverifiestheeffectivenessofthecorrec-tiveactiontakenduringthenextauditorvisitorby evaluating the evidence or written responsesubmittedbythemeteorologicalserviceprovider;

(h) Repeatsteps(d)to(g)iftheauditorisnotsatisfied;(i) The lead auditor signs off the corrective action

requestformandthecaseisformallyclosed.

6.3.3 The meteorological service providershould ensure that prompt action is also takenagainst any nonconformities/potential noncon-formities identified through the monitoring andmeasuringofthequalitymanagementsystemproc-esses. ISO 9001:2008 requires that a documentedprocedure be established on corrective action andpreventive action respectively (Clauses 8.5.2 and8.5.3 of ISO 9001:2008). The meteorological serv-ice provider should follow these procedures toeliminate the causes of the internally identifiedor potential nonconformities in an expeditiousmanner.

29

7.1 STEPS TO CERTIFICATION

Thereareanumberof steps that themeteorologicalserviceproviderwillgothroughinthedevelopmentandimplementationofaqualitymanagementsystem,and ultimately taking the system to certification.Thesestepstypicallyincludethefollowing:

(a) Commitmentfromtopmanagement; It is of foremost importance to obtain a formal

andstrongcommitmentfromthehighestlevelofmanagementasithastoallocateallthenecessaryresources required by the quality managementsystem.

(b) Settingupofaprojectteam; Thisinvolvestheappointmentofaprojectteam

leader who will eventually become the manage-ment representative in the quality managementsystem.Theworkof theproject teamshouldbedirected by the Chief Executive or Director ofthemeteorologicalserviceprovider,orasteeringcommittee chaired by senior management. As astarting point, the project team will prepare thebudget estimate and seek financial commitmentfromtopmanagement.

(c) Engagementofaconsultant; Additionalcostswillbeincurredforengagingan

externalconsultantbuttheconsultantwillguidethe meteorological service provider throughoutthe implementation process. In particular, theconsultant will assist in the preparation of thequality management system documentation toensurethateveryrequirementofISO9001isprop-erly addressed. Alternatively, the developmentof the quality management system can be donetotallyin-house.Tothisend,seniorstaffwhoarefamiliarwiththeoperationofthemeteorologicalservice provider can be provided with intensivetrainingintheISO9000seriesofstandards.TheywouldthentakeuptheassignmentastheinternalconsultantsinhelpingthemeteorologicalserviceprovidertoachieveISO9000certification.Itmaybe possible for such capacity-building trainingcoursestobeorganizedcentrallyoronaregionalbasistomakethemmorecost-effective.

(d) Processandgapanalysis; The existing key business and quality processes

of the meteorological service provider will beidentified and documented (see 7.3). This is tobe followedbyanobjectiveassessmentonthese

processes, to determine what needs to be doneto close the gap and meet the requirements ofISO9001.

(e) Formaltraining; This shouldbeprovided to the entireworkforce

of themeteorological serviceprovideror sectionseekingISO9000certification.Itisanintegralpartof thequalitymanagementsystem.Thetrainingshouldincludethefollowing:— Basicawarenesstrainingforallstafftoincrease

their awareness about the quality manage-mentsystem;

— Documentation writing for staff who areresponsible for thepreparationofdocumen-tationrequiredbyISO9001;and

— Internalauditor training for staff selected toconducttheinternalaudits.

(f) Documentation; Thequalitypolicyandobjectives,qualitymanual,

documented procedures for various processes asappropriateandqualityrecordswillbedevelopedand communicated to all staff. Details on thedocumentationrequiredbyISO9001:2008canbefoundinChapter4.

(g) Formal implementation of the quality manage-mentsystem;

This includes the formal application of qual-ityprocedures,deploymentofquality functions,monitoring andmeasurementof the results andinitiation of the improvement actions, that istheactivationofthePlan–Do–Check–Act(PDCA)cycle(seeChapter2,2.6.2).

(h) Internalaudit; Trained internal auditors must conduct one or

more internal audits before certification. Theinternalauditswillidentifyanynonconformityinthequalitymanagementsystemandofferoppor-tunities for further improvement of the system.Proper corrective and preventive action shouldbe taken against the nonconformities/potentialnonconformities identified during the internalaudits.

(i) Certification/registrationaudit; The successful completion of the above steps

would indicate that the meteorological serviceprovider is ready to proceed with the certifica-tion/registrationaudit.Normallythecertificationbodies/registrars will request that the quality

CHAPTER 7

STEPS TO CERTIFICATION AND OTHER PRACTICAL ISSUES

30


managementsystemberunningforatleastthreemonthsbeforetheyareconvincedthatthesystemhas been implemented successfully and is readyfor the certification/registration audit. Detaileddescriptions of a certification/registration auditareprovidedinChapter5,5.4.

7.2 TIME AND COST CONSIDERATIONS

7.2.1 Withtheassistanceofoutsideconsultants,thewholeprocess from implementation tocertifica-tion would typically take from 12 to 18 months tocomplete. Should the implementationbeperformedtotallyin-house,thecompletionperiodmayneedtobe prolonged as the internal consultants appointedmayworkonlypart-time.Theperiodactuallyrequireddoesvaryconsiderablyandisdependentonthescopeand complexity of the quality management systemtobeimplementedandwhetherornotsomeformofquality management practices and/or procedures isalreadyinplace.

7.2.2 In general, the costs involved in theimplementationandcertificationofaqualitymanage-mentsystemshouldincludethefollowing:(a) Wagesforqualityfunctionpersonnel;(b) Consultancy;(c) Training;(d) Internalaudits;(e) Certification/registration audit and certification

cost;and(f) Incentivestostaff,ifany.

7.2.3 Any costs associated with the imple-mentation of the quality management system forthe meteorological service provider can be subjectto cost recovery following the ICAO Manual on Air Navigation Services Economics(Doc9161),specificallyparagraphs 6.16 and 6.18, and Appendix 3 —Guidance fordetermining the costsof aeronauticalmeteorological services, and the WMO Guide on Aeronautical Meteorological Services Cost Recovery(WMO-No.904).

7.3 PROCESS ANALYSIS FOR THE METEOROLOGICAL SERVICE PROVIDER

7.3.1 To embark on the analysis and docu-mentation of the processes needed by the qualitymanagement system of the meteorological serviceprovider, it is convenient to start from the process-basedqualitymanagementsystemmodelintroducedin ISO 9001:2008 (see Figure 3-1). The model basi-cally covers all the requirements of ISO 9001:2008,however,itonlyshowsthemajorprocessesandtheirlinkagesatthehighestlevel,namelythefollowing:

(a) Respectiveprocessformanagementresponsibility(Clause5ofISO9001:2008);

(b) Resourcemanagement(Clause6ofISO9001:2008);(c) Product realization (Clause7of ISO9001:2008);

and(d) Measurement,analysisandimprovement(Clause8

ofISO9001:2008).

The meteorological service provider needs to iden-tifyanddescribethesubprocessesandtheirsequenceandinteraction,forexampleintheformofaseriesofprocessflowdiagrams,sothatpropercontrolcanbeplacedoneachoftheprocesses.

7.3.2 Itisimportanttorememberthatthereisnoneedtocontroleveryactivity.Itwouldbeadequateto only focus on and develop procedures for thoseactivities thathave an impacton thequalityof theproductsandservicesprovidedtotheusers.Typically,managementreviewandprovisionoftrainingshouldbe the key process of management responsibilityand resource management respectively. The existingoperationalactivitiesorprocessesofthemeteorologi-calserviceproviderwouldnaturallycombinetoformthe product realization process. The key processesinvolvedandtheirinteractionunderproductrealiza-tionforatypicalmeteorologicalserviceprovidermaybesimilartothatdescribedinFigure7-1.

7.3.3 ToaddresstherequirementssetoutinISO9001:2008, themeasurement,analysisand improve-mentprocessmay,asaminimum,besubdividedintotheprocessofinternalaudit,theprocessofcustomersatisfaction,productsandprocessesmonitoring,andalsotheprocessofanalysisofdata.Forthelastmajorblockofcontinual improvement, twokeyprocesses,namely the corrective action and the preventiveaction, are explicitly required by ISO 9001:2008(Clauses8.5.2and8.5.3).

7.4 PERFORMANCE INDICATORS FOR METEOROLOGICAL PRODUCTS AND SERVICES

7.4.1 It is required by ISO 9001:2008 thatperformance of the quality management system bemeasured (Clause 8.1). In particular, informationon customer satisfaction has to be monitored bythe meteorological service provider (Clause 8.2.1).Measurements are extended to the monitoring andmeasurement of the products and also the qualitymanagement system processes (Clauses 8.2.3 and8.2.4).

7.4.2 The measurements are to be comparedagainst the prescribed quality objectives. The qual-ityobjectives,asdeterminedbymanagement,shouldbemeasurableandconsistentwiththequalitypolicy

31

Chapter7—Stepstocertificationandotherpracticalissues

(Clause 5.4.1 of ISO 9001:2008). The performanceindicators that are of particularly relevance to themeteorologicalserviceproviderareasfollows:(a) Satisfactionrateofairline/aircrewcustomers;(b) Timely implementation of new/modified ICAO/

WMOstandards;(c) Numberofcorrectedorretardmessagesissued;(d) Timely issuance of flight documents to airline

operators;(e) Timelypreparationofroutinereports;and(f) Accuracyofforecastsissued.

7.5 INTERFACING ASPECTS WITH EXTERNAL SYSTEMS

7.5.1 Meteorological service providers rely ontheproductsprovidedbyanumberofsuppliersexter-naltothequalitymanagementsystemintheprovisionof weather services for international air navigation.Theseexternalsuppliersincludethefollowing:— The twoworldarea forecast centres (WAFCs) for

supply of global forecasts of upper winds andtemperatures,andsignificanten-routeweatherforupperlevels;

— The nine volcanic ash advisory centres (VAACs)foradvisoryinformationontheextentandfore-castmovementofvolcanicashintheatmospherefollowingvolcaniceruptions;and

— The seven tropical cyclone advisory centres(TCACs)foradvisoryinformationontheposition,

forecast movement and intensity of tropicalcyclones.

7.5.2 These products constitute the majorsources of information required by meteorologicalservice providers in the product realization proc-essandwill thereforehaveaprofoundeffectonthequalityoftheservicesprovidedbythemeteorologicalserviceproviders.ItisinthisaspectthatClause7.4ofISO9001:2008onpurchasingprocesswillapplyandthe meteorological service providers should exercisetightcontrolontheproductsprovidedbytheseexter-nalsuppliers(inspections, follow-upactions,etc.). Itisimportantfortheseexternalsupplierstoassistthemeteorological serviceprovidersby establishingandmaintainingtheirownqualitymanagementsystems,thatshouldpreferablybeinconformitywiththeISO9000seriesofstandards.Ifthemeteorologicalserviceprovidersfailtodothis,theymayexperiencedifficul-tiesindemonstratingtotheauditorsthatthequalityof their services is assured and having their qualitymanagementsystemcertified/registered.

7.6 ISO ASSISTANCE FOR DEVELOPING COUNTRIES

ISOhasestablished the ISOCommitteeondevelop-ing country matters (DEVCO) to identify the needsand requirements of the developing countries relat-ingtostandardization.Italsoprovidesaforumforthe

Figure7-1 Keyprocessofproductrealization

Review of productrequirements

Forecasts

Warnings

Meteorologicalobservations

Flight documentation

Measurements

Input: productrequirements

Output: productsto users

32


discussionofallaspectsofstandardizationactivitiesindevelopingcountries.DEVCOalsoprovidesitsdevel-oping country members with regular informationabout courses on standardization that are availableworldwide.ISOprogrammesfordevelopingcountriesaredrawnuponathree-yearlybasisandimplemented

by DEVCO to assist these countries. The assistanceprovidedthroughtheseprogrammesincludestraining,preparation and publication of development manu-als, seminars, sponsorships/fellowships and otheractivities.FurtherdetailsabouttheprogrammescanbeobtainedfromtheISOwebsiteathttp://www.iso.org.

33

8.1 BACKGROUND

8.1.1 This case study is written based on theexperienceof theHongKongObservatory in imple-mentingaqualitymanagementsystemforitsaviationweatherserviceandobtainingtheISO9000certifica-tionofthesystem.

8.1.2 The Hong Kong Observatory, the desig-natedmeteorologicalauthorityofHongKong,China,operatestheairportmeteorologicalofficeattheHongKongInternationalAirport.Theairportmeteorologi-caloffice,withatotalof23employees,servesastheaerodrome meteorological office and aeronauticalmeteorologicalstationattheHongKongInternationalAirport, and themeteorologicalwatchoffice for theHongKongairspace.Itembarkedonqualitymanage-mentinlate2001andaqualitymanagementsysteminconformitywiththeISO9000seriesofstandardswasimplemented in early 2002. An accredited certifica-tionbodyawardedcertificationtotheISO9001:2000standardinlate2002.

8.1.3 As the Management Representative ofthe airport meteorological office has remarked, “thecertificationoftheHongKongaviationweatherserv-icedemonstratestotheaviationcommunitythattheproductsandservicesprovidedbytheairportmeteoro-logicalofficemeetthestandardsthathavecometobeexpectedinternationally.Italsoenhancesusersatisfac-tionbyassuringtotheuserthatcontinualimprovementtothesystemremainsapermanentobjective.”

8.2 QUALITY POLICY

The quality policy as endorsed by the directorate/managementoftheHongKongObservatoryis:

“Provideprofessionalmeteorologicalserviceforinter-nationalairnavigation.Aim at complying with all relevant requirements,standards and regulations and ensuing continuedenhancement of the service levels, operations andeffectivenessofthequalitymanagementsystem.”

8.3 STEPS FOLLOWED THAT LED TO THE CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM

8.3.1 Theofficer-in-chargeoftheairportmete-orological office was appointed the Management

Representative to spearhead the project. A DeputyManagement Representative was also appointedto assist the Management Representative. TheManagementRepresentativepreparedthebudgetandsoughtfinancialcommitmentfromthemanagementoftheHongKongObservatory.

8.3.2 Anexternalconsultantwascontractedtoguide the airport meteorological office through theprocessofqualitymanagementsystemimplementation.

8.3.3 Theoperationalandqualityprocessesofthe airport meteorological office were reviewed andthe disparity between these processes and the ISOrequirements were identified. Procedures were thendevelopedtoeliminatethedifferences.

8.3.4 Formal training on basic awareness toallstaff,documentationwritingtothoseinvolvedinpreparingdocumentation,andinternalaudittointer-nalauditorswereprovidedbyaconsultant.Oneofthesenior staff in the airport meteorological office wasalsonominatedtoattendtheInternationalRegisterofCertificatedAuditors(IRCA)-certifiedISO9000SeriesAuditor/LeadAuditorTrainingCourse.

8.3.5 The quality management system docu-mentation, which includes the quality policy andobjectives, quality manual, quality managementsystem procedures, operational manuals and workprocedures,formsandrecords,wasdeveloped.

8.3.6 Regular meetings were held with theconsultanttoresolveissuesrelatedtotheimplemen-tationofthequalitymanagementsystem.Thequalitymanagementsystemwasformallylaunchedfollowingasystemimplementationbriefingtoallstafftoraisetheirawarenessofthesystemthathadbeensetupfortheairportmeteorologicaloffice.

8.3.7 The quality management system wasallowedtorunforsixmonthstofamiliarizestaffwiththesystemandtoverifythatitwasimplementedandmaintainedeffectively.

8.3.8 A formal internal audit was thenperformedtodetectandremoveanynonconformitiesinthequalitymanagementsysteminpreparationfortheinitialcertificationaudit.

8.3.9 Following the formal internal audit, amockcertificationauditwasconductedbytheconsult-antasthefinalcheck.

CHAPTER 8

HONG KONG, CHINA CASE STUDY (2002)

34


8.3.10 The initial certification audit wasconductedbyanaccreditedcertificationbody,whichhadbeenselectedandappointedearlierfollowingtheformal implementation of the quality managementsystem.

8.3.11 The entire process from start to finishtookabout16monthstocomplete.Theimplementa-tiontimetablefollowedbytheairportmeteorologicalofficeisasshowninTable8-1.

8.4 DOCUMENTATION SYSTEM PUT IN PLACE

8.4.1 Level 1 documentation consists of thequality manual, quality policy and objectives. Theestablishedqualityobjectives,alongwithanoutlineoftheairportmeteorologicalofficequalitymanualaregiveninAppendix2,AandB.

8.4.2 Level 2 documentation consists of thequalitymanagementsystemproceduresdescribinghowthequalitymanagement system ismanaged.A list of the quality management system proce-dures maintained by the airport meteorologicalofficeisgiveninAppendix2,C.Anexampleoftheproceduresoncontrolofnonconformingproduct(oneofthesixmandatorydocumentedproceduresrequired by ISO 9001:2000) is also reproduced inAppendix2,D.

8.4.3 Level 3 documentationconsistsoftwosetsofdocuments.Thefirst isanoperational forecastingmanual,whichdetailstheservicesprovidedtovarioususers,namelyflightcrewmembers,airlineoperators,airtrafficservicesunits,HongKongairportauthority,search and rescue services, and overseas meteoro-logical services, etc. It also describes the equipmentandfacilitiesandforecastingtechniquesavailableforuse by the airport meteorological office staff in theprovisionofservice.Thesecondisasetofproceduremanualscontainingthedetailedworkinstructionsforeachoperationalstaffpositionintheairportmeteoro-logicaloffice,namelytheaviationforecasters,assistantaviation forecasters, weather observers and weatherserviceofficers.Anexampleoftheworkinstructionson reportingof specialobservations for theweatherobserversisgiveninAppendix2,E.

8.4.4 Level 4 documentationconsistsofallqual-ity forms and records of the quality managementsystem. As an example, the corrective/preventiveaction request formbeingusedby theairportmete-orologicalofficeisreproducedinAppendix2,F.

NOTE:ExamplesofdocumentationareincludedinAppendix2to illustrate the format required and thedesirable levelofdetailofthedocumentation.TheyrepresentasnapshotofthedocumentationofthequalitymanagementsystemtakeninDecember2004.Thedocuments are subject to changesarisingfromnewuser,statutoryorregulatoryrequirements,andthecontinualimprovementprocessofthesystem.

Stages2001 2002

J A S O N D J F M A M J J A S O

1. Engagement with an external consultant

2. Process and gap analysis

3. Formal training

4. Preparation of documentation

5. System implementation

6. Maintenance of system

7. Internal audit

8. Mock certification audit by consultant

9. Certification audit

Table8-1 ActionplanandtimetableofimplementationofqualitymanagementsystembytheHongKongObservatory

35

Chapter8—HongKong,Chinacasestudy

8.5 SPECIFIC MONITORING AND MEASUREMENT ACTIVITIES EMPLOYED

8.5.1 A user survey is conducted every yearto monitor information on user perception as towhether the airport meteorological office has metuser requirements. Liaison group meetings are heldtwice a year for face-to-face discussion with airlineoperators and pilots to listen to their suggestionsand feedback on the services provided. The liaisongroup meetings also provide a forum for consid-ering agreements on local arrangements in theprovisionoftheservicesasstipulatedinICAOAnnex3/WMOTechnicalRegulations[C.3.1].

8.5.2 Regularmeetingswithairtrafficpersonnel,andvisitstoairlinesandtotheairportmeteorologicaloffice are conducted to foster better mutual under-standing.Aworkinggroupcomprisingrepresentativesfrom the user community has also been set up todiscussissuesspecificallyrelatedtothewindshearandturbulence warning services provided by the airportmeteorologicalofficefortheHongKongInternationalAirport.

8.5.3 User suggestions and feedback areformallyrecordedandfollowedup.Formalresponsewillbegiventotheuserbeforeasuggestionorfeed-backisconsideredclosed.

8.5.4 All meteorological instruments are cali-brated regularly for traceability to international ornationalstandardsfollowingtheGuide to Meteorological Instruments and Methods of Observation(WMO-No.8).Where international or national standards are notavailable, thebasis forcalibrationwillbedefinedorsupplied by the manufacturer, for example, in thecase of the runway visual range transmissometers.Procedureshavealsobeenestablishedfortheobserv-erstochecktheofficialrecordinginstrumentsagainsttheir standbys when making observations to ensurethattheinstrumentsareworkingproperly.

8.5.5 A forecast verification system has beendevelopedtomonitortheaccuracyoftheaerodromeforecasts issued by the airport meteorological officeinaccordancewiththeICAO/WMOguidanceonthedesirable accuracy of each of the weather elements(Attachment B of ICAO Annex 3/WMO TechnicalRegulations[C.3.1]refers).

8.5.6 The technical know-how of all aviationforecastersisauditedonanannualbasisbywayofaself-auditcheckform.

8.5.7 In addition to the yearly managementreviews,anoperationandmanagementgroupcomprising

representatives from all staff grades involved in theairport meteorological office operation and systemsarealso formed.Meetingsof thegroupare regularlyheldtoidentifyareasofimprovementtotheservice.

8.5.8 Formalinternalserviceagreementslayingdownthescopeofservicetobeprovidedhavebeenestablishedwiththeinternalsupplierstoensurethatbothpartiesfullyunderstandtheirresponsibilities.

8.6 QUALITY MANAGEMENT SYSTEM COST TO THE HONG KONG OBSERVATORY

8.6.1 Staff timeaccounted for amajorpartofthe cost incurred for the establishment of the qual-ity management system. While the ManagementRepresentative and the Deputy ManagementRepresentative worked part-time on the qualitymanagement system, considerable staff time wasneeded in different phases in the implementationprocess,vis-à-vis,to:(a) Conductsystemreview;(b)Attendtraining;(c) Preparethedocumentation;(d) Applythequalityprocedures;(e) Carryoutinternalauditandthefollow-upaction;

and(f) Prepareforandparticipateintheinitialcertifica-

tionaudit.

Itisestimatedthatatotalofabout180staff-dayshadbeenspentontheseactivitieswithabouthalfbeingincurred by managers and the remainder by opera-tionalstaff.

8.6.2 Partof thecost incurredwas forconsul-tancy fees. The services provided by the externalconsultantincludedthefollowing:(a) Theconductofthesystemreviewtoidentifythe

discrepanciesbetweentheexistingsystemandtherequirementsofISO9001:2000;

(b) Provisionof trainingandbriefings for theHongKongObservatorystaff;

(c) Provisionofadviceontheselectionofandliaisonwiththecertificationbody;

(d) Provisionofdetailedguidanceonthepreparationofthequalitymanagementsystemdocumentation;

(e) Theconductofamockcertificationaudit;and(f) Provisionof support inoperatingandmaintain-

ingthesystemforsixmonths.

ThetotalconsultancyfeesforalloftheaboveserviceswereaboutUS$13000.

8.6.3 As with consultancy fees, the certifica-tioncostsdependlargelyonthescopeofthequality

36


managementandthesizeoftheorganization.Inthecase of the airport meteorological office, which hada total workforce of 23 employees, the certificationcostwasaboutUS$2500.Therecurrentcostformain-tainingthecertification(surveillancecost)wasaboutUS$1000peryear.

8.7 CRITICAL SUCCESS FACTORS

Several critical factors were identified for thesuccessful implementation of the quality manage-mentsystemoftheairportmeteorologicaloffice,asfollows:(a) Fullcommitmentfromtopmanagement; Topmanagementprovidedsupportbyallocating

alltheresourcesrequiredwhichmadetheimple-mentationquickandsuccessful.

(b) Commitmentandunderstandingfromallpartsoftheorganization;and

Staff had to take on additional responsibilitiessuchasday-to-dayconsistencychecksandotherqualitycontrolprocesses.Staffbuy-inwasamajorcontributingfactortothesystem’ssuccess.

(c) Theprovisionofadequatetrainingtostaff. This was critical in raising quality awareness

amongthestaffandallowingthemtoacquiretheskillsnecessarytomaketheeffectiveimplementa-tionandmaintenanceofthesystempossible.

8.8 QUALITY MANAGEMENT SYSTEM BENEFITS TO THE ORGANIZATION

8.8.1 The quality management system guidesthe airport meteorological office to focus on usersatisfaction and to address user concerns. A closerrelationshipisfosteredbetweentheairportmeteoro-logical office and the users, who are gaining deeper

appreciationfortheservicesprovided.Overallithelpstoimproveuserloyalty.

8.8.2 The system helps control and improveservicequality,increaseresponsibility,accountabilityandqualityconsciousnessamongstaff.

8.8.3 The system helps enhance efficiencythroughthestreamliningofprocesses.

8.8.4 Withtheestablishmentofclearlydefinedand measurable objectives, both management andstaffareguidedtowardsachievingthegoals.

8.8.5 The system provides a mechanism forprompt follow-up to any problems identified andfeedbackreceivedfromtheusers.

8.8.6 The performance and effectiveness oftheoperationareregularlymeasuredandreportedtomanagement.

8.8.7 A formal mechanism is now in placefor conscious continual improvement to the airportmeteorologicalofficeoperation.

8.9 EXPERIENCE OF A NATIONAL METEOROLOGICAL SERVICE PROVIDER

InadditiontotheHongKong,Chinaexampleabove,anotherexampleofthecertificationprocessbasedontheexperienceofamedium-sizednationalmeteorolog-icalserviceproviderwhichhasundergonecertificationandrecertificationprocesseswithabroadscopecover-ingtheheadquarters,regionalcentres,observationandtelecommunicationnetworksisgiveninAppendix3.ThecasehasbeengeneralizedtosuppressinformationthatisspecifictoaparticularState.

37

APPENDIX 1

(4.1.5 refers)

RECORDS REQUIRED BY ISO 9001:2008

Relevant ISO 9001:2008

clauseRecords required

Paragraph in this

publication

5.6.1 Management review 3.3.5.12, 3.3.5.13

6.2.2 Records of education, training, skills and experience 3.3.6.4

7.1 Evidence that the realization processes and resulting product meet requirements 3.3.7.2, 3.3.7.3

7.2.2 Results of the review of the requirements related to the product and actions arising from the review 3.3.7.5

7.3.2 Design and development inputs related to product requirements 3.3.7.11

7.3.4 Results of design and development reviews and any necessary actions 3.3.7.13

7.3.5 Results of design and development verification and any necessary actions 3.3.7.14

7.3.6 Results of design and development validation and any necessary actions 3.3.7.15

7.3.7 Design and development changes and the results of the review of changes and any necessary actions 3.3.7.16

7.4.1 Results of evaluations of suppliers and any necessary actions 3.3.7.18

7.5.2 Results of validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement 3.3.7.24

7.5.3 Unique identification of the product where traceability is a requirement 3.3.7.27

7.5.4 User property which is lost, damaged or otherwise found to be unsuitable for use 3.3.7.28

7.6 Basis used for calibration or verification when no measurement standards exist 3.3.7.33

7.6 Results of calibration and verification of measuring equipment 3.3.7.34

7.6 Validity of previous measuring results when equipment is found not to conform to requirements 3.3.7.34

8.2.2 Results of internal audits 3.3.8.8

8.2.4 Evidence of conformity with the acceptance criteria. Indication of the person(s) authorizing release of product 3.3.8.12

8.3 Nature of the nonconformities of product and any subsequent actions taken, including concessions obtained 3.3.8.17

8.5.2 Results of corrective action taken 3.3.8.21

8.5.3 Results of preventive action taken 3.3.8.23

39

A. QUALITY OBJECTIVES ESTABLISHED FOR THE AIRPORT METEOROLOGICAL OFFICE

1. Satisfaction rate of airline/aircrew users on the aviation meteorological service provided shall be 95 per cent or over.

2. Annual average of forecasting accuracy shall comply with the requirement based on ICAO recommendations and desirable accuracy of forecasts.

3. Implement new/modified ICAO standards before the applicability date.

4. Work shall be performed in accordance with the work schedule for each staff position as laid down in the procedure manuals.

5. Number of correction messages (“CC” as shown in teleprinters) after message issuance shall be less than 1 per cent

6. Number of retard messages (“RR” as shown in teleprinters) shall be less than 1 per cent.

7. Over 99 per cent of flight documents shall be issued to the airline operators 2 hours before the scheduled time of departure.

8. Over 95 per cent of reports in METAR code form shall be filed for transmission within 5 minutes.

9. Check the compliance with quality objectives on a quarterly basis.

APPENDIX 2

(8.4 refers)

HONG KONG, CHINA DOCUMENTATION SYSTEM

40


B. OUTLINE OF THE QUALITY MANUAL OF THE AIRPORT METEOROLOGICAL OFFICE

AIRPORT METEOROLOGICAL OFFICE

HONG KONG OBSERVATORYQUALITY MANUAL

Version: X.X

A. Table of Contents

B. ControlSheet[A description of the purpose and scope of the manual, the mechanism to control and maintain the manual and an amendment history of the manual follow.]

C. DistributionList[Personnel and locations to which the manual will be distributed are listed here.]

Prepared by: Copy No.: Reviewed by: Approved by:

Date: Date:

1 Introduction[An introduction of the airport meteorological office (AMO) and its functions are described here.]

2 ScopeThe scope (i.e. provision of aviation weather services for international air navigation) of the quality management system, with reference to the specific quality management standard (ISO 9001:2000) being applied, is stated here.]

3 Reference, Abbreviations and Definitions[A list of references, abbreviations and definitions referred to in the manual follows.]

4 Quality Management SystemAqualitymanagementsystemhasbeenestablished,documentedandmaintainedwiththeobjectiveofcontinual improvement in the AMO in accordance with the requirements of ISO 9001:2000 and ICAOdocuments.

…

[Statements describing how AMO intends to conform to each of the requirements of the ISO 9001:2000 standard, with references to specific quality management system procedures, operation manuals and external documents are put under the respective sections 4 to 8 of the manual.]

4.1 General Requirements4.2 Documentation Requirements

5 Management Responsibility5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority and Communication5.6 Management Review

41

Appendix 2 – Hong Kong, China documentation system

6 Resource Management6.1 Provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work Environment

7 Product Realization7.1 Planning of Product Realization7.2 User-related Processes7.3 Design and Development7.4 Purchasing7.5 Production and Service Provision7.6 Control of Monitoring and Measuring Devices

8 Measurement, Analysis and Improvement8.1 General8.2 Monitoring and Measurement8.3 Control of Nonconforming Product8.4 Analysis of Data8.5 Improvement

Appendix I – Quality Policy[The quality policy of AMO is included in the manual as an appendix.]

Appendix II – Procedure Cross-reference Table[A cross-reference table listing all the quality management system procedures is included here.]

Appendix III – Organization Chart[A description of the structure of AMO in the form of an organization chart follows.]

Appendix IV – Responsibilities and Authorities[Responsibilities and authorities of each staff position follow.]

Appendix V – Description of Interaction between Key Processes[Process flow diagrams showing the processes of the quality management system and their interaction follow.]

42


C. QUALITY MANAGEMENT SYSTEM PROCEDURES MAINTAINED BY THE AIRPORT METEOROLOGICAL OFFICE

Procedure reference number

DescriptionRelevant ISO 9001:2000

clauses

Explicitly required by ISO 9001:2000

(Y/N)?

QSP-1 Document Control – Quality Management System Documents 4.2.3 Y

QSP-2 Document Control – Forms 4.2.3 Y

QSP-3 Document Control – Regulations, Manuals and Notices 4.2.3 Y

QSP-4 Control of Records 4.2.4 Y

QSP-5 Planning 5.4.2, 7.3 N

QSP-6 Management Review 5.6 N

QSP-7 Training 6.2.2 N

QSP-8 Review of Product Requirements 7.2.2 N

QSP-9 Evaluation and Control of Suppliers for Products and Services 7.4.1 N

QSP-10 Purchasing of Products and Services 7.4.2 N

QSP-11 Provision of AMO Services 7.5 N

QSP-12 Calibration of Measuring and Monitoring Devices 7.6 N

QSP-13 User Satisfaction Survey 8.2.1 N

QSP-14 Internal Audit 8.2.2 Y

QSP-15 Monitoring and Measurement of AMO Processes/Products 8.2.3, 8.2.4 N

QSP-16 Control of Nonconforming Product 8.3 Y

QSP-17 Analysis of Data and Continual Improvement 8.4 N

QSP-18 Corrective Action and Preventive Action 8.5.2, 8.5.3 Y

43


D. EXAMPLE OF A QUALITY MANAGEMENT SYSTEM PROCEDURE (CONTROL OF NONCONFORMING PRODUCT)

44


45


46


47


48


49


E. EXAMPLE OF WORK INSTRUCTIONS FOR WEATHER OBSERVERS

REPORTING SPECIAL OBSERVATIONS

1 Local special reports and SPECI should be issued WHENEVER one or more criterion given in Appendix II (Criteria for making special reports in the SPECI code form and local special reports)1 is met. When deterio-is met. When deterio-ration of one weather element is accompanied by improvement in another, only one special report should be issued. The distinction between local special reports and SPECI must be clearly understood. SPECI will be disseminated beyond the aerodrome while local special reports will only be made available to the operators and to other users at the aerodrome.

2 A SPECI/local special report representing a deterioration of conditions should be issued immediately after the observation. Those representing improvements of conditions should be issued only after the improve- Those representing improvements of conditions should be issued only after the improve-Those representing improvements of conditions should be issued only after the improve- improvements of conditions should be issued only after the improve-improvements of conditions should be issued only after the improve-ment has lasted for TEN MINUTES. When issued, the report should reflect the conditions at the end of this 10-minute period.

3 A web-based tool is available on the Intranet to alert Observers that the criteria given in Appendix II are met.

1 Determined in consultation with the appropriate ATS authority, operators and others concerned in accordance with ICAOAnnex 3, Chapter 4, 4.4.1.

50


F. EXAMPLE OF THE FORM BEING USED IN THE AIRPORT METEOROLOGICAL OFFICE

51

1. SUMMARY OF THE STATEMENT OF MISSION, VISION AND QUALITY POLICY

1.1 Mission — To provide reliable meteorological information to the society contributing positively in the decision-making process associated with the development of the country.

1.2 Vision — To be a major contributor to the devel-— To be a major contributor to the devel-To be a major contributor to the devel-o be a major contributor to the devel-opment of the knowledge and use of meteorology and climatology at both national and international levels through innovation and partnership with social and productive sectors of the society.

1.3 Quality Policy — Search for recognition, trust and high level of satisfaction of users through the effi-cient monitoring of meteorological conditions, use of modern weather forecast tools, and timely delivery of the products and services required.

2. STATE REASONS TO IMPLEMENT A QUALITY MANAGEMENT SYSTEM

The reasons to implement a quality management system are as follows:(a) Obtain national recognition through the ISO

certification;(b) Search excellence through continuous improve-

ment of activities, processes, products, services and customer satisfaction;

(c) Use and expand the knowledge of meteorology;(d) Involve staff in all processes, from data collection

to realization of products; and(e) Have an integrated view of the organization.

3. UNDERSTANDING QUALITY MANAGEMENT SYSTEM

The principles required to understand quality manage-ment system are as follows:(a) Standardization and implementation of docu-

mented procedures for the development of the end activities;

(b) Based on the government regulations, ICAO and WMO standards and the ISO 9001:2000 interna-tional standard;

(c) Structuring of the processes/services oriented to customer satisfaction and continuous improve-ment; and

(d) Management of processes through the indicators of quality objective and the continuous monitor-ing of activities.

4. PERCEPTION OF WHAT IS NEEDED TO BE DONE TO FULFIL THE REQUIREMENTS OF ISO 9001

The following are needed in order to fulfil the require-ments of ISO 9001:(a) The commitment and involvement of top

management;(b) Statement of a quality policy, mission and vision;(c) Writing of a quality manual;(d) Writing and implementing procedures, instruc-

tions and manual/guides;(e) Management review of the quality management

system; and(f) Internal and external auditing.

5. HOW IT IS DONE

The following are needed:(a) Hiring of a national consultancy firm, a national

association of quality control, that is a non-profit organization;

(b) Definition of a high-level quality committee;(c) Designation of a quality representative;(d) Creation of a quality control section;(e) Preparation of documentation through a multi-

functional group;(f) Training of instructors;(g) Certification through an international accredited

company; and(h) Recertification three years later.

6. LEVEL OF DOCUMENTATION

The level of documentation needed is as follows: (a) Strategic — the quality manual, including the

statement of mission, vision and quality policy;(b) Tactic — documented procedures; and(c) Operational — working instructions.

7. STAFF STRUCTURE

The following staff are required:(a) Quality representative of the top management at

headquarters;(b) Head of the quality section at headquarters;

APPENDIX 3

(8.9 refers)

EXAMPLE OF A CERTIFICATION PROCESS UNDERGONE BY A NATIONAL METEOROLOGICAL SERVICE PROVIDER

52


Procedure Objective

Control of documents Establishes the criteria for the control of the quality management system documents, including those of external origin

Control of records Establishes the guidelines for identification, storage, protection, retrieval, retention time and disposal manner

Internal audit Establishes a system for planning, coordination and execution of the internal quality audits

Corrective and preventive actions

Establishes a system for implementation of corrective and preventive actions with a view to eliminating actual and potential nonconformity causes

Control of nonconform-ing products

Ensures that products and services non-compliant with the requirements be identified and controlled to avoid their use or non-intentional delivery

Meteorological products and services

Establishes the basic guidelines for the coordination, execution, monitoring and process control for the products and services provided

Installation and mainte-nance of equipment and instruments

Establishes the basic guidelines for coordination, execution and process control of the installation and maintenance of equipment and station instruments

Data collection, trans-mission and storage of meteorological data

Establishes the basic guidelines for coordination, execution and process control of the data collection and transmission

Telecommunication instruction Establishes the instruction for compilation of meteorological bulletins for transmission

Measurement and monitoring

Establishes a systematic control of all meteorological measurement and monitoring devices with a view to ensuring their adequate use

Table A3-1. List of quality management system procedures

(c) Internal auditor(s) at headquarters;(d) Lead auditor(s) at headquarters;(e) Quality engineer; and(f) Quality representative at each regional centre.

8. NUMBER OF QUALITY PROCEDURES

Fourteen documented procedures were implemented, including the six mandatory ones.

9. EXAMPLES OF QUALITY INDICATORS

Examples of quality indicators are as follows:(a) Number of hours of staff training per year;(b) Success index of the weather forecast per region of

the country;

(c) Provision of meteorological data;(d) Measure of success of the model output;(e) Availability of the climatological data records;(f) Number of messages received;(g) Availability of telecommunication lines; and(h) Number of stations inspected.

10. MONITORING FORMS AND TOOLS

The following are needed in order to fulfil the require-ments of ISO 9001:(a) Daily reports of nonconformity or report of

trouble detection;(b) Monthly reports covering nonconformities; and(c) Half-yearly internal and external audits; request of

preventive and corrective actions and meetings of the high-level quality committee.

53

Appendix 3 – Example of a certification process undergone by a national meteorological service provider

Example A3-1. Outline of quality manual

QM.00110/08/2004-Rev. 00

QUALITY MANUAL

1. Introduction

This Section contains an introduction of the quality management system, historical facts of the organization and describes the objectives and the structure of the Quality Manual and the mechanisms to control and make appropriate revision of the quality management system documents.

2. Scope

This section describes the scope of the Quality Manual and includes the statement of the Mission, Vision and Quality Policy of the organization. It also includes a flowchart of the organization and makes reference to pertinent government regulations and provides a list of products and services available to users.

3. Responsibility

The responsibilities of top management, including the Director, the Representative of Quality, the Head of Quality Section, Technical Divisions, Administration Division and Heads of regional centres and concerned staff, with respect to the quality management system are included in this section.

4. Structure of the QMS

This constitutes the main section of the Quality Manual. It includes a general description the quality management system requirements and flowcharts depicting processes. It also includes the description of the activities related to the following headings:

4.1 Documentation requirements, including Quality Manual, Quality procedures, Quality Instructions, Guides, Manuals, Records, Control of documents and Control of records.

4.2 Management responsibility, customer focus, quality policy and objectives, planning process, internal communication and the mechanisms for management review.

4.3 Resource management4.4 Product realization4.5 Measurement, Analyses and Improvement4.6 Correlation Matrix indicating the responsibility of each section/division with sections of the

standard4.7 History of reviews of the document

______________________ ________________________ Prepared by Approved byChief of Laboratory Chief of Division

54


Example A3-2. Outline of a quality management system procedure

INSTRUM.QP.00110/08/2004 – Rev.00

Control of Measurement and Monitoring Devices

1. Objective

To establish a systematic control of all meteorological measurement and monitoring devices with a view to ensuring their adequate use.

2. Definitions

This section contains definitions of terms related to instruments and methods of observation, such as Measurement and Monitoring Devices, Calibration, Calibration Standard, Inspection Standard, Management Calibration System, etc.

3. General Principles

This section provides general guidance about the quality and accuracy required, the traceability of calibrated instruments, the conditions for outsourcing calibration and measurements, the rejection of uncalibrated instruments, the care with handling the instruments, etc.

4. Responsibilities

The responsibilities of concerned staff are indicated in this section, including those of the Director, Division and Section chiefs, Laboratory chief and staff, concerned staff at the regional centres, etc.

5. Description of the Procedures

This is the main section of the document. It provides details of the work processes of the Central Laboratory, Regional Laboratories, Calibration Management system, and also the instructions for calibration of the instruments of the observation stations.

6. Flowchart Description of the Procedures

Graphical description of the procedures to facilitate understanding.

7. Annex

Includes forms and models of identification tags containing information about the current status of the instruments.

8. Reviews of the Document

Includes the history of reviews of this document according to the adopted procedure of controlling documents to ensure the correct version is used.

______________________ ________________________ Prepared by Approved byChief of Laboratory Chief of Division

2011 edition

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