accreditation of labs & profisiensi test schemes

8/2/2019 Accreditation of Labs & Profisiensi Test Schemes

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KENYA

KISUMU

MOMBASA

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ELDORET

John M. Rukaria

Labs. Accreditation

Kenya Accreditation Service

Email: [email protected]

Accreditation of Laboratories &Proficiency Testing Schemes


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Outline

Introduction

Terms

Accreditation & Trade

KENAS and its role

Benefits of accreditation of medical labs.

The need and operation for P.T. schemes

Way forward


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1.0 Introduction

The aim of this presentation is two fold :-

Give an overview of KENAS mandate inproviding regulatory and or accreditation

services to its customers in the field ofaccreditation of laboratories (CABs).

Highlight its role in the operation of

proficiency testing schemes, a tool usedin demonstrating the competence of alaboratory to carry out the task of testing


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2. (a)Terms-Quality infrastructure


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(b)What is Accreditation?

The word accreditation comes from Latincredere(to give believe, to be confident in)therefore means to give confidence

Essentially, accreditation is a procedure by whichan authoritative body (NAB) gives formalrecognition to a person or organization for theircompetence to carryout specific tasks.

This recognition can be awarded to: certificationbodies; laboratories (Calibration & testing); andinspection bodies

Therefore it relates to the assessment ofcompetence


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Definition

ISO 17011: 2004-conformity assessmentgeneralrequirements for accreditation bodiesaccrediting conformity assessment bodies.

(NABs e.g. KENAS to meet these Requirements toattain international recognition )

Third party attestation related to a conformity

assessment body conveying formaldemonstration of its competence to carry outspecific conformity assessment tasks.


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(c) What about Certification?

Certification is a procedure by which acertification body confirms that a product, processor service conforms to a specific standard orspecification- Compliance

Certification is a commercial activity where severalcertification bodies compete with each other forbusinessTherefore it relates to the assessment of conformityExamples:

ISO 9001:2000 (QMS)ISO 14001:1996 (EMS)Codex Principles 1997/ISO 22000: 2005 (HACCP)Product Certification (Diamond Mark of Quality)EUREPGAPISO 18001:1999(OHASS)


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Then Conformity assessment?

Conformity as defined in ISO 9000:2005

Fulfilment of a requirement

Conformity Assessment:demonstration that specifiedrequirements relating to a product, process,system, person or body are fulfilled

Conformity assessment include activities such astesting, inspection and certification


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(LAB) Proficiency testing

Determination of Lab testing by means ofinter-laboratory comparison

Incl.

Qualitative schemesData transformation exercises

Single item testing

One off exercisesContinuous schemes

Sampling


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Inter-laboratory comparisons

Organization, Performance & Evaluationof tests on the same or similar test itemsby two or more laboratories in

accordance with pre-determinedconditions.

N/B

One of the labs involved may be the labwhich provided the assigned value for thetest item.


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3.0 Accreditation & Trade

WTO/TBT agreement

Article 15.2

Each member shall inform WTO on

measures in existence or those taken toensure implementation andadministration of the agreement

Includes article 6 on conformity

assessment activities which include:-certification, quality assurance, testing,inspection &Accreditation


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Accreditation & trade cont..

6.1& 6.1.1 acceptance of results ofconformity assessment of other memberstates so long as such results aregenerated by competent CAB

6.3 provisions of recognition of resultsthrough signing of Mutual Recognition

Agreements (MRAs) & Multilateralarrangements (MLAs)


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Barriers to Trade

Tariff trade BarriersNon-Tariff trade

Barriers

Non-Technical Technical

- Physical Units

- Product Specification

- Conformity Assessment

- Test Certificate

The Technical Barrier to trade (TBT)


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Accreditation of CABs e.g. Lab

Done on the basis of compliance to:-

International Stds. & Guides

e.g

ISO 17025 (LABS),17020 (IBs),15189 (clinicallabs) etc.

ISO guide 43:1997 pt 1 & 2

Laws and Regulations

Support Org. documentation on Mgt. Of activitiesI.e. Manuals, Procedures, records ( QMS )etc.

Other market requirement docs. e.g. Contractsetc.


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4.0 Present situation -National

A number of accreditation programmes havebeen undertaken I.e

Accreditation of Certification Bodies through

Quality assessment Committee(QSAC) from 1995vide L.N.90/95

Accreditation of calibration by KEBS under theNational Calibration Scheme(NCS) from 1984vide L.N. 80/84(Assumed by KENAS under Sec.ofKENAS L.N. 14)


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Present situationNational cont..

A number of KEBS laboratories have beenassessed by external Accreditation bodies UKAS(U.K.) & DKD (Germany).

2 metrology labs. (AC/DC & Volume ) by DKD of

Germany and three testing labs by UKAS of theUnited Kingdom(Chemistry,Micro &Food & Agric.Labs) are waiting accreditation

Other accredited labs include :- SGS lab, KEPHISlabs, Pathway Medical Lab. by SANAS of SouthAfrica.

QSAC undertook registration of assessors underthe provisions of L.N. 90/95 (Assumed by KENASSec. 14 of KENAS L.N.).


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Present situation - NationalCertification bodies -ISO/IEC 17021:20064 Active bodies

SGS, BVQI, KEBS & CVA international

Calibration Laboratories -ISO/IEC 17025:20057 - various fields of measurement ( 12 requests )

Personnel -ISO/IEC 17024:2003114 -Assessors (43 new applicants)


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Present situation - Nationalcont.

Inspection bodies- ISO/IEC 17020:1998New area being developed

1 requestPublic health, plant health, local authority, motor

vehicle, seed, buildings, lifts & escalators etc

Testing Laboratories - ISO/IEC 17025:2005New area15 Request

2 from medical labs(ISO 15189:2003)


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Present situation- National cont.

Laboratories Proficiency Testing

Programmes by the EAC Bureaux

KENAS scheme on Mineral water

Private schemes by HuQAS ( Human Quality

Assessment Scheme for medical DiagnosticLabs.


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5.0 KENAS - ObjectivesProvision of accreditation and regulatoryservices to conformity assessment bodies (CABs)

Registration of assessors, inspectors &

Management Systems training course providers

Creation of order in trade and service

Elimination of incompetent practices

Provision of level playing ground to CABs

Realize local accreditation services that are of

lower cost than those being provided by externalaccreditation bodies.


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red Political Support

blue Administration

yellow Technical Support KENAS

green External Relations

30

28

29 14Public Relations

26Special courses

27

12 24Working groups

11 21Proficiency Testing

25

10Personnel

20Pre-Assessments

13

5 9Equipment

19Metrology

23

8

Management structure

18

Technical committees

4Legal status

7Location

17Training system

2 6Director

16Technical assessors

22

3Legal entity

15Lead assessors

1

Financial policy

National coordination

Quality documentation

Internationally recognized

Regional Accreditation System

National policy

Independency

Pre-Evaluation

MRA / MLA

Client organisations

Joint accreditations

Associations

Control board

Monopole

First scope


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KENAS & its Role cont.

KENAS established in March 2005 underL.N. 26/2005

KENAS is Affiliate member of ILACw.e.f.July 2005

TC Membership will represent allstakeholders CBs, C&T labs, IBs, TPs etc


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Mandate of KENAS

Registration of assessors, auditors, conformityassessment inspectors & training providers (TPs)

Accreditation of CABs ie CBs, IBs,C&Tlabs.(incl.medical &diagnostic labs. ISO 15189:2003)Cooperation with Regional & internationalaccreditation bodies e.g EACAB (East AfricanCommunity Accreditation Board), IAF (Int.

Accreditation Forum), ILAC ( Int. LaboratoryAccreditation Cooperation).

Accounts auditable by the Controller & Auditorgeneral


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Accreditation awareness sessions donefor:-

Policy makers & stake holders (Nairobi)

AKMLSO (Assoc . of Kenya Medical Lab.scientific officers) (Eldoret. )

Vet Lab officers (Machakos)


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Stakeholders-31st March 2005


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ELDORETStudy visit to Germany Jan. 2006


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Accreditation seminar2nd Nov.2006


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6.0 Current situation EAC level

A draft SQMT(Standardisation, Qualityassurance, metrology & testing) bill hasbeen formulated through joint efforts ofthe three states . UG, KEN, TZ

This will also address Conformityassessment issues

It is in the process of being finalisedAwaiting ascent by country CEOs ofKenya ,Uganda, Tanzania to become Law


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Current situation EAC level

Sub-commitees on Metrology, testingstandardisation & accreditation to discussand chart way forward on appropriateconformity assessment issues

Regular meetings of the CEOs of the threeNSBs to articulate these issues

Training and or awareness on conformity

assessment activities undertaken undervarious support programmes e.g. By PTBof Germany , USDA(US), SIDA(Sweden)


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TANAS KENAS UNAS

IndustriesTanzania

IndustriesKenya

IndustriesUganda

N

A

T

I

O

N

A

L

N

A

T

I

O

N

A

L

EACAS

BOARD

Experts Committee

Tech.Committee

TCTC

Accre.Committee

E. A. Community Experts

East Africa Region


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Accreditation-International level

ILAC

EA APLAC

IAAC

IAAC Inter-American Accreditation Cooperation

EA European co-operation for Accreditation

APLAC Asia Pacific Laboratory Accreditation Cooperation

SADCA Southern African Accreditation Cooperation

EACAS East Africa Community Accreditation System

SADCA

C ti G t &I d t C ti


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Cooperation

ILAC MRA

Govt.&Industryrecognition

Cooperation

IAF MRA

Confidence regarding compliance regulations

Products

TestedPer spec.

2nd

parties

Mutual recog.EA/APLAC/IAAC/SADCA

Mutual recog.EA,APLAC/IAAC/ SADCA

Accreditation bodies

Accredit labs&Insp. bodies

ISO/IEC 17011&17010

Accreditation bodies

Accredit certification bodies

ISO/IEC GUIDE61

Labs.

Medical/Testspecimen/Materi

15189 / 17025

Insp. bodies

inspectProducts/items

ISO/IEC 17020

Personnel

ISO/IEC

17024

Cert.bodies

Certify pdts.

Guide 65

Cert.bodiesCertify

systems

17O21

ProductsTestedPer spec.

Productsinspected

Per spec.

personnelexamined

Per spec.

ProductsmarkedPer spec.

QMS/EMScertified

Per req.

Conformity

AssessmentAccreditationHierarchy


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7.0 Accreditation of Medical Labs- Benefits

Recognition and trust

Improved confidence on the part of users of thelab

Reduced risks of wrong diagnosis

Reduced risks of litigations

Reduced complaints

Improved productivity

Improved trade and or business

Improved efficiency & effectiveness henceproductivity

Reduced cost of doing business


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8.0 The Need for P.T scheme

Gauging of the technical competence of a Lab.

Used in self evaluation of performance

A vehicle for establishing mutual confidence

between users of different labsCurrently a condition for accreditation by e.g.KENAS

Enable continual improvement of the lab. QMS

Identification of interlab. DifferencesAssigning Values to reference Materials (RMs) &assessment


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KENAS & P.T. schemes

As Per Requirements of ISO 17011:2004

KENAS shall establish procedure

governing the assessment & decision making

as labs participation & performance in P.T. -Cl 7.15.1

KENAS may organize P.T. schemes -Cl. 7.15.2

One on mineral water is running

Participants include KEBS, UNBS, TBS,SABS,BOBS, one lab. In Germany


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KENAS & P.T. schemes cont..

KENAS may involve another bodyjudged to becompetent e.g. HuQas? Cl 7.15.2KENAS shall maintain a list of appropriate P.T.and other lab comparison programmes- Cl.7.15.2KENAS shall ensure its accredited labsparticipate in P.T. where available & appropriate-Cl.7.15.3KENAS shall ensure thatCorrective actions(CAs)are carried out when necessary -Cl.7.15.3KENAS shall specify minimum amount of P.T.testing, frequency of participation in liaison withinterested parties e.g Labs.- Cl.7.15.3


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9.0 Operation of a P.T scheme

Consider:- ISO/IEC Guide 43-1:1997

Selection of P.T. scheme (cl.4)

Organization & design (cl.5)

Operation & reporting (cl.6)

Confidentiality/ethical considerations(cl.7)

(Aim at having an operating accredited P.Tscheme)- HuQas?


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10.0 Way Forward

Aim at :-

One test accepted every where

Also,

Use of ILAC/IAF Cross frontier accreditation Policy

Hence need:-

For labs (medical) to carry out conformityassessment activities (testing)competently in linewith the requirements of National/International

standards e.g. ISO 15189/15195/ Guide 43 pt 1& 2To verify or assess the said competence tofacilitate trade at National and internationalarena I.e. Accreditation services by e.g.KENAS


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Way Forward cont

Reduction/elimination of multipleinspections/certifications, testing of goods asthey transcend borders

safeguarding credibility of results of conformity

assessment activities by entering into ILAC/IAFMRAs/MLAs

Evolution of KENAS in Line with the 30 milestones

Need for provision of appropriate support from

Government, stakeholders,donors to realiseWTO/TBT agreements, that include areas ofconformity assessment

KENAS Pursuit of full recognition by IAF & ILAC


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Quality

Manual

Internal Auditor

Company S.A.


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QM

Internal Auditor

Company

ISO 9000 Auditor

ISO 9000ISO 9001

Certification

Body


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QM

Internal Auditor

Company

ISO 9000 Auditor

ISO 9000ISO 9000Certification

Body

ISO 17021 Auditor

ISO 17021Accreditation

Body


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QM

Internal Auditor

Company

ISO 9000 Auditor

ISO 9000ISO 9000Certification

Body

ISO 17021 Auditor

ISO 17021

Accreditation

Body

ISO 17011

Peer Evaluator

ILAC

IAF


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End

THANK YOU

accreditation of labs & profisiensi test schemes

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