quality infrastructure and accreditation in germany dr. tilman denkler workshop certification for...

Quality Infrastructureand Accreditation

in Germany

Dr. Tilman Denkler

Workshop“Certification for agricultural commodities and accreditation

for certifying bodies (March 14th to April 1st 2011)”Berlin, 2011-03-28

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Dr. Tilman Denkler

Content

What is a Quality Infrastructure?

Tasks of BAM in the area of Quality Infrastructure

Introduction to the principles of product certification

General and special requirements of ISO/IEC Guide 65

Accreditation of certification bodies

The German accreditation body DAkkS(separate presentation)

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Dr. Tilman Denkler

Tilman Denkler

Scientific employee at BAM Federal Institute for Materials Research and TestingSection S.3 – "International Technology Transfer" - iCATT

Lead assessor at DAkkS

Employee, lead assessor and case manager at DAP from 2003 - 2007

Diploma in GeologyM.A. economy and managementDr. rer. nat.

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What is a Quality Infrastructure?

“Quality infrastructure refers … to all aspects of metrology, standardization, testing, quality management, certification and accreditation that have a bearing on conformity assessment (abbreviated as MSTQ).

This includes both public and private institutions and the regulatory framework within which they operate.”(BMZ 2004)

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Source: Ulrich Harmes-Liedtke (2010): The Relevance of Quality Infrastructure to Promote Innovation Systems in Developing Countries

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Quality Infrastructure in about 5 minutes

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Branch FabeckstraßeUnter den Eichen 44 – 46

Headquarter LichterfeldeUnter den Eichen 87

Branch AdlershofRichard-Willstätter-Straße 11

BAM Test Site Technical Safety – BAM TTSAn der Düne 44, Baruth/Mark

Locations of BAM

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Dr. Tilman Denkler

Tasks of BAM in the field of quality infrastructure

Preparation of Reference Materials

Development of testing and reference methods

Test and approval of dangerous goods and Containment Systems for Dangerous Goods

Analysis of damage mechanism and damage analysis

Participation in more than 500 standardisation committees (ISO, CEN, DIN)

Notified Body:89/106/EEC: Construction products 93/15/EEC: Explosives for civil uses94/9/EC: Equipment explosive atmospheres (ATEX) 97/23/EC: Pressure equipment (PED)1999/36/EC: Transportable pressure equipment

(TPED)2007/23/EC: Pyrotechnic articles

Collapsed high-voltage pylon

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Dr. Tilman Denkler

Tasks of BAM in the field of quality infrastructure – Department S

Secretariat of the German Accreditation Advisory Board (AKB)

Working group product requirements (Ecodesign energy-using products/PCP/MS)

Secretariat of Eurolab-Germany

Database for proficiency testing schemes EPTIS

Standardisation committees the field of conformity assessment CEN TC und ISO CASCO

Technology transfer (iCATT)

Research in the area of QI:Cooperation with the TU Berlin

Accreditation, Quality in

Testing

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iCATT Profile

Working group for technical cooperation within the BAM (S.3)

10 staff members

Transfer of know-how in the fields of conformity assessment, accreditation and management systems

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Our Mission

To support our partner countries in establishing and upgrading internationally recognised quality infrastructure systems with the aim:

Safety and reliability to ensure an effective consumer protection

Removal of technical barriers to trade and export promotion

Facilitation of mutual recognition of the accreditation of conformity assessment bodies (testing and calibration laboratories, certification and inspection bodies)

Integration in regional and international trade systems

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Our competences

iCATT offers customized training and consultancy services in the following integrated fields of competence:

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Our experience (1)

Over 15 years of experience in international project management

Successful implementation of 34 international projects worldwide

technical infrastructure of the BAM

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Our experience (2)

Active participation of our staff in accreditation issues

Close cooperation with German Accreditation Advisory Board, national organizations like DIN, PTB and GIZ as well as with international partners from industry and the scientific community

http://nmi.nl/?lg=it

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Types of conformity assessment bodies

Conformity assessment

CertificationBodies

AccreditationBody

InspectionBodies

TestingLaboratories

third-party attestation related to a conformity assessment body conveying formal demonstrationof its competence to carry out specific conformity assessment tasks

demonstration that specified requirements relating to a product, process, system, person or body are fulfilled

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Differences between inspection and certification

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General requirements for certification

Products (including Processes and Services):ISO/IEC Guide 65:1996General requirements for bodies operating product certification systems

Management Systems:ISO/IEC 17021:2011Conformity assessment -- General requirements for bodies providing audit and certification of management systems

PersonsISO/IEC 17024:2003Conformity assessment -- General requirements for bodies operating certification of persons

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additional documents on product certification

ISO/IEC Guide 23:1982 Methods of indicating conformity with standards for third-party certification systems

ISO/IEC Guide 28:2004Conformity assessment -- Guidance on a third-party certification system for products

ISO/IEC Guide 53:2005Conformity assessment -- Guidance on the use of an organization's quality management system in product certification

ISO/IEC Guide 67:2004 Conformity assessment -- Fundamentals of product certification

includes guidance on the use of certificates and marks

describes different types of product certification systems

includes annexes with examples for application form, certificate of conformity, licensing agreements, ...

includes checklists as example for the evaluation of quality management systems

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Additional relevant documents

ISO/IEC 17020:1998General criteria for the operation of various types of bodies performing inspection

ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories

for testings used as criteria in the certification system (replaces ISO/IEC Guide 25:1990)

Competence of subcontractors: for inspections used in the

certification system (replaces ISO/IEC Guide 39:1988)

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Process of Certification

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Owner of the certification system

Certification body

Inspection body

Testing laboratory

Accreditation body

Product Certification

System

subcontracts

attests competenceimplements

defines

checks

Function of parties involved in the certification process (1)

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Function of parties involved in the certification process (2)

Certification body

Inspection body

Testing laboratory

Product Certification

System

subcontracts

Applicant/Supplier

Product/Service/Process

producesCheck

fulfilment of

require-ments

requirements (i. e. QMS) requirements

(i.e. auditor qualification)

check fulfilment of requirements

(QMS)

requirements on the product

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Contractual arrangements between parties involved in the certification process

Certification body

Inspection body

Testing laboratory

Contract necessary

Applicant/Supplier

Product/Service/Process

marks/labels

Accreditation body

Owner of the certification system

contractContract necessary

contract

Contract necessary

SQF

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Different types of product certification

1. Pressure because of 22. Pressure because of business relations3. Pressure because of former/actual

employment4. Financial pressure, attempts to influence

the results of conformity assessments5. Financial pressure

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Possible influences and pressures as well as expectations related to product certification bodies

related bodies

employees

CAB

owner ofthe CAB

society, state,interested

customerof the CAB

customer ofthe customerof the CAB

parties

Expectations6. reliable results, competence, impartiality7. competence, practice-oriented operation8. reliable results

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What customers are expecting from certification bodies?

Accreditation:

The formal recognition of technical competence

technical and procedural criteria

independenceimpartiality quality management

use of recognised methods of testing and evaluation

use of methods with recognised quality and reliability criteria

reliable results with an extensive acceptance

results in an acceptable time at acceptable costs

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The accredited certification bodies benefit by:

a „credential“ of qualification to provide a determined (accredited) service

regular, objective „check-up“

a continuous potential of improvement

an entrée to a given market that would otherwise be closed to the laboratory

the reduction of numerous CAB audits by the customers,

the increase in international recognition of competence, mutual recognition

the promotion of the up-to-date level of technological development in the accredited field of certification

an increased performance of staff

the fulfilment of staff obligations as a result of the quality management

ensuring the traceability of all activities and of the results

ensuring the traceability to national and international certification rules and instructions

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An introduction to the principles of product certification based on

ISO/IEC Guide 65

contents

interpretation

application

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Product certification based on ISO/IEC Guide 65Content:• Introduction1. Scope2. References3. Definitions4. Certification body5. Certification body personnel6. Changes in certification requirements7. Appeals, complaints and disputes8. Application for certification9. Preparation for evaluation10.Evaluation11.Evaluation report12.Decision on certification13.Surveillance14.Use of licences, certificates and marks of conformity15.Complaints to supplier

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Product certification based on ISO/IEC Guide 65

Introduction:

certification of a product is a means of providing assurance that it complies with specific standards

ISO/IEC Guide 65 specifies requirements for independent certification bodies operating third-party-certification systems

the requirements are general criteria, which may have to be amplified

certification systems for particular products will often need explanatory documentation

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Scope (1):

ISO/IEC Guide 65 specifies requirements, that a third-party operating a product certification system shall meet

product is used in the widest sense, including processes and services

standard is used in a wide sense, including other normative documents

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Scope (2):

as described in ISO/IEC Guide 53 the certification system may include one or more of the following:

Type testing or examination

Testing or inspection of samples (from open market and/or suppliers stock)

Testing or inspection of every or a particular product (new or in use)

Batch testing or inspection

Design appraisal

coupled with assessment of production and/or quality management system

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4 Certification body (CB)

4.1 General provisions (1)

non-discriminatory policies and procedures of CB (4.1.1)

procedures not used to inhibit or impede the access by applicants (4.1.1)

CB accessible for all applicants (in the field of operation) (4.1.2)

no undue financial or other conditions (4.1.2)

membership in an association or group or number of already issued certificates are not allowed to be a condition for applicants (4.1.2)

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4.1 General provisions (2)

Evaluation criteria must be outlined in specific standards, which have to meet the requirements of ISO/IEC Guide 7 (4.1.3)If explanation of the standards is needed, it has to be done by competent and impartial persons/committees and published by the certification body (4.1.3)

CB´s shall confine requirements, evaluation and decision on certification on those matters related to the considered scope (4.1.4)

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4.2 Organization (1)

The structure of the CB shall foster confidence. Therefore the CB shall:

be impartial (4.2 a))

be responsible for decisions related to granting, maintaining, extending, suspending and withdrawing its certifications (4.2 b))

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identify the management responsible for:

performance of testing, inspection, evaluation and certification (4.2. c)1))formulation of policy related to the operation of the CB and supervision of their implementation (4.2. c)2)) (4.2. c)4))decisions on certification (4.2. c)3))supervision of finances (4.2. c)5))delegation of authority to committees/persons (4.2. c)6))technical basis for granting certification (4.2. c)7))

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be a legal entity (4.2 d))

do evaluation and decision on certification by different persons (4.2 f))

have rights and resposibilities relevant to its certification activities (4.2 g))

have financial stability and resources (4.2 i))

cover liabilities (4.2 h)) usually done by an insurance policy

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Product certification based on ISO/IEC Guide 654 Certification body (CB)



have a documented structure, which safeguards impartiality (4.2 e)

IAF Guidance on the Application of ISO/IEC Guide 65:1996:G 4.2.14 Application of clause 4.2.e) of ISO/IEC Guide 65 requires judgment on whether all parties significantly concerned in the system are able to participate. What are essential is that all identifiable major interests should be given the opportunity to participate, and that a balance of interests, where no single interestpredominates, is achieved. The members should normally be chosen at leastfrom among representatives of the following groups: manufacturers or suppliers, users, consumers, conformity assessment experts. For practical reasons there may be a need to restrict the number of persons.

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employ sufficient number of competent personnel under a responsible senior executive (4.2. j))

have a quality management system (QMS) (4.2. k))

distinguish between product certification and other activities by policies and procedures (4.2. l))

have policies/procedures for resolution of complaints/appeals/disputes (4.2. p))

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be free from any commercial, financial and other pressures (which might influence certification process) (4.2. m))

have formal rules and structures for the appointment and operation of committees involved in the certification process. Such committees shall be free from any commercial, financial and other pressures (which might influence their decisions) (4.2. n))

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ensure that activities of a related body do not affect the confidentiality, objectivity or impartiality of the certification body (4.2 o)).

and NOT:supply or design products it certifies (4.2 o)1))give advice or provide consultancy (4.2 o)2))provide any products or services which could compromise the confidentiality, objectivity or impartiality of the certification process/decision (4.2 o)3))

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A related body is one which is linked to the CB by:

common ownership, in whole or part,

directors

contractual arrangement

a common name

informal understanding or other means such that the related body has a vested interest in any certification decision or has a potential ability to influence the process.

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IAF Guidance on the Application of ISO/IEC Guide 65:1996:

G.4.2.30 The certification body is allowed to explain its findings and/or clarify the requirements of the normative documents but shall not give prescriptive advice or consultancy as part of an evaluation.

This does not preclude normal exchange of information with the clients and other interested parties

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Methods of assuring impartiality of CB´s descibed in chapter 4.2:

Zertifizierungs-stelle

- Supplies or design products it certifies

- gives advice or provides consultancy

- provides any products or services which could compromise the confidentiality, objectivity or impartiality

A related body linked to the CB by:• common ownership, in whole or part, • directors• contractual arrangement• a common name• informal understanding• other means

Documented Structure

safeguards impartiality

Do activities affect the confidentiality, objectivity or impartiality of the certification body?

CertificationBody

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4.3 Operations

The CB shall evaluate conformance with relevant product standards according to requirements of specific product certification system. Based on this the CB shall:

specify relevant standards

specify other requirements (i. e. for sampling, testing, inspection)

specify requirements for suitability and competence of persons/bodies carrying out testing, inspection and certification/registration

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4.4 Subcontracting

CB´s are allowed to (permanently) subcontract parts of the certification process (e.g. inspection, testing), but NEVER decisions about granting, maintaining, extending, suspending and withdrawing its certifications.

In the case of subcontracting the CB shall:have a documented agreement covering:

arrangementsconfidentialityconflict of interests

take full responsibility for subcontracted work (4.4 a))ensure competence and impartiality of subcontractors (4.4 b))obtain the applicant´s consent (4.4 c))

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4.5 Quality system (1)

Policy:Management shall define/document policy, objectives and commitment to quality and ensure, that the policy is understood, implemented and maintained (4.5.1).

Quality management system (QMS):An effective, documented QMS shall be implemented and operated by the CB (4.5.2).

Quality Manager:A person with defined authority for implementing and maintaining the QMS and reporting to the management shall be designated. The person needs direct access to the highest executive level of the CB (4.5.2).

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Quality manual (1):The QMS shall be documented in a manual and associated procedures, containing/referring to:

quality policy statement (4.5.3 a))

description of legal status incl. names of owners/controlling persons (4.5.3 b))

names, qualifications, experience and terms of reference of certification personnel (internal & external) (4.5.3 c))

organization chart and a description of the organization (4.5.3 d))

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Product certification based on ISO/IEC Guide 654.5 Quality system (3)


policy/procedures for:management reviews (4.5.3 f))administrative processes (4.5.3 g))document control (4.5.3 g))recruitment, selection, training and performance monitoring of certification body personnel (4.5.3 i))assessing, recording and monitoring subcontractors competence (4.5.3 j))handling of non-conformities (4.5.3 k))dealing with appeals, complaints and disputes (4.5.3 m))conducting internal audits (4.5.3 n))

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policy/procedures for:evaluating products (4.5.3 l))implementing the certification process (4.5.3 l))conditions for issue, retention and withdrawal of certification documents (4.5.3 l)1))use/application of documents of the certification process (4.5.3 l)2))

list of approved subcontractors (4.5.3 j))operational and functional duties and services pertaining to quality (4.5.3 h))

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4.6 Conditions and procedures for granting, maintaining,

extending, suspending and withdrawing certification

Conditions for above shall be specified (4.6.1)

There shall be documented procedures for:granting, maintaining, suspending and withdrawing certification (4.6.2 a))extension/reduction of scope of certification (4.6.2 b))re-evaluation in case of significant changes in (4.6.2 c))

product designstandards, to which compliance is certifiedownership/structure/management of the supplier

re-evaluation in the case, that any other information indicates, that the product no longer complies with the requirements (4.6.2 c))

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4.10 ConfidentialityThe CB shall safeguard the confidentiality of information (obtained in a certification process) (4.10.1)

at all organizational levelsat all committees and external bodies/individuals.

The confidentiality regulations shall be consistent with existing laws.Information (about a particular product/supplier) shall not be disclosed without a written consent of the supplier (4.10.2).Exceptions:

requirements of this standard (i.e. 4.8.1 g))requirements by law (in this case the supplier has to be informed about the provided information)

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5 Certification body personnel 5.1 General

Personnel shall be competent (5.1.1), particularly with regard to:

making required technical judgements

framing policies

implementing policies

Duties and responsibilities shall be described in clearly documented instructions (5.1.2).These instructions shall be:

available for the personnel

maintained up to date

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5.2 Qualification criteria

The CB shall define the minimum qualification criteria (5.2.1).The CB shall ensure and document how any contracted personnel satisfy the requirements of this standard (5.2.2).

The CB shall maintain and keep up to date the following information of personnel involved in the certification process (5.2.3):

name and addressorganization affiliation and positioneducational qualification and professional statusexperience and trainingdate of the updating of recordsperformance appraisal

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8 Application for certification8.1 Information on the procedure (1)

The CB shall provide to applicants the following up-to-date information (8.1.1):

detailed description of the evaluation procedure of each certification schemedetailed description of the certification procedure of each certification schemedocuments describing the requirements for certificationapplicants rightsduties of certified suppliersfees to be paid by applicantsfees to be paid by suppliers of certified products

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The CB shall require that a supplier:always complies with the (relevant provisions) of the certification program (8.1.2 a))

makes all necessary provisions for the conduct of the evaluation (8.1.2 b)):

provision for examining documentation

access to all areas

access to all records (incl. internal audit reports)

access to personnel

access to documentation about the resolution of complaints

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The CB shall require that a supplier:only makes claims regarding certification in respect of the certified scope (8.1.2 c))does not misuse its certification in a way, that may disrepute the CB (8.1.2 d))does not make any statement regarding its certification, which the CB may consider misleading or unauthorized (8.1.2 d))In the case of suspension or cancelation of certification (8.1.2 e)) :stops using advertising matter containing a reference to the certificationreturns all certification documents the CB requires

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The CB shall require that a supplier:only uses certification to indicate, that products are certified as being in conformity with specific standards (8.1.2 f))

endeavours to ensure, that no certificate/report (or parts of these) is used in a misleading manner (8.1.2 g))

only makes reference to the certification in a way, which complies with the requirements of the CB (8.1.2 h))

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The CB shall provide the following information to the applicant:

any explanations needed, if the desired scope of certification is related to a specific system or type of system operated by the CB (8.1.2 f))

additional application information on request (8.1.4)

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8 Application for certification8.2 The application (1)

The CB shall require the completion of an official application form (8.2.1) which is:

signed by an authorized representative of the CB (8.2.1)

The application form shall include (or have attached):

the scope of the desired certification (8.2.1 a))

a statement, that the applicant agrees to comply with the requirements of the CB (8.2.1 b))

a statement, that the applicant agrees to supply any information needed (8.2.1 b))

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8 Application for certification8.2 The application (2)

The applicant shall provide following information:

corporate entity (8.2.2 a))

name and address (8.2.2 a))

legal status (8.2.2 a))

Definition of products to be certified (8.2.2 b))

If known by the applicant:certification system and standards, against which each product is to be certified (8.2.2 b))

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9 Preparation of evaluation

Before proceeding with the evaluation the CB shall review the application to assure that:

the requirements for certification are:

clearly defined (9.1 a))

documented (9.1 a))

understood (9.1 a))

differences in understanding between CB and applicant are resolved (9.1 b))

the CB has the capability to perform the certification

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Product certification based on ISO/IEC Guide 659 Preparation of evaluationThe CB shall

prepare a plan of the evaluation (9.2) (and send it to the applicant, so that necessary arrangements can be managed)

assign personnel appropriately qualified (9.3)

assign personnel, which has not been involved in/employed by a body involved in:

designsupplyinstallationmaintenance

of such products in a manner and within a time period, which could conflict with impartiality (9.3)

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10 Evaluation

The CB shall evaluate the products of the applicant against the standards covered by the scope according to all certification criteria specified in the scheme

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11 Evaluation report (1)

The CB shall have adequate reporting procedures, ensuring - as a minimum - that:

the report documents the findings related to all certification requirements (11 a))

a full report on the outcome of the evaluation is promptly brought to the applicant (11 b)), identifying

nonconformities

extent of further evaluation required

extent of further testing required

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11 Evaluation report (2)

The CB shall repeat only the necessary parts of the evaluation procedure, if the applicant can show that remedial action has been taken within a specified time limit (11 b)).

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12 Decision on certification

The CB shall take a decision on certification on the basis of:

information gathered during evaluation (12.1)

any other relevant information

The CB shall not delegate authority to an outside person or body for:

granting certification (12.2)maintaining certification (12.2)extending certification (12.2)suspending certification (12.2)withdrawing certification (12.2)

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13 Surveillance (1)

The CB shall have documented procedures to enable surveillance to be carried out in accordance with the criteria applicable to the relevant certification system (13.1) and document its activities (13.3).

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13 Surveillance (2)

The CB shall require the supplier to inform it about changes such as:

intended modification of:

the product (13.2)

the manufacturing process (13.2)

the QMS (if relevant) (13.2)

the product design (4.6.2 c))

changes in ownership/structure/management of the supplier (4.6.2 c))

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