unido the conformity assessment toolbox-building trust.pdf

7/28/2019 UNIDO The Conformity Assessment Toolbox-Building Trust.pdf

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The Conformity Assessment Toolbox


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The Conformity Assessment Toolbox

The Conformiti Assessment Toollbox


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Building trust The Conformity As-

sessment Toolbox is a comprehensive,

user-friendly handbook covering all as-

pects of conformity assessment and its

role in international trade, and will beuseful for business managers, regula-

tors and consumer representatives. It

is the latest in a series of joint publica-

tions issued by ISO and UNIDO, and

is the result of the long-standing and

fruitful partnership between the two

organizations to strengthen the stan-

dardization and quality infrastructuresof developing countries and coun-

tries with economies in transition. Al-

though aimed specifically at this group

of countries, these publications are

also intended to serve as handy refer-

ence tools for all who are involved or

interested in conformity assessment

and trade.

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Where technical regulations govern

the transaction, the decision as to the

means of conformity assessment maybe taken out of the hands of the two

main parties to the transaction, and

proof of conformity, in a prescribed

format, might be required. This raises

the question of how the competence

and independence of the third party

conformity assessment providers can

be demonstrated, and introduces thesubject of accreditation.

ISO/IEC 17000 defines accreditation

as the third-party attestation related

to a conformity assessment body con-

veying formal demonstration of its

competence to carry out specific con-

formity assessment tasks. Accredita-

tion can relate to competence in the

performance of tests and calibrations

in laboratories, or to the competence ofcertification and inspection bodies.

Accreditation bodies need themselves

to show that they are independent and

unbiased, and for this reason are often

established as national or regional en-

tities that in practice need to demon-

strate the existence of mutual rec-ognition arrangements by means of

membership of relevant international

bodies that engage in peer reviews of

each other.

In the accreditation sphere, two key in-

ternational groups are the International

Laboratory Accreditation Cooperation


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Certification bodies will typically use

Figure 7 outlines a typical sequence in

the process of seeking and obtaining


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Certification bodies will typically use

specialist auditors to undertake their

assessments of the management sys-

tems of their clients. Such auditors will

normally require training in auditingpractices and principles (such as those

embodied in ISO 19011) as well as

being qualified by auditor certification

bodies (itself a form of personnel cer-

tification).

This should include examination of

the auditors knowledge of the rele-vant management systems standards.

Prior to their recognition as compe-

tent auditors, they will be expected to

participate in a number of audits in

various roles as observers and, pro-

gressively, under the supervision of

experienced auditors.

It is also necessary for the audit team

to include expertise relevant to the

technical area in which the client or-

ganization works. Such expertise could

relate, for example, to the design fea-

tures of a product, its means of produc-

tion, the ways in which it is used and re-lated legislation and industry codes of

practice. It is not uncommon for certi-

fication bodies to use external techni-

cal auditors as part of the assessment

teams to complement the expertise of

their own auditors.

the process of seeking and obtaining

certification.

There may be a number of addition-

al steps in the above process if, forexample, a follow up assessment visit

is required to confirm that deficiencies

found in the initial assessment visit,

have been rectified.

An important component in the pro-

cess is the need for ongoing surveil-

lance of the certified quality systemscontinuing compliance. The frequen-

cy of visits and off-site surveillance will

vary, and details of these cycles should

be publicly available from all certifica-

tion bodies.

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A recent UNIDO Technical Assistance

project illustrates the ability of existing

infrastructures to be used effectively

to extend the conformity assessment

capabilities in a developing coun-

try. In Bangladesh, the lack of a localbody for management system certifica-

tion was considered a gap, but assessed

as an activity with great potential for

growth to upgrade the functioning of

exporting enterprises and to increase

Bangladeshs share in the international

market.


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Standard and/or project Potential users

ISO/IEC 17000 :2004Conformity assessment Vocabularyand general principles

Standards Bodies ; Conformity Assessment Bodies ; AccrediBodies ; Government Authorities ; Regulators ; MRA AgreemGroups ; Trade Officials ; Academic Institutions ; Industry anAssociations ; Professional Bodies ; Specifying Bodies

ISO/PAS 17001 :2005Conformity assessment I ti lit P i i l d

Standards Bodies ; Conformity Assessment Bodies ; AccrediBodies ; Government Authorities ; Regulators ; MRA AgreemG


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Impartiality Principles andrequirements

Groups

ISO/PAS 17002 :2004Conformity assessment Confidentiality Principles andrequirements

Standards Bodies ; Conformity Assessment Bodies ; AccrediBodies ; Government Authorities ; Regulators ; MRA AgreemGroups

ISO/PAS 17003 :2004Conformity assessment Complaintsand appeals Principles and

requirements


ISO/PAS 17004 :2005Conformity assessment Disclosureof information Principles andrequirements


ISO/PAS 17005 :2008Conformity assessment Use ofmanagement systems Principlesand requirements

Standards Bodies ; Systems Certification Bodies ; AuditorAssociations ; Accreditation Bodies

ISO/IEC DIS 17007Conformity assessment Guidelinesfor drafting normative documentssuitable for use for conformityassessment

Standards Bodies ; Regulators ; Specification Writers ; ConfoAssessment Bodies ; Accreditation Bodies


ISO/IEC 17011 :2004Conformity assessment Generalrequirements for accreditationbodies accrediting conformityassessment bodies

Accreditation Bodies ; Trade Officials ; Government AuthoriMRA Agreement Groups (e.g. IAF, ILAC, APLAC, EA, IAPAC, SADCA)

ISO/IEC 17020 :1998

General criteria for the operation ofvarious types of bodies performinginspection

Inspection Bodies ; Specifiers and Users of Inspection Bodie

Regulators ; Accreditation Bodies ; Purchasing Bodies ; MRAAgreement Groups (e.g. ILAC and IAF)

ISO/IEC 17021 :2006Conformity assessment Require-ments for bodies providing audit and

Management Systems (e.g. quality and environmental) CertBodies ; Auditor Associations ; Accreditation Bodies ; MRAAgreement Groups (e g IAF)


ISO/IEC 17030 :2003Conformity assessment Generalrequirements for third-party marksof conformity

Third Party Certification Bodies ;Consumer Associations ; Regulators ; Accreditation Bodies

ISO/IEC 17040 :2005Conformity assessment Generalrequirements for peer assessment of

MRA Agreement Groups ; Laboratories ; Inspection Bodies Product, Systems and Personnel Certification Bodies


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requirements for peer assessment ofconformity assessment bodies andaccreditation bodies

ISO/IEC DIS 17043Conformity assessment Generalrequirements for proficiency testing

Proficiency Testing Bodies ; Laboratories ; Accreditation BodReference Material Producers ; Regulators ; Standards BodiProfessional Bodies (for educational value of proficiency tes

ISO/IEC 17050-1 :2004Conformity assessment Suppliersdeclaration of conformity Part 1 :

General requirements

Manufacturers and Service Providers ; Regulators ; RetailersComponent Purchasing Bodies

ISO/IEC 17050-2 :2004Conformity assessment Suppliersdeclaration of conformity Part 2 :Supporting documentation

Manufacturers and Service Providers ; Regulators ; RetailersComponent Purchasing Bodies

ISO/IEC CD 17065Conformity assessment Require-ments for certification bodies certify-ing products, processes and services

Product Certification Bodies ;Accreditation Bodies ; Standards Bodies ; Regulators ; ConsuAssociations ; Manufacturers and Service Providers ; MajorRetailers ; Industry Associations ; Importers and Exporters

ISO/IEC Guide 7 :1994

Guidelines for drafting of standardssuitable for use for conformityassessment

Standards Bodies ; Conformity Assessment Bodies ; AccrediBodies ; Regulators ; Trade Officials ; Consumer and IndustryAssociations


ISO/IEC Guide 23 :1982Methods of indicating conformitywith standards for third-party certifi-cation systems

Certification Bodies

ISO Guide 27 :1983Guidelines for corrective action tobe taken by a certification body inthe event of misuse of its mark ofconformity

Certification Bodies ; Accreditation Bodies

Status

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rentJuly2009

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rentJuly2009

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rentJuly2008


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Standardand/orproject

Potentialusers

ISO/IECGuide60:2004

ConformityassessmentC

odeof

goodpractice

ConformityAssessmentBodies;Accreditatio

nBodies;Trade

Officials;Regula

tors;ConsumerAssociations;IndustryandTrade

Associations;MRAAgreementGroups

Cur

ISO/IECGuide65:1996

Generalrequirementsforbodies

operatingproductcertifica

tion

systems

ProductCertificationBodies;

AccreditationBodies;StandardsBodies;Regulators;Consumer

Associations;ManufacturersandServicePro

viders;Major

Retailers;IndustryAssociations;Importersa

ndExporters

Cur(repIECcom

ISO/IECGuide67:2004

Conformityassessment

Fundamentalsofproduct

certification

ProductCertificationBodies;ConsumerAssociations;Regulators;

AccreditationBodies(forproductcertificatio

n);MRAAgreement

Groups(e.g.IAF

);Suppliers;Manufacturers

andServiceProviders;

Retailers

Cur

ISO/IECGuide68:2002

Arrangementsforthereco

gnition

andacceptanceofconform

ity

assessmentresults

PurchasingAuth

orities;Regulators;TradeOfficials;Accreditation

Bodies;Conform

ityAssessmentBodies;MR

AAgreementGroups

Cur


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Recognition Arrangements (MRA/

MLA) have been successfully peer-

evaluated by ILAC).

Stakeholders Open to representa-

tive international, regional and na-

tional organizations having an inter-

est in the work of ILAC and include

members determine the policies of the

organizations while specialist commit-

tees work on different aspects such as

the development of guidance material

for members or promotion of accredi-

tation. Stakeholders in the outcome of

accreditation such as associations of


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est in the work of ILAC and includebodies such as associations of labo-

ratories, associations of laboratory

practitioners, inspection body asso-

ciations, purchasing organizations,

regulatory authorities, consumer as-

sociations and trade organizations.

Both ILAC and IAF are organized insuch a way that the accreditation body

accreditation such as associations oftesting laboratories and certification

bodies, end users and regulatory au-

thorities are allowed to participate in

the work of the forums but their voting

rights are limited.

The structures of the two internation-

al bodies are as shown in the Figures17 and 18 :

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International Organizationfor Standardization

1, chemin de la Voie-CreuseCase postale 56

CH -1211 Genve 20Switzerland

Tel. + 41 22 749 01 11Fax + 41 22 733 34 30E-mail [email protected] www.iso.org

IS BN 978-92-67-10511-6

ISO, 2009-10/

ISO Central Secretariat

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