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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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3GDBDQSHkB@SHNMOQNBDRR
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
Standards Bodies ; Conformity Assessment Bodies ; AccrediBodies ; Government Authorities ; Regulators ; MRA AgreemGroups
ISO/PAS 17004 :2005Conformity assessment Disclosureof information Principles andrequirements
Standards Bodies ; Conformity Assessment Bodies ; AccrediBodies ; Government Authorities ; Regulators ; MRA AgreemGroups
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
Standard and/or project Potential users
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)
Standard and/or project Potential users
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
Standard and/or project Potential users
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
u
rentJuly2009
u
rentJuly2009
p
lacementbynewISO/
EC
17065expectedon
om
pletionandadoption)
u
rentJuly2009
u
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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