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BRITISH STANDARD BS EN ISO/IEC

17050-2:2004

Conformity
assessment —
Supplier’s declaration
of conformity —
Part 2: Supporting documentation
(c) BSI

The European Standard EN ISO/IEC 17050-2:2004 has the status of a

British Standard

ICS 03.120.20

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BS EN ISO/IEC 17050-2:2004

National foreword
This British Standard is the official English language version of
EN ISO/IEC 17050-2:2004. It is identical with ISO/IEC 17050-2:2004.
It together with BS EN ISO/IEC 17050-1:2004, supersdes BS EN 45014:1998
which is withdrawn.
NOTE The first edition of ISO/IEC 17050-2, together with ISO/IEC 17050-1, cancels and replaces
the second edition of ISO/IEC Guide 22:1996, General Criteria for supplier’s declaration of
conformity.
BS EN ISO/IEC 17050:2004 consists of the following parts, under the general
title Conformity assessment — Supplier’s declaration of conformity:
— Part 1: General requirements;
— Part 2: Supporting documentation.
The UK participation in its preparation was entrusted to Technical Committee
QS/3, Conformity assessment procedures, which has the responsibility to:

— aid enquirers to understand the text;

— present to the responsible international/European committee any

enquiries on the interpretation, or proposals for change, and keep the
UK interests informed;
— monitor related international and European developments and
promulgate them in the UK.

A list of organizations represented on this committee can be obtained on

request to its secretary.
Cross-references
The British Standards which implement international or European
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publications referred to in this document may be found in the BSI Catalogue

under the section entitled “International Standards Correspondence Index”, or
by using the “Search” facility of the BSI Electronic Catalogue or of
British Standards Online.
This publication does not purport to include all the necessary provisions of a
contract. Users are responsible for its correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, the EN ISO/IEC
title page, the EN ISO/IEC foreword page, the ISO/IEC title page, pages ii to iv,
pages 1 and 2, an inside back cover and a back cover.
The BSI copyright notice displayed in this document indicates when the
document was last issued.

Amendments issued since publication

This British Standard was
published under the authority Amd. No. Date Comments
of the Standards Policy and
Strategy Committee on
26 October 2004

© BSI 26 October 2004

ISBN 0 580 44684 0

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EUROPEAN STANDARD EN ISO/IEC 17050-2

NORME EUROPÉENNE
EUROPÄISCHE NORM October 2004

ICS 03.120.20 Supersedes EN 45014:1998

English version

Conformity assessment - Supplier's declaration of conformity -

Part 2: Supporting documentation (ISO/IEC 17050-2:2004)

Evaluation de la conformité - Déclaration de conformité du Konformitätsbewertung - Konformitätserklärung von

fournisseur - Partie 2: Documentation d'appui (ISO/IEC Anbeitern - Teil 2: Unterstützende Dokumentation (ISO/IEC
17050-2:2004) 17050-2:2004)

This European Standard was approved by CEN and CENELEC on 30 September 2004.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN or CENELEC member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
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CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria,
Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.

CEN Management Centre: CENELEC Central Secretariat:

rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels

© 2004 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17050-2:2004 E
worldwide for CEN national Members and for CENELEC
Members.
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EN ISO/IEC 17050−2:2004

Foreword

This document (EN ISO/IEC 17050-2:2004) has been prepared by Technical Committee
ISO/CASCO "Committee on conformity assessment" in collaboration with Technical Committee
CEN/CLC/TC 1 "Criteria for conformity assessment bodies", the secretariat of which is held by
SN.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by April 2005, and conflicting national
standards shall be withdrawn at the latest by April 2005.

This document supersedes EN 45014:1998.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of

the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice

The text of ISO/IEC 17050-2:2004 has been approved by CEN and CENELEC as EN ISO/IEC
17050-2:2004 without any modifications.
(c) BSI
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EN ISO/IEC 17050−2:2004
INTERNATIONAL ISO/IEC
STANDARD 17050-2

First edition
2004-10-01

Conformity assessment — Supplier's

declaration of conformity —
Part 2:
Supporting documentation
Évaluation de la conformité — Déclaration de conformité du
fournisseur —
Partie 2: Documentation d'appui
(c) BSI

Reference number
ISO/IEC 17050-2:2004(E)
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EN ISO/IEC 17050−2:2004

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(c) BSI

ii
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EN ISO/IEC 17050−2:2004

Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are members of
ISO or IEC participate in the development of International Standards through technical committees
established by the respective organization to deal with particular fields of technical activity. ISO and IEC
technical committees collaborate in fields of mutual interest. Other international organizations, governmental
and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity
assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of
International Standards and Guides.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

Draft International Standards are circulated to the national bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the national bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO/IEC 17050-2 was prepared by the ISO Committee on conformity assessment (CASCO).

It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both
organizations.
(c) BSI

This first edition of ISO/IEC 17050-2, together with ISO/IEC 17050-1, cancels and replaces the second edition
of ISO/IEC Guide 22:1996, General criteria for supplier's declaration of conformity.

ISO/IEC 17050 consists of the following parts, under the general title Conformity assessment — Supplier's
declaration of conformity:

 Part 1: General requirements

 Part 2: Supporting documentation

iii
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EN ISO/IEC 17050−2:2004

Introduction
A supplier’s declaration of conformity is a form of attestation of conformity to meet demands from the market
and regulators for confidence. The acceptance of a supplier’s declaration of conformity could be enhanced by
retaining documented information on which the supplier bases the declaration and making this documentation
available upon request.

This part of ISO/IEC 17050 specifies requirements for the documentation to support a supplier’s declaration of
conformity. Besides enhancing confidence in the supplier's declaration of conformity, such documentation
may assist relevant authorities in their surveillance activities.

Conformity of a product (including service), process, management system, person or body to specified
requirements, which can include normative documents such as standards, guides, technical specifications,
laws and regulations, may need to be rigorously substantiated under the responsibility of the supplier,
irrespective of the industry sector involved.
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iv
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EN ISO/IEC 17050−2:2004
INTENRATIONAL TSANDADR IS/OIE05071 C-2:002(4)E

Conformity assessment — Supplier's declaration

of conformity —

Part 2:
Supporting documentation

1 Scope
This part of ISO/IEC 17050 specifies general requirements for supporting documentation to substantiate a
supplier’s declaration of conformity, as described in ISO/IEC 17050-1.

For the purposes of this part of ISO/IEC 17050, the object of a declaration of conformity can be a product,
process, management system, person or body.

Instead of “supplier's declaration of conformity”, the term “declaration of conformity” can be used when
appropriate.
(c) BSI

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

ISO/IEC 17000:2004, Conformity assessment —Vocabulary and general principles

ISO/IEC 17050-1:2004, Conformity assessment — Supplier's declaration of conformity — Part 1: General

requirements

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC 17000 apply.

NOTE 1 “Supplier's declaration of conformity” is a “declaration” as defined in ISO/IEC 17000, i.e. first-party attestation.

NOTE 2 To avoid any confusion with attestation by certification bodies, the term “self-certification” is deprecated and
should not be used.

4 General requirements

4.1 Traceability

Supporting documentation shall be developed, kept, controlled and maintained in a way that allows traceability
from a supplier’s declaration of conformity.

1
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EN ISO/IEC 17050−2:2004

4.2 Availability

The issuer (issuing organization or person) of the declaration of conformity shall make supporting
documentation available, as requested, to the relevant regulatory authority to the extent necessary to satisfy
regulatory requirements. The issuer may make supporting documentation available to any other requesting
person or body.

4.3 Retention period

The retention of supporting documentation shall be for a period in accordance with applicable laws and
regulations, but may be longer at the discretion of the issuer. Specific needs of customers and other interested
parties shall be considered.

5 Contents of the supporting documentation

5.1 The supporting documentation shall include, as applicable, the following information to demonstrate
conformity with the declared requirements (see ISO/IEC 17050-1:2004, Clause 6 and Annex A):

a) description of the object of the declaration (product, process, management system, person or body);

b) design documentation (e.g. descriptions, diagrams, drawings, identification of the area of expertise and
competence, specifications);

c) conformity assessment results, such as


(c) BSI

description of methods used (e.g. auditing; audit procedures; batch testing; design review,
verification and validation; inspection; sampling plan; serial testing; test methods; type testing) and
reasons for their selection,

 results (e.g. audit report, test report), and

 evaluation of results, including deviations and concessions;

d) identification and relevant qualifications and technical competence of the first-, second- or third-party
conformity assessment bodies involved, and details of their accreditation status (e.g. scope, name of the
accreditation body).

5.2 Where necessary to demonstrate conformity to declared requirements, the following should also be
included:

a) description of the management system relevant to the object of the declaration;

b) other relevant information (e.g. risk analysis, re-assessment procedures and schedules).

5.3 Any change in the supporting documentation described in 5.1 and 5.2 which affects the validity of the
declaration of conformity shall be documented.

2
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BS EN ISO/IEC
17050-2:2004
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