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 It together with BS EN ISO/IEC 17050‑1:2004, supersdes BS EN 45014:1998 which is withdrawn.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 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.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 26 October 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.

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

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.

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 reference s 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 tra nslation under the responsibility of a CEN or CENELEC member into its own language and notified to the CEN Management Centre has the sam e status as the official versions.

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.

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.

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.

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Traceability

4.2 Availability

4.3 Retention period

5 Contents of the supporting documentation

5.1

5.2

5.3

BS EN ISO/IEC 17050-2:2004

Conformity assessment. Supplier's declaration of conformity - Supporting documentation

Current

Published:

26 Oct 2004