BRITISH STANDARD BS EN ISO/IEC

17050-1:2010

Conformity assessment
— Supplier's
declaration of
conformity
Part 1: General requirements (ISO/
IEC 17050-1:2004, corrected version
2007-06-15)

ICS 03.120.20

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

BS EN ISO/IEC 17050-1:2010

National foreword

This British Standard is the UK implementation of

EN ISO/IEC 17050-1:2010. It is identical to ISO/IEC 17050-1:2004,
corrected version 2007-06-15. It supersedes BS EN ISO/IEC 17050-1:2004
which is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CAS/1, Conformity assessment.
A list of organizations represented on this committee can be obtained on
request to its secretary.
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 cannot confer immunity
from legal obligations.

This British Standard Amendments/corrigenda issued since publication

was published under the
authority of the Standards
Policy and Strategy Date Comments
Committee on 31 May 2010

© BSI 2010

ISBN 978 0 580 70040 8

EUROPEAN STANDARD EN ISO/IEC 17050-1
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2010

ICS 03.120.20 Supersedes EN ISO/IEC 17050-1:2004

English version

Conformity assessment - Supplier's declaration of conformity -

Part 1: General requirements (ISO/IEC 17050-1:2004, corrected
version 2007-06-15)

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

fournisseur - Partie 1: Exigences générales (ISO/IEC Anbietern - Teil 1: Allgemeine Anforderungen (ISO/IEC
17050-1:2004, version corrigée 2007-06-15) 17050-1:2004, korrigierte Fassung 2007-06-15)

This European Standard was approved by CEN on 13 March 2010.

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 and 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 and CENELEC member into its own language and notified to the CEN Management Centre has the same
status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.

CEN Management Centre: CENELEC Central Secretariat:

Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels

© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17050-1:2010 E
worldwide for CEN national Members and for CENELEC
Members.
BS EN ISO/IEC 17050-1:2010
EN ISO/IEC 17050-1:2010 (E)

Foreword
The text of ISO/IEC 17050-1:2004, corrected version 2007-06-15 has been prepared by Committee on
conformity assessment (CASCO) of the International Organization for Standardization (ISO) and the
International Electrotechnical Commission (IEC) and has been taken over as EN ISO/IEC 17050-1:2010 by
Technical Committee CEN/CLC/TC 1 “Criteria for conformity assessment bodies” the secretariat of which is
held by BSI.

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 October 2010, and conflicting national standards shall be withdrawn at
the latest by October 2010.

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

This document supersedes EN ISO/IEC 17050-1:2004.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO/IEC 17050-1:2004, corrected version 2007-06-15 has been approved by CEN as a EN
ISO/IEC 17050-1:2010 without any modification.

3
 BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

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 17050-1 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 17050-1, together with ISO/IEC 17050-2, 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

This corrected version of ISO/IEC 17050-1:2004 incorporates the correction of the numbering of the list
in 10.2, and an updated Bibliography.

© ISO 2004 — All rights reserved iii

BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

Introduction
This part of ISO/IEC 17050 has been developed with the objective of providing general requirements for a
supplier’s declaration of conformity.

It addresses one of the three types of attestation of conformity, namely attestation undertaken by the first party
(e.g. the supplier of a product). Other types are second-party attestation (e.g. where a user issues an
attestation for the product the user is using) or third-party attestation. Each of these three types is used in the
market in order to increase confidence in the conformity of an object.

This part of ISO/IEC 17050 specifies requirements applicable when the individual or organization responsible
for fulfilment of specified requirements (supplier) provides a declaration that a product (including service),
process, management system, person or body is in conformity with specified requirements, which can include
normative documents such as standards, guides, technical specifications, laws and regulations. Such a
declaration of conformity can also make reference to the results of assessments by one or more first, second
or third parties. Such references are not to be interpreted as reducing the responsibility of the supplier in any
way.

These general requirements are applicable to all sectors. However, these requirements might need to be
supplemented for specific purposes, for example for use in connection with regulations.

A supplier's declaration of conformity of a product (including service), process, management system, person
or body to specified requirements can be substantiated by supporting documentation under the responsibility
of the supplier. In cases where this is desirable, or necessary, reference is made to ISO/IEC 17050-2.

iv © ISO 2004 — All rights reserved

 BS EN ISO/IEC 17050-1:2010
INTERNATIONAL STANDARD ISO/IEC 17050-1:2004(E)

Conformity assessment — Supplier's declaration

of conformity —

Part 1:
General requirements

1 Scope
This part of ISO/IEC 17050 specifies general requirements for a supplier’s declaration of conformity in cases
where it is desirable, or necessary, that conformity of an object to the specified requirements be attested,
irrespective of the sector involved. 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.

This part of ISO/IEC 17050 does not define any particular object for the declaration of conformity.

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

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

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 Purpose of the declaration of conformity

The purpose of the declaration is to give assurance of conformity of the identified object to specified
requirements to which the declaration refers, and to make clear who is responsible for that conformity and
declaration. A supplier’s declaration of conformity may be used alone or in conjunction with another conformity
assessment procedure for regulatory or non-regulatory purposes.

© ISO 2004 — All rights reserved 1

BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

5 General requirements

The issuer (issuing organization or person) of a declaration of conformity shall be responsible for issuing,
maintaining, extending, reducing, suspending or withdrawing the declaration and the conformity of the object
to the specified requirements.

The declaration of conformity shall be based on results of an appropriate type of conformity assessment
activity (e.g. testing, measurement, auditing, inspection or examination) carried out by one or more first,
second or third parties. Conformity assessment bodies involved, where applicable, should consult relevant
International Standards, Guides and other normative documents.

Where a declaration of conformity is for a group of products of a similar type, it shall cover each individual
product of the group. Where a declaration of conformity is for similar products delivered over a period of time,
it shall cover each product as delivered or accepted.

It is recommended, as good conformity assessment practice, that the person reviewing the conformity
assessment results be different from the signatory.

6 Contents of the declaration of conformity

6.1 The issuer of the declaration of conformity shall ensure that the declaration contains sufficient
information to enable the recipient of the declaration of conformity to identify the issuer of the declaration, the
object of the declaration, the standards or other specified requirements with which conformity is declared, and
the person signing for and on behalf of the issuer of the declaration of conformity.

As a minimum, the declaration of conformity shall contain the following:

a) unique identification of the declaration of conformity;

b) the name and contact address of the issuer of the declaration of conformity;

c) the identification of the object of the declaration of conformity (e.g. name, type, date of production or
model number of a product, description of a process, management system, person or body, and/or other
relevant supplementary information);

d) the statement of conformity;

e) a complete and clear list of standards or other specified requirements, as well as the selected options, if
any;

f) the date and place of issue of the declaration of conformity;

g) the signature (or equivalent sign of validation), name and function of the authorized person(s) acting on
behalf of the issuer;

h) any limitation on the validity of the declaration of conformity.

6.2 Additional supporting information may be provided to relate the declaration to the conformity
assessment results on which it is based, for example:

a) the name and address of any conformity assessment body involved (e.g. testing or calibration laboratory,
inspection body, certification body);

b) reference to relevant conformity assessment reports, and the date of the reports;

c) reference to any management systems involved;

2 © ISO 2004 — All rights reserved

 BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

d) reference to the accreditation documents of conformity assessment bodies involved where the scope of
accreditation is relevant to the declaration of conformity;

e) reference to the existence of associated supporting documentation, such as that described in

ISO/IEC 17050-2;

f) additional information regarding certificates, registrations or marks that have been obtained;

g) other activities or programmes of the conformity assessment body (e.g. membership in an agreement
group).

References in the documentation to conformity assessment results shall not misrepresent their applicability
nor mislead the recipient of the declaration of conformity.

7 Form of declaration of conformity

See Annex A for an example of a declaration of conformity. The declaration of conformity may be in hardcopy,
electronic media, or any other suitable medium.

8 Accessibility
A copy of the declaration of conformity may be included in other documentation, such as a statement,
catalogue, invoice, user's instructions or website, relevant to the object of the declaration of conformity.

9 Product marking
If any marking is placed on the product to indicate the existence of a declaration of conformity, such marking
shall be in such a format that it will not be confused with any certification mark. Such marking shall be
traceable to the declaration of conformity.

10 Continuing validity of the declaration of conformity

10.1 The issuer of the declaration of conformity shall have procedures in place to ensure the continued
conformity of the object, as delivered or accepted, with the stated requirements of the declaration of
conformity.

10.2 The issuer of the declaration of conformity shall have procedures in place to re-evaluate the validity of
the declaration of conformity, in the event of

a) changes significantly affecting the object’s design or specification,

b) changes in the standards to which conformity of the object is stated,

c) changes in the ownership or structure of management of the supplier, if relevant, or

d) relevant information indicating that the object may no longer conform to the specified requirements.

© ISO 2004 — All rights reserved 3

BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

Annex A
(informative)

Supplier's declaration of conformity

A.1 Guidance to complete the form of declaration of conformity

NOTE Numbers 1) to 7) refer to the form shown in A.2.

1) Every declaration of conformity should be uniquely identified.

2) The responsible issuer should be unequivocally specified. For large organizations, it may be necessary to
specify operational groups or departments.

3) a) The “object” should be unequivocally described so that the declaration of conformity may be related
to the object in question.

3) b) For mass-produced products, it is not necessary to give individual serial numbers. In such cases it is
sufficient to give the name, type, model number, etc.

4) For products, an alternative conformity statement may be: “As delivered, the object of the declaration
described above is in conformity with the requirements of the following documents”.

5) Requirements documents should be listed with their identification numbers, titles and dates of issue.

6) Text should appear here only if any limitation on the validity of the declaration of conformity and/or any
additional information are given. The latter information may, for example, correspond to 6.2 or may make
reference to related product marking in accordance with Clause 9. Such product marking or other
indication (e.g. on the product) may be an attachment to the declaration of conformity.

7) Full name and function of the signing person(s) authorised by the issuer's management to sign on its
behalf should be given. The number of signatures, or equivalent, included will be the minimum
determined by the legal form of the issuer’s organization.

4 © ISO 2004 — All rights reserved

 BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

A.2 Example of form of declaration of conformity

Supplier's declaration of conformity (in accordance with ISO/IEC 17050-1)

1) No. .........................................

2) Issuer's name: ...................................................................................................................

Issuer's address: ...................................................................................................................

...................................................................................................................

3) Object of the declaration: ...................................................................................................................

...................................................................................................................

...................................................................................................................

4) The object of the declaration described above is in conformity with the requirements of the
following documents:

Documents No. Title Edition/Date of issue

5) .......................... ............................................................................. ................................................

.......................... ............................................................................. ................................................

.......................... ............................................................................. ................................................

Additional information:

6) .................................................................................................................................................................

.................................................................................................................................................................

.................................................................................................................................................................

Signed for and on behalf of:

..................................................

..................................................

(Place and date of issue)

7) .................................................. ............................................................................................................

(Name, function) (Signature or equivalent authorized by the issuer)

© ISO 2004 — All rights reserved 5

BS EN ISO/IEC 17050-1:2010
ISO/IEC 17050-1:2004(E)

Bibliography

[1] ISO 9000:2000, Quality management systems — Fundamentals and vocabulary

[2] ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing

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

[4] ISO/IEC 17021:2006, Conformity assessment — Requirements for bodies providing audit and
certification of management systems

[5] ISO/IEC 17024:2003, Conformity assessment — General requirements for bodies operating
certification of persons

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

[7] ISO/IEC 17040:2005, Conformity assessment — General requirements for peer assessment of
conformity assessment bodies and accreditation bodies

[8] ISO/IEC 17050-2:2004, Conformity assessment — Supplier’s declaration of conformity — Part 2:

Supporting documentation

[9] ISO/IEC Guide 65:1996, General requirements for bodies operating product certification systems

6 © ISO 2004 — All rights reserved

BS EN ISO/IEC 17050-1:2010
BS EN ISO/IEC
17050-1:2010
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