SIST-TS ISO/TS 22003:2016
Food safety management systems -- Requirements for bodies providing audit and certification of food safety management systems
Food safety management systems -- Requirements for bodies providing audit and certification of food safety management systems
ISO/TS 22003:2013 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements). It also provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.
Systèmes de management de la sécurité des denrées alimentaires -- Exigences pour les organismes procédant à l'audit et à la certification de systèmes de management de la sécurité des denrées alimentaires
L'ISO/TS 22003:2013 définit les règles applicables à l'audit et à la certification d'un système de management de la sécurité des denrées alimentaires (SMSDA) conforme aux exigences données dans l'ISO 22000 (ou à d'autres ensembles d'exigences spécifiées en la matière). Elle fournit également aux clients les informations nécessaires sur la manière de procéder à la certification de leurs fournisseurs et leur donne ainsi confiance dans cette certification.
Sistemi vodenja varnosti živil - Zahteve za organe, ki izvajajo presoje in certificiranje sistemov vodenja varnosti živil
Ta tehnična specifikacija določa pravila, ki se uporabljajo za presojanje in certificiranje sistema vodenja varnosti živil v skladu z zahtevami standarda ISO 22000 (ali drugimi nabori zahtev za sisteme vodenja varnosti živil). Poleg tega podaja potrebne informacije in ponuja osnovo za zaupanje odjemalcev glede načina certificiranja njihovih dobaviteljev.
Certificiranje sistemov vodenja varnosti živil je dejavnost ugotavljanja skladnosti, ki jo opravljajo tretje osebe (kot je določeno v točki 5.5 standarda ISO/IEC 17000:2004); organi, ki izvajajo to aktivnost, so zunanji organi za ugotavljanje skladnosti.
OPOMBA 1: V tej tehnični specifikaciji se izraza »proizvod« in »storitev« uporabljata ločeno (v nasprotju z definicijo izraza »proizvod«, podano v standardu ISO/IEC 17000).
OPOMBA 2: To tehnično specifikacijo je mogoče uporabiti kot dokument z merili za akreditacijo ali medsebojno ocenjevanje certifikacijskih organov, ki želijo prejeti potrdilo o usposobljenosti za certificiranje sistemov vodenja varnosti živil v skladu s standardom ISO 22000. Namenjen je tudi za uporabo kot dokument z merili za upravne organe in industrijske konzorcije, ki omogočajo neposredno potrditev certifikacijskih organov glede usposobljenosti za certificiranje sistemov vodenja varnosti živil v skladu s standardom ISO 22000. Nekatere zahteve, ki jih vključuje, so lahko uporabne tudi za druge udeležence v postopku ugotavljanja skladnosti tovrstnih certifikacijskih organov in organov za certificiranje skladnosti sistemov vodenja varnosti živil z drugimi merili, ki niso zajeta v standardu ISO 22000. Certificiranje sistemov vodenja varnosti živil ne dokazuje varnosti ali primernosti proizvodov določene organizacije znotraj prehranjevalne verige. Vendar ISO 22000 zahteva, da organizacija izpolnjuje vse ustrezne zakonske in upravne zahteve v zvezi z varnostjo živil v okviru svojega sistema vodenja organizacije.
OPOMBA 3: Certificiranje sistema vodenja varnosti živil v skladu s standardom ISO 22000 pomeni certificiranje sistema upravljanja in ne certificiranje proizvodov.
Drugi uporabniki sistema vodenja varnosti živil lahko uporabljajo koncepte in zahteve te tehnične specifikacije pod pogojem, da so zahteve ustrezno prilagojene.
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SLOVENSKI STANDARD
01-april-2016
Sistemi vodenja varnosti živil - Zahteve za organe, ki izvajajo presoje in
certificiranje sistemov vodenja varnosti živil
Food safety management systems -- Requirements for bodies providing audit and
certification of food safety management systems
Systèmes de management de la sécurité des denrées alimentaires -- Exigences pour les
organismes procédant à l'audit et à la certification de systèmes de management de la
sécurité des denrées alimentaires
Ta slovenski standard je istoveten z: ISO/TS 22003:2013
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
67.020 Procesi v živilski industriji Processes in the food
industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL ISO/TS
SPECIFICATION 22003
Second edition
2013-12-15
Food safety management systems —
Requirements for bodies providing
audit and certification of food safety
management systems
Systèmes de management de la sécurité des denrées alimentaires —
Exigences pour les organismes procédant à l’audit et à la certification
de systèmes de management de la sécurité des denrées alimentaires
Reference number
©
ISO 2013
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 2
5 General requirements . 2
5.1 General . 2
5.2 Management of impartiality . 2
6 Structural requirements . 2
7 Resource requirements . 2
7.1 Competence of management and personnel . 2
7.2 Personnel involved in the certification activities . 3
7.3 Use of individual external auditors and external technical advisors . 3
7.4 Personnel records. 3
7.5 Outsourcing. 3
8 Information requirements . 4
9 Process requirements . 4
9.1 General requirements . 4
9.2 Initial audit and certification . 6
9.3 Surveillance activities . 7
9.4 Recertification . 7
9.5 Special audits . 7
9.6 Suspending, withdrawing or reducing the scope of certification . 7
9.7 Appeals . 7
9.8 Complaints . 8
9.9 Records of applicants and clients . 8
10 Management system requirements for certification bodies . 8
Annex A (normative) Classification of food chain categories . 9
Annex B (normative) Minimum audit time .12
Annex C (normative) Required food safety management system (FSMS) competence .14
Annex D (informative) Guidance on generic certification functions .18
Annex E (informative) Food safety management systems and product certification .22
Bibliography .26
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is Technical Committee ISO/TC 34, Food products,
Subcommittee SC 17, Management systems for food safety, in collaboration with the ISO Committee on
conformity assessment (CASCO).
This second edition cancels and replaces the first edition (ISO/TS 22003:2007), which has been
technically revised.
iv © ISO 2013 – All rights reserved
Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line
with its policy.
Requirements for an FSMS can originate from a number of sources. This Technical Specification has
been developed to assist in the certification of FSMS that fulfil the requirements of ISO 22000. The
contents of this Technical Specification can also be used to support certification of FSMS that are based
on other sets of specified FSMS requirements.
This Technical Specification is intended for use by bodies that carry out audit and certification of FSMS
by providing generic requirements for such bodies. Such bodies are referred to as certification bodies.
This wording is not intended to be an obstacle to the use of this Technical Specification by bodies with
other designations that undertake activities covered by the scope of this Technical Specification. This
Technical Specification is intended to be used by anybody involved in the assessment of FSMS. It can also
be used to support other types of food safety certifications based on a combination of ISO/IEC 17021 and
ISO/IEC 17065.
Certification activities involve the audit of an organization’s FSMS. The form of attestation of conformity
of an organization’s FSMS to a specific FSMS standard (e.g. ISO 22000) or other specified requirements
is normally a certification document or a certificate.
It is for the organization being certified to develop its own management systems (e.g. FSMS in
accordance with ISO 22000, other sets of specified FSMS requirements, quality management systems,
environmental management systems or occupational health and safety management systems) and,
other than where relevant legislative requirements specify to the contrary, it is for the organization to
decide how the various components of these will be arranged. The degree of integration between the
various management system components will vary from organization to organization. It is therefore
appropriate for certification bodies that operate in accordance with this Technical Specification to
take into account the culture and practices of their clients with respect to the integration of their FSMS
within the wider organization.
TECHNICAL SPECIFICATION ISO/TS 22003:2013(E)
Food safety management systems — Requirements for
bodies providing audit and certification of food safety
management systems
1 Scope
This Technical Specification defines the rules applicable for the audit and certification of a food safety
management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of
specified FSMS requirements). It also provides the necessary information and confidence to customers
about the way certification of their suppliers has been granted.
Certification of FSMS is a third-party conformity assessment activity (as described in ISO/IEC 17000:2004,
5.5), and bodies performing this activity are third-party conformity assessment bodies.
NOTE 1 In this Technical Specification, the terms “product” and “service” are used separately (in contrast with
the definition of “product” given in ISO/IEC 17000).
NOTE 2 This Technical Specification can be used as a criteria document for the accreditation or peer assessment
of certification bodies which seek to be recognized as be
...
TECHNICAL ISO/TS
SPECIFICATION 22003
Second edition
2013-12-15
Food safety management systems —
Requirements for bodies providing
audit and certification of food safety
management systems
Systèmes de management de la sécurité des denrées alimentaires —
Exigences pour les organismes procédant à l’audit et à la certification
de systèmes de management de la sécurité des denrées alimentaires
Reference number
©
ISO 2013
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 2
5 General requirements . 2
5.1 General . 2
5.2 Management of impartiality . 2
6 Structural requirements . 2
7 Resource requirements . 2
7.1 Competence of management and personnel . 2
7.2 Personnel involved in the certification activities . 3
7.3 Use of individual external auditors and external technical advisors . 3
7.4 Personnel records. 3
7.5 Outsourcing. 3
8 Information requirements . 4
9 Process requirements . 4
9.1 General requirements . 4
9.2 Initial audit and certification . 6
9.3 Surveillance activities . 7
9.4 Recertification . 7
9.5 Special audits . 7
9.6 Suspending, withdrawing or reducing the scope of certification . 7
9.7 Appeals . 7
9.8 Complaints . 8
9.9 Records of applicants and clients . 8
10 Management system requirements for certification bodies . 8
Annex A (normative) Classification of food chain categories . 9
Annex B (normative) Minimum audit time .12
Annex C (normative) Required food safety management system (FSMS) competence .14
Annex D (informative) Guidance on generic certification functions .18
Annex E (informative) Food safety management systems and product certification .22
Bibliography .26
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is Technical Committee ISO/TC 34, Food products,
Subcommittee SC 17, Management systems for food safety, in collaboration with the ISO Committee on
conformity assessment (CASCO).
This second edition cancels and replaces the first edition (ISO/TS 22003:2007), which has been
technically revised.
iv © ISO 2013 – All rights reserved
Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line
with its policy.
Requirements for an FSMS can originate from a number of sources. This Technical Specification has
been developed to assist in the certification of FSMS that fulfil the requirements of ISO 22000. The
contents of this Technical Specification can also be used to support certification of FSMS that are based
on other sets of specified FSMS requirements.
This Technical Specification is intended for use by bodies that carry out audit and certification of FSMS
by providing generic requirements for such bodies. Such bodies are referred to as certification bodies.
This wording is not intended to be an obstacle to the use of this Technical Specification by bodies with
other designations that undertake activities covered by the scope of this Technical Specification. This
Technical Specification is intended to be used by anybody involved in the assessment of FSMS. It can also
be used to support other types of food safety certifications based on a combination of ISO/IEC 17021 and
ISO/IEC 17065.
Certification activities involve the audit of an organization’s FSMS. The form of attestation of conformity
of an organization’s FSMS to a specific FSMS standard (e.g. ISO 22000) or other specified requirements
is normally a certification document or a certificate.
It is for the organization being certified to develop its own management systems (e.g. FSMS in
accordance with ISO 22000, other sets of specified FSMS requirements, quality management systems,
environmental management systems or occupational health and safety management systems) and,
other than where relevant legislative requirements specify to the contrary, it is for the organization to
decide how the various components of these will be arranged. The degree of integration between the
various management system components will vary from organization to organization. It is therefore
appropriate for certification bodies that operate in accordance with this Technical Specification to
take into account the culture and practices of their clients with respect to the integration of their FSMS
within the wider organization.
TECHNICAL SPECIFICATION ISO/TS 22003:2013(E)
Food safety management systems — Requirements for
bodies providing audit and certification of food safety
management systems
1 Scope
This Technical Specification defines the rules applicable for the audit and certification of a food safety
management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of
specified FSMS requirements). It also provides the necessary information and confidence to customers
about the way certification of their suppliers has been granted.
Certification of FSMS is a third-party conformity assessment activity (as described in ISO/IEC 17000:2004,
5.5), and bodies performing this activity are third-party conformity assessment bodies.
NOTE 1 In this Technical Specification, the terms “product” and “service” are used separately (in contrast with
the definition of “product” given in ISO/IEC 17000).
NOTE 2 This Technical Specification can be used as a criteria document for the accreditation or peer assessment
of certification bodies which seek to be recognized as being competent to certify that an FSMS complies with
ISO 22000. It is also intended to be used as a criteria document by regulatory authorities and industry consortia
which engage in direct recognition of certification bodies to certify that an FSMS complies with ISO 22000. Some of
its requirements could also be useful to other parties involved in the conformity assessment of such certification
bodies, and in the conformity assessment of bodies that undertake to certify the compliance of FSMS with criteria
additional to, or other than, those in ISO 22000.
FSMS certification does not attest to the safety or fitness of the products of an organization within
the food chain. However, ISO 22000 requires an organization to meet all applicable food-safety-related
statutory and regulatory requirements through its management system.
NOTE 3 Certification of an FSMS according to ISO 22000 is a management system certification, not a product
certification.
Other FSMS users can use the concepts and requirements of this Technical Specification provided that
the requirements are adapted as necessary.
2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this document
and are indispensable for its application. For dated references, only the edi
...
TECHNICAL ISO/TS
SPECIFICATION 22003
Redline version
compares second edition
to first edition
Food safety management systems —
Requirements for bodies providing
audit and certification of food safety
management systems
Systèmes de management de la sécurité des denrées alimentaires —
Exigences pour les organismes procédant à l’audit et à la certification
de systèmes de management de la sécurité des denrées alimentaires
Reference number
ISO/TS 22003:redline:2014(E)
©
ISO 2014
ISO/TS 22003:redline:2014(E)
IMPORTANT — PLEASE NOTE
This is a provisional mark-up copy and uses the following colour coding:
Text example 1 — indicates added text (in green)
Text example 2 — indicates removed text (in red)
— indicates added graphic figure
— indicates removed graphic figure
1.x . — Heading numbers containg modifications are highlighted in yellow in
the Table of Contents
DISCLAIMER
This Redline version provides you with a quick and easy way to compare the main changes
between this edition of the standard and its previous edition. It doesn’t capture all single
changes such as punctuation but highlights the modifications providing customers with
the most valuable information. Therefore it is important to note that this Redline version is
not the official ISO standard and that the users must consult with the clean version of the
standard, which is the official standard, for implementation purposes.
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO/TS 22003:redline:2014(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Principles . 2
5 General requirements . 3
5.1 General . 3
5.2 Management of impartiality . 3
6 Structural requirements . 3
7 Resource requirements . 3
7.1 Competence of management and personnel . 3
7.2 7.1 Personnel involved in the certification activities Competence of management
and personnel . 3
7.2 Personnel involved in the certification activities . 9
7.3 Use of individual external auditors and external technical experts advisors . 9
7.4 Personnel records. 9
7.5 Outsourcing. 9
8 Information requirements . 9
9 Process requirements . 9
9.1 General requirements . 9
9.2 Initial audit and certification .12
9.3 Surveillance activities .14
9.4 Recertification .14
9.5 Special audits .14
9.6 Suspending, withdrawing or reducing the scope of certification .14
9.7 Appeals .14
9.8 Complaints .14
9.9 Records of applicants and clients .14
10 Management system requirements for certification bodies .14
Annex A (normative) Classification of food chain categories .15
Annex B (informative normative) Minimum audit time .18
Annex C (normative) Required food safety management system (FSMS) competence .21
Annex D (informative) Guidance on generic certification functions .25
Annex E (informative) Food safety management systems and product certification .29
Bibliography .33
ISO/TS 22003:redline:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical
experts in an ISO working group and is accepted for publication if it is approved by more than
50 % of the members of the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a
technical committee and is accepted for publication if it is approved by 2/3 of the members of the
committee casting a vote.
This document is being issued in the Technical Specification series of publications (according toThe
procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1, 3.1) as a “prospective standard for provisional application” in the field
of food safety because there is an urgent need for guidance on how standards in this field should be used
to meet an identified need 1. In particular the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of
the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
This document is not to be regarded as an “International Standard”. It is proposed for provisional
application so that information and experience of its use in practice may be gathered. Comments on the
content of this document should be sent to the ISO Central Secretariat.
A review of this Technical Specification will be carried out not later than 3 years after its publication with
the options of: extension for another 3 years; conversion into an International Standard; or withdrawal.
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO/TS 22003 was prepared by Technical Committee The committee responsible for this document is
Technical Committee ISO/TC 34, Food products, Subcommittee SC 17, Management systems for food
safety, in collaboration with the ISO Committee on conformity assessment (ISO/CASCO).
iv © ISO 2014 – All rights reserved
ISO/TS 22003:redline:2014(E)
This second edition cancels and replaces the first edition (ISO/TS 22003:2007), which has been
technically revised.
ISO/TS 22003:redline:2014(E)
Introduction
Certification of the food safety management system (FSMS) of an organization is one means of providing
assurance that the organization has implemented a system for the management of food safety in line
with its policy.
Requirements for FSMSsan FSMS can originate from a number of sources, and this. This Technical
Specification has been developed to assist in the certification of FSMSsFSMS that fulfil the requirements
of ISO 22000, Food safety management systems — Requirements for any organization in the food chain.
The contents of this Technical Specification maycan also be used to support certification of FSMSsFSMS
that are based on other sets of specified FSMS requirements.
This Technical Specification is intended for use by bodies that carry out audit and certification of
FSMSs. It givesFSMS by providing generic requirements for such certification bodies performing audit
and certification in the field of food safety management systemsbodies. Such bodies are referred to as
certification bodies. This wording should notis not intended to be an obstacle to the use of this Technical
Specification by bodies with other designations that undertake activities covered by the scope of this
document. Indeed, this Technical Specification should be usable by any bodyTechnical Specification.
This Technical Specification is intended to be used by anybody involved in the assessment of FSMSs.
FSMS. It can also be used to support other types of food safety certifications based on a combination of
ISO/IEC 17021 and ISO/IEC 17065.
Certification a
...
SPÉCIFICATION ISO/TS
TECHNIQUE 22003
Deuxième édition
2013-12-15
Systèmes de management de la
sécurité des denrées alimentaires —
Exigences pour les organismes
procédant à l’audit et à la certification
de systèmes de management de la
sécurité des denrées alimentaires
Food safety management systems — Requirements for bodies
providing audit and certification of food safety management systems
Numéro de référence
©
ISO 2013
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2013
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Version française parue en 2014
Publié en Suisse
ii © ISO 2013 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Principes . 2
5 Exigences générales . 2
5.1 Généralités . 2
5.2 Gestion de l’impartialité . 2
6 Exigences structurelles . 2
7 Exigences relatives aux ressources . 3
7.1 Compétence de la direction et du personnel. 3
7.2 Personnel intervenant dans les activités de certification . 3
7.3 Intervention d’auditeurs et d’experts techniques externes individuels . 3
7.4 Enregistrements relatifs au personnel . 4
7.5 Externalisation . 4
8 Exigences relatives aux informations . 4
9 Exigences relatives aux processus . 4
9.1 Exigences générales . 4
9.2 Évaluation et certification initiales . 6
9.3 Activités de surveillance . 7
9.4 Renouvellement de la certification . 7
9.5 Audits particuliers . 8
9.6 Suspension, retrait ou réduction du périmètre de la certification . 8
9.7 Appels . 8
9.8 Plaintes . 8
9.9 Enregistrements relatifs aux demandeurs et aux clients . 8
10 Exigences relatives au système de management des organismes de certification .8
Annexe A (normative) Classification des catégories de la chaîne alimentaire .9
Annexe B (normative) Durée minimale de l’audit .12
Annexe C (normative) Compétences requises en matière de systèmes de management de la
sécurité des denrées alimentaires (SMSDA) .15
Annexe D (informative) Recommandations relatives aux fonctions de certification génériques .19
Annexe E (informative) Systèmes de management de la sécurité des denrées alimentaires et
certification de produits .23
Bibliographie .28
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (CEI) en ce qui concerne
la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/CEI, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/CEI, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les
références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de l’élaboration
du document sont indiqués dans l’Introduction et/ou sur la liste ISO des déclarations de brevets reçues
(voir www.iso.org/brevets).
Les éventuelles appellations commerciales utilisées dans le présent document sont données pour
information à l’intention des utilisateurs et ne constituent pas une approbation ou une recommandation.
Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à l’évaluation
de la conformité, aussi bien que pour des informations au sujet de l’adhésion de l’ISO aux principes de
l’OMC concernant les obstacles techniques au commerce (OTC) voir le lien suivant: Avant-propos —
Informations supplémentaires.
Le comité chargé de l’élaboration du présent document est l’ISO/TC 34, Produits alimentaires, sous-
comité SC 17, Systèmes de management pour la sécurité des denrées alimentaires, en collaboration avec le
Comité ISO pour l’évaluation de la conformité (CASCO).
Cette seconde édition annule et remplace la première édition (ISO/TS 22003:2007), qui a fait l’objet
d’une révision technique.
iv © ISO 2013 – Tous droits réservés
Introduction
La certification du système de management de la sécurité des denrées alimentaires (SMSDA) d’une
organisation est l’un des moyens permettant d’assurer que l’organisation a mis en œuvre un SMSDA
conforme à sa politique.
Les exigences applicables à un SMSDA peuvent émaner d’un certain nombre de sources et la présente
Spécification technique a été élaborée pour apporter une aide à la certification des SMSDA qui satisfont
aux exigences de l’ISO 22000. Le contenu de la présente Spécification technique peut également servir
à accompagner la certification des SMSDA qui sont fondés sur d’autres ensembles d’exigences spécifiées
en la matière.
La présente Spécification technique est destinée à l’usage des organismes qui auditent et qui certifient
des SMSDA en fournissant des exigences génériques applicables à ces organismes. Ces organismes
sont appelés organismes de certification. Ce libellé n’est pas destiné à faire obstacle à l’utilisation de
la présente Spécification technique par des organismes désignés différemment qui entreprennent des
activités couvertes par le domaine d’application décrit dans cette Spécification technique. La présente
Spécification technique est destinée à être utilisée par tout organisme impliqué dans l’évaluation de
SMSDA. Elle peut également servir à accompagner d’autres types de certifications en matière de sécurité
des denrées alimentaires fondées sur une combinaison de l’ISO/CEI 17021 et de l’ISO/CEI 17065.
Les activités de certification comprennent l’audit du SMSDA d’une organisation. La manière d’attester
la conformité de ce système à une norme spécifique de SMSDA (par exemple ISO 22000) ou à d’autres
exigences spécifiées prend généralement la forme d’un document de certification ou d’un certificat.
Il incombe à l’organisation soumise à la procédure de certification de mettre au point ses propres
systèmes de management (par exemple un SMSDA conforme à l’ISO 22000, d’autres ensembles d’exigences
spécifiées en la matière, des systèmes de management de la qualité, des systèmes de management
environnemental ou des systèmes de management de l’hygiène et de la sécurité au travail) et, sauf
spécifications contraires dans les exigences réglementaires applicables, il appartient à l’organisation de
décider de l’agencement des divers composants desdits systèmes. Le degré d’intégration entre les divers
composants des systèmes de management variera d’une organisation à l’autre. Il est donc approprié
pour les organismes de certification qui opèrent conformément à la présente Spécification technique
de prendre en compte la culture et les pratiques de leurs clients, eu égard à l’intégration de leur SMSDA
dans un cadre plus large.
SPÉCIFICATION TECHNIQUE ISO/TS 22003:2013(F)
Systèmes de management de la sécurité des denrées
alimentaires — Exigences pour les organismes procédant à
l’audit et à la certification de systèmes de management de
la sécurité des denrées alimentaires
1 Domaine d’application
La présente Spécification technique définit les règles applicables à l’audit et à la certification d’un système
de management de la sécurité des denrées alimentaires (SMSDA) conforme aux exigences données dans
l’ISO 22000 (ou à d’autres ensembles d’exigences spécifiées en la matière). Elle fournit également aux
clients les informations nécessaires sur la manière de procéder à la certification de leurs fournisseurs et
leur donne ainsi confiance dans cette certification.
La certification des SMSDA est une activité d’évaluation de la conformité par tierce partie (tel que décrit
dans le 5.5 de l’ISO/CEI 17000:2004) et les organismes exerçant cette activité sont des organismes
d’évaluation de la conformité par tierce partie.
NOTE 1 Dans la présente Spécification technique, les termes «produit» et «service» sont employés séparément
(contrairement à la définition de «produit» donnée dans l’ISO/CEI 17000).
NOTE 2 La présente Spécification technique peut être utilisée comme référentiel pour l’accréditation
ou l’évaluation par des tiers des organismes de certification qui cherchent à se faire reconnaître comme
étant compétents pour certifier qu’un SMSDA est conforme à l’ISO 22000. Elle est également destinée à êtr
...
ТЕХНИЧЕСКИЕ ISO/TS
УСЛОВИЯ 22003
Второе издание
2013-12-15
Системы менеджмента безопасности
пищевых продуктов. Требования к
органам, проводящим аудит и
сертификацию систем менеджмента
безопасности пищевых продуктов
Food safety management systems – Requirement for bodies providing
audit and certification of food safety management systems
Ответственность за подготовку русской версии несёт GOST R
(Российская Федерация) в соответствии со статьёй 18.1 Устава ISO
Ссылочный номер
SO/TS 22003:2013(R)
©
ISO 2013
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Содержание Cтраница
Предисловие .iv
Введение .v
1 Область применения .1
2 Нормативные ссылки .1
3 Термины и определения .2
4 Принципы.2
5 Общие требования .3
5.1 Общие положения .3
5.2 Контроль беспристрастности .3
6 Структурные требования.3
7 Требования к ресурсам .3
7.1 Компетентность руководства и персонала .3
7.2 Персонал, участвующий в деятельности по сертификации.4
7.3 Использование сторонних аудиторов и технических экспертов .4
7.4 Записи о персонале.4
7.5 Аутсорсинг.4
8 Информационные требования .4
9 Требования к процессам.4
9.1 Общие требования.4
9.2 Первоначальный аудит и сертификация .6
9.3 Деятельность по инспекционному контролю.8
9.4 Повторная сертификация.8
9.5 Специальные аудиты.8
9.6 Приостановление, отмена действия сертификата или сужение области
сертификации .8
9.7 Апелляции.8
9.8 Жалобы .8
9.9 Записи о заявителях и заказчиках.8
10 Требования к системе менеджмента для органов по сертификации .8
Приложение А (нормативное) Классификация категорий в цепи создания пищевой
продукции .9
Приложение В (информативное) Минимальная продолжительность аудита.12
Приложение С (нормативное) Требуемая компетентность по системе менеджмента
безопасности пищевой продукции (FSMS).14
Приложение D (информативное) Руководство по основным сертификационным
мероприятиям .18
Приложение Е (информативное) Системы менеджмента безопасности пищевой продукции
сертификация продукции .22
Библиография.26
Предисловие
Международная организация по стандартизации (ISO) всемирная федерация национальных органов
по стандартизации (комитеты-члены ISO). Работа по подготовке международных стандартов обычно
ведется через технические комитеты ISO. Каждый комитет-член ISO, проявляющий интерес к
тематике, по которой учрежден технический комитет, имеет право быть представленным в этом
комитете. Международные организации, государственные и негосударственные, имеющие связи с ISO,
также принимают участие в работе. ISO тесно сотрудничает с Международной электротехнической
комиссией (IEC) по всем вопросам стандартизации в области электротехники.
Процедуры, используемые для разработки данного документа, и процедуры, предусмотренные для его
дальнейшего ведения, описаны в Директивах ISO/IEC Directives, Part 1. В частности, следует отметить
различные критерии утверждения, требуемые для различных типов документов ISO. Проект данного
документа был разработан в соответствии с редакционными правилами Директив ISO/IEC Directives,
Part 2. www.iso.org/directives .
Необходимо обратить внимание на возможность того, что ряд элементов данного документа могут
быть предметом патентных прав. Международная организация ISO не должна нести ответственность
за идентификацию таких прав, частично или полностью. Сведения о патентных правах,
идентифицированных при разработке документа, будут указаны во Введении и/или в перечне
полученных ISO объявлениях о патентном праве. www.iso.org/patents.
Любое торговое название, использованное в данном документе, является информацией,
предоставляемой для удобства пользователей, а не свидетельством в пользу того или иного товара
или той или иной компании.
Для пояснения значений конкретных терминов и выражений ISO, относящихся к оценке соответствия, а
также информация о соблюдении Международной организацией ISO принципов ВТО по техническим
барьерам в торговле (TБT), см. следующий унифицированный локатор ресурса (URL): Foreword -
Supplementary information
Технический комитет, несущий ответственность за данный документ, ISO/TC 34, Пищевые продукты,
Подкомитет SC 17, Системы менеджмента безопасности пищевых продуктов в сотрудничестве
с Комитетом ISO по оценке соответствия (CASCO).
Настоящее второе издание отменяет и заменяет первое издание (ISO/TS 22003:2007) после
технического пересмотра.
iv © ISO 2013 – Все права сохраняются
Введение
Сертификация системы менеджмента безопасности пищевых продуктов (FSMS) проводится в
заданной организации для получения гарантии, что эта организация реализовала систему для
менеджмента безопасности пищевых продуктов согласно своей политике.
Требования для систем FSMS могут быть получены из нескольких источников, и настоящие
технические условия разработаны, чтобы помочь в сертификации систем FSMS, которые выполняют
требования ISO 22000. Содержание этих технических условий можно также использовать для
содействия сертификации систем FSMS, которые основаны на некоторых других установленных
требованиях к FSMS.
Эти технические условия предназначены для использования органами, которые проводят аудит и
сертификацию систем FSMS. Они дают общие требования для органов по сертификации,
выполняющих аудит и сертификацию в области систем менеджмента безопасности пищевых
продуктов. Такие органы называют органами по сертификации. Эта формулировка не должна быть
препятствием к использованию данных технических условий организациями, предназначенными для
других целей, которые занимаются деятельностью, относящейся к области применения этого
документа. В действительности эти технические условия годятся для всех органов, занимающихся
оценкой систем FSMS. Их также можно использовать для поддержки других типов сертификации
безопасности пищевых продуктов на основе сочетания ISO/IEC 17021 и ISO/IEC 17065.
Деятельность по сертификации включает аудит FSMS в какой-либо организации. Форма аттестации
соответствия FSMS в организации конкретному стандарту на системы FSMS (например, ISO 22000)
или другим установленным требованиям обычно является сертификационным документом или
сертификатом.
Организация, в которой проводится сертификация, разрабатывает свои собственные системы
менеджмента (включая FSMS по ISO 22000, ряд других установленных требований для FSMS, системы
менеджмента качества, системы менеджмента окружающей среды или системы менеджмента гигиены
труда и техники безопасности), и, кроме случаев, когда имеются противоположные законодательные
требования, именно организация должна решать, как будут устроены различные компоненты этих
систем. Степень интеграции различных компонентов систем менеджмента будет разной в разных
организациях. Поэтому уместно, чтобы органы по сертификации, которые работают согласно
настоящим техническим условиям, учитывали культуру и практику работы своих клиентов
относительно интеграции их систем FSMS внутри более крупной организации.
ТЕХНИЧЕСКИЕ УСЛОВИЯ ISO/TS 22003:2013(R)
Системы менеджмента безопасности пищевых продуктов.
Требования к органам, проводящим аудит и сертификацию
систем менеджмента безопасности пищевых продуктов
1 Область применения
Настоящие технические условия определяют правила, применяемые для аудита и сертификации
системы менеджмента безопасности пищевых продуктов (FSMS), соответствующие требованиям,
данным в ISO 22000 (или ряду других установленных требований для FSMS). Они также обеспечивают
необходимую информацию и доверие заказчиков к полученным их поставщиками сертификатам.
Сертификация систем FSMS является деятельностью третьей стороны по оценке соответствия
(см. ISO/IEC 17000:2004, 5.5). Органы, выполняющие эту деятельность, являются, следовательно,
органами по оценке соответствия третьей стороной.
ПРИМЕЧАНИЕ 1 В данных Технических условиях термины “продукция” и “услуга” используются по отдельности
(по контрасту с определением “продукция”, данным в ISO/IEC 17000).
ПРИМЕЧАНИЕ 2 Эти технические условия можно использовать в качестве документа, устанавливающего
критерии для аккредитации или взаимооценки органов по сертификации, которые хотят получить признание своей
компетентности для сертификации соответствия систем FSMS стандарту ISO 22000. Эти технические условия
также предназначены для использования в качестве критериев органами по техническому регулированию и
промышленными консорциумами, которые занимаются непосредственным признанием органов по сертификации,
устанавливающих соответствие системы FSMS стандарту ISO 22000. Некоторые из указанных требований могли
бы также быть полезными и другим сторонам, участвующим в оценке соответствия таких органов по
сертификации и в оценке соответствия всех органов, которые проводят сертификацию соответствия систем FSMS
критериям, дополнительным или не указанным в ISO 22000.
Сертификация систем FSMS не удостоверяет безопасность или пригодность продукции организации в
цепи создания пищевой продукции. В то же время, ISO 22000 требует, чтобы организация
удовлетворяла всем применяемым законодательным и нормативным требованиям, связанным с
безопасностью пищевых продуктов, посредством своей системы менеджмента.
ПРИМЕЧАНИЕ 3 Сертификация FSMS соглас
...
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