SIST EN ISO/IEC 17067:2013
(Main)Conformity assessment - Fundamentals of product certification and guidelines for product certification schemes (ISO/IEC 17067:2013)
Conformity assessment - Fundamentals of product certification and guidelines for product certification schemes (ISO/IEC 17067:2013)
This International Standard describes the fundamentals of product certification and provides guidelines for understanding, developing, operating or maintaining certification schemes for products, processes and services. It is intended for use by all with an interest in product certification, and especially by certification scheme owners.
Konformitätsbewertung - Grundlagen der Produktzertifizierung und Leitlinien für Produktzertifizierungsprogramme (ISO/IEC 17067:2013)
Diese Internationale Norm beschreibt die Grundlagen der Zertifizierung von Produkten und liefert Leitlinien für das Verständnis, die Entwicklung, die Durchführung bzw. die Aufrechterhaltung von Zertifizierungs-programmen für Produkte, Prozesse und Dienstleistungen.
Sie ist vorgesehen zur Verwendung durch alle, die ein Interesse an der Produktzertifizierung haben und insbesondere durch Zertifizierungsprogrammeigner.
ANMERKUNG 1 In dieser Internationalen Norm kann der Begriff „Produkt“ auch als „Prozess“ oder „Dienstleistung“ verstanden werden, außer in jenen Fällen, in denen eigene Anforderungen für „Prozesse“ oder „Dienstleistungen“ festgelegt werden. Definitionen zu den Begriffen Produkt, Prozess und Dienstleistung sind in ISO/IEC 17065 festgelegt.
ANMERKUNG 2 Die Zertifizierung von Produkten, Prozessen und Dienstleistungen ist eine Konformitätsbewertungstätigkeit durch eine dritte Seite (siehe ISO/IEC 17000), die von Produktzertifizierungsstellen durchgeführt wird. Die Anforderungen an Produktzertifizierungsstellen sind in ISO/IEC 17065 festgelegt.
Évaluation de la conformité - Éléments fondamentaux de la certification de produits et lignes directrices pour les programmes de certification de produits (ISO/IEC 17067:2013)
L'ISO/CEI 17067:2013 décrit les principes essentiels de la certification de produits et fournit des lignes directrices permettant de comprendre, développer, exploiter ou maintenir des programmes de certification de produits, de processus et de services.
L'ISO/CEI 17067:2013 est prévue pour être utilisée par tous ceux pour qui la certification de produits présente un intérêt et en particulier les propriétaires de programmes de certification.
Ugotavljanje skladnosti - Osnovna pravila za certificiranje proizvodov in smernice za sheme certificiranja proizvodov (ISO/IEC 17067:2013)
Ta mednarodni standard opisuje osnove certificiranja proizvodov in daje smernice za razumevanje, razvoj, upravljanje in vzdrževanje shem certificiranja za izdelke, procese in storitve. Namenjen je vsem, ki se zanimajo za certifikacijo proizvodov, zlasti lastnikom shem certificiranja.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 17067:2013
01-november-2013
Ugotavljanje skladnosti - Osnovna pravila za certificiranje proizvodov in smernice
za sheme certificiranja proizvodov (ISO/IEC 17067:2013)
Conformity assessment - Fundamentals of product certification and guidelines for
product certification schemes (ISO/IEC 17067:2013)
Konformitätsbewertung - Grundlagen der Produktzertifizierung und Leitlinien für
Produktzertifizierungsprogramme (ISO/IEC 17067:2013)
Évaluation de la conformité - Éléments fondamentaux de la certification de produits et
lignes directrices pour les programmes de certification de produits (ISO/IEC 17067:2013)
Ta slovenski standard je istoveten z: EN ISO/IEC 17067:2013
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17067:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17067:2013
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SIST EN ISO/IEC 17067:2013
EUROPEAN STANDARD
EN ISO/IEC 17067
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2013
ICS 03.120.20
English version
Conformity assessment - Fundamentals of product certification
and guidelines for product certification schemes (ISO/IEC
17067:2013)
Évaluation de la conformité - Éléments fondamentaux de la Konformitätsbewertung - Grundlagen der
certification de produits et lignes directrices pour les Produktzertifizierung und Leitlinien für
programmes de certification de produits (ISO/IEC Produktzertifizierungsprogramme (ISO/IEC 17067:2013)
17067:2013)
This European Standard was approved by CEN on 12 July 2013.
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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2013 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17067:2013 E
worldwide for CEN national Members and for CENELEC
Members.
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SIST EN ISO/IEC 17067:2013
EN ISO/IEC 17067:2013 (E)
Contents Page
Foreword .3
2
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SIST EN ISO/IEC 17067:2013
EN ISO/IEC 17067:2013 (E)
Foreword
This document (EN ISO/IEC 17067:2013) 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 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 February 2014, and conflicting national standards shall be withdrawn
at the latest by February 2014.
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.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEC 17067:2013 has been approved by CEN as EN ISO/IEC 17067:2013 without any
modification.
3
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SIST EN ISO/IEC 17067:2013
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SIST EN ISO/IEC 17067:2013
INTERNATIONAL ISO/IEC
STANDARD 17067
First edition
2013-08-01
Conformity assessment —
Fundamentals of product certification
and guidelines for product
certification schemes
Évaluation de la conformité — Éléments fondamentaux de la
certification de produits et lignes directrices pour les programmes de
certification de produits
Reference number
ISO/IEC 17067:2013(E)
©
ISO 2013
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SIST EN ISO/IEC 17067:2013
ISO/IEC 17067:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Tel. + 41 22 749 01 11
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E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
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SIST EN ISO/IEC 17067:2013
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Product certification . 2
4.1 Concept of product certification . 2
4.2 Objectives of product certification . 2
5 Product certification schemes . 2
5.1 Basics . 2
5.2 Functions and activities in product certification schemes . 3
5.3 Types of product certification schemes . 4
6 Development and operation of a product certification scheme . 6
6.1 General . 6
6.2 Relationship between product certification scheme and product certification system . 6
6.3 Scheme owner . 7
6.4 Development of product certification schemes . 8
6.5 Content of a scheme . 9
6.6 Maintenance and improvement of a scheme .12
6.7 Scheme documentation .12
Bibliography .13
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SIST EN ISO/IEC 17067:2013
ISO/IEC 17067:2013(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 member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member 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 17067 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 17067 cancels and replaces ISO/IEC Guide 67:2004, which has been
technically revised.
The following major changes have been made compared with ISO/IEC Guide 67:2004:
— a new Clause 6 has been added, providing guidelines on setting up and operating a product
certification scheme;
— some of the text originally in the main body of ISO/IEC Guide 67 has been moved to the Introduction;
— the functional approach to conformity assessment has been emphasised;
— Table 1 has been extended to reflect the functional approach;
— explicit provision has been made for type and batch certification schemes;
— references to ISO/IEC 17065:2012 have replaced references to ISO/IEC Guide 65:1996;
— the text has been made more concise in places.
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SIST EN ISO/IEC 17067:2013
ISO/IEC 17067:2013(E)
Introduction
This International Standard describes the fundamentals of product certification and provides guidelines
for product certification schemes. In this International Standard references to the term “product” can
also be read to mean “services” or “processes”.
As products are designed, produced, distributed, used and ultimately disposed of, they can give rise to
concerns with purchasers, users and society in general. Such concerns could relate to safety, health or
environmental impacts, durability, compatibility, suitability for intended purposes or for stated conditions.
Generally, these concerns are addressed by specifying the required product attributes in a normative
document such as a standard.
The supplier of the product then has the task of demonstrating that the product conforms to the
requirements of the normative document.
It might be sufficient for the supplier to assess and declare its product’s conformity, but in other cases
the user or a regulatory authority might require that conformity be assessed by a competent and
impartial third party.
Assessment and impartial third party attestation that fulfilment of specified requirements has been
demonstrated for the product is referred to as product certification.
This International Standard outlines how schemes for product certification can be structured and
managed. It identifies common assessment techniques that are used as a basis for product certification,
such as product testing, inspection and auditing.
This International Standard is intended for use by those involved with product certification, particularly
those who are, or who are considering becoming, product certification scheme owners. Product
certification scheme owners can include:
a) product certification bodies;
b) government and regulators;
c) purchasing agencies;
d) non-government organizations;
e) industry and retail associations; and
f) consumer organizations.
This International Standard provides only guidance and does not contain requirements. It is compatible
with ISO/IEC 17065, which specifies requirements for product certification bodies.
In this International Standard, the following verbal forms are used:
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
The modal verb “shall”, which indicates a requirement, is not used because this International Standard
only provides guidelines.
Further details can be found in the ISO/IEC Directives, Part 2.
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SIST EN ISO/IEC 17067:2013
INTERNATIONAL STANDARD ISO/IEC 17067:2013(E)
Conformity assessment — Fundamentals of product
certification and guidelines for product certification schemes
1 Scope
This International Standard describes the fundamentals of product certification and provides guidelines
for understanding, developing, operating or maintaining certification schemes for products, processes
and services.
It is intended for use by all with an interest in product certification, and especially by certification
scheme owners.
NOTE 1 In this International Standard the term “product” can also be read as “process” or “service”, except in
those instances where separate provisions are stated for “processes” or “services”. Definitions of product, process
and service are given in ISO/IEC 17065.
NOTE 2 The certification of products, processes and services is a third-party conformity assessment activity
(see ISO/IEC 17000) carried out by product certification bodies. The requirements for product certification bodies
are specified in ISO/IEC 17065.
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 17065:2012, Conformity assessment — Requirements for bodies certifying products, processes and
services
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17065 and
the following apply.
3.1
certification system
rules, procedures and management for carrying out certification
[SOURCE: ISO/IEC 17000:2004, 2.7, modified]
3.2
certification scheme
certification system (3.1) related to specified products, to which the same specified requirements,
specific rules and procedures apply
Note 1 to entry: The rules, procedures and management for implementing product, process and service certification
are stipulated by the certification scheme.
[SOURCE: ISO/IEC 17065:2012, 3.9, modified]
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3.3
scheme owner
person or organization responsible for developing and maintaining a specific certification scheme (3.2)
Note 1 to entry: The scheme owner can be the certification body itself, a governmental authority, a trade
association, a group of certification bodies or others.
[SOURCE: ISO/IEC 17065:2012, 3.11]
4 Product certification
4.1 Concept of product certification
4.1.1 Product certification is the provision of assessment and impartial third-party attestation
that fulfilment of specified requirements has been demonstrated. Product certification is carried out
by product certification bodies which should conform to ISO/IEC 17065. Specified requirements for
products are generally contained in standards or other normative documents.
4.1.2 Product certification is an established conformity assessment activity that provides confidence
to consumers, regulators, industry and other interested parties that products conform to specified
requirements, including for example product performance, safety, interoperability and sustainability.
4.1.3 Product certification can facilitate trade, market access, fair competition and consumer
acceptance of products on a national, regional and international level.
4.2 Objectives of product certification
4.2.1 The fundamental objectives of product certification are:
a) to address the needs of consumers, users and, more generally, all interested parties by giving
confidence regarding fulfilment of specified requirements;
b) to allow suppliers to demonstrate to the market that their product has been attested to fulfil
specified requirements by an impartial third party body.
4.2.2 Product certification should provide the following:
— confidence for those with an interest in fulfilment of requirements, and
— sufficient value so that suppliers can effectively market products.
5 Product certification schemes
5.1 Basics
5.1.1 Product certification schemes should implement the functional approach as described in
ISO/IEC 17000:2004, Annex A. The functions are:
— selection, which includes planning and preparation activities in order to collect or produce all the
information and input needed for the subsequent determination function;
— determination, which may include conformity assessment activities such as testing, measuring,
inspection, design appraisal, assessment of services and processes and auditing to provide
information regarding the product requirements as input to the review and attestation functions;
— review, which means verification of the suitability, adequacy and effectiveness of selection and
determination activities, and the results of these activities, with regard to fulfilment of specified
requirements (see ISO/IEC 17000:2004, 5.1);
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— decision on certification;
— attestation, which means issue of a statement of conformity, based on a decision following review,
that fulfilment of specified requirements has been demonstrated (see ISO/IEC 17000:2004, 5.2);
— surveillance (where needed), which means systematic iteration of conformity assessment activities
as a basis for maintaining the validity of the statement of conformity (see ISO/IEC 17000:2004, 6.1).
NOTE 1 Further information about the functions is given in ISO/IEC 17000.
NOTE 2 In ISO/IEC 17065, the functions of “selection” and “determination” have been combined and are
referred to as “evaluation”.
NOTE 3 In ISO/IEC 17065, the function of “attestation” is related to the subclause on “certification
documentation” (see ISO/IEC 17065:2012, 7.7).
5.1.2 Whenever product certification is performed, a certification scheme (see 3.2) is in place.
5.2 Functions and activities in product certification schemes
5.2.1 Product certification schemes are developed by defining specific activities for each of the
applicable functions described in 5.1.1. Table 1 shows how to build a product certification scheme by
using these functions, and outlines some of the combinations of activities in use in the wide range of
fields where product certification is employed. The types of product certification schemes in Table 1 are
further described in 5.3.
5.2.2 Clause 6 describes the process for deciding which activities to use for a given situation and the
factors to be taken into account in making the decision.
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Table 1 — Building a product certification scheme
a b
Conformity assessment functions and activities Types of product certification schemes
c,d
within product certification schemes 1a 1b 2 3 4 5 6 N
I Selection, including planning and preparation activities, specification x x x x x x x x
of requirements, e.g. normative documents, and sampling, as applicable
II Determination of characteristics, as applicable, by: x x x x x x x x
a) testing
b) inspection
c) design appraisal
d) assessment of services or processes
e) other determination activities, e.g. verification
III Review x x x x x x x x
Examining the evidence of conformity obtained during the determina-
tion stage to establish whether the specified requirements have been
met
IV Decision on certification x x x x x x x x
Granting, maintaining, extending, reducing, suspending, withdrawing
certification
V Attestation, licensing
a) issuing a certificate of conformity or other statement of conformity
x x x x x x x x
(attestation)
b) granting the right to use certificates or other statements of conform-
x x x x x x x
ity
c) issuing a certificate of conformity for a batch of products x
d) granting the right to use marks of conformity (licensing) is based on
x x x x x x
surveillance (VI) or certification of a batch.
VI Surveillance, as applicable (see 5.3.4 to 5.3.8), by:
a) testing or inspection of samples from the open market x x x
b) testing or inspection of samples from the factory x x x
c) assessment of the production, the delivery of the service or the opera-
x x x x
tion of the process
d) management system audits combined with random tests or inspec-
x x
tions
a
Where applicable, the activities can be coupled with initial audit and surveillance audit of the applicant’s management
system (an example is given in ISO/IEC Guide 53) or initial assessment of the production process. The order in which the
assessments are performed may vary and will be defined within the scheme.
b
An often used and well-tried model for a product certification scheme is described in ISO/IEC Guide 28; it is a product
certification scheme corresponding to scheme type 5.
c
A product certification scheme includes at least the activities I, II, III, IV and V a).
d
The symbol N has been added to show an undefined number of possible other schemes, which can be based on different
activities.
5.3 Types of product certification schemes
5.3.1 General
The examples given in 5.3.2 to 5.3.8 do not represent all possible types of product certification schemes.
They may be used with many types of requirements and may use a wide variety of statements of
conformity (see ISO/IEC 17000:2004, 5.2, Note 1). All types of product certification schemes involve
selection, determination, review, decision and attestation. One or more determination activities should
be selected from among those in Table 1, taking into account the product and the specified requirements.
The types of schemes referred to in Table 1 differ according to which surveillance activities (if applicable)
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ISO/IEC 17067:2013(E)
are carried out. For scheme types 1a and 1b, no surveillance is required since the attestation relates only
to the product items which have been subjected to the determination activities. For the other scheme
types, 5.3.4 to 5.3.8 outline the way in which the different surveillance activities can be used and the
circumstances to which they could be applicable.
5.3.2 Scheme type 1a
In this scheme, one or more samples of the product are subjected to the determination activities. A
certificate of conformity or other statement of conformity (e.g. a letter) is issued for the product type,
the characteristics of which are detailed in the certificate or a document referred to in the certificate.
Subsequent production items are not covered by the certification body’s attestation of conformity.
The samples are representative of subsequent production items which could be referred to by the
manufacturer as being manufactured in accordance with the certified type.
The certification body may grant to the manufacturer the right to use the type certificate or other
statement of conformity (e.g. letter) as a basis for the manufacturer to declare that subsequent production
items conform to the specified requirements.
5.3.3 Scheme type 1b
This scheme type involves the certification of a whole batch of products, following selection and
determination as specified in the scheme. The proportion to be tested, which can include testing of all
the units in the batch (100% testing), would be based, for example, on the homogeneity of the items in
the batch and the application of a sampling plan, where appropriate. If the outcome of the determination,
review and decision is positive, all items in the batch may be described as certified and may have a mark
of conformity affixed, if that is included in the scheme.
5.3.4 Scheme type 2
The surveillance part of this scheme involves periodically taking samples of the product from the market
and subjecting them to determination activities to check that items produced subsequent to the initial
attestation fulfil the specified requirements.
While this scheme may identify the impact of the distribution channel on conformity, the resources
it requires can be extensive. Also, when significant nonconformities are found, effective corrective
measures may be limited since the product has already been distributed to the market.
5.3.5 Scheme type 3
The surveillance part of this scheme involves periodically taking samples of the product from the point
of production and subjecting them to determination activities to check that items produced subsequent
to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment
of the production process.
This scheme does not provide any indication of the impact the distribution channel plays on conformity.
When serious nonconformities are found, the opportunity may exist to resolve them before widespread
market distribution occurs.
5.3.6 Scheme type 4
The surveillance part of this scheme allows for the choice between periodically taking samples of
the product from the point of production, or from the market, or from both, and subjecting them to
determination activities to check that items produced subsequent to the initial attestation fulfil the
specified requirements. The surveillance includes periodic assessment of the production process.
This scheme can both indicate the impact of the distribution channel on conformity and provide a pre-
market mechanism to identify and resolve serious nonconformities. Significant duplication of effort may
take place for those products whose conformity is not affected during the distribution process.
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5.3.7 Scheme type 5
The surveillance part of this scheme allows for the choice between periodically taking samples of the
product either from the point of production, or from the market, or from both, and subjecting them
to determination activities to check that items produced s
...
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