SIST EN ISO/IEC 17065:2012
(Main)Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065:2012)
Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065:2012)
This International Standard contains requirements for the competence, consistent operation and impartiality of product, process and service certification bodies. Certification bodies operating to this International Standard need not offer all types of products, processes and services certification. Certification of products, processes and services is a third party conformity assessment activity (5.5 of ISO/IEC 17000:2004). In the text the term "product" can be read as "process" or "service", except in those instances where separate provisions are stated for "processes" or "services".
Konformitätsbewertung - Anforderungen an Stellen, die Produkte (einschließlich Dienstleistungen) und Prozesse zertifizieren (ISO/IEC 17065:2012)
Diese Internationale Norm enthält Anforderungen an die Kompetenz, die einheitliche Arbeitsweise und die Unparteilichkeit von Zertifizierungsstellen für Produkte, Prozesse und Dienstleistungen. Zertifizierungsstellen, die nach dieser Internationalen Norm arbeiten, müssen nicht alle Arten von Zertifizierungen für Produkte, Prozesse und Dienstleistungen anbieten. Zertifizierung von Produkten, Prozessen und Dienstleistungen sind Konformitätsbewertungstätigkeiten durch eine dritte Seite (siehe ISO/IEC 17000:2004, Definition 5.5).
In dieser Internationalen Norm kann der Begriff "Produkt" als "Prozess" oder "Dienstleistung" verstanden werden, ausgenommen in denjenigen Fällen, in denen eigene Bestimmungen für "Prozesse" oder "Dienstleistungen" angegeben werden (siehe Anhang B).
Évaluation de la conformité - Exigences pour les organismes de certification, certifiant les produits, les services et les procédés (ISO/IEC 17065:2012)
L'ISO/IEC 17065:2012 comporte des exigences portant sur les compétences, la cohérence des activités et l'impartialité des organismes de certification de produits, processus et services. Les organismes de certification exerçant selon l'ISO/IEC 17065:2012 ne sont pas tenus de proposer tous les types de certification de produits, processus et services.
Ugotavljanje skladnosti - Zahteve za organe, ki certificirajo proizvode, procese in storitve (ISO/IEC 17065:2012)
Ta mednarodni standard vključuje zahteve za konkurenčnost, dosledno delovanje in nepristranskost organov za certificiranje proizvodov, procesov in storitev. Organi za certificiranje, ki delujejo na področju tega mednarodnega standarda, niso zavezani k ponudbi vseh vrst certificiranja proizvodov, procesov in storitev. Certificiranje proizvodov, procesov in storitev je dejavnost ugotavljanja skladnosti, ki jo opravljajo tretje osebe (5.5 standarda ISO/IEC 17000:2004). Izraz »proizvod« v besedilu lahko pomeni »proces« ali »storitev«, razen v primerih, ko so za »procese« oziroma »storitve« navedene ločene določbe.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 17065:2012
01-november-2012
1DGRPHãþD
SIST EN 45011:1998
Ugotavljanje skladnosti - Zahteve za organe, ki certificirajo proizvode, procese in
storitve (ISO/IEC 17065:2012)
Conformity assessment - Requirements for bodies certifying products, processes and
services (ISO/IEC 17065:2012)
Konformitätsbewertung - Anforderungen an Stellen, die Produkte (einschließlich
Dienstleistungen) und Prozesse zertifizieren (ISO/IEC 17065:2012)
Évaluation de la conformité - Exigences pour les organismes de certification, certifiant
les produits, les services et les procédés (ISO/IEC 17065:2012)
Ta slovenski standard je istoveten z: EN ISO/IEC 17065:2012
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17065:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17065:2012
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SIST EN ISO/IEC 17065:2012
EUROPEAN STANDARD
EN ISO/IEC 17065
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2012
ICS 03.120.20 Supersedes EN 45011:1998
English version
Conformity assessment - Requirements for bodies certifying
products, processes and services (ISO/IEC 17065:2012)
Évaluation de la conformité - Exigences pour les Konformitätsbewertung - Anforderungen an Stellen, die
organismes certifiant les produits, les procédés et les Produkte, Prozesse und Dienstleistungen zertifizieren
services (ISO/IEC 17065:2012) (ISO/IEC 17065:2012)
This European Standard was approved by CEN on 18 August 2012.
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
© 2012 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17065:2012 E
worldwide for CEN national Members and for CENELEC
Members.
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SIST EN ISO/IEC 17065:2012
EN ISO/IEC 17065:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO/IEC 17065:2012
EN ISO/IEC 17065:2012 (E)
Foreword
This document (EN ISO/IEC 17065:2012) 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 March 2013, and conflicting national standards shall be withdrawn at
the latest by March 2013.
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 45011:1998.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 17065:2012 has been approved by CEN as a EN ISO/IEC 17065:2012 without any
modification.
3
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SIST EN ISO/IEC 17065:2012
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SIST EN ISO/IEC 17065:2012
INTERNATIONAL ISO/IEC
STANDARD 17065
First edition
2012-09-15
Conformity assessment — Requirements
for bodies certifying products, processes
and services
Évaluation de la conformité — Exigences pour les organismes certifiant
les produits, les procédés et les services
Reference number
ISO/IEC 17065:2012(E)
©
ISO 2012
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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 2012 — All rights reserved
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
4.1 Legal and contractual matters . 4
4.2 Management of impartiality . 6
4.3 Liability and financing . 7
4.4 Non-discriminatory conditions . 7
4.5 Confidentiality . 7
4.6 Publicly available information . 8
5 Structural requirements . 8
5.1 Organizational structure and top management . 8
5.2 Mechanism for safeguarding impartiality . 9
6 Resource requirements . 10
6.1 Certification body personnel . 10
6.2 Resources for evaluation. 11
7 Process requirements . 12
7.1 General . 12
7.2 Application . 13
7.3 Application review . 13
7.4 Evaluation . 14
7.5 Review . 15
7.6 Certification decision . 15
7.7 Certification documentation . 16
7.8 Directory of certified products . 16
7.9 Surveillance . 17
7.10 Changes affecting certification . 17
7.11 Termination, reduction, suspension or withdrawal of certification . 18
7.12 Records . 18
7.13 Complaints and appeals . 19
8 Management system requirements . 19
8.1 Options . 19
8.2 General management system documentation (Option A) . 20
8.3 Control of documents (Option A) . 20
8.4 Control of records (Option A) . 21
8.5 Management review (Option A) . 21
8.6 Internal audits (Option A) . 22
8.7 Corrective actions (Option A) . 22
8.8 Preventive actions (Option A) . 23
Annex A (informative) Principles for product certification bodies and their certification activities . 24
Annex B (informative) Application of this International Standard for processes and services . 26
Bibliography . 27
© ISO 2012 – All rights reserved iii
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(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 17065 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 17065 cancels and replaces ISO/IEC Guide 65:1996, which has been technically
revised.
The following major changes have been made compared with ISO/IEC Guide 65:1996:
restructuring of this International Standard based on the common structure adopted by ISO/CASCO;
modifications based on ISO/PAS 17001, ISO/PAS 17002, ISO/PAS 17003, ISO/PAS 17004 and
ISO/PAS 17005;
introduction of the ISO/IEC 17000 functional approach in the process requirements of Clause 7;
information on the application of this International Standard for processes and services in Annex B;
revision of the terms and definitions in Clause 3;
improvement of the impartiality requirements (mechanism);
consolidation of the management system requirements in Clause 8;
inclusion of principles for product certification bodies and their activities in Annex A;
improvement by taking into account IAF GD 5;
inclusion of a reference to certification schemes, for which further information is provided in
ISO/IEC 17067.
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
Introduction
The overall aim of certifying products, processes or services is to give confidence to all interested parties that
a product, process or service fulfils specified requirements. The value of certification is the degree of
confidence and trust that is established by an impartial and competent demonstration of fulfilment of specified
requirements by a third party. Parties that have an interest in certification include, but are not limited to:
a) the clients of the certification bodies;
b) the customers of the organizations whose products, processes or services are certified;
c) governmental authorities;
d) non-governmental organizations; and
e) consumers and other members of the public.
Interested parties can expect or require the certification body to meet all the requirements of this International
Standard as well as when relevant, those of the certification scheme.
Certification of products, processes or services is a means of providing assurance that they comply with
specified requirements in standards and other normative documents. Some product, process or service
certification schemes may include initial testing or inspection and assessment of its suppliers' quality
management systems, followed by surveillance that takes into account the quality management system and
the testing or inspection of samples from the production and the open market. Other schemes rely on initial
testing and surveillance testing, while still others comprise type testing only.
This International Standard specifies requirements, the observance of which is intended to ensure that
certification bodies operate certification schemes in a competent, consistent and impartial manner, thereby
facilitating the recognition of such bodies and the acceptance of certified products, processes and services on
a national and international basis and so furthering international trade. This International Standard can be
used as a criteria document for accreditation or peer assessment or designation by governmental authorities,
scheme owners and others.
The requirements contained in this International Standard are written, above all, to be considered as general
criteria for certification bodies operating product, process or service certification schemes; they may have to
be amplified when specific industrial or other sectors make use of them, or when particular requirements such
as health and safety have to be taken into account. Annex A contains principles relating to certification bodies
and certification activities that they provide.
This International Standard does not set requirements for schemes and how they are developed and is not
intended to restrict the role or choice of scheme owners, however scheme requirements should not contradict
or exclude any of the requirements of this International Standard.
Statements of conformity to the applicable standards or other normative documents can be in the form of
certificates and/or marks of conformity. Schemes for certifying particular products or product groups,
processes and services to specified standards or other normative documents will, in many cases, require their
own explanatory documentation.
While this International Standard is concerned with third parties providing product, process or service
certification, many of its provisions may also be useful in first- and second-party product conformity
assessment procedures.
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
In this International Standard, the following verbal forms are used:
“shall” indicates a requirement;
“should” indicates a recommendation;
“may” indicates a permission;
“can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
vi © ISO 2012 – All rights reserved
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SIST EN ISO/IEC 17065:2012
INTERNATIONAL STANDARD ISO/IEC 17065:2012(E)
Conformity assessment — Requirements for bodies certifying
products, processes and services
1 Scope
This International Standard contains requirements for the competence, consistent operation and impartiality of
product, process and service certification bodies. Certification bodies operating to this International Standard
need not offer all types of products, processes and services certification. Certification of products, processes
and services is a third-party conformity assessment activity (see ISO/IEC 17000:2004, definition 5.5).
In this International Standard, the term “product” can be read as “process” or “service”, except in those
instances where separate provisions are stated for “processes” or “services” (see Annex B).
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, Conformity assessment — Vocabulary and general principles
ISO/IEC 17020, Conformity assessment — Requirements for the operation of various types of bodies
performing inspection
ISO/IEC 17021, Conformity assessment — Requirements for bodies providing audit and certification of
management systems
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the following apply.
3.1
client
organization or person responsible to a certification body for ensuring that certification requirements (3.7),
including product requirements (3.8), are fulfilled
NOTE Whenever the term “client” is used in this International Standard, it applies to both the “applicant” and the
“client”, unless otherwise specified.
3.2
consultancy
participation in
a) the designing, manufacturing, installing, maintaining or distributing of a certified product or a product to be
certified, or
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
b) the designing, implementing, operating or maintaining of a certified process or a process to be certified, or
c) the designing, implementing, providing or maintaining of a certified service or a service to be certified
NOTE In this International Standard, the term “consultancy” is used in relation to activities of certification bodies,
personnel of certification bodies and organizations related or linked to certification bodies.
3.3
evaluation
combination of the selection and determination functions of conformity assessment activities
NOTE The selection and determination functions are specified in ISO/IEC 17000:2004, Clauses A.2 and A.3.
3.4
product
result of a process
NOTE 1 Four generic product categories are noted in ISO 9000:2005:
services (e.g. transport) (see definition in 3.6);
software (e.g. computer program, dictionary);
hardware (e.g. engine, mechanical part);
processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called
service, software, hardware or processed material depends on the dominant element.
NOTE 2 Products include results of natural processes, such as growth of plants and formation of other natural
resources.
NOTE 3 Adapted from ISO/IEC 17000:2004, definition 3.3.
3.5
process
set of interrelated or interacting activities which transforms inputs into outputs
EXAMPLES Welding engineering processes; heat treatment processes; manufacturing processes requiring
confirmation of process capability (e.g. operating or producing product within specified tolerances); food production
processes; plant growth processes.
NOTE Adapted from ISO 9000:2005, definition 3.4.1.
3.6
service
result of at least one activity necessarily performed at the interface between the supplier and the customer,
which is generally intangible
NOTE 1 Provision of a service can involve, for example, the following:
an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax
return);
the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
the creation of ambience for the customer (e.g. in hotels and restaurants).
NOTE 2 Adapted from ISO 9000:2005, definition 3.4.2.
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
3.7
certification requirement
specified requirement, including product requirements (3.8), that is fulfilled by the client (3.1) as a condition
of establishing or maintaining certification
NOTE Certification requirements include requirements imposed on the client by the certification body [usually via the
certification agreement (see 4.1.2)] to meet this International Standard, and can also include requirements imposed on the
client by the certification scheme. “Certification requirements”, as used in this International Standard, do not include
requirements imposed on the certification body by the certification scheme.
EXAMPLE The following are certification requirements that are not product requirements:
completing the certification agreement;
paying fees;
providing information about changes to the certified product;
providing access to certified products for surveillance activities.
3.8
product requirement
requirement that relates directly to a product, specified in standards or in other normative documents identified
by the certification scheme
NOTE Product requirements can be specified in normative documents such as regulations, standards and technical
specifications.
3.9
certification scheme
certification system related to specified products, to which the same specified requirements, specific rules and
procedures apply
NOTE 1 Adapted from ISO/IEC 17000:2004, definition 2.8.
NOTE 2 A “certification system” is a “conformity assessment system”, which is defined in ISO/IEC 17000:2004,
definition 2.7.
NOTE 3 The rules, procedures and management for implementing product, process and service certification are
stipulated by the certification scheme.
NOTE 4 General guidance for the development of schemes is given in ISO/IEC 17067, in combination with
ISO/IEC Guide 28 and ISO/IEC Guide 53.
3.10
scope of certification
identification of
the product(s), process(es) or service(s) for which the certification is granted,
the applicable certification scheme, and
the standard(s) and other normative document(s), including their date of publication, to which it is judged
that the product(s), process(es) or service(s) comply
3.11
scheme owner
person or organization responsible for developing and maintaining a specific certification scheme (3.9)
NOTE The scheme owner can be the certification body itself, a governmental authority, a trade association, a group
of certification bodies or others.
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
3.12
certification body
third-party conformity assessment body operating certification schemes
NOTE A certification body can be non-governmental or governmental (with or without regulatory authority).
3.13
impartiality
presence of objectivity
NOTE 1 Objectivity is understood to mean that conflicts of interest do not exist, or are resolved so as not to adversely
influence the activities of the body.
NOTE 2 Other terms that are useful in conveying the element of impartiality are independence, freedom from conflicts
of interest, freedom from bias, freedom from prejudice, neutrality, fairness, open-mindedness, even-handedness,
detachment and balance.
4 General requirements
4.1 Legal and contractual matters
4.1.1 Legal responsibility
The certification body shall be a legal entity, or a defined part of a legal entity, such that the legal entity can be
held legally responsible for all its certification activities.
NOTE A governmental certification body is deemed to be a legal entity on the basis of its governmental status.
4.1.2 Certification agreement
4.1.2.1 The certification body shall have a legally enforceable agreement for the provision of certification
activities to its clients. Certification agreements shall take into account the responsibilities of the certification
body and its clients.
4.1.2.2 The certification body shall ensure its certification agreement requires that the client comply at
least, with the following:
a) the client always fulfils the certification requirements (see 3.7), including implementing appropriate
changes when they are communicated by the certification body (see 7.10);
b) if the certification applies to ongoing production, the certified product continues to fulfil the product
requirements (see 3.8);
c) the client makes all necessary arrangements for
1) the conduct of the evaluation (see 3.3) and surveillance (if required), including provision for
examining documentation and records, and access to the relevant equipment, location(s), area(s),
personnel, and client's subcontractors;
2) investigation of complaints;
3) the participation of observers, if applicable;
d) the client makes claims regarding certification consistent with the scope of certification (see 3.10);
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SIST EN ISO/IEC 17065:2012
ISO/IEC 17065:2012(E)
e) the client does not use its product certification in such a manner as to bring the certification body into
disrepute and does not make any statement regarding its product certification that the certification body
may consider misleading or unauthorized;
f) upon suspension, withd
...
SLOVENSKI SIST EN ISO/IEC 17065
STANDARD
april 2012
Ugotavljanje skladnosti – Zahteve za organe, ki certificirajo proizvode,
procese in storitve (ISO/IEC 17065:2012)
Conformity assessment – Requirements for bodies certifying products, processes
and services (ISO/IEC 17065:2012)
Évaluation de la conformité – Exigences pour les organismes certifiant les
produits, les procédés et les services (ISO/IEC 17065:2012)
Konformitätsbewertung – Anforderungen an Stellen, die Produkte (einschließlich
Dienstleistungen) und Prozesse zertifizieren (ISO/IEC 17065:2012)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17065:2012 (sl, en)
Nadaljevanje na straneh II in III ter od 1 do 48
© 2013-10. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17065 : 2012
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17065 (sl, en), Ugotavljanje skladnosti – Zahteve za organe, ki certificirajo
proizvode, procese in storitve (ISO/IEC 17065:2012), 2012, ima status slovenskega standarda in je
enakovreden evropskemu standardu EN ISO/IEC 17065, Conformity assessment – Requirements for
bodies certifying products, processes and services (ISO/IEC 17065:2012), 2012.
NACIONALNI PREDGOVOR
Besedilo standarda EN ISO/IEC 17065:2012 je pripravil tehnični odbor ISO/CASCO "Odbor za
ugotavljanje skladnosti" v sodelovanju s tehničnim odborom CEN/CLC/TC 1 "Merila za organe za
ugotavljanje skladnosti", katerega sekretariat vodi BSI.
Slovenski standard SIST ISO/IEC 17065:2012 je prevod angleškega besedila evropskega standarda
EN ISO/IEC 17065:2012. V primeru spora glede besedila slovenskega prevoda v tem standardu je
odločilen izvirni evropski standard v angleškem jeziku. Slovensko-angleško izdajo standarda je
pripravil SIST/TC UGA Ugotavljanje skladnosti.
Odločitev za privzem tega standarda je dne 1. oktobra 2012 sprejel tehnični odbor SIST/TC UGA
Ugotavljanje skladnosti.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standardov, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO/IEC 17000:2005 (sl,en,ne,fr) Ugotavljanje skladnosti – Slovar in splošna načela
(enakovreden z ISO/IEC 17000:2004)
SIST EN ISO/IEC 17020:2012 (sl,en) Ugotavljanje skladnosti – Zahteve za delovanje različnih
organov, ki izvajajo kontrolo (ISO/IEC 17020:2012)
SIST EN ISO/IEC 17021:2011 (en) Ugotavljanje skladnosti – Zahteve za organe, ki presojajo
in certificirajo sisteme vodenja (ISO/IEC 17021:2011)
SIST EN ISO/IEC 17025:2005 (sl,en) Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev (ISO/IEC 17025:2005)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO/IEC 17065:2012
PREDHODNA IZDAJA
– SIST EN 45011:1998
OPOMBE
– Povsod, kjer se v besedilu standarda uporabljata izraza "evropski standard ali “mednarodni
standard”, v SIST EN ISO/IEC 17065:2012 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
II
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SIST EN ISO/IEC 17065 : 2012
– Ta nacionalni dokument je istoveten EN ISO/IEC 17065:2012 in je objavljen z dovoljenjem
CEN
Avenue Marnix 17
1050 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17065:2012 and is published with the
permission of
CEN
Avenue Marnix 17
1050 Bruxelles
Belgium
III
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EVROPSKI STANDARD EN ISO/IEC 17065
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE september 2012
ICS: 03.120.20 Nadomešča EN 45011:1998
Slovenska izdaja
Ugotavljanje skladnosti – Zahteve za organe, ki certificirajo proizvode, procese in storitve
(ISO/IEC 17065:2012)
Conformity assessment – Évaluation de la conformité – Konformitätsbewertung –
Requirements for bodies certifying Exigences pour les organismes Anforderungen an Stellen, die
products, processes and services certifiant les produits, les procédés Produkte (einschließlich
(ISO/IEC 17065:2012) et les services (ISO/IEC Dienstleistungen) und Prozesse
17065:2012) zertifizieren (ISO/IEC 17065:2012)
Ta evropski standard je CEN sprejel 18. avgusta 2012.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je
predpisano, da mora biti ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard.
Najnovejši seznami teh nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko
dobijo pri Upravnem centru CEN-CENELEC ali katerem koli članu CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih različicah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški komiteji
Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške,
Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske
republike Makedonije, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.
CEN CENELEC
Evropski komite za standardizacijo Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Upravni center CEN-CENELEC: Upravni center CEN-CENELEC:
Avenue Marnix 17, B-1000 Bruselj Avenue Marnix 17, B-1000 Bruselj
© 2012. Lastnice avtorskih pravic so vse države članice CEN in CENELEC Ref. št. EN ISO/IEC 17065:2012 E
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SIST EN ISO/IEC 17065 : 2012
Predgovor Foreword
Ta dokument (EN ISO/IEC 17065:2012) je This document (EN ISO/IEC 17065:2012) has
pripravil tehnični odbor ISO/CASCO "Odbor za been prepared by Technical Committee
ugotavljanje skladnosti" v sodelovanju s ISO/CASCO"Committee on conformity
tehničnim odborom CEN/CLC/TC 1 "Merila za assessment" in collaboration with Technical
organe za ugotavljanje skladnosti", katerega Committee CEN/CLC/TC 1 “Criteria for
sekretariat vodi BSI. conformity assessment bodies” the secretariat
of which is held by BSI.
Ta evropski standard mora z objavo This European Standard shall be given the
istovetnega besedila ali z razglasitvijo dobiti status of a national standard, either by
status nacionalnega standarda najpozneje do publication of an identical text or by
marca 2013, nacionalne standarde, ki so v endorsement, at the latest by March 2013, and
nasprotju s tem standardom, pa je treba conflicting national standards shall be
umakniti najpozneje do marca 2013. withdrawn at the latest by March 2013.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. CEN [in/ali CENELEC] ne prevzema subject of patent rights. CEN [and/or
odgovornosti za identifikacijo katerih koli ali CENELEC] shall not be held responsible for
vseh takih patentnih pravic. identifying any or all such patent rights.
Ta dokument nadomešča EN 45011:1998. This document supersedes EN 45011:1998.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standarde organisations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Czech Republic, Denmark, Estonia, Finland,
Islandije, Italije, Latvije, Litve, Luksemburga, Former Yugoslav Republic of Macedonia,
Madžarske, Malte, Nekdanje jugoslovanske France, Germany, Greece, Hungary, Iceland,
republike Makedonije, Nemčije, Nizozemske, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Norveške, Poljske, Portugalske, Romunije, Malta, Netherlands, Norway, Poland, Portugal,
Slovaške, Slovenije, Španije, Švedske, Švice, Romania, Slovakia, Slovenia, Spain, Sweden,
Turčije in Združenega kraljestva. Switzerland, Turkey and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo ISO/IEC 17065:2012 je CEN odobril The text of ISO/IEC 17065:2012 has been
kot EN ISO/IEC 17065:2012 brez sprememb. approved by CEN as a EN ISO/IEC 17065:2012
without any modification.
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Vsebina Stran Contents Page
Predgovor.5 Foreword.5
Uvod.7 Introduction .7
1 Področje uporabe . 9 1 Scope .9
2 Zveza s standardi.9 2 Normative references .9
3 Izrazi in definicije.9 3 Terms and definitions .9
4 Splošne zahteve.13 4 General requirements . 13
4.1 Pravne in pogodbene zadeve. 13 4.1 Legal and contractual matters . 13
4.2 Obvladovanje nepristranskosti.15 4.2 Management of impartiality . 15
4.3 Obveznosti in financiranje.18 4.3 Liability and financing . 18
4.4 Nediskriminatorni pogoji . 18 4.4 Non-discriminatory conditions . 18
4.5 Zaupnost.18 4.5 Confidentiality . 18
4.6 Javno dostopne informacije. 19 4.6 Publicly available information . 19
5 Strukturne zahteve.19 5 Structural requirements . 19
5.1 Organizacijska struktura in 5.1 Organizational structure and top
najvišje vodstvo. 19 management . 19
5.2 Mehanizem za varovanje 5.2 Mechanism for safeguarding
nepristranskosti. 20 impartiality .20
6 Zahteve glede virov.22 6 Resource requirements . 22
6.1 Osebje certifikacijskega organa . 22 6.1 Certification body personnel . 22
6.2 Viri za vrednotenje.24 6.2 Resources for evaluation. 24
7 Zahteve glede procesov.26 7 Process requirements . 26
7.1 Splošno.26 7.1 General . 26
7.2 Vloga.27 7.2 Application . 27
7.3 Pregled vloge.28 7.3 Application review . 28
7.4 Vrednotenje.29 7.4 Evaluation . 29
7.5 Pregled .30 7.5 Review . 30
7.6 Odločitev o certifikaciji. 30 7.6 Certification decision . 30
7.7 Certifikacijska dokumentacija.31 7.7 Certification documentation . 31
7.8 Register certificiranih proizvodov . 32 7.8 Directory of certified products . 32
7.9 Nadzor . 33 7.9 Surveillance . 33
7.10 Spremembe, ki vplivajo na 7.10 Changes affecting certification . 33
certifikacijo. 33
7.11 Prekinitev veljavnosti, krčenje obsega, 7.11 Termination, reduction, suspension or
začasni odvzem ali preklic certifikata. 34 withdrawal of certification . 34
7.12 Zapisi.36 7.12 Records . 36
7.13 Pritožbe in prizivi.36 7.13 Complaints and appeals . 36
8 Zahteve glede sistema vodenja.37 8 Management system requirements . 37
8.1 Možnosti.37 8.1 Options . 37
8.2 Splošna dokumentacija sistema 8.2 General management system
vodenja (možnost A). 38 documentation (Option A) . 38
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8.3 Obvladovanje dokumentov 8.3 Control of documents (Option A) . 38
(možnost A). 38
8.4 Obvladovanje zapisov (možnost A). 39 8.4 Control of records (Option A) . 39
8.5 Vodstveni pregled (možnost A) . 39 8.5 Management review (Option A) . 39
8.6 Notranje presoje (možnost A). 40 8.6 Internal audits (Option A) . 40
8.7 Korektivni ukrepi (možnost A) . 41 8.7 Corrective actions (Option A) . 41
8.8 Preventivni ukrepi (možnost A) . 42 8.8 Preventive actions (Option A) . 42
Dodatek A (informativni): Načela za Annex A (informative): Principles for product
certifikacijske organe za proizvode ter certification bodies and their certification
njihove aktivnosti certificiranja. 43 activities . 43
Dodatek B (informativni): Uporaba tega Annex B (informative): Application of this
mednarodnega standarda na področju International Standard for processes and
procesov in storitev . 46 services . 46
Literatura.47 Bibliography . 47
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SIST EN ISO/IEC 17065 : 2012
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
in IEC (Mednarodna elektrotehniška komisija) Standardization) and IEC (the International
tvorita specializiran sistem za svetovno Electrotechnical Commission) form the
standardizacijo. Nacionalni organi, ki so člani specialized system for worldwide standardization.
ISO ali IEC, sodelujejo pri pripravi mednarodnih National bodies that are members of ISO or IEC
standardov prek tehničnih odborov, ki jih za participate in the development of International
obravnavanje določenih strokovnih področij Standards through technical committees
ustanovi ustrezna organizacija. Tehnični odbori established by the respective organization to deal
ISO in IEC sodelujejo na področjih skupnega with particular fields of technical activity. ISO and
interesa. Pri delu sodelujejo tudi druge IEC technical committees collaborate in fields of
mednarodne, vladne in nevladne organizacije v mutual interest. Other international organizations,
povezavi z ISO in IEC. Odbor ISO za governmental and non-governmental, in liaison
ugotavljanje skladnosti (CASCO) je odgovoren with ISO and IEC, also take part in the work. In
za pripravo mednarodnih standardov in vodil na the field of conformity assessment, the ISO
področju ugotavljanja skladnosti. Committee on conformity assessment (CASCO)
is responsible for the development of International
Standards and Guides.
Mednarodni standardi so pripravljeni skladno s International Standards are drafted in
pravili, podanimi v Direktivah ISO/IEC, 2. del. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Osnutki mednarodnih standardov se pošljejo Draft International Standards are circulated to
nacionalnim organom v glasovanje. Za objavo the national bodies for voting. Publication as an
mednarodnega standarda je treba pridobiti International Standard requires approval by at
soglasje vsaj 75 odstotkov nacionalnih organov, ki least 75 % of the national bodies casting a vote.
so oddali svoje glasove.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. ISO ne prevzema odgovornosti za subject of patent rights. ISO shall not be held
prepoznavanje katerih koli ali vseh takih responsible for identifying any or all such patent
patentnih pravic. rights.
ISO/IEC 17065 je pripravil Odbor ISO za ISO/IEC 17065 was prepared by the ISO
ugotavljanje skladnosti (CASCO). Committee on conformity assessment (CASCO).
Poslan je bil v glasovanje nacionalnim organom It was circulated for voting to the national
ISO in IEC; obe organizaciji sta ga odobrili. bodies of both ISO and IEC, and was approved
by both organizations.
Ta prva izdaja ISO/IEC 17065 razveljavlja in This first edition of ISO/IEC 17065 cancels and
nadomešča ISO/IEC Vodilo 65:1996, ki je replaces ISO/IEC Guide 65:1996, which has
strokovno revidirano. been technically revised.
V primerjavi z ISO/IEC Vodilom 65:1996 so bile The following major changes have been made
izvedene naslednje večje spremembe: compared with ISO/IEC Guide 65:1996:
– prestrukturiranje tega mednarodnega – restructuring of this International Standard
standarda na podlagi enotne strukture, ki based on the common structure adopted
jo je sprejel ISO/CASCO; by ISO/CASCO;
– spremembe na podlagi javno dostopnih – modifications based on ISO/PAS 17001,
specifikacij ISO/PAS 17001, ISO/PAS ISO/PAS 17002, ISO/PAS 17003,
17002, ISO/PAS 17003, ISO/PAS 17004 in ISO/PAS 17004 and ISO/PAS 17005;
ISO/PAS 17005;
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SIST EN ISO/IEC 17065 : 2012
– uvedba funkcionalnega pristopa ISO/IEC – introduction of the ISO/IEC 17000 functional
17000 v zahteve glede procesov v točki 7; approach in the process requirements of
Clause 7;
– informacije o uporabi tega mednarodnega – information on the application of this
standarda na področju procesov in storitev International Standard for processes and
v dodatku B; services in Annex B;
– revizija izrazov in definicij v točki 3; – revision of the terms and definitions in
Clause 3;
– izboljšava zahtev glede nepristranskosti – improvement of the impartiality
(mehanizem); requirements (mechanism);
– konsolidacija zahtev glede sistema – consolidation of the management system
vodenja v točki 8; requirements in Clause 8;
– vključitev načel za certifikacijske organe za – inclusion of principles for product
proizvode ter njihove dejavnosti v dodatek certification bodies and their activities in
A; Annex A;
– izboljšava z upoštevanjem vodila IAF GD – improvement by taking into account
5; IAF GD 5;
– vključitev sklicevanja na certifikacijske – inclusion of a reference to certification
sheme, za katere so na voljo nadaljnje schemes, for which futher information is
informacije v standardu ISO/IEC 17067. provided in ISI/IEC 17067.
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SIST EN ISO/IEC 17065 : 2012
Uvod Introduction
Splošni cilj certificiranja proizvodov, procesov The overall aim of certifying products, proces-
ali storitev je pri vseh zainteresiranih strankah ses or services is to give confidence to all
vzbuditi zaupanje, da proizvod, proces ali interested parties that a product, process or
storitev izpolnjuje specificirane zahteve. service fulfils specified requirements. The value
Vrednost certifikacije je v stopnji zaupanja, ki ga of certification is the degree of confidence and
tretja stranka vzpostavi z nepristranskim in trust that is established by an impartial and
kompetentnim dokazovanjem izpolnjevanja competent demonstration of fulfilment of
specificiranih zahtev. K strankam, ki so specified requirements by a third party. Parties
zainteresirane za certifikacijo, sodijo med that have an interest in certification include, but
drugim: are not limited to:
a) naročniki certifikacijskih organov, a) the clients of the certification bodies;
b) odjemalci organizacij, katerih proizvodi, b) the customers of the organizations whose
procesi ali storitve so certificirani, products, processes or services are certified;
c) državni organi, c) governmental authorities;
d) nevladne organizacije ter d) non-governmental organizations; and
e) potrošniki in drugi člani javnosti. e) consumers and other members of the
public.
Zainteresirane stranke lahko od certifikacijskega Interested parties can expect or require the
organa pričakujejo ali zahtevajo, da izpolnjuje vse certification body to meet all the requirements
zahteve tega mednarodnega standarda, ter če je of this International Standard as well as when
relevantno, tudi zahteve certifikacijske sheme. relevant, those of the certification scheme.
Certifikacija proizvodov, procesov ali storitev je Certification of products, processes or services
sredstvo za zagotavljanje njihove skladnosti z is a means of providing assurance that they
zahtevami, določenimi v standardih in drugih comply with specified requirements in
normativnih dokumentih. Nekatere certifika- standards and other normative documents.
cijske sheme za proizvode, procese ali storitve Some product, process or service certification
lahko vključujejo začetno preskušanje ali schemes may include initial testing or
kontrolo in ocenjevanje sistema vodenja inspection and assessment of its suppliers'
kakovosti dobaviteljev, ki jim sledi nadzor, ki quality management systems, followed by
upošteva sistem vodenja kakovosti ter surveillance that takes into account the quality
preskušanje ali kontrolo vzorcev iz proizvodnje management system and the testing or
in odprtega trga. Druge sheme se opirajo na inspection of samples from the production and
začetno preskušanje in nadzorno preskušanje, the open market. Other schemes rely on initial
spet druge pa zajemajo samo preskušanje tipa. testing and surveillance testing, while still
others comprise type testing only.
Ta mednarodni standard določa zahteve, This International Standard specifies
katerih upoštevanje je namenjeno zagotav- requirements, the observance of which is
ljanju, da certifikacijski organi kompetentno, intended to ensure that certification bodies
dosledno in nepristransko izvajajo certifikacijske operate certification schemes in a competent,
sheme, s čimer omogoča priznavanje takih consistent and impartial manner, thereby
organov in sprejemanje certificiranih proiz- facilitating the recognition of such bodies and
vodov, procesov in storitev na nacionalni in the acceptance of certified products, processes
mednarodni ravni ter s tem pospeševanje and services on a national and international
mednarodne trgovine. Ta mednarodni standard basis and so furthering international trade. This
se lahko uporablja kot dokument s kriteriji za International Standard can be used as a criteria
akreditacijo ali strokovno ocenjevanje ali document for accreditation or peer assessment
imenovanje, ki jih izvajajo državni organi, or designation by governmental authorities,
lastniki shem in drugi. scheme owners and others.
V tem mednarodnem standardu so zahteve The requirements contained in this International
zapisane predvsem zato, da bi se upoštevale Standard are written, above all, to be
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SIST EN ISO/IEC 17065 : 2012
kot splošni kriteriji za certifikacijske organe, ki considered as general criteria for certification
izvajajo certifikacijske sheme za proizvode, bodies operating product, process or service
procese ali storitve; če jih uporabljajo posebni certification schemes; they may have to be
industrijski ali drugi sektorji ali če je treba amplified when specific industrial or other
upoštevati posebne zahteve, kot sta na primer sectors make use of them, or when particular
zdravje in varnost, jih bo morda treba razširiti. requirements such as health and safety have to
Dodatek A vsebuje načela v zvezi s be taken into account. Annex A contains
certifikacijskimi organi in z aktivnostmi principles relating to certification bodies and
certificiranja, ki jih zagotavljajo. certification activities that they provide.
Ta mednarodni standard ne postavlja zahtev za This International Standard does not set
sheme in kako se te razvijajo ter ni namenjen requirements for schemes and how they are
omejevanju vloge ali izbire lastnikov shem, developed and is not intended to restrict the
vendar pa naj zahteve shem ne bodo v role or choice of scheme owners, however
nasprotju z nobeno zahtevo tega scheme requirements should not contradict or
mednarodnega standarda ali jo izločajo. exclude any of the requirements of this
International Standard.
Izjave o skladnosti z veljavnimi standardi ali Statements of conformity to the applicable
drugimi normativnimi dokumenti imajo lahko standards or other normative documents can be
obliko certifikatov in/ali znakov skladnosti. in the form of certificates and/or marks of
Sheme za certificiranje določenih proizvodov ali conformity. Schemes for certifying particular
skupin proizvodov, procesov in storitev v skladu products or product groups, processes and
z določenimi standardi ali drugimi normativnimi services to specified standards or other
dokumenti bodo v številnih primerih zahtevale normative documents will, in many cases,
lastno razlagalno dokumentacijo. require their own explanatory documentation.
Čeprav se ta mednarodni standard nanaša na While this International Standard is concerned
tretje stranke, ki izvajajo certificiranje with third parties providing product, process or
proizvodov, procesov ali storitev, pa se lahko service certification, many of its provisions may
mnoge njegove določbe uporabijo tudi v also be useful in first- and second-party product
postopkih ugotavljanja skladnosti proizvodov, ki conformity assessment procedures.
jih izvajata prva in druga stranka.
V tem mednarodnem standardu se uporabljajo In this International Standard, the following
naslednje glagolske oblike: verbal forms are used:
– "mora, je treba" označuje zahtevo; – “shall” indicates a requirement;
– "naj" označuje priporočilo; – “should” indicates a recommendation;
– "lahko" označuje dovoljenje; – “may” indicates a permission;
– "je mogoče" označuje možnost ali – “can” indicates a possibility or a capability.
sposobnost.
Nadaljnje podrobnosti je mogoče najti v Further details can be found in the ISO/IEC
Direktivah ISO/IEC, 2. del. Directives, Part 2.
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SIST EN ISO/IEC 17065 : 2012
Ugotavljanje skladnosti – Zahteve za Conformity assessment –
organe, ki certificirajo proizvode, Requirements for bodies certifying
procese in storitve products, processes and services
1 Področje uporabe 1 Scope
Ta mednarodni standard vsebuje zahteve za This International Standard contains requirements
kompetentnost, dosledno delovanje in nepri- for the competence, consistent operation and
stranskost organov, ki certificirajo proizvode, impartiality of product, process and service
procese in storitve. Certifikacijskim organom, ki certification bodies. Certification bodies
delujejo v skladu s tem mednarodnim stan- operating to this International Standard need not
dardom, ni treba nuditi certificiranja vseh vrst offer all types of products, processes and
proizvodov, procesov in storitev. Certifikacija services certification. Certification of products,
proizvodov, procesov in storitev je dejavnost processes and services is a third-party
ugotavljanja skladnosti, ki jo opravljajo tretje conformity assessment activity (see ISO/IEC
osebe (glej ISO/IEC 17000:2004, definicija 5.5). 17000:2004, definition 5.5).
V tem mednarodnem standardu se izraz In this International Standard, the term “product”
"proizvod" lahko bere kot "proces" ali "storitev", can be read as “process” or “service”, except in
razen v primerih, ko so "procesi" ali "storitve" those instances where separate provisions are
navedeni posebej (glej dodatek B). stated for “processes” or “services” (see Annex B).
2 Zveza s standardi
2 Normative references
Za uporabo tega standarda so nujno potrebni The following referenced documents are
spodaj navedeni dokumenti. Pri datiranem indispensable for the application
...
Questions, Comments and Discussion
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