SIST EN ISO/IEC 17020:2012
(Main)Conformity assessment - Requirements for the operation of various types of bodies performing inspection (ISO/IEC 17020:2012)
Conformity assessment - Requirements for the operation of various types of bodies performing inspection (ISO/IEC 17020:2012)
This International Standard contains requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C, as defined in this International Standard, and it applies to any stage of inspection.
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen durchführen (ISO/IEC 17020:2012)
Diese Internationale Norm legt Anforderungen an die Kompetenz von Stellen, die Inspektionen durch¬führen, sowie an die Unparteilichkeit und Konsistenz ihrer Inspektionstätigkeiten fest.
Sie gilt, wie in dieser Internationalen Norm festgelegt, für Inspektionsstellen des Typs A, B oder C und ist auf jede Stufe der Inspektion anwendbar.
ANMERKUNG Stufen der Inspektion beinhalten Konstruktion/Planung, Baumusterprüfung, Erstinspektion, Inspektionen während des Betriebs und Überwachung.
Évaluation de la conformité - Exigences pour le fonctionnement de différents types d'organismes procédant à l'inspection (ISO/IEC 17020:2012)
L'ISO/CEI 17020:2012 contient les exigences en matière de compétences des organismes procédant à des inspections, ainsi qu'en matière d'impartialité et de cohérence de leurs activités d'inspection.
Elle s'applique aux organismes d'inspection des types A, B ou C, comme définis dans l'ISO/CEI 17020:2012 et à toute étape de l'inspection.
Ugotavljanje skladnosti - Zahteve za delovanje različnih organov, ki izvajajo kontrolo (ISO/IEC 17020:2012)
Ta mednarodni standard vsebuje zahteve za kompetentnost organov, ki izvajajo kontrolo, ter za nepristranskost in doslednost njihovih aktivnosti kontrole. Uporablja se za kontrolne organe tipov A, B ali C, kot so določeni v tem mednarodnem standardu, ter za katero koli stopnjo kontrole.
General Information
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Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 17020:2012
01-april-2012
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SIST EN ISO/IEC 17020:2004
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Conformity assessment - Requirements for the operation of various types of bodies
performing inspection (ISO/IEC 17020:2012)
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen
durchführen (ISO/IEC 17020:2012)
Évaluation de la conformité - Exigences pour le fonctionnement de différents types
d'organismes procédant à l'inspection (ISO/IEC 17020:2012)
Ta slovenski standard je istoveten z: EN ISO/IEC 17020:2012
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17020:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17020:2012
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SIST EN ISO/IEC 17020:2012
EUROPEAN STANDARD
EN ISO/IEC 17020
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2012
ICS 03.120.20 Supersedes EN ISO/IEC 17020:2004
English version
Conformity assessment - Requirements for the operation of
various types of bodies performing inspection (ISO/IEC
17020:2012)
Évaluation de la conformité - Exigences pour le Konformitätsbewertung - Anforderungen an den Betrieb
fonctionnement de différents types d'organismes procédant verschiedener Typen von Stellen, die Inspektionen
à l'inspection (ISO/IEC 17020:2012) durchführen (ISO/IEC 17020:2012)
This European Standard was approved by CEN on 18 February 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, 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 17020:2012 E
worldwide for CEN national Members and for CENELEC
Members.
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SIST EN ISO/IEC 17020:2012
EN ISO/IEC 17020:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO/IEC 17020:2012
EN ISO/IEC 17020:2012 (E)
Foreword
This document (EN ISO/IEC 17020:2012) 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 September 2012, and conflicting national standards shall be
withdrawn at the latest by September 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17020:2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEC 17020:2012 has been approved by CEN as a EN ISO/IEC 17020:2012 without any
modification.
3
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SIST EN ISO/IEC 17020:2012
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SIST EN ISO/IEC 17020:2012
INTERNATIONAL ISO/IEC
STANDARD 17020
Second edition
2012-03-01
Conformity assessment — Requirements
for the operation of various types of
bodies performing inspection
Évaluation de la conformité — Exigences pour le fonctionnement de
différents types d'organismes procédant à l'inspection
Reference number
ISO/IEC 17020:2012(E)
©
ISO 2012
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(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 17020:2012
ISO/IEC 17020:2012(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Impartiality and independence . 3
4.2 Confidentiality . 4
5 Structural requirements . 4
5.1 Administrative requirements . 4
5.2 Organization and management . 4
6 Resource requirements . 5
6.1 Personnel . 5
6.2 Facilities and equipment. 6
6.3 Subcontracting . 8
7 Process requirements . 8
7.1 Inspection methods and procedures . 8
7.2 Handling inspection items and samples . 9
7.3 Inspection records . 9
7.4 Inspection reports and inspection certificates . 9
7.5 Complaints and appeals . 10
7.6 Complaints and appeals process . 10
8 Management system requirements . 11
8.1 Options . 11
8.2 Management system documentation (Option A) . 11
8.3 Control of documents (Option A) . 12
8.4 Control of records (Option A) . 12
8.5 Management review (Option A) . 13
8.6 Internal audits (Option A) . 13
8.7 Corrective actions (Option A) . 14
8.8 Preventive actions (Option A) . 14
Annex A (normative) Independence requirements for inspection bodies . 15
Annex B (informative) Optional elements of inspection reports and certificates . 17
Bibliography . 18
© ISO 2012 – All rights reserved iii
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(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 17020 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 second edition cancels and replaces the first edition (ISO/IEC 17020:1998), which has been technically
revised.
iv © ISO 2012 – All rights reserved
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(E)
Introduction
This International Standard has been drawn up with the objective of promoting confidence in bodies
performing inspection.
Inspection bodies carry out assessments on behalf of private clients, their parent organizations, or authorities,
with the objective of providing information about the conformity of inspected items with regulations, standards,
specifications, inspection schemes or contracts. Inspection parameters include matters of quantity, quality,
safety, fitness for purpose, and continued safety compliance of installations or systems in operation. The
general requirements with which these bodies are required to comply in order that their services are accepted
by clients and by supervisory authorities are harmonized in this International Standard.
This International Standard covers the activities of inspection bodies whose work can include the examination
of materials, products, installations, plants, processes, work procedures or services, and the determination of
their conformity with requirements and the subsequent reporting of results of these activities to clients and,
when required, to authorities. Inspection can concern all stages during the lifetime of these items, including
the design stage. Such work normally requires the exercise of professional judgement in performing
inspection, in particular when assessing conformity with general requirements.
This International Standard can be used as a requirements document for accreditation or peer assessment or
other assessments.
This set of requirements can be interpreted when applied to particular sectors.
Inspection activities can overlap with testing and certification activities where these activities have common
characteristics. However, an important difference is that many types of inspection involve professional
judgement to determine acceptability against general requirements, for which reason the inspection body
needs the necessary competence to perform the task.
Inspection can be an activity embedded in a larger process. For example, inspection can be used as a
surveillance activity in a product certification scheme. Inspection can be an activity that precedes maintenance
or simply provides information about the inspected item with no determination of conformity with requirements.
In such cases, further interpretation might be needed.
The categorization of inspection bodies as type A, B or C is essentially a measure of their independence.
Demonstrable independence of an inspection body can strengthen the confidence of the inspection body's
clients with respect to the body's ability to carry out inspection work with impartiality.
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.
© ISO 2012 – All rights reserved v
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SIST EN ISO/IEC 17020:2012
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SIST EN ISO/IEC 17020:2012
INTERNATIONAL STANDARD ISO/IEC 17020:2012(E)
Conformity assessment — Requirements for the operation of
various types of bodies performing inspection
1 Scope
This International Standard contains requirements for the competence of bodies performing inspection and for
the impartiality and consistency of their inspection activities.
It applies to inspection bodies of type A, B or C, as defined in this International Standard, and it applies to any
stage of inspection.
NOTE The stages of inspection include design stage, type examination, initial inspection, in-service inspection or
surveillance.
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
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
inspection
examination of a product (3.2), process (3.3), service (3.4), or installation or their design and determination
of its conformity with specific requirements or, on the basis of professional judgment, with general
requirements
NOTE 1 Inspection of processes can include personnel, facilities, technology or methodology.
NOTE 2 Inspection procedures or schemes can restrict inspection to examination only.
NOTE 3 Adapted from ISO/IEC 17000:2004, definition 4.3.
NOTE 4 The term “item” is used in this International Standard to encompass product, process, service or installation,
as appropriate.
3.2
product
result of a process
NOTE 1 Four generic product categories are noted in ISO 9000:2005:
services (e.g. transport) (see definition in 3.4);
software (e.g. computer program, dictionary);
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(E)
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.
3.3
process
set of interrelated or interacting activities which transforms inputs into outputs
NOTE Adapted from ISO 9000:2005, definition 3.4.1.
3.4
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, Note 2.
3.5
inspection body
body that performs inspection (3.1)
NOTE An inspection body can be an organization, or part of an organization.
3.6
inspection system
rules, procedures, and management for carrying out inspection
NOTE 1 An inspection system can be operated at international, regional, national or sub-national level.
NOTE 2 Adapted from ISO/IEC 17000:2004, definition 2.7.
3.7
inspection scheme
inspection system (3.6) to which the same specified requirements, specific rules and procedures apply
NOTE 1 Inspection schemes can be operated at international, regional, national or sub-national level.
NOTE 2 Schemes are sometimes also referred to as “programmes”.
NOTE 3 Adapted from ISO/IEC 17000:2004, definition 2.8.
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(E)
3.8
impartiality
presence of objectivity
NOTE 1 Objectivity means that conflicts of interest do not exist or are resolved so as not to adversely influence
subsequent activities of the inspection body.
NOTE 2 Other terms that are useful in conveying the element of impartiality are: independence, freedom from conflict
of interests, freedom from bias, lack of prejudice, neutrality, fairness, open-mindedness, even-handedness, detachment,
balance.
3.9
appeal
request by the provider of the item of inspection to the inspection body for reconsideration by that body of a
decision it has made relating to that item
NOTE Adapted from ISO/IEC 17000:2004, definition 6.4.
3.10
complaint
expression of dissatisfaction, other than appeal, by any person or organization to an inspection body, relating
to the activities of that body, where a response is expected
NOTE Adapted from ISO/IEC 17000:2004, definition 6.5.
4 General requirements
4.1 Impartiality and independence
4.1.1 Inspection activities shall be undertaken impartially.
4.1.2 The inspection body shall be responsible for the impartiality of its inspection activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
4.1.3 The inspection body shall identify risks to its impartiality on an ongoing basis. This shall include those
risks that arise from its activities, or from its relationships, or from the relationships of its personnel. However,
such relationships do not necessarily present an inspection body with a risk to impartiality.
NOTE A relationship that threatens the impartiality of the inspection body can be based on ownership, governance,
management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales
commission or other inducement for the referral of new clients, etc.
4.1.4 If a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates
or minimizes such risk.
4.1.5 The inspection body shall have top management commitment to impartiality.
4.1.6 The inspection body shall be independent to the extent that is required with regard to the conditions
under which it performs its services. Depending on these conditions, it shall meet the minimum requirements
stipulated in Annex A, as outlined below.
a) An inspection body providing third party inspections shall meet the type A requirements of Clause A.1
(third party inspection body).
b) An inspection body providing first party inspections, second party inspections, or both, which forms a
separate and identifiable part of an organization involved in the design, manufacture, supply, installation,
use or maintenance of the items it inspects and which supplies inspection services only to its parent
organization (in-house inspection body) shall meet the type B requirements of Clause A.2.
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(E)
c) An inspection body providing first party inspections, second party inspections, or both, which forms an
identifiable but not necessarily a separate part of an organization involved in the design, manufacture,
supply, installation, use or maintenance of the items it inspects and which supplies inspection services to
its parent organization or to other parties, or to both, shall meet the type C requirements of Clause A.3.
4.2 Confidentiality
4.2.1 The inspection body shall be responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of inspection activities. The
inspection body shall inform the client, in advance, of the information it intends to place in the public domain.
Except for information that the client makes publicly available, or when agreed between the inspection body
and the client (e.g. for the purpose of responding to complaints), all other information is considered proprietary
information and shall be regarded as confidential.
NOTE Legally enforceable commitments can be, for example, contractual agreements.
4.2.2 When the inspection body is required by law or authorized by contractual commitments to release
confidential information, the client or individual concerned shall, unless prohibited by law, be notified of the
information provided.
4.2.3 Information about the client obtained from sources other than the client (e.g. complainant, regulators)
shall be treated as confidential.
5 Structural requirements
5.1 Administrative requirements
5.1.1 The inspection body shall be a legal entity, or a defined part of a legal entity, such that it can be held
legally responsible for all its inspection activities.
NOTE A governmental inspection body is deemed to be a legal entity on the basis of its governmental status.
5.1.2 An inspection body that is part of a legal entity involved in activities other than inspection shall be
identifiable within that entity.
5.1.3 The inspection body shall have documentation which describes the activities for which it is competent.
5.1.4 The inspection body shall have adequate provision (e.g. insurance or reserves) to cover liabilities
arising from its operations.
NOTE The liability can be assumed by the State in accordance with national laws, or by the organization of which the
inspection body forms a part.
5.1.5 The inspection body shall have documentation describing the contractual conditions under which it
provides the inspection, except when it provides inspection services to the legal entity of which it is a part.
5.2 Organization and management
5.2.1 The inspection body shall be structured and managed so as to safeguard impartiality.
5.2.2 The inspection body shall be organized and managed so as to enable it to maintain the capability to
perform its inspection activities.
NOTE Inspection schemes can require that the inspection body participates in the exchange of technical experience
with other inspection bodies in order to maintain this capability.
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SIST EN ISO/IEC 17020:2012
ISO/IEC 17020:2012(E)
5.2.3 The inspection body shall define and document the responsibilities and reporting structure of the
organization.
5.2.4 Where the inspection body forms a part of a legal entity performing other activities, the relationship
between these other activities and inspection activities shall be defined.
5.2.5 The inspection body shall have available one or more person(s) as technical manager(s) who have
overall responsibility to ensure that the inspection activities are carried out in accordance with this
International Standard.
NOTE This person fulfilling this function does not always have the title of technical manager.
The person(s) fulfilling this function shall be technically competent and experienced in the operation of the
inspection body. Where the inspection body has more than one technical manager, the specific
responsibilities of each manager shall be defined and documented.
5.2.6 The inspection body shall have one or more named person(s) who will deputize in the absence of any
technical manager responsible for ongoing inspection activities.
5.2.7 The inspection body shall have a job description or other documentation for each position category
within its organization involved in inspection activities.
6 Resource requirements
6.1 Personnel
6.1.1 The inspection body shall define and document the competence requirements for all personnel
involved in inspection activities, including requirements for education, training, technical knowledge, skills and
experience.
NOTE The competence requirements can be part of the job description or other documentation mentioned in 5.2.7.
6.1.2 The inspection body shall employ, or have contracts with, a sufficient number of persons with the
required competencies, including, where needed, the ability to make professional judgements, to perform the
type, range and volume of its inspection activities.
6.1.3 The personnel responsible for inspection shall have appropriate qualifications, training, experience
and a satisfactory knowledge of the requirements of the inspections to be carried out. They shall also have
relevant knowledge of the following:
the technology used for the manufacture of the products inspected, the operation of processes and the
delivery of services;
the way in which products are used, processes are operated and services are delivered;
any defects which may occur during the use of the product, any failures in the operation of the process
and any deficiencies in the delivery of services.
They shall understand the significance of deviations found with regard to the normal use of the products, the
operation of the processes and the delivery of services.
6.1.4 The inspection body shall make clear to each person their duties, responsibilities and authorities.
6.1.5 The inspection body shall have documented procedures for selecting, training, formally authorizing,
and monitoring inspectors and other personnel involved in inspection activities.
© ISO 2012 – All rights reserved 5
...
SLOVENSKI SIST EN ISO/IEC 17020
STANDARD
april 2012
Ugotavljanje skladnosti – Zahteve za delovanje različnih tipov organov, ki
izvajajo kontrolo (ISO/IEC 17020:2012)
Conformity assessment – Requirements for the operation of various types of
bodies performing inspection (ISO/IEC 17020:2012)
Évaluation de la conformité – Exigences pour le fonctionnement de différents
types d'organismes procédant à l'inspection (ISO/IEC 17020:2012)
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die
Inspektionen durchführen (ISO/IEC 17020:2012)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17020:2012 (sl, en)
Nadaljevanje na strani II in od 1 do 31
© 2013-02. 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 17020 : 2012
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17020 (sl,en), Ugotavljanje skladnosti – Zahteve za delovanje različnih
tipov organov, ki izvajajo kontrolo (ISO/IEC 17020:2012), 2012, ima status slovenskega standarda in
je enakovreden evropskemu standardu EN ISO/IEC 17020, Conformity assessment – Requirements
for the operation of various types of bodies performing inspection (ISO/IEC 17020:2012), 2012.
NACIONALNI PREDGOVOR
Besedilo standarda EN ISO/IEC 17020:2012 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 17020:2012
je prevod angleškega besedila evropskega standarda EN ISO/IEC 17020:2012. 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 16. marca 2012 sprejel 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 standarda, ki smo ga že sprejeli 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)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO/IEC 17020:2012
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17020:2004
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v SIST EN ISO/IEC
17020:2012 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO/IEC 17020:2012 in je objavljen z dovoljenjem
CEN
Avenue Marnix 17
1050 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17020:2012 and is published with the
permission of
CEN
Avenue Marnix 17
1050 Bruxelles
Belgium
II
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EVROPSKI STANDARD EN ISO/IEC 17020
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE marec 2012
ICS: 03.120.20 Nadomešča EN ISO/IEC 17020:2004
Slovenska izdaja
Ugotavljanje skladnosti – Zahteve za delovanje različnih tipov organov, ki
izvajajo kontrolo (ISO/IEC 17020:2012)
Conformity assessment – Évaluation de la conformité – Konformitätsbewertung –
Requirements for the operation of Exigences pour le fonctionnement Anforderungen an den Betrieb
various types of bodies performing de différents types d'organismes verschiedener Typen von Stellen, die
inspection procédant à l'inspection Inspektionen durchführen
(ISO/IEC 17020:2012) (ISO/IEC 17020:2012) (ISO/IEC 17020:2012)
Ta evropski standard je CEN sprejel 18. februarja 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.
Ta evropski standard obstaja v treh uradnih različicah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN 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 odbori Avstrije,
Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske,
Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, 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 17020:2012 E
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SIST EN ISO/IEC 17020 : 2012
Predgovor
Ta dokument (EN ISO/IEC 17020:2012) 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.
Ta evropski standard mora z objavo istovetnega besedila ali z razglasitvijo dobiti status nacionalnega
standarda najpozneje do septembra 2012, nacionalne standarde, ki so v nasprotju s tem standardom,
pa je treba umakniti najpozneje do septembra 2012.
Opozoriti je treba na možnost, da je lahko nekaj elementov tega dokumenta predmet patentnih pravic.
CEN [in/ali CENELEC] ne prevzema odgovornosti za identifikacijo katerih koli ali vseh takih patentnih
pravic.
Ta dokument nadomešča EN ISO/IEC 17020:2004.
V skladu z notranjimi predpisi CEN/CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standardizacijo naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.
Razglasitvena objava
Besedilo ISO/IEC 17020:2012 je CEN odobril kot EN ISO/IEC 17020:2012 brez sprememb.
2
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SIST EN ISO/IEC 17020 : 2012
Vsebina Stran Contents Page
Predgovor . 4
Foreword.4
Uvod.5 Introduction. 5
1 Področje uporabe . 7 1 Scope . 7
2 Zveza s standardi.7 2 Normative references . 7
3 Izrazi in definicije.7 3 Terms and definitions . 7
4 Splošne zahteve.10 4 General requirements. 10
4.1 Nepristranskost in neodvisnost . 10 4.1 Impartiality and independence . 10
4.2 Zaupnost.11 4.2 Confidentiality. 11
5 Strukturne zahteve.11 5 Structural requirements . 11
5.1 Upravne zahteve.11 5.1 Administrative requirements. 11
5.2 Organizacija in vodenje . 12 5.2 Organization and management. 12
6 Zahteve glede virov.13 6 Resource requirements . 13
6.1 Osebje.13 6.1 Personnel . 13
6.2 Zmogljivosti in oprema.15 6.2 Facilities and equipment. 15
6.3 Sklepanje podpogodb.17 6.3 Subcontracting . 17
7 Zahteve glede procesov.18 7 Process requirements . 18
7.1 Metode in postopki kontrole.18 7.1 Inspection methods and procedures . 18
7.2 Ravnanje s predmeti kontrole in 7.2 Handling inspection items and
vzorci . 19 samples. 19
7.3 Zapisi o kontroli.20 7.3 Inspection records . 20
7.4 Poročila in potrdila/certifikati o kontroli. 20 7.4 Inspection reports and inspection
certificates. 20
7.5 Pritožbe in prizivi.21 7.5 Complaints and appeals. 21
7.6 Pritožbeni in prizivni proces. 21 7.6 Complaints and appeals process . 21
8 Zahteve glede sistema vodenja.22 8 Management system requirements. 22
8.1 Možnosti . 22 8.1 Options . 22
8.2 Dokumentacija sistema vodenja 8.2 Management system documentation
(možnost A). 22 (Option A). 22
8.3 Obvladovanje dokumentov (možnost A) . 23 8.3 Control of documents (Option A). 23
8.4 Obvladovanje zapisov (možnost A). 24 8.4 Control of records (Option A) . 24
8.5 Vodstveni pregled (možnost A) . 24 8.5 Management review (Option A). 24
8.6 Notranje presoje (možnost A). 25 8.6 Internal audits (Option A) . 25
8.7 Korektivni ukrepi (možnost A) . 26 8.7 Corrective actions (Option A) . 26
8.8 Preventivni ukrepi (možnost A) . 26 8.8 Preventive actions (Option A). 26
Dodatek A (normativni): Zahteve za Annex A (normative): Independence
neodvisnost kontrolnih organov . 27 requirements for inspection bodies. 27
Dodatek B (informativni): Neobvezni elementi Annex B (informative): Optional elements of
poročil in potrdil/certifikatov o kontroli. 30 inspection reports and certificates . 30
Literatura.31 Bibliography. 31
3
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SIST EN ISO/IEC 17020 : 2012
Predgovor Foreword
ISO (Mednarodna organizacija za ISO (the International Organization for
standardizacijo) in IEC (Mednarodna Standardization) and IEC (the International
elektrotehniška komisija) tvorita specializiran Electrotechnical Commission) form the
sistem za svetovno standardizacijo. Nacionalni specialized system for worldwide
organi, ki so člani ISO ali IEC, sodelujejo pri standardization. National bodies that are
pripravi mednarodnih standardov prek tehničnih members of ISO or IEC participate in the
odborov, ki jih za obravnavanje določenih development of International Standards through
strokovnih področij ustanovi ustrezna technical committees established by the
organizacija. Tehnični odbori ISO in IEC respective organization to deal with particular
sodelujejo na področjih skupnega interesa. Pri fields of technical activity. ISO and IEC
delu sodelujejo tudi druge mednarodne, vladne technical committees collaborate in fields of
in nevladne organizacije, povezane z ISO in mutual interest. Other international
IEC. Odbor ISO za ugotavljanje skladnosti organizations, governmental and non-
(CASCO) je odgovoren za pripravo governmental, in liaison with ISO and IEC, also
mednarodnih standardov in vodil na področju take part in the work. In the field of conformity
ugotavljanja skladnosti. assessment, the ISO 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, least 75 % of the national bodies casting a vote.
ki 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 17020 je pripravil Odbor ISO za ISO/IEC 17020 was prepared by the ISO
ugotavljanje skladnosti (CASCO). Committee on conformity assessment
(CASCO).
Standard je bil poslan v glasovanje nacionalnim It was circulated for voting to the national
organom ISO in IEC; obe organizaciji sta ga bodies of both ISO and IEC, and was approved
odobrili. by both organizations.
Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the
izdajo (ISO/IEC 17020:1998), ki je strokovno first edition (ISO/IEC 17020:1998), which has
revidirana. been technically revised.
4
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SIST EN ISO/IEC 17020 : 2012
Uvod Introduction
Namen tega mednarodnega standarda je This International Standard has been drawn up
povečati zaupanje v organe, ki izvajajo kontrolo. with the objective of promoting confidence in
bodies performing inspection.
Kontrolni organi v imenu zasebnih naročnikov, Inspection bodies carry out assessments on
svojih matičnih organizacij ali organov oblasti behalf of private clients, their parent
izvajajo ocenjevanje, da bi pridobili informacije organizations, or authorities, with the objective
o skladnosti predmetov kontrole s predpisi, of providing information about the conformity of
standardi, specifikacijami, kontrolnimi shemami inspected items with regulations, standards,
ali pogodbami. Kontrolni parametri zajemajo specifications, inspection schemes or contracts.
zadeve v zvezi s količino, kakovostjo, varnostjo, Inspection parameters include matters of
primernostjo namenu in s stalnim izpolnje- quantity, quality, safety, fitness for purpose, and
vanjem varnostnih zahtev za inštalacije ali continued safety compliance of installations or
sisteme v obratovanju. V tem mednarodnem systems in operation. The general requirements
standardu so usklajene splošne zahteve, ki jih with which these bodies are required to comply
morajo ti organi izpolnjevati, da bi naročniki in in order that their services are accepted by
nadzorni organi sprejeli njihove storitve. clients and by supervisory authorities are
harmonized in this International Standard.
Ta mednarodni standard obsega aktivnosti This International Standard covers the activities of
kontrolnih organov, katerih delo lahko zajema inspection bodies whose work can include the
pregled materialov, proizvodov, inštalacij, examination of materials, products, installations,
obratov, procesov, delovnih postopkov ali plants, processes, work procedures or services,
storitev ter ugotavljanje njihove skladnosti z and the determination of their conformity with
zahtevami in poročanje o rezultatih teh requirements and the subsequent reporting of
aktivnosti naročnikom in po potrebi organom results of these activities to clients and, when
oblasti. Kontrola se lahko nanaša na vse required, to authorities. Inspection can concern all
stopnje v življenjski dobi teh predmetov, stages during the lifetime of these items, including
vključno s snovanjem. Tako delo navadno the design stage. Such work normally requires the
zahteva uporabo strokovne presoje pri izvajanju exercise of professional judgement in performing
kontrole, zlasti kadar se ugotavlja skladnost s inspection, in particular when assessing
splošnimi zahtevami. conformity with general requirements.
Ta mednarodni standard se lahko uporablja kot This International Standard can be used as a
dokument z zahtevami za akreditacijo ali requirements document for accreditation or
strokovno ocenjevanje ali za druga ocenjevanja. peer assessment or other assessments.
Ta zbir zahtev je mogoče razlagati, ko se This set of requirements can be interpreted
uporabljajo za določena področja. when applied to particular sectors.
Kadar imajo aktivnosti kontrole ter aktivnosti Inspection activities can overlap with testing
preskušanja in certificiranja skupne značilnosti, and certification activities where these activities
se lahko prekrivajo. Vendar pa je pomembna have common characteristics. However, an
razlika v tem, da številne vrste kontrole important difference is that many types of
vsebujejo strokovno presojo za ugotavljanje inspection involve professional judgement to
sprejemljivosti glede na splošne zahteve, zaradi determine acceptability against general
česar mora biti kontrolni organ ustrezno requirements, for which reason the inspection
kompetenten za izvajanje te naloge. body needs the necessary competence to
perform the task.
Kontrola je lahko dejavnost, ki je vključena v Inspection can be an activity embedded in a
širši proces. Kontrola se na primer lahko larger process. For example, inspection can be
uporabi kot nadzorna dejavnost pri shemi used as a surveillance activity in a product
certificiranja proizvodov. Kontrola je lahko certification scheme. Inspection can be an
dejavnost, ki se izvaja pred vzdrževanjem, ali activity that precedes maintenance or simply
pa preprosto zagotavlja informacije o predmetu provides information about the inspected item
kontrole, ne da bi se ugotavljala skladnost z with no determination of conformity with
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SIST EN ISO/IEC 17020 : 2012
zahtevami. V takih primerih bi utegnila biti requirements. In such cases, further
potrebna dodatna razlaga. interpretation might be needed.
Razvrstitev kontrolnih organov v tipe A, B ali C The categorization of inspection bodies as type
je v bistvu merilo njihove neodvisnosti. A, B or C is essentially a measure of their
Dokazljiva neodvisnost kontrolnega organa independence. Demonstrable independence of
lahko okrepi zaupanje naročnikov kontrolnega an inspection body can strengthen the
organa v sposobnost organa, da bo kontrolo confidence of the inspection body's clients with
izvedel nepristransko. respect to the body's ability to carry out
inspection work with impartiality.
V tem mednarodnem standardu se uporabljajo In this International Standard, the following
naslednje glagolske oblike: verbal forms are used:
– "mora" označuje zahtevo; – “shall” indicates a requirement;
– "naj" označuje priporočilo; – “should” indicates a recommendation;
– "sme" označuje dovoljenje; – “may” indicates a permission;
– "lahko" označuje možnost ali sposobnost. – “can” indicates a possibility or a capability.
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SIST EN ISO/IEC 17020 : 2012
Ugotavljanje skladnosti – Conformity assessment –
Zahteve za delovanje različnih tipov Requirements for the operation of
organov, ki izvajajo kontrolo various types of bodies performing
inspection
1 Področje uporabe 1 Scope
Ta mednarodni standard vsebuje zahteve za This International Standard contains
kompetentnost organov, ki izvajajo kontrolo, ter requirements for the competence of bodies
za nepristranskost in doslednost njihovih performing inspection and for the impartiality
aktivnosti kontrole. and consistency of their inspection activities.
Uporablja se za kontrolne organe tipov A, B ali It applies to inspection bodies of type A, B or C,
C, kot so določeni v tem mednarodnem as defined in this International Standard, and it
standardu, ter za katero koli stopnjo kontrole. applies to any stage of inspection.
OPOMBA: Stopnje kontrole zajemajo snovanje, The stages of inspection include design stage, type
pregled tipa, začetno kontrolo, kontrolo med examination, initial inspection, in-service inspection or
obratovanjem ali nadzor. surveillance.
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 of this
sklicevanju se uporablja samo navedena izdaja. document. For dated references, only the
Pri nedatiranem sklicevanju se uporablja zadnja edition cited applies. For undated references,
izdaja dokumenta (vključno z morebitnimi the latest edition of the referenced document
spremembami). (including any amendments) applies.
ISO/IEC 17000, Ocenjevanje skladnosti – ISO/IEC 17000, Conformity assessment –
Slovar in splošna načela Vocabulary and general principles
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo izrazi in For the purposes of this document, the terms
definicije iz standarda ISO/IEC 17000 ter and definitions given in ISO/IEC 17000 and the
naslednji izrazi. following apply.
3.1 3.1
kontrola inspection
pregled proizvoda (3.2), procesa (3.3), examination of a product (3.2), process (3.3),
storitve (3.4) ali inštalacije ali njihove zasnove service (3.4), or installation or their design and
in ugotavljanje njegove skladnosti s specifičnimi determination of its conformity with specific
zahtevami oziroma, na podlagi strokovne requirements or, on the basis of professional
presoje, s splošnimi zahtevami judgment, with general requirements
OPOMBA 1: Kontrola procesov lahko vključuje osebje, NOTE 1 Inspection of processes can include
zmogljivosti, tehnologijo ali metodologijo. personnel, facilities, technology or
methodology.
OPOMBA 2: S kontrolnimi postopki ali shemami se lahko NOTE 2 Inspection procedures or schemes can
kontrola omeji samo na pregled. restrict inspection to examination only.
OPOMBA 3: Prirejeno po ISO/IEC 17000:2004, definicija NOTE 3 Adapted from ISO/IEC 17000:2004,
4.3. definition 4.3.
OPOMBA 4: Izraz "predmet", uporabljen v tem NOTE 4 The term “item” is used in this International
mednarodnem standardu, obsega proizvod, Standard to encompass product, process,
proces, storitev ali inštalacijo, kot je service or installation, as appropriate.
primerno.
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SIST EN ISO/IEC 17020 : 2012
3.2 3.2
proizvod product
rezultat procesa result of a process
OPOMBA 1: V standardu ISO 9000:2005 so navedene NOTE 1 Four generic product categories are noted
štiri temeljne kategorije proizvodov: in ISO 9000:2005:
– storitve (npr. prevoz) (glej definicijo v – services (e.g. transport) (see definition
točki 3.4); in 3.4);
– miselni proizvod (npr. računalniški – software (e.g. computer program,
program, slovar); dictionary);
– materialni proizvod (npr. stroj, – hardware (e.g. engine, mechanical
mehanski del); part);
– predelani materiali (npr. mazivo). – processed materials (e.g. lubricant).
Številni proizvodi vsebujejo elemente, ki pripadajo Many products comprise elements belonging to
različnim temeljnim kategorijam proizvodov. Od different generic product categories. Whether
prevladujočega elementa je odvisno, ali se bo the product is then called service, software,
proizvod imenoval storitev, miselni proizvod, hardware or processed material depends on the
materialni proizvod ali predelani material. dominant element.
OPOMBA 2: K proizvodom sodijo tudi rezultati naravnih NOTE 2 Products include results of natural
procesov, kot so rast rastlin in nastajanje processes, such as growth of plants and
drugih naravnih virov. formation of other natural resources.
OPOMBA 3: Prirejeno po ISO/IEC 17000:2004, definicija NOTE 3 Adapted from ISO/IEC 17000:2004,
3.3. definition 3.3.
3.3 3.3
proces process
skupek med seboj povezanih ali medsebojno set of interrelated or interacting activities which
vplivajočih aktivnosti, ki pretvarjajo vhode v izhode transforms inputs into outputs
OPOMBA: Prirejeno po ISO 9000:2005, definicija NOTE Adapted from ISO 9000:2005, definition
3.4.1. 3.4.1.
3.4 3.4
storitev service
rezultat vsaj ene aktivnosti, obvezno izvedene result of at least one activity necessarily
med dobaviteljem in odjemalcem, ki je na performed at the interface between the supplier
splošno neotipljiva and the customer, which is generally intangible
OPOMBA 1: Izvedba storitve lahko vključuje npr. NOTE 1 Provision of a service can involve, for
naslednje: example, the following:
– aktivnost, izvedeno na otipljivem – an activity performed on a customer-
proizvodu, ki ga priskrbi odjemalec (npr. supplied tangible product (e.g.
popravilo avtomobila); automobile to be repaired);
– aktivnost, izvedeno na neotipljivem – an activity performed on a customer-
proizvodu, ki ga priskrbi odjemalec (npr. supplied intangible product (e.g. the income
napoved dohodnine); statement needed to prepare a tax return);
– dobavo neotipljivega proizvoda (npr. – the delivery of an intangible product
dobavo informacij v zvezi s prenosom (e.g. the delivery of information in the
znanja); context of knowledge transmission);
– ustvarjanje vzdušja za odjemalca (npr. – the creation of ambience for the customer
v hotelih in restavracijah). (e.g. in hotels and restaurants).
OPOMBA 2: Prirejeno po ISO 9000:2005, definicija NOTE 2 Adapted from ISO 9000:2005, definition
3.4.2, opomba 2. 3.4.2, Note 2.
3.5 3.5
kontrolni organ inspection body
organ, ki izvaja kontrolo (3.1) body that performs inspection (3.1)
OPOMBA: Kontrolni organ je lahko organizacija ali del NOTE An inspection body can be an organization,
organizacije. or part of an organization.
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SIST EN ISO/IEC 17020 : 2012
3.6 3.6
kontrolni sistem inspection system
pravila, postopki in vodenje za izvajanje rules, procedures, and management for
kontrole carrying out inspection
OPOMBA 1: Kontrolni sistemi se lahko izvajajo na NOTE 1 An inspection system can be operated at
mednarodni, regionalni, nacionalni ali international, regional, national or sub-
podnacionalni ravni. national level.
OPOMBA 2: Prirejeno po ISO/IEC 17000:2004, definicija NOTE 2 Adapted from ISO/IEC 17000:2004,
2.7. definition 2.7.
3.7 3.7
kontrolna shema inspection scheme
kontrolni sistem (3.6), za katerega veljajo iste inspection system (3.6) to which the same
specificirane zahteve, posebna pravila in specified requirements, specific rules and
postopki procedures apply
OPOMBA 1: Kontrolne sheme se lahko izvajajo na NOTE 1 Inspection schemes can be operated at
mednarodni, regionalni, nacionalni ali international, regional, national or sub-
podnacionalni ravni. national level.
OPOMBA 2: Sheme se včasih imenujejo tudi "programi". NOTE 2 Schemes are sometimes also referred to as
“programmes”.
OPOMBA 3: Prirejeno po ISO/IEC 17000:2004, definicija NOTE 3 Adapted from ISO/IEC 17000:2004,
2.8. definition 2.8.
3.8 3.8
nepristranskost impartiality
prisotnost objektivnosti presence of objectivity
OPOMBA 1: Objektivnost pomeni, da nasprotja interesov NOTE 1 Objectivity means that conflicts of interest
ne obstajajo oziroma so rešena tako, da ne do not exist or are resolved so as not to
ogrožajo nadaljnjih aktivnosti kontrolnega adversely influence subsequent activities of
organa. the inspection body.
OPOMBA 2: Drugi uporabni izrazi pri podajanju NOTE 2 Other terms that are useful in conveying the
elementa nepristranskosti so: neodvisnost, element of impartiality are: independence,
odsotnost nasprotja interesov, odsotnost freedom from conflict of interests, freedom
pristranskosti, odsotnost predsodkov, from bias, lack of prejudice, neutrality,
nevtralnost, pravičnost, odprtost duha, fairness, open-mindedness, even-
enakopravno obravnavanje, neopredelje- handedness, detachment, balance.
nost, uravnoteženost.
3.9 3.9
priziv appeal
zahteva, ki jo tisti, ki priskrbi predmet kontrole, request by the provider of the item of inspection
posreduje kontrolnemu organu, naj ponovno to the inspection body for reconsideration by
pretehta odločitev, ki jo je sprejel v zvezi s tem that body of a decision it has made relating to
predmetom that item
OPOMBA: Prirejeno po ISO/IEC 17000:2004, defin
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 17020:2011
01-marec-2011
6SORãQDPHULOD]DGHORYDQMHUD]OLþQLKRUJDQRYNLL]YDMDMRNRQWUROR ,62,(&',6
General criteria for the operation of various types of bodies performing inspection
(ISO/IEC DIS 17020:2011)
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen
durchführen (ISO/IEC DIS 17020)
Critères généraux pour le fonctionnement de différents types d'organismes procédant à
l'inspection (ISO/IEC DIS 17020)
Ta slovenski standard je istoveten z: prEN ISO/IEC 17020
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
oSIST prEN ISO/IEC 17020:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/IEC 17020:2011
EUROPEAN STANDARD
DRAFT
prEN ISO/IEC 17020
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2011
ICS 03.120.20 Will supersede EN ISO/IEC 17020:2004
English version
Conformity assessment - General criteria for the operation of
various types of bodies performing inspection (ISO/IEC/DIS
17020:2011)
Evaluation de la conformité - Critères généraux pour le Konformitätsbewertung - Allgemeine Kriterien für den
fonctionnement de différents types d'organismes procédant Betrieb verschiedener Typen von Stellen, die Inspektionen
à l'inspection (ISO/IEC/DIS 17020:2011) durchführen (ISO/IEC/DIS 17020:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/CLC/TC 1.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN and CENELEC 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2011 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO/IEC 17020:2011 E
worldwide for CEN national Members and for CENELEC
Members.
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prEN ISO/IEC 17020:2011 (E)
Contents Page
Foreword .3
2
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prEN ISO/IEC 17020:2011 (E)
Foreword
This document (prEN ISO/IEC 17020:2011) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN/ISO/IEC 17020:2004.
Endorsement notice
The text of ISO/IEC/DIS 17020:2011 has been approved by CEN as a prEN ISO/IEC 17020:2011 without any
modification.
3
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oSIST prEN ISO/IEC 17020:2011
DRAFT INTERNATIONAL STANDARD ISO/IEC 17020
CASCO Secretariat: ISO/CS
Voting begins on Voting terminates on
2011-01-13 2011-06-13
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION • МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ • COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
Conformity assessment — General criteria for the operation of
various types of bodies performing inspection
Évaluation de la conformité — Critères généraux pour le fonctionnement de différents types d'organismes
procédant à l'inspection
[Revision of first edition (ISO/IEC 17020:1998)]
ICS 03.120.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2011
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ISO/IEC DIS 17020
PDF disclaimer
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ii © ISO 2011 – All rights reserved
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Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Impartiality . 3
4.2 Confidentiality . 3
5 Structural requirements . 4
5.1 Administrative requirements . 4
5.2 Organization and management . 4
6 Resource requirements . 5
6.1 Personnel . 5
6.2 Facilities and equipment. 6
6.3 Subcontracting . 7
7 Process requirements . 8
7.1 Inspection methods and procedures . 8
7.2 Handling inspection items and samples . 9
7.3 Inspection records . 9
7.4 Inspection reports and inspection certificates . 9
7.5 Complaints and appeals . 10
7.6 Complaints and appeals procedure . 10
8 Management system requirements for inspection bodies . 10
8.1 General . 10
8.2 General management system . 11
8.3 Control of documents . 11
8.4 Control of records . 12
8.5 Management review . 12
8.5.1 General . 12
8.5.2 Review inputs . 12
8.5.3 Review outputs . 12
8.6 Internal audits . 13
8.7 Corrective actions . 13
8.8 Preventive actions . 14
Annex A (normative) Type criteria for inspection bodies . 15
A.1 Criteria for third-party inspection bodies (Type A) . 15
A.2 Criteria for inspection bodies of first and second party (Type B) . 16
A.3 Criteria for inspection bodies of first and second party (Type C) . 16
Annex B (informative) Optional elements of inspection reports and certificates . 17
Bibliography . 18
© ISO/IEC 2010 – All rights reserved iii
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ISO/IEC DIS 17020
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 17020 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 edition of ISO/IEC 17020 cancels and replaces ISO/IEC 17020:1998, which has been technically revised.
iv © ISO/IEC 2010 – All rights reserved
DRAFT 2011
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Introduction
This International Standard has been drawn up with the objective of promoting confidence in bodies
performing inspection.
Inspection bodies carry out assessments on behalf of private clients, their parent organizations, or authorities
with the objective of providing information about the conformity of inspected items with regulations, standards,
specifications, inspection schemes or contracts. Inspection parameters include matters of quantity, quality,
safety, fit for purpose, and continued safety compliance of installations or systems in operation. The general
criteria, with which these bodies are required to comply in order that their services are accepted by clients and
by supervisory authorities, are harmonized in this International Standard.
This International Standard, therefore, covers the activities of inspection bodies whose work can include the
examination of materials, products, installations, plants, processes, work procedures or services and the
determination of their conformity with requirements and the subsequent reporting of results of these activities
to clients and, when required, to authorities. Inspection can concern all stages during the lifetime of these
items, including the design stage. Such work normally requires the exercise of professional judgement in
performing inspection, in particular when assessing conformity with general requirements.
Organizations (e.g. accreditation bodies or authorities) that recognize the competence of inspection bodies
can use this International Standard as the basis for their recognition.
This set of criteria can be interpreted when applied to particular sectors.
Inspection activities can overlap with testing and certification activities where these activities have common
characteristics. However, an important difference is that many types of inspection involve professional
judgement to determine acceptability against general requirements and thus the inspection body needs the
necessary competence to perform the task.
Inspection can be an activity embedded in a larger process. For example, inspection can be used as a
surveillance activity in a product certification scheme. Inspection can be an activity that precedes maintenance
or simply provides information about the inspected item with no decision that requirements are fulfilled.
Consideration can be needed when applying this standard to inspection as an activity as opposed to
inspection as stand-alone conformity assessment.
The categorization of inspection bodies as Type A, B or C is essentially a measure of their independence.
Demonstrable independence of an inspection body can strengthen the confidence of the inspection body’s
clients in the body’s ability to carry out inspection work with impartiality.
© ISO/IEC 2010 – All rights reserved v
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DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 17020
Conformity assessment — General criteria for the operation of
various types of bodies performing inspection
1 Scope
This International Standard contains requirements for the competence of bodies performing inspection and the
impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C as
defined in this International Standard and it applies to any stage of inspection (e.g. type examination, initial
inspection, in-service inspection or surveillance).
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.
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
inspection
examination of a product (3.2), process (3.3), service (3.4), or installation or their design and determination of
its conformity with specific requirements or, on the basis of professional judgment, with general requirements
NOTE 1 Inspection of processes can include personnel, facilities, technology or methodology.
NOTE 2 Inspection procedures or schemes can restrict inspection to examination only.
NOTE 3 Adapted from ISO/IEC 17000:2004, definition 4.3.
3.2
product
result of a process
NOTE 1 Four generic product categories are noted in ISO 9000:2005: services (e.g. transport) (see definition in 3.4);
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.
© ISO/IEC 2010 – All rights reserved 1
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3.3
process
set of interrelated or interacting activities which transforms inputs into outputs
NOTE Adapted from ISO 9000:2005, definition 3.4.1.
3.4
service
result of at least one activity necessarily performed at the interface between the supplier and the customer,
that 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, 3.4.2, Note 2.
3.5
inspection body
body that performs inspection (3.1)
NOTE A body can be an organization, or part of an organization.
3.6
inspection system
rules, procedures, and management for carrying out inspection
NOTE 1 Inspection system can be operated at international, regional, national or sub-national level.
NOTE 2 Adapted from ISO/IEC 17000:2004, definition 2.7.
3.7
inspection scheme
inspection system (3.6) to which the same specified requirements, specific rules and procedures apply
NOTE 1 Inspection schemes can be operated at international, regional, national or sub-national level.
NOTE 2 Schemes are sometimes also referred to as “programmes”.
NOTE 3 Adapted from ISO/IEC 17000:2004, definition 2.8.
3.8
impartiality
presence of objectivity
NOTE 1 Objectivity means that conflicts of interest do not exist or are resolved so as not to adversely influence
subsequent activities of the inspection body.
NOTE 2 Other terms that are useful in conveying the element of impartiality are: independence, freedom from conflict
of interests, freedom from bias, lack of prejudice, neutrality, fairness, open-mindedness, even-handedness, detachment,
balance.
2 © ISO/IEC 2010 – All rights reserved
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3.9
appeal
request by the provider of the item of inspection to the inspection body for reconsideration by that body of a
decision it has made relating to that item
NOTE Adapted from ISO/IEC 17000:2004, definition 6.4.
3.10
complaint
expression of dissatisfaction, other than appeal, by any person or organization to an inspection body, relating
to the activities of that body, where a response is expected
NOTE Adapted from ISO/IEC 17000:2004, definition 6.5.
4 General requirements
4.1 Impartiality and independence
4.1.1 Inspection activities shall be undertaken impartially.
4.1.2 The inspection body shall be responsible for the impartiality of its inspection activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
4.1.3 The inspection body shall identify risks to its impartiality on an ongoing basis. This shall include those
risks that arise from its activities, its relationships, or from the relationships of its personnel. However, such
relationships do not necessarily present an inspection body with a risk to impartiality.
NOTE A relationship that compromises the impartiality of the inspection body can be based on ownership,
governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment
of a sales commission or other inducement for the referral of new clients, etc.
4.1.4 If a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates
or minimizes such risk to an acceptable level.
4.1.5 The inspection body shall have top management commitment to impartiality.
4.1.6 The inspection body shall be independent to the extent that is required with regard to the conditions
under which it performs its services. Depending on these conditions it shall meet the minimum criteria
stipulated in the Annex A (normative).
4.1.6.1 An inspection body providing third-party inspections shall meet the type A criteria of Annex A
(normative).
4.1.6.2 An inspection body providing first or second party inspections which forms a separate and
identifiable part of an organization involved in the design, manufacture, supply, installation, use or
maintenance of the items it inspects and supplies inspection services only to its parent organization shall meet
the type B criteria of Annex A (normative).
4.1.6.3 An inspection body providing first or second party inspections which forms a separate or an
identifiable part of an organization involved in the design, manufacture, supply, installation, use or
maintenance of the items it inspects and supplies inspection services to its parent organization or to other
parties, or to both, shall meet the type C criteria of Annex A (normative).
4.2 Confidentiality
4.2.1 The inspection body shall be responsible, through legally enforceable arrangements, for the
management of all information obtained or created during the performance of inspection activities. The
inspection body shall inform the client, in advance, of the information it intends to place in the public domain.
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Except for information that the client makes publicly available, or when agreed between the inspection body
and the client (e.g. for the purpose of responding to complaints), all other information is considered proprietary
information and shall be regarded as confidential.
NOTE Legally enforceable arrangements can be, for example, contractual agreements.
4.2.2 When the inspection body is required by law or authorized by contractual arrangements to release
confidential information, the client or individual concerned shall, unless prohibited by law, be notified of the
information provided.
4.2.3 Information about the client obtained from sources other than the client (e.g. complainant, regulators)
shall be treated as confidential.
5 Structural requirements
5.1 Administrative requirements
5.1.1 The inspection body shall be a legal entity, or a defined part of a legal entity, such that it can be held
legally responsible for all its inspection activities.
NOTE A governmental inspection body is deemed to be a legal entity on the basis of its governmental status.
5.1.2 An inspection body that is part of a legal entity involved in activities other than inspection shall be
identifiable within that entity.
5.1.3 The inspection body shall have documentation which describes the activities for which it is competent.
5.1.4 The inspection body shall have adequate provision (e.g. insurance or reserves) to cover liabilities
arising from its operations.
NOTE The liability can be assumed by the State in accordance with national laws or by the organization of which the
inspection body forms a part.
5.1.5 The inspection body shall have documentation describing the contractual conditions under which it
provides the inspection unless it is part of a legal entity and when it provides inspe
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