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)
ISO/IEC 17020:2012 specifies 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 ISO/IEC 17020:2012, and it applies to any stage of inspection.
Konformitätsbewertung - Anforderungen an 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2012
1DGRPHãþD
SIST EN ISO/IEC 17020:2004
8JRWDYOMDQMHVNODGQRVWL=DKWHYH]DGHORYDQMHUD]OLþQLKRUJDQRYNLL]YDMDMR
NRQWUROR ,62,(&
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
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
ISO/IEC 17020:2012(E)
© 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
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/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
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.
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);
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.
2 © ISO 2012 – All rights reserved
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.
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.
4 © ISO 2012 – All rights reserved
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/IEC 17020:2012(E)
6.1.6 The documented procedures for training (see 6.1.5) shall address the following stages:
a) an induction period;
b) a mentored working period with experienced inspectors;
c) continuing training to keep pace with developing technology and inspection methods.
6.1.7 The training required shall depend upon the ability, qualifications and experience of each inspector
and other personnel involved in inspection activities, and upon the results of monitoring (see 6.1.8).
6.1.8 Personnel familiar with the inspection methods and procedures shall monitor all inspectors and other
personnel involved in inspection activities for satisfactory performance. Results of monitoring shall be used as
a means of identifying training needs (see 6.1.7).
NOTE Monitoring can include a combination of techniques, such as on-site observations, report reviews, interviews,
simulated inspections and other techniques to assess performance, and will depend on the nature of inspection activities.
6.1.9 Each inspector shall be observed on-site, unless there is sufficient supporting evidence that the
inspector is continuing to perform competently.
NOTE It is expected that on-site observations are performed in a way that minimizes the disturbance of the
inspections, especially from the client's viewpoint.
6.1.10 The inspection body shall maintain records of monitoring, education, training, technical knowledge,
skills, experience and authorization of each member of its personnel involved in inspection activities.
6.1.11 The personnel involved in inspection activities shall not be remunerated in a way that influences the
results of inspections.
6.1.12 All personnel of the inspection body, either internal or external, that could influence the inspection
activities shall act impartially.
6.1.13 All per
...
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.
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
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
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.
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
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.
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
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.
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.
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.
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, definicija NOTE Adapted from ISO/IEC 17000:2004, definition
6.4. 6.4.
3.10 3.10
pritožba complaint
izraz nezadovoljstva, ki ni priziv in ki ga lahko expression of dissatisfaction, other than appeal,
vsaka oseba ali organizacija posreduje by any person or organization to an inspection
kontrolnemu organu v zvezi z aktivnostmi tega body, relating to the activities of that body,
organa ter nanj pričakuje odgovor where a response is expected
OPOMBA: Prirejeno po ISO/IEC 17000:2004, definicija NOTE Adapted from ISO/IEC 17000:2004, definition
6.5. 6.5.
SIST EN ISO/IEC 17020 : 2012
4 Splošne zahteve 4 General requirements
4.1 Nepristranskost in neodvisnost 4.1 Impartiality and independence
4.1.1 Aktivnosti kontrole je treba izvajati 4.1.1 Inspection activities shall be undertaken
nepristransko. impartially.
4.1.2 Kontrolni organ mora biti odgovoren za 4.1.2 The inspection body shall be responsible
nepristranskost svojih aktivnosti kontrole in ne for the impartiality of its inspection activities and
sme dovoliti, da bi jo ogrožali komercialni, shall not allow commercial, financial or other
finančni ali drugi pritiski. pressures to compromise impartiality.
4.1.3 Kontrolni organ mora stalno identificirati 4.1.3 The inspection body shall identify risks to
tveganje za svojo nepristranskost. To mora its impartiality on an ongoing basis. This shall
vključevati tiste vrste tveganja, ki izhajajo iz include those risks that arise from its activities,
njegovih aktivnosti ali njegovih odnosov ali iz or from its relationships, or from the
odnosov njegovega osebja. Vendar ni nujno, da relationships of its personnel. However, such
taki odnosi predstavljajo tveganje za relationships do not necessarily present an
nepristranskost kontrolnega organa. inspection body with a risk to impartiality.
OPOMBA: Odnos, ki ogroža nepristranskost NOTE A relationship that threatens the impartiality of
kontrolnega organa, lahko temelji na the inspection body can be based on
lastništvu, upravljanju, vodenju, osebju, ownership, governance, management,
skupnih virih, financah, pogodbah, trženju personnel, shared resources, finances,
(vključno s trženjem blagovne znamke) in contracts, marketing (including branding), and
plačevanju provizije ali druge spodbude za payment of a sales commission or other
napotitev novih naročnikov itd. inducement for the referral of new clients, etc.
4.1.4 Če je tveganje za nepristranskost 4.1.4 If a risk to impartiality is identified, the
identificirano, mora biti kontrolni organ sposoben inspection body shall be able to demonstrate
dokazati, kako tako tveganje odpravi ali čim bolj how it eliminates or minimizes such risk.
zmanjša.
4.1.5 Kontrolni organ mora imeti zavezo 4.1.5 The inspection body shall have top
najvišjega vodstva o nepristranskosti. management commitment to impartiality.
4.1.6 Kontrolni organ mora biti neodvisen do 4.1.6 The inspection body shall be independent
take mere, kot je potrebno glede na razmere, v to the extent that is required with regard to the
katerih izvaja svoje storitve. Odvisno od teh conditions under which it performs its services.
razmer mora izpolnjevati najmanjše zahteve, Depending on these conditions, it shall meet
kot so navedene v dodatku A in povzete v the minimum requirements stipulated in Annex
nadaljevanju. A, as outlined below.
a) Kontrolni organ, ki izvaja kontrole kot tretja a) An inspection body providing third party
stranka, mora izpolnjevati zahteve za inspections shall meet the type A
kontrolne organe tipa A iz točke A.1 requirements of Clause A.1 (third party
(kontrolni organ kot tretja stranka). inspection body).
b) Kontrolni organ, ki izvaja kontrole kot prva b) An inspection body providing first party
stranka, druga stranka ali kot obe ter je inspections, second party inspections, or
ločen in določljiv del organizacije, vključen both, which forms a separate and
v snovanje, proizvodnjo, dobavo, montažo, identifiable part of an organization involved
uporabo ali vzdrževanje predmetov, ki jih in the design, manufacture, supply,
kontrolira, in ki izvaja storitve kontrole installation, use or maintenance of the
samo za svojo matično organizacijo items it inspects and which supplies
(notranji kontrolni organ), mora izpolnjevati inspection services only to its parent
zahteve za kontrolne organe tipa B iz točke organization (in-house inspection body)
A.2. shall meet the type B requirements of
Clause A.2.
c) Kontrolni organ, ki izvaja kontrole kot prva c) An inspection body providing first party
stranka, druga stranka ali obe in je inspections, second party inspections, or
SIST EN ISO/IEC 17020 : 2012
prepoznaven, a ne nujno ločen del both, which forms an identifiable but not
organizacije, vključen v snovanje, necessarily a separate part of an
proizvodnjo, dobavo, montažo, uporabo ali organization involved in the design,
vzdrževanje predmetov, ki jih kontrolira, in manufacture, supply, installation, use or
ki izvaja storitve kontrole za svojo matično maintenance of the items it inspects and
organizacijo ali druge stranke ali za oboje, which supplies inspection services to its
mora izpolnjevati zahteve za kontrolne parent organization or to other parties, or
organe tipa C iz točke A.3. to both, shall meet the type C requirements
of Clause A.3.
4.2 Zaupnost 4.2 Confidentiality
4.2.1 Kontrolni organ mora biti s pravno 4.2.1 The inspection body shall be responsible,
izvršljivimi zavezami odgovoren za upravljanje z through legally enforceable commitments, for the
vsemi informacijami, pridobljenimi ali nastalimi management of all information obtained or
med izvajanjem aktivnosti kontrole. Kontrolni created during the performance of inspection
organ mora naročnika vnaprej obvestiti o activities. The inspection body shall inform the
informacijah, ki jih namerava objaviti. Vse client, in advance, of the information it intends to
informacije, razen tistih, ki jih naročnik da na place in the public domain. Except for information
voljo javnosti ali ki so dogovorjene med that the client makes publicly available, or when
kontrolnim organom in naročnikom (npr. za agreed between the inspection body and the
odzivanje na pritožbe), se štejejo za pravno client (e.g. for the purpose of responding to
zaščitene informacije in se označijo za zaupne. complaints), all other information is considered
proprietary information and shall be regarded as
confidential.
OPOMBA: Pravno izvršljive zaveze so npr. lahko NOTE Legally enforceable commitments can be,
pogodbe. for example, contractual agreements.
4.2.2 Kadar zakon zahteva od kontrolnega 4.2.2 When the inspection body is required by
organa, da izda zaupno informacijo, ali kadar je law or authorized by contractual commitments
kontrolni organ za to pooblaščen s pogodbo, to release confidential information, the client or
mora biti naročnik oziroma prizadeti individual concerned shall, unless prohibited by
posameznik obveščen o posredovani law, be notified of the information provided.
informaciji, razen kadar zakon to prepoveduje.
4.2.3 Informacije o naročniku, pridobljene iz 4.2.3 Information about the client obtained from
drugih virov, kot je naročnik (npr. pritožnik, sources other than the client (e.g. complainant,
zakonodajalci), se štejejo za zaupne. regulators) shall be treated as confidential.
5 Strukturne zahteve 5 Structural requirements
5.1 Upravne zahteve 5.1 Administrative requirements
5.1.1 Kontrolni organ mora biti pravna oseba 5.1.1 The inspection body shall be a legal
ali določeni del pravne osebe, tako da je lahko entity, or a defined part of a legal entity, such
pravno odgovoren za vse svoje aktivnosti that it can be held legally responsible for all its
kontrole. inspection activities.
OPOMBA: Državni kontrolni organ se na podlagi NOTE A governmental inspection body is deemed
svojega vladnega statusa šteje za pravno to be a legal entity on the basis of its
osebo. governmental status.
5.1.2 Kontrolni organ, ki je del pravne osebe, ki 5.1.2 An inspection body that is part of a legal
je vključena v dejavnosti, ki niso kontrola, mora entity involved in activities other than inspection
biti v tej osebi prepoznaven. shall be identifiable within that entity.
5.1.3 Kontrolni organ mora imeti dokumentacijo, 5.1.3 The inspection body shall have
v kateri so opisane aktivnosti, za katere je documentation which describes the activities for
kompetenten. which it is competent.
SIST EN ISO/IEC 17020 : 2012
5.1.4 Kontrolni organ mora imeti ustrezne 5.1.4 The inspection body shall have adequate
rezervacije (npr. zavarovanje ali rezerve) za provision (e.g. insurance or reserves) to cover
izpolnjevanje obveznosti, ki izhajajo iz liabilities arising from its operations.
njegovega delovanja.
OPOMBA: Obveznosti lahko naloži država v skladu z NOTE The liability can be assumed by the State in
nacionalno zakonodajo ali organizacija, accordance with national laws, or by the
katere del je kontrolni organ. organization of which the inspection body
forms a part.
5.1.5 Kontrolni organ mora imeti dokumentacijo, 5.1.5 The inspection body shall have
ki opisuje pogodbene pogoje, pod katerimi documentation describing the contractual
izvaja kontrolo, razen kadar storitve kontrole conditions under which it provides the
izvaja za pravno osebo, katere del je. inspection, except when it provides inspection
services to the legal entity of which it is a part.
5.2 Organizacija in vodenje
5.2 Organization and management
5.2.1 Kontrolni organ mora biti strukturiran in 5.2.1 The inspection body shall be structured
voden tako, da varuje nepristranskost. and managed so as to safeguard impartiality.
5.2.2 Kontrolni organ mora biti organiziran in 5.2.2 The inspection body shall be organized
voden tako, da mu je omogočeno vzdrževati and managed so as to enable it to maintain the
sposobnost izvajanja njegovih aktivnosti kontrole. capability to perform its inspection activities.
OPOMBA: V kontrolnih shemah se lahko zahteva, da NOTE Inspection schemes can require that the
mora kontrolni organ sodelovati pri inspection body participates in the
izmenjavi strokovnih izkušenj z drugimi exchange of technical experience with other
kontrolnimi organi, da bi vzdrževal svojo inspection bodies in order to maintain this
sposobnost. capability.
5.2.3 Kontrolni organ mora določiti in 5.2.3 The inspection body shall define and
dokumentirati odgovornosti in strukturo document the responsibilities and reporting
poročanja organizacije. structure of the organization.
5.2.4 Kadar je kontrolni organ sestavni del 5.2.4 Where the inspection body forms a part
pravne osebe, ki izvaja druge aktivnosti, je of a legal entity performing other activities, the
treba opredeliti odnos med temi drugimi relationship between these other activities and
aktivnostmi in aktivnostmi kontrole. inspection activities shall be defined.
5.2.5 Kontrolni organ mora imeti na voljo eno 5.2.5 The inspection body shall have available
ali več oseb kot tehničnega(-e) vodjo(-e), ki je one or more person(s) as technical manager(s)
(so) v celoti odgovoren(-ni) za zagotavljanje, da who have overall responsibility to ensure that
se aktivnosti kontrole izvajajo v skladu s tem the inspection activities are carried out in
mednarodnim standardom. accordance with this International Standard.
OPOMBA: Oseba, ki opravlja to funkcijo, nima vedno NOTE This person fulfilling this function does not
naziva tehnični vodja. always have the title of technical manager.
Oseba(-e), ki opravlja(-jo) to funkcijo, mora(-jo) The person(s) fulfilling this function shall be
biti strokovno kompetentna(-e) in izkušena(-e) technically competent and experienced in the
na področju delovanja kontrolnega organa. operation of the inspection body. Where the
Kadar ima kontrolni organ več tehničnih vodij, inspection body has more than one technical
mora določiti in dokumentirati posebne manager, the specific responsibilities of each
odgovornosti vsakega posameznega vodje. manager shall be defined and documented.
5.2.6 Kontrolni organ mora imenovati eno ali več 5.2.6 The inspection body shall have one or
oseb, ki bo(-do) nadomeščala(-e) odsotnega more named person(s) who will deputize in the
tehničnega vodjo, odgovornega za aktivnosti absence of any technical manager responsible
kontrole, ki so v teku. for ongoing inspection activities.
SIST EN ISO/IEC 17020 : 2012
5.2.7 Kontrolni organ mora imeti opis dela ali 5.2.7 The inspection body shall have a job
drugo dokumentacijo za vsako delovno mesto description or other documentation for each
znotraj svoje organizacije, ki je vključeno v position category within its organization
aktivnosti kontrole. involved in inspection activities.
6 Zahteve glede virov 6 Resource requirements
6.1 Osebje 6.1 Personnel
6.1.1 Kontrolni organ mora določiti in 6.1.1 The inspection body shall define and
dokumentirati zahteve za kompetentnost vsega document the competence requirements for all
osebja, ki je vključeno v aktivnosti kontrole, personnel involved in inspection activities,
vključno z zahtevami za izobrazbo, usposabljanje, including requirements for education, training,
strokovno znanje, veščine in izkušnje. technical knowledge, skills and experience.
OPOMBA: Zahteve za kompetentnost so lahko del NOTE The competence requirements can be part
opisa delovnega mesta ali druge of the job description or other
dokumentacije, omenjene v točki 5.2.7. documentation mentioned in 5.2.7.
6.1.2 Da bi kontrolni organ lahko izvajal vrsto, 6.1.2 The inspection body shall employ, or
razpon in obseg svojih aktivnosti kontrole, mora have contracts with, a sufficient number of
zaposliti ali skleniti pogodbe z zadostnim persons with the required competencies,
številom oseb z zahtevano kompetentnostjo, po including, where needed, the ability to make
potrebi vključno s sposobnostjo strokovne professional judgements, to perform the type,
presoje. range and volume of its inspection activities.
6.1.3 Osebje, odgovorno za kontrolo, mora 6.1.3 The personnel responsible for inspection
imeti ustrezne kvalifikacije, opravljeno shall have appropriate qualifications, training,
usposabljanje, izkušnje in zadovoljivo znanje o experience and a satisfactory knowledge of the
zahtevah za kontrole, ki jih izvaja. Prav tako requirements of the inspections to be carried
mora imeti ustrezno znanje o: out. They shall also have relevant knowledge of
the following:
– tehnologiji, ki se uporablja za proizvodnjo – the technology used for the manufacture of
proizvodov, ki so predmet kontrole, ter za the products inspect
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