SIST EN ISO/IEC 17025:2017
(Main)General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017)
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017)
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien (ISO/IEC 17025:2017)
1.1 Diese Internationale Norm legt allgemeine Anforderungen an die Kompetenz, Unparteilichkeit und für die einheitliche Arbeitsweise von Laboratorien, wie in der Norm definiert, fest.
1.2 Diese Internationale Norm ist auf alle Organisationen, die Laboratoriumstätigkeiten durchführen, unabhängig von der Anzahl der Mitarbeiter, anwendbar (siehe 3.6).
1.3 Kunden von Laboratorien, Behörden, Organisationen und Programme, die eine Begutachtung unter Gleichrangigen anwenden, Akkreditierungsstellen und andere können diese Internationale Norm ebenfalls zur Bestätigung oder Anerkennung der Kompetenz von Laboratorien einsetzen.
Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais (ISO/IEC 17025:2017)
ISO/IEC 17025:2017 établit les exigences générales de compétence, d'impartialité et de cohérence des activités des laboratoires.
ISO/IEC 17025:2017 est applicable à toutes les organisations réalisant des activités de laboratoire, quels que soient leurs effectifs.
ISO/IEC 17025:2017 est utilisé par les clients des laboratoires, les autorités réglementaires, les organisations et systèmes utilisant l'évaluation par des pairs, les organismes d'accréditation et d'autres, pour confirmer ou reconnaître la compétence des laboratoires.
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih laboratorijev (ISO/IEC 17025:2017)
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SLOVENSKI STANDARD
SIST EN ISO/IEC 17025:2017
01-december-2017
1DGRPHãþD
SIST EN ISO/IEC 17025:2005
SIST EN ISO/IEC 17025:2005/AC:2007
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih laboratorijev
(ISO/IEC 17025:2017)
General requirements for the competence of testing and calibration laboratories (ISO/IEC
17025:2017)
Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien
(ISO/IEC 17025:2017)
Exigences générales concernant la compétence des laboratoires d'étalonnages et
d'essais (ISO/IEC 17025:2017)
Ta slovenski standard je istoveten z: EN ISO/IEC 17025:2017
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
19.020 Preskuševalni pogoji in Test conditions and
postopki na splošno procedures in general
SIST EN ISO/IEC 17025:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17025:2017
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SIST EN ISO/IEC 17025:2017
EUROPEAN STANDARD
EN ISO/IEC 17025
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2017
ICS 03.120.20
Supersedes EN ISO/IEC 17025:2005
English version
General requirements for the competence of testing and
calibration laboratories (ISO/IEC 17025:2017)
Exigences générales concernant la compétence des Allgemeine Anforderungen an die Kompetenz von
laboratoires d'étalonnages et d'essais (ISO/IEC Prüf- und Kalibrierlaboratorien (ISO/IEC 17025:2017)
17025:2017)
This European Standard was approved by CEN on 10 November 2017.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2017 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO/IEC 17025:2017 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO/IEC 17025:2017
EN ISO/IEC 17025:2017 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO/IEC 17025:2017
EN ISO/IEC 17025:2017 (E)
European foreword
This document (EN ISO/IEC 17025:2017) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/JTC 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 June 2018 and conflicting national standards shall be
withdrawn at the latest by December 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17025:2005.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Endorsement notice
The text of ISO/IEC 17025:2017 has been approved by CEN as EN ISO/IEC 17025:2017 without any
modification.
3
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SIST EN ISO/IEC 17025:2017
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SIST EN ISO/IEC 17025:2017
INTERNATIONAL ISO/IEC
STANDARD 17025
Third edition
2017-11
General requirements for the
competence of testing and calibration
laboratories
Exigences générales concernant la compétence des laboratoires
d'étalonnages et d'essais
Reference number
ISO/IEC 17025:2017(E)
©
ISO/IEC 2017
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO/IEC 2017 – All rights reserved
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
Contents Page
Foreword .v
Introduction .vi
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
6 Resource requirements . 5
6.1 General . 5
6.2 Personnel . 5
6.3 Facilities and environmental conditions . 6
6.4 Equipment . 6
6.5 Metrological traceability . 8
6.6 Externally provided products and services . 8
7 Process requirements . 9
7.1 Review of requests, tenders and contracts . 9
7.2 Selection, verification and validation of methods.10
7.2.1 Selection and verification of methods .10
7.2.2 Validation of methods . .11
7.3 Sampling .12
7.4 Handling of test or calibration items .12
7.5 Technical records .13
7.6 Evaluation of measurement uncertainty .13
7.7 Ensuring the validity of results .13
7.8 Reporting of results .14
7.8.1 General.14
7.8.2 Common requirements for reports (test, calibration or sampling) .15
7.8.3 Specific requirements for test reports .15
7.8.4 Specific requirements for calibration certificates .16
7.8.5 Reporting sampling – specific requirements .16
7.8.6 Reporting statements of conformity .17
7.8.7 Reporting opinions and interpretations .17
7.8.8 Amendments to reports .17
7.9 Complaints .17
7.10 Nonconforming work .18
7.11 Control of data and information management .19
8 Management system requirements .19
8.1 Options .19
8.1.1 General.19
8.1.2 Option A .20
8.1.3 Option B .20
8.2 Management system documentation (Option A) .20
8.3 Control of management system documents (Option A) .20
8.4 Control of records (Option A).21
8.5 Actions to address risks and opportunities (Option A) .21
8.6 Improvement (Option A) .22
8.7 Corrective actions (Option A) .22
8.8 Internal audits (Option A) .23
8.9 Management reviews (Option A) .23
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
Annex A (informative) Metrological traceability .25
Annex B (informative) Management system options .27
Bibliography .29
iv © ISO/IEC 2017 – All rights reserved
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which
a technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. In the field of conformity assessment, ISO and the International Electrotechnical Commission
(IEC) develop joint ISO/IEC documents under the management of the ISO Committee on Conformity
assessment (ISO/CASCO).
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated
for voting to the national bodies of both ISO and IEC, and was approved by both organizations.
This third edition cancels and replaces the second edition (ISO/IEC 17025:2005), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the risk-based thinking applied in this edition has enabled some reduction in prescriptive
requirements and their replacement by performance-based requirements;
— there is greater flexibility than in the previous edition in the requirements for processes, procedures,
documented information and organizational responsibilities;
— a definition of “laboratory” has been added (see 3.6).
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
Introduction
This document has been developed with the objective of promoting confidence in the operation of
laboratories. This document contains requirements for laboratories to enable them to demonstrate they
operate competently, and are able to generate valid results. Laboratories that conform to this document
will also operate generally in accordance with the principles of ISO 9001.
This document requires the laboratory to plan and implement actions to address risks and opportunities.
Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the
management system, achieving improved results and preventing negative effects. The laboratory is
responsible for deciding which risks and opportunities need to be addressed.
The use of this document will facilitate cooperation between laboratories and other bodies, and assist
in the exchange of information and experience, and in the harmonization of standards and procedures.
The acceptance of results between countries is facilitated if laboratories conform to this document.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
For the purposes of research, users are encouraged to share their views on this document and their
priorities for changes to future editions. Click on the link below to take part in the online survey:
17025_ed3_usersurvey
vi © ISO/IEC 2017 – All rights reserved
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SIST EN ISO/IEC 17025:2017
INTERNATIONAL STANDARD ISO/IEC 17025:2017(E)
General requirements for the competence of testing and
calibration laboratories
1 Scope
This document specifies the general requirements for the competence, impartiality and consistent
operation of laboratories.
This document is applicable to all organizations performing laboratory activities, regardless of the
number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment,
accreditation bodies, and others use this document in confirming or recognizing the competence of
laboratories.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 Guide 99, International vocabulary of metrology — Basic and general concepts and associated
1)
terms (VIM)
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 Guide 99 and
ISO/IEC 17000 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
impartiality
presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely
influence subsequent activities of the laboratory (3.6).
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “freedom from
conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-
handedness”, “detachment”, “balance”.
[SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — The words “the certification body” have been replaced
by “the laboratory” in Note 1 to entry, and the word “independence” has been deleted from the list in
Note 2 to entry.]
1) Also known as JCGM 200.
© ISO/IEC 2017 – All rights reserved 1
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
3.2
complaint
expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities
or results of that laboratory, where a response is expected
[SOURCE: ISO/IEC 17000:2004, 6.5, modified — The words “other than appeal” have been deleted, and
the words “a conformity assessment body or accreditation body, relating to the activities of that body”
have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]
3.3
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by
two or more laboratories in accordance with predetermined conditions
[SOURCE: ISO/IEC 17043:2010, 3.4]
3.4
intralaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items
within the same laboratory (3.6) in accordance with predetermined conditions
3.5
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons (3.3)
[SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]
3.6
laboratory
body that performs one or more of the following activities:
— testing;
— calibration;
— sampling, associated with subsequent testing or calibration
Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned
activities.
3.7
decision rule
rule that describes how measurement uncertainty is accounted for when stating conformity with a
specified requirement
3.8
verification
provision of objective evidence that a given item fulfils specified requirements
EXAMPLE 1 Confirmation that a given reference material as claimed is homogeneous for the quantity value
and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are
achieved.
EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.
Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.
Note 2 to entry: The item may be, for example, a process, measurement procedure, material, compound, or
measuring system.
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
Note 3 to entry: The specified requirements may be, for example, that a manufacturer's specifications are met.
Note 4 to entry: Verification in legal metrology, as defined in VIML, and in conformity assessment in general,
pertains to the examination and marking and/or issuing of a verification certificate for a measuring system.
Note 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (3.9).
Note 6 to entry: In chemistry, verification of the identity of the entity involved, or of activity, requires a description
of the structure or properties of that entity or activity.
[SOURCE: ISO/IEC Guide 99:2007, 2.44]
3.9
validation
verification (3.8), where the specified requirements are adequate for an intended use
EXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentration of
nitrogen in water, may be validated also for measurement of mass concentration of nitrogen in human serum.
[SOURCE: ISO/IEC Guide 99:2007, 2.45]
4 General requirements
4.1 Impartiality
4.1.1 Laboratory activities shall be undertaken impartially and structured and managed so as to
safeguard impartiality.
4.1.2 The laboratory management shall be committed to impartiality.
4.1.3 The laboratory shall be responsible for the impartiality of its laboratory activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
4.1.4 The laboratory shall identify risks to its impartiality on an on-going 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 a laboratory with a risk to impartiality.
NOTE A relationship that threatens the impartiality of the laboratory 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 customers, etc.
4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates
or minimizes such risk.
4.2 Confidentiality
4.2.1 The laboratory shall be responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of laboratory activities.
The laboratory shall inform the customer in advance, of the information it intends to place in the public
domain. Except for information that the customer makes publicly available, or when agreed between the
laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is
considered proprietary information and shall be regarded as confidential.
4.2.2 When the laboratory is required by law or authorized by contractual arrangements to release
confidential information, the customer or individual concerned shall, unless prohibited by law, be
notified of the information provided.
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SIST EN ISO/IEC 17025:2017
ISO/IEC 17025:2017(E)
4.2.3 Information about the customer obtained from sources other than the customer (e.g. complainant,
regulators) shall be confidential between the customer and the laboratory. The provider (source) of this
information shall be confidential to the laboratory and shall not be shared with the customer, unless
agreed by the source.
4.2.4 Personnel, including any committee members, contractors, personnel of external bodies, or
individuals acting on the laboratory's behalf, shall keep confidential all information obtained or created
during the performance of laboratory activities, except as required by law.
5 Structural requirements
5.1 The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible
for
...
SLOVENSKI SIST EN ISO/IEC 17025
STANDARD december 2017
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2017)
General requirements for the competence of testing and calibration laboratories
(ISO/IEC 17025:2017)
Exigences générales concernant la compétence des laboratoires d'étalonnages
et d'essais (ISO/IEC 17025:2017)
Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien
(ISO/IEC 17025:2017)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17025:2017 (sl, en)
Nadaljevanje na straneh II in od 1 do 50
© 2018-05. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17025 : 2017
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17025 (sl, en), Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev (ISO/IEC 17025:2017), 2017, ima status slovenskega standarda in je
istoveten evropskemu standardu EN ISO/IEC 17025 (en), General requirements for the competence of
testing and calibration laboratories (ISO/IEC 17025:2017), 2017-12.
NACIONALNI PREDGOVOR
Evropski standard EN ISO/IEC 17025:2017 je pripravil Odbor za ugotavljanje skladnosti CASCO v
sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/CLC TC 1 Merila za
ugotavljanje skladnosti", katerega sekretariat vodi BSI.
Slovenski standard SIST EN ISO/IEC 17025:2017 je prevod evropskega standarda EN ISO/IEC
17025:2017. Ob sporu zaradi 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 izdajo tega standarda je dne 1. decembra 2017 sprejel SIST/TC UGA Ugotavljanje
skladnosti.
ZVEZA S STANDARDI
S prevzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST-V ISO/IEC Vodilo 99:2012 (sl,en,fr) Mednarodni slovar za meroslovje – Osnovni in splošni
koncepti ter z njimi povezani izrazi (VIM)
SIST EN ISO/IEC 17000:2005 (sl,en,ne,fr) Ugotavljanje skladnosti – Slovar in splošna načela
(enakovreden z ISO/IEC 17000:2004)
PREDHODNI IZDAJI
‒ SIST EN ISO/IEC 17025:2005 (sl, en), Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev (ISO/IEC 17025:2005)
‒ SIST EN ISO/IEC 17025:2005/AC:2007 (en, ne), Splošne zahteve za usposobljenost
preskuševalnih in kalibracijskih laboratorijev (ISO/IEC 17025:2005/Cor.1:2006)
OPOMBE
‒ Povsod, kjer se v besedilu standarda uporablja izraz »evropski standard« oziroma »mednarodni
standard«, v SIST EN ISO/IEC 17025:2017 to pomeni »slovenski standard«.
‒ Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
‒ Ta nacionalni dokument je enakovreden EN ISO/IEC 17025:2017 in je objavljen z dovoljenjem
CEN-CENELEC
Upravni center
Rue de la Science 23
B-1040 Bruselj
This national document is identical with EN ISO/IEC 17025:2017 and is published with the
permission of
CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels
II
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EVROPSKI STANDARD EN ISO/IEC 17025
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2017
EUROPÄISCHE NORM
ICS 03.120.20 Nadomešča EN ISO/IEC 17025:2005
Slovenska izdaja
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2017)
General requirements for the Exigences générales concernant Allgemeine Anforderungen an die
competence of testing and la compétence des laboratoires Kompetenz von Prüf- und
calibration laboratories d'étalonnages et d'essais Kalibrierlaboratorien
(ISO/IEC 17025:2017) (ISO/IEC 17025:2017) (ISO/IEC 17025:2017)
Ta evropski standard je CEN odobril 10. novembra 2017.
Člani CEN in CENELEC morajo izpolnjevati notranje predpise CEN/CENELEC, s katerimi je predpisano,
da mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na zahtevo na voljo pri
Upravnem centru CEN-CENELEC ali pri članicah CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih članice CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški komiteji Avstrije,
Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske,
Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske republike
Makedonije, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije,
Srbije, 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: Rue de la Science 23, B-1040 Bruselj
© 2017 CEN Lastnice vseh oblik avtorskih pravic so vse države Ref. oznaka EN ISO/IEC 17025:2017 E
članice CEN in CENELEC.
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SIST EN ISO/IEC 17025 : 2017
Evropski predgovor
Ta dokument (EN ISO/IEC 17025:2017) je pripravil tehnični odbor ISO/CASCO "Odbor za ugotavljanje
skladnosti" v sodelovanju s tehničnim odborom CEN/CLC/JTC 1 "Merila za ugotavljanje skladnosti",
katerega sekretariat vodi BSI.
Ta evropski standard mora z objavo istovetnega besedila ali z razglasitvijo dobiti status nacionalnega
standarda najpozneje do junija 2018, nacionalne standarde, ki so v nasprotju s tem standardom, pa je
treba umakniti najpozneje do junija 2018.
Opozoriti je treba na možnost, da je lahko nekaj elementov tega dokumenta predmet patentnih pravic.
CEN ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih pravic.
Ta dokument nadomešča EN ISO/IEC 17025:2005.
V skladu z notranjimi predpisi CEN/CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standardizacijo naslednjih držav: Avstrije, Belgije, Bivše jugoslovanske republike
Makedonije, 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, Srbije, Španije, Švedske, Švice, Turčije in
Združenega kraljestva.
Razglasitvena objava
Besedilo ISO/IEC 17025:2017 je CEN brez sprememb odobril kot EN ISO/IEC 17025:2017.
2
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SIST EN ISO/IEC 17025 : 2017
VSEBINA Stran CONTENTS Page
Predgovor . 5 Foreword . 5
Uvod . 7 Introduction . 7
1 Področje uporabe . 8 1 Scope . 8
2 Zveze s standardi . 8 2 Normative references . 8
3 Izrazi in definicije . 8 3 Terms and definitions . 8
4 Splošne zahteve . 11 4 General requirements . 11
4.1 Nepristranskost . 11 4.1 Impartiality . 11
4.2 Zaupnost . 11 4.2 Confidentiality . 11
5 Strukturne zahteve . 12 5 Structural requirements . 12
6 Zahteve glede virov . 14 6 Resource requirements . 14
6.1 Splošno . 14 6.1 General . 14
6.2 Osebje . 14 6.2 Personnel . 14
6.3 Prostori in okoljske razmere . 15 6.3 Facilities and environmental
conditions . 15
6.4 Oprema . 15 6.4 Equipment . 15
6.5 Meroslovna sledljivost . 18 6.5 Metrological traceability . 18
6.6 Izdelki in storitve zunanjih 6.6 Externally provided products and
ponudnikov . 19 services . 19
7 Zahteve glede procesov . 20 7 Process requirements . 20
7.1 Pregled naročil, ponudb in pogodb . 20 7.1 Review of requests, tenders and
contracts . 20
7.2 Izbira, preverjanje in validacija metod . 21 7.2 Selection, verification and validation
of methods . 21
7.2.1 Izbira in preverjanje metod . 21 7.2.1 Selection and verification of
methods . 21
7.2.2 Validacija metod . 23 7.2.2 Validation of methods . 23
7.3 Vzorčenje . 24 7.3 Sampling . 24
7.4 Ravnanje s primerki za preskus ali 7.4 Handling of test or calibration items . 25
kalibracijo . 25
7.5 Tehnični zapisi . 26 7.5 Technical records . 26
7.6 Ovrednotenje merilne negotovosti . 26 7.6 Evaluation of measurement
uncertainty . 26
7.7 Zagotavljanje veljavnosti rezultatov . 27 7.7 Ensuring the validity of results . 27
7.8 Poročanje o rezultatih . 28 7.8 Reporting of results . 28
7.8.1 Splošno . 28 7.8.1 General . 28
7.8.2 Skupne zahteve za poročila (o 7.8.2 Common requirements for reports
preskusu, kalibraciji ali vzorčenju) . 28 (test, calibration or sampling) . 28
7.8.3 Posebne zahteve za poročila o 7.8.3 Specific requirements for test
preskusu . 30 reports . 30
7.8.4 Posebne zahteve za certifikate o 7.8.4 Specific requirements for calibration
kalibraciji . 30 certificates . 30
7.8.5 Poročanje o vzorčenju – posebne 7.8.5 Reporting sampling – specific
zahteve . 31 requirements . 31
7.8.6 Podajanje izjav o skladnosti . 32 7.8.6 Reporting statements of conformity . 32
7.8.7 Podajanje mnenj in razlag . 32 7.8.7 Reporting opinions and
interpretations . 32
7.8.8 Dopolnila k poročilom . 33 7.8.8 Amendments to reports . 33
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SIST EN ISO/IEC 17025 : 2017
7.9 Pritožbe . 33 7.9 Complaints . 33
7.10 Neskladno delo . 34 7.10 Nonconforming work . 34
7.11 Obvladovanje podatkov in 7 11 Control of data and information
upravljanje informacij . 35 management . 35
8 Zahteve za sistem vodenja . 36 8 Management system requirements . 36
8.1 Možnosti . 36 8.1 Options . 36
8.1.1 Splošno . 36 8.1.1 General . 36
8.1.2 Možnost A . 36 8.1.2 Option A . 36
8.1.3 Možnost B . 36 8.1.3 Option B . 36
8.2 Dokumentacija sistema vodenja 8.2 Management system documentation
(možnost A) . 37 (Option A) . 37
8.3 Obvladovanje dokumentov sistema 8.3 Control of management system
vodenja (možnost A) . 37 documents (Option A) . 37
8.4 Obvladovanje zapisov (možnost A) . 38 8.4 Control of records (Option A) . 38
8.5 Ukrepi za obravnavanje tveganj in 8.5 Actions to address risks and
priložnosti (možnost A) . 38 opportunities (Option A) . 38
8.6 Izboljševanje (možnost A) . 39 8.6 Improvement (Option A) . 39
8.7 Korektivni ukrepi (možnost A) . 39 8.7 Corrective actions (Option A) . 39
8.8 Notranje presoje (možnost A) . 40 8.8 Internal audits (Option A) . 40
8.9 Vodstveni pregledi (možnost A) . 41 8.9 Management reviews (Option A) . 41
Dodatek A (informativni): Meroslovna Annex A (informative) Metrological
sledljivost . 43 traceability . 43
Dodatek B (informativni): Možnosti Annex B (informative) Management
sistema vodenja . 46 system options . 46
Literatura . 48 Bibliography . 48
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SIST EN ISO/IEC 17025 : 2017
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).
praviloma pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is
član, ki ga zanima področje, za katero je bil normally carried out through ISO technical
ustanovljen tehnični odbor, ima pravico biti committees. Each member body interested in a
zastopan v tem odboru. Pri delu sodelujejo tudi subject for which a technical committee has
mednarodne vladne in nevladne organizacije, been established has the right to be represented
povezane z ISO. Na področju ugotavljanja on that committee. International organizations,
skladnosti ISO in Mednarodna elektrotehniška governmental and non-governmental, in liaison
komisija (IEC) pod vodstvom Odbora ISO za with ISO, also take part in the work. In the field
ugotavljanje skladnosti (ISO/CASCO) razvijata of conformity assessment, ISO and the
skupne dokumente ISO/IEC. International Electrotechnical Commission (IEC)
develop joint ISO/IEC documents under the
management of the ISO Committee on
Conformity assessment (ISO/CASCO).
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in postopki, predvideni za njegovo and those intended for its further maintenance
nadaljnje vzdrževanje, so opisani v Direktivah are described in the ISO/IEC Directives, Part 1.
ISO/IEC, 1. del. Posebna pozornost naj se In particular the different approval criteria
nameni različnim kriterijem odobritve, potrebnim needed for the different types of ISO documents
za različne vrste dokumentov ISO. Ta dokument should be noted. This document was drafted in
je bil pripravljen v skladu z uredniškimi pravili accordance with the editorial rules of the
Direktiv ISO/IEC, 2. del (glej ISO/IEC Directives, Part 2 (see
www.iso.org/directives). www.iso.org/directives).
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
identifikacijo katerihkoli ali vseh takih patentnih responsible for identifying any or all such patent
pravic. Podrobnosti o morebitnih patentnih rights. Details of any patent rights identified
pravicah, identificiranih med pripravo tega during the development of the document will be
dokumenta, bodo navedene v uvodu in/ali na in the Introduction and/or on the ISO list of patent
seznamu patentnih izjav, ki jih je prejela declarations received (see
organizacija ISO (glej www.iso.org/patents). www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
Za razlago prostovoljne narave standardov, For an explanation on the voluntary nature of
pomena specifičnih pojmov in izrazov ISO, standards, the meaning of ISO specific terms
povezanih z ugotavljanjem skladnosti, ter and expressions related to conformity
informacij o tem, kako ISO spoštuje načela assessment, as well as information about ISO's
Mednarodne trgovinske organizacije (WTO) v adherence to the World Trade Organization
Tehničnih ovirah pri trgovanju (TBT), glej (WTO) principles in the Technical Barriers to
naslednji naslov URL: Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html. www.iso.org/iso/foreword.html.
Ta dokument je pripravil Odbor ISO za This document was prepared by the ISO
ugotavljanje skladnosti (CASCO) in ga poslal v Committee on Conformity Assessment (CASCO)
glasovanje nacionalnim organom ISO in IEC; and circulated for voting to the national bodies of
obe organizaciji sta ga odobrili. both ISO and IEC, and was approved by both
organizations.
5
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SIST EN ISO/IEC 17025 : 2017
Ta tretja izdaja standarda razveljavlja in This third edition cancels and replaces the
nadomešča drugo izdajo (ISO/IEC 17025:2005), second edition (ISO/IEC 17025:2005), which
ki je bila tehnično revidirana. has been technically revised.
Glavne spremembe v primerjavi s prejšnjo izdajo The main changes compared to the previous
so: edition are as follows:
– the risk-based thinking applied in this
‒ razmišljanje na podlagi tveganja,
edition has enabled some reduction in
uporabljeno v tej izdaji, je omogočilo, da je
prescriptive requirements and their
predpisanih zahtev nekaj manj in da so
replacement by performance-based
nadomeščene z zahtevami, ki temeljijo na
requirements;
učinkih delovanja;
‒ prilagodljivost zahtev za procese, postopke, ‒ there is greater flexibility than in the
dokumentirane informacije in odgovornosti previous edition in the requirements for
organizacije je večja kot pri prejšnji izdaji processes, procedures, documented
standarda; information and organizational
responsibilities;
‒ dodana je definicija laboratorija (glej točko ‒ a definition of “laboratory” has been added
3.6). (see 3.6).
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SIST EN ISO/IEC 17025 : 2017
Introduction
Uvod
Ta dokument je bil razvit s ciljem, da bi This document has been developed with the
spodbudili zaupanje v delovanje laboratorijev. objective of promoting confidence in the
Vsebuje zahteve za laboratorije, ki bi jim operation of laboratories. This document
omogočile dokazati, da so usposobljeni za contains requirements for laboratories to enable
zagotavljanje veljavnih rezultatov. Laboratoriji, ki them to demonstrate they operate competently,
delujejo v skladu s tem dokumentom, bodo na and are able to generate valid results.
splošno delovali tudi v skladu z načeli standarda Laboratories that conform to this document will
ISO 9001. also operate generally in accordance with the
principles of ISO 9001.
Ta dokument zahteva od laboratorija, da planira This document requires the laboratory to plan
in izvaja ukrepe za obravnavanje tveganj in and implement actions to address risks and
priložnosti. Z obravnavanjem tako tveganj kakor opportunities. Addressing both risks and
tudi priložnosti se vzpostavi podlaga za večjo opportunities establishes a basis for increasing
učinkovitost sistema vodenja, doseganje the effectiveness of the management system,
izboljšanih rezultatov in preprečevanje achieving improved results and preventing
negativnih učinkov. Laboratorij je odgovoren za negative effects. The laboratory is responsible
odločanje, katera tveganja in priložnosti je treba for deciding which risks and opportunities need
obravnavati. to be addressed.
Uporaba tega dokumenta bo olajšala The use of this document will facilitate
sodelovanje med laboratoriji in drugimi organi ter cooperation between laboratories and other
pomagala pri izmenjavi informacij in izkušenj ter bodies, and assist in the exchange of information
pri usklajevanju standardov in postopkov. Če and experience, and in the harmonization of
laboratoriji delujejo v skladu s tem dokumentom, standards and procedures. The acceptance of
je lažje tudi meddržavno sprejemanje rezultatov. results between countries is facilitated if
laboratories conform to this document.
V tem dokumentu so uporabljene naslednje In this document, the following verbal forms are
glagolske oblike: used:
– " je treba" ali "mora" označuje zahtevo; – “shall” indicates a requirement;
– "naj" označuje priporočilo; – “should” indicates a recommendation;
– "lahko" označuje dovoljenje; – “may” indicates a permission;
– "je mogoče, lahko" označuje možnost ali – “can” indicates a possibility or a capability.
sposobnost.
Nadaljnje podrobnosti so opisane v Direktivah Further details can be found in the ISO/IEC
ISO/IEC, 2. del. Directives, Part 2.
Uporabnikom priporočamo, da v raziskovalne For the purposes of research, users are
namene sporočijo svoje mnenje o tem encouraged to share their views on this
dokumentu in o svojih prednostnih nalogah document and their priorities for changes to
glede sprememb v prihodnjih izdajah. Če želite future editions. Click on the link below to take
sodelovati v spletni raziskavi, kliknite na spodnjo part in the online survey:
povezavo:
17025_ed3_usersurvey 17025_ed3_usersurvey
7
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SIST EN ISO/IEC 17025 : 2017
Splošne zahteve za usposobljenost General requirements for the
preskuševalnih in kalibracijskih competence of testing and
laboratorijev calibration laboratories
1 Scope
1 Področje uporabe
This document specifies the general
Ta dokument opredeljuje splošne zahteve za
requirements for the competence, impartiality
usposobljenost, nepristranskost in konsistentno
and consistent operation of laboratories.
delovanje laboratorijev.
This document is applicable to all organizations
Ta dokument lahko uporabljajo vse organizacije,
performing laboratory activities, regardless of
ki izvajajo laboratorijske aktivnosti, ne glede na
the number of personnel.
število osebja.
Laboratory customers, regulatory authorities,
Odjemalci laboratorijev, regulativni organi,
organizations and schemes using peer-
organizacije in sheme, ki uporabljajo
assessment, accreditation bodies, and others
medsebojno ocenjevanje, akreditacijski organi in
use this document in confirming or recognizing
drugi uporabljajo ta dokument pri potrjevanju ali
the competence of laboratories.
priznavanju usposobljenosti laboratorijev.
2 Zveze s standardi 2 Normative references
Besedilo se sklicuje na naslednje dokumente The following documents are referred to in the
tako, da njihova vsebina v celoti ali delno text in such a way that some or all of their content
predstavlja zahteve tega dokumenta. Pri constitutes requirements of this document. For
datiranem sklicevanju se uporablja samo dated references, only the edition cited applies.
navedena izdaja. Pri nedatiranem sklicevanju se For undated references, the latest edition of the
uporablja zadnja izdaja dokumenta (vključno z referenced document (including any
morebitnimi dopolnili). amendments) applies.
ISO/IEC Vodilo 99 Mednarodni slovar meros- ISO/IEC Guide 99 International vocabulary of
lovja – Osnovni in splošni metrology — Basic and
pojmi ter z njimi povezani general concepts and
1) 1)
izrazi (VIM) associated terms (VIM)
ISO/IEC 17000 Ugotavljanje skladnosti – ISO/IEC 17000, Conformity assessment –
Slovar in splošna načela Vocabulary and general
principles
1)
Poznan tudi kot JCGM 200.
1)
Also known as JCGM 200.
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo izrazi in For the purposes of this document, the terms
definicije, navedeni v ISO/IEC Vodilu 99 in v and definitions given in ISO/IEC Guide 99 and
standardu ISO/IEC 17000, ter naslednji izrazi. ISO/IEC 17000 and the following apply.
ISO in IEC vzdržujeta terminološke podatkovne ISO and IEC maintain terminological databases
baze za uporabo v standardizaciji na naslednjih for use in standardization at the following
naslovih: addresses:
‒ Spletna platforma ISO: dostopna na ‒ ISO Online browsing platform: available at
https://www.iso.org/obp https://www.iso.org/obp
‒ Elektropedija IEC: dostopna na ‒ IEC Electropedia: available at
http://www.electropedia.org/ http://www.electropedia.org/
8
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SIST EN ISO/IEC 17025 : 2017
3.1 3.1
nepristranskost impartiality
prisotnost objektivnosti presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest
OPOMBA 1: Objektivnost pomeni, da nasprotja interesov
do not exist, or are resolved so as not to
ne obstajajo ali da so rešena tako, da ne
adversely influence subsequent activities
vplivajo negativno na nadaljnje aktivnosti
of the laboratory (3.6).
laboratorija (3.6).
Note 2 to entry: Other terms that are useful in conveying
OPOMBA 2: Drugi uporabni izrazi pri podajanju elementa
the element of impartiality include
nepristranskosti so: "odsotnost nasprotja
"freedom from conflict of interests",
interesov", "odsotnost pristranskosti",
"freedom from bias", "lack of prejudice",
"odsotnost predsodkov", "nevtralnost",
"neutrality", "fairness", "open-
"poštenost", "odprtost duha", "enakopravno
mindedness", "evenhandedness",
obravnavanje", "neopredeljenost", "urav-
"detachment", "balance".
noteženost".
[SOURCE: ISO/IEC 17021‐1:2015, 3.2, modified
[VIR: ISO/IEC 17021-1:2015, 3.2, spremenjen –
V OPOMBI 1 sta besedi "certifikacijski organ" – The words "the certification body" have been
replaced by "the laboratory" in Note 1 to entry,
zamenjani z besedo "laboratorij", v OPOMBI 2
pa je s seznama brisana beseda "neodvisnost".] and the word "independence" has been deleted
from the list in Note 2 to entry.]
3.2 3.2
pritožba complaint
izraz nezadovoljstva, ki ga lahko vsaka oseba ali expression of dissatisfaction by any person or
organizacija posreduje laboratoriju (3.6) v zvezi organization to a laboratory (3.6), relating to the
z aktivnostmi ali rezultati tega laboratorija ter activities or results of that laboratory, where a
nanj pričakuje odgovor. response is expected
[VIR: ISO/IEC 17000:2004, 6.5, spremenjen – [SOURCE: ISO/IEC 17000:2004, 6.5, modified –
Besedi "razen priziva" sta črtani, besede "organu The words "other than appeal" have been
za ugotavljanje skladnosti ali akreditacijskemu deleted, and the words "a conformity
organu v zvezi z aktivnostmi tega organa" pa so assessment body or accreditation body, relating
zamenjane z besedami "laboratoriju v zvezi z to the activities of that body" have been replaced
aktivnostmi ali rezultati tega laboratorija".] by "a laboratory, relating to the activities or
results of that laboratory".]
3.3 3.3
medlaboratorijska primerjava interlaboratory comparison
organiziranje, izvajanje in ovrednotenje meritev orga
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 17025:2017
01-januar-2017
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih laboratorijev
(ISO/IEC DIS 17025:2016)
General requirements for the competence of testing and calibration laboratories (ISO/IEC
DIS 17025:2016)
Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien
(ISO/IEC DIS 17025:2016)
Exigences générales concernant la compétence des laboratoires d'étalonnages et
d'essais (ISO/IEC DIS 17025:2016)
Ta slovenski standard je istoveten z: prEN ISO/IEC 17025 rev
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
19.020 Preskuševalni pogoji in Test conditions and
postopki na splošno procedures in general
oSIST prEN ISO/IEC 17025:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/IEC 17025:2017
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oSIST prEN ISO/IEC 17025:2017
DRAFT INTERNATIONAL STANDARD
ISO/IEC DIS 17025
ISO/CASCO Secretariat: ISO
Voting begins on: Voting terminates on:
2016-12-29 2017-03-22
General requirements for the competence of testing and
calibration laboratories
Exigences générales concernant la compétence des laboratoires d’étalonnages et d’essais
ICS: 03.120.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/IEC DIS 17025:2016(E)
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. ISO/IEC 2016
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oSIST prEN ISO/IEC 17025:2017
ISO/IEC DIS 17025:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO/IEC 2016 – All rights reserved
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oSIST prEN ISO/IEC 17025:2017
ISO/IEC DIS 17025 :2016(E)
Contents
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 General requirements .7
4.1 Impartiality.7
4.2 Confidentiality.8
5 Structural requirements .8
6 Resource requirements .9
6.1 General .9
6.2 Personnel .9
6.3 Laboratory facilities and environmental conditions . 10
6.4 Equipment . 11
6.5 Metrological traceability. 12
6.6 Externally provided products and services . 13
7 Process requirements. 14
7.1 Review of requests, tenders and contracts . 14
7.2 Selection, verification and validation of methods . 15
7.3 Sampling. 17
7.4 Handling of test or calibration items . 17
7.5 Technical records . 18
7.6 Evaluation of measurement uncertainty . 18
7.7 Assuring the quality of results . 18
7.8 Reporting of results. 20
7.9 Complaints . 23
7.10 Management of nonconforming work . 24
7.11 Control of data – Information management . 25
8 Management requirements . 26
8.1 Options . 26
8.2 Management system documentation (Option A) . 26
8.3 Control of management system documents (Option A) . 27
8.4 Control of records (Option A) . 27
8.5 Actions to address risks and opportunities (Option A). 27
8.6 Improvement (Option A). 28
8.7 Corrective action (Option A). 28
8.8 Internal audits (Option A) . 29
8.9 Management reviews (Option A). 29
Annex A. 31
Annex B. 33
Bibliography. 35
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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 t echnical 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, ISO and IEC develop joint ISO/IEC documents under the
management of the ISO Committee on Conformity assessment (ISO/CASCO).
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
Details of any patent rights identified during the development of the document will be in the
Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Agreement on
Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO/IEC 17025 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 third edition cancels and replaces the second edition (ISO/IEC 17025:2005), which has been
technically revised.
The first edition (1999) of this International Standard was produced as the result of extensive
experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it replaced. It
contained all of the requirements that testing and calibration laboratories have to meet if they wish to
demonstrate that they operate a management system, are technically competent, and are able to
generate technically valid results. ISO/IEC 17025 was aligned with ISO 9001:2000 in 2005. Since then
ISO 9001 has been revised twice.
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Introduction
This International Standard has been developed with the objective of promoting confidence in the
operation of laboratories.
This International Standard contains requirements for laboratories to enable them to demonstrate they
operate competently, and are able to generate valid results.
Laboratories that conform to this International Standard will also operate generally in accordance with
the principles of ISO 9001.
This International Standard requires the laboratory to plan and implement actions to address risks and
opportunities. Addressing both risks and opportunities establishes a basis for increasing the
effectiveness of the management system, achieving improved results and preventing negat ive effects.
The laboratory is responsible for deciding which risks and opportunities need to be addressed.
The use of this International Standard will facilitate cooperation between laboratories and other bodies,
and assist in the exchange of information and experience, and in the harmonization of standards and
procedures. The acceptance of results between countries is facilitated if laboratories conform to this
International Standard.
In this International Standard, the following verbal forms are used:
- “shall” indicates a requirement;
- “should” indicates a recommendation;
- “may” indicates a permission;
- “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
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General requirements for the competence of testing and
calibration laboratories
1 Scope
1.1 This International Standard specifies the general requirements for the competence, impartiality
and consistent operation of laboratories as defined in the standard.
1.2 This International Standard is applicable to all organizations, regardless of the number of personnel,
performing laboratory activities (see 3.6) .
1.3 Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment,
accreditation bodies, and others can also use this International Standard in confirming or recognizing
the competence of laboratories.
2 Normative references
The following referenced document is 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.
JCGM 200:2012, International vocabulary of metrology — basic and general concepts and associated
rd
terms (VIM), 3 edition issued by BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP and OIML
3 Terms and definitions
For the purposes of this document, the following terms and definitions given in ISO/IEC 17000 and
1
JCGM 200:2012 and the following apply .
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
IEC Electropedia: available at http://www.electropedia.org/
ISO Online browsing platform: available at http://www.iso.org/obp
3.1
impartiality
presence of objectivity
Note 1 to entry: Objectivity is understood to mean that conflicts of interest do not exist, or are resolved so as
not to adversely influence the activities of the laboratory.
1
Where there is more than one definition for the same term, the definitions in ISO/IEC 17000 and JCGM
200:2012 take precedence.
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Note 2 to entry: Other terms that are useful in conveying the element of impartiality are freedom from conflicts
of interest, freedom from bias, freedom from prejudice, neutrality, fairness, open-mindedness, even-handedness,
detachment and balance.
[SOURCE: ISO/IEC 17021-1:2015, 3.2]
3.2
complaint
expression of dissatisfaction by any person or organization to a laboratory, relating to the activities or
results of that laboratory, where a response is expected
[SOURCE: ISO 17000:2004, 6.5 — modified: conformity assessment body or accreditation body replaced by
laboratory and added the term results and removed appeals]
3.3
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by
two or more laboratories in accordance with predetermined conditions
[SOURCE: ISO/IEC 17043:2010, 3.4]
3.4
intralaboratory comparison
organization performance and evaluation of measurements or tests on the same or similar items, within
the same laboratory, in accordance with predetermined conditions
3.5
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons
[SOURCE: ISO/IEC 17043:2010, 3.7— modified: the reference to the Annex and notes deleted.]
3.6
laboratory
body that performs one or more of the following activities:
calibration
testing
sampling, associated with subsequent calibration or testing
3.7
decision rule
a rule that describes how measurement uncertainty will be accounted for when stating conformity
with a specified requirement
4 General requirements
4.1 Impartiality
4.1.1 Laboratory activities shall be undertaken impartially and structured and managed so as to
safeguard impartiality.
4.1.2 The laboratory management shall be committed to impartiality.
4.1.3 The laboratory shall be responsible for the impartiality of its laboratory activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
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4.1.4 The laboratory shall identify risks to its impartiality on an on-going 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 a laboratory with a risk to
impartiality.
NOTE A relationship that threatens the impartiality of the laboratory 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 customers, etc.
4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it
eliminates or minimizes such risk.
4.2 Confidentiality
4.2.1 The laboratory shall ensure the protection of its customers' confidential information and
proprietary rights, including protecting the electronic storage and transmission of results.
4.2.2 The laboratory shall be responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of laboratory activities. The
laboratory shall inform the customer in advance, of the information it intends to place in the public
domain. Except for information that the customer makes publicly available, or when agreed between
the laboratory and the customer (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.
4.2.3 When the laboratory is required by law or authorized by contractual arrangements to release
confidential information, the customer or individual concerned shall, unless prohibited by law, be
notified of the information provided.
4.2.4 Information about the customer obtained from sources other than the customer (e.g.
complainant, regulators) shall be confidential between the customer and the laboratory. The provider
(source) of this information shall be confidential to the laboratory and shall not be shared with the
customer, unless agreed by the source.
4.2.5 Personnel, including any committee members, contractors, personnel of external bodies, or
individuals acting on the laboratory's behalf, shall keep confidential all information obtained or created
during the performance of laboratory activities, except as required by law.
5 Structural requirements
5.1 The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible
for all its activities.
NOTE For the purpose of this international standard, a governmental laboratory is deemed to be a legal entity
on the basis of its governmental status.
5.2 The laboratory shall identify management who have overall responsibility for the laboratory.
5.3 The laboratory shall carry out its activities in such a way as to meet the requirements of this
International Standard, its customers, regulatory authorities and organizations providing recognition.
The laboratory shall be responsible for activities performed in all its permanent facilities, at sites away
from its permanent facilities, in associated temporary or mobile facilities or at a customer’s facility.
5.4 The laboratory shall define and document the range of laboratory activities for which it conforms
with this International Standard. The laboratory shall only claim conformity with this International
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Standard for the range of laboratory activities, which excludes externally provided laboratory activities
on an ongoing basis.
5.5 The laboratory shall:
a) define the organization and management structure of the laboratory, its place in any parent
organization, and the relationships between management, technical operations and support
services;
b) specify the responsibility, authority and interrelationship of all personnel who manage, perform or
verify work affecting the results of laboratory activities;
c) document its procedures to the extent necessary to assure the consistent application of its activities
and validity of the results.
5.6 The laboratory shall have personnel who, irrespective of other responsibilities, have the
authority and resources needed to carry out their duties, including:
a) implementation, maintenance and improvement of the management system;
b) identification of deviations from the management system or from the procedures for performing
laboratory activities;
c) initiation of actions to prevent or minimize such deviations;
d) reporting to laboratory management on the performance of the management system and any need
for improvement; and
e) ensuring the required validity of laboratory activities.
5.7 Laboratory management shall ensure that:
a) the integrity of the management system is maintained when changes to the management system
are implemented;
b) communication takes place regarding the effectiveness of the management system and the
importance of meeting customer and other requirements.
6 Resource requirements
6.1 General
The laboratory shall have available the personnel, facilities, equipment, systems and support services
necessary to perform its laboratory activities.
6.2 Personnel
6.2.1 All personnel of the laboratory, either internal or external, that could influence the laboratory
activities shall act impartially, be supervised and competent, and shall work in accordance with the
laboratory's management system.
6.2.2 The laboratory shall document the competence requirements for each function influencing the
results of laboratory activities, including requirements for education, qualification, training, technical
knowledge, skills, experience.
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6.2.3 The laboratory shall ensure that the personnel have the competence to perform the laboratory
activities for which they are responsible and understand the significance of and response to deviations
found with regard to the laboratory activities.
6.2.4 The laboratory shall communicate to each person their duties, responsibilities and authorities.
6.2.5 The laboratory shall have procedure(s) and maintain records for:
a) determining the competence requirements;
b) selection of personnel;
c) training of personnel;
d) supervision of personnel;
e) authorization of personnel;
f) monitoring of competence of personnel.
6.2.6 The laboratory shall authorize personnel to:
a) develop, modify, verify and validate methods;
b) perform specific laboratory activities;
c) analyze results, including statements of conformity or opinions and interpretations; and
d) report results.
6.3 Laboratory facilities and environmental conditions
6.3.1 The facilities and environmental conditions shall be suitable for the laboratory activities and
shall not adversely affect the validity of results.
6.3.2 The requirements for facilities and environmental conditions necessary for the performance of
the laboratory activities shall be documented
6.3.3 The laboratory shall monitor, control and record environmental conditions as required by the
relevant specifications, methods and procedures or where they influence the validity of the results.
6.3.4 Measures to control facilities shall be implemented, monitored and periodically reviewed and
shall include, but not be limited to:
a) access to and use of areas affecting laboratory activities;
b) prevention of contamination, interference or adverse influences on the laboratory activities;
c) effective separation between areas in which there are incompatible laboratory activities.
NOTE Influences that can adversely affect the validity of results include biological sterility, dust,
electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound and vibration levels.
6.3.5 When the laboratory performs activities at facilities outside its permanent control, it shall
ensure that the requirements related to facilities and environmental conditions of this International
Standard are met.
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6.4 Equipment
6.4.1 The laboratory shall have access to equipment required for the correct performance of the
laboratory activities. Equipment includes measuring instruments, software, measurement standards,
reference materials, reference data, reagents and consumables or auxiliary apparatus or combination
thereof necessary for laboratory activities and which can influence the result.
6.4.2 In those cases where the laboratory uses equipment outside its permanent control, it shall
ensure that the requirements for equipment of this International Standard are met.
6.4.3 The laboratory shall have a procedure for handling, transport, storage, use and planned
maintenance of equipment to ensure proper functioning and in order to prevent contamination or
deterioration.
6.4.4 The laboratory shall verify that equipment complies with specified requirements before being
placed into service.
6.4.5 The equipment used for measurement shall be capable of achieving the measurement accuracy
and measurement uncertainty required to provide a valid result.
6.4.6 When the measurement accuracy and measurement uncertainty affect the validity of the
reported result, or metrological traceability is a requirement, measuring equipment shall be calibrated.
NOTE Types of equipment having an effect on the validity of the reported results may include:
those used for the direct measurement of the measurand, for example, use of a balance to perform a mass
measurement;
those used to make corrections to the measured value, for example, temperature measurements;
those used to obtain a measurement result calculated from multiple measurements.
6.4.7 The laboratory shall establish a calibration program to ensure metrological traceability of the
measurement results is maintained. The calibration program shall be reviewed and adjusted as
necessary in order to maintain confidence in the status of calibration.
6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labelled,
coded or otherwise identified to allow the user of the equipment to readily identify the status of
calibration or period of validity.
6.4.9 Records shall be maintained for equipment which can influence the laboratory activities. The
records shall include at least the following:
a) the identity of equipment, including software and firmware version (where available) ;
b) the manufacturer's name, type identification, and serial number or other unique identification;
c) evidence of verification that equipment conforms with specified requirements;
d) the current location, where appropriate;
e) calibration dates, results of all calibrations, adjustments, acceptance criteria, and the due date of
next calibration or the calibration frequency;
f) dates, results and documentation of reference materials, acceptance criteria, and the period of
validity;
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g) the maintenance plan and maintenance carried out to date, where relevant to the performance of
the equipment;
h) details of any damage, malfunction, modification or repair to the equipment.
6.4.10 Equipment that has been subjected to overloading or mishandling, gives questionable results,
or has been shown to be defective or outside specified requirements, shall be taken out of service. It
shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been
repaired and verified to perform correctly. The laboratory shall examine the effect of the defect or
deviation f
...
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