SIST EN ISO/IEC 17025:2005
(Main)General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)
This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. This International Standard is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. This International Standard is applicable to all laboratories regardless of t he number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not under take one or more of the activities covered by this International Standard, such as sampling and the design/development of new methods, the requirements of those clauses do not apply. The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard. This International Standard is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. This International Standard is no t intended to be used as the basis for certification of laboratories.
Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien (ISO/IEC 17025:2005)
Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais (ISO/IEC 17025:2005)
L'ISO/CEI 17025:2005 établit les exigences générales de compétence pour effectuer des essais et/ou des étalonnages, y compris l'échantillonnage. Elle couvre les essais et les étalonnages effectués au moyen de méthodes normalisées, de méthodes non normalisées et de méthodes élaborées par les laboratoires.
Elle est applicable à toutes les organisations qui procèdent à des essais et/ou des étalonnages. Par exemple, des laboratoires de première, deuxième et tierce parties, ainsi que des laboratoires où les essais et/ou les étalonnages font partie du contrôle et de la certification de produits.
L'ISO/CEI 17025:2005 est applicable à tous les laboratoires, quels que soient leurs effectifs, l'étendue du domaine de leurs activités d'essai et/ou d'étalonnage. Lorsqu'un laboratoire ne procède pas à une ou plusieurs des activités traitées dans la présente Norme internationale, telles que l'échantillonnage et la conception/développement de méthodes nouvelles, les prescriptions des chapitres concernés ne s'appliquent pas.
L'ISO/CEI 17025:2005 est destinée à être utilisée par les laboratoires qui élaborent leur système de management pour la qualité et les activités administratives et techniques. Elle peut également être utilisée par les clients des laboratoires, les autorités réglementaires et les organismes d'accréditation engagés dans des activités de confirmation ou de reconnaissance de la compétence des laboratoires. L'ISO/CEI 17025:2005 n'est pas destinée à être utilisée comme référentiel pour la certification des laboratoires.
La conformité aux prescriptions réglementaires et de sécurité relatives à l'exploitation des laboratoires n'est pas traitée par L'ISO/CEI 17025:2005.
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih laboratorijev (ISO/IEC 17025:2005)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih laboratorijev (ISO/IEC 17025:2005)Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien (ISO/IEC 17025:2005)Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais (ISO/IEC 17025:2005)General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)19.020Preskuševalni pogoji in postopki na splošnoTest conditions and procedures in general03.120.20Certificiranje proizvodov in podjetij. Ugotavljanje skladnostiProduct and company certification. Conformity assessmentICS:Ta slovenski standard je istoveten z:EN ISO/IEC 17025:2005SIST EN ISO/IEC 17025:2005sl,en01-julij-2005SIST EN ISO/IEC 17025:2005SLOVENSKI
STANDARDSIST EN ISO/IEC 17025:20021DGRPHãþD
SIST EN ISO/IEC 17025:2005
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO/IEC 17025
May 2005 ICS 03.120.20 Supersedes EN ISO/IEC 17025:2000English version
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)
Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais (ISO/IEC 17025:2005)
Allgemeine Anforderungen an die Kompetenz von Prüf-und Kalibrierlaboratorien (ISO/IEC 17025:2005) This European Standard was approved by CEN and CENELEC on 15 March 2005.
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 Management Centre or to any CEN or 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 or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium,Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:rue de Stassart, 36
B-1050 Brussels rue de Stassart, 35
B-1050 Brussels© 2005 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17025:2005 ESIST EN ISO/IEC 17025:2005
EN ISO/IEC 17025:2005 (E)
2
Foreword
This document (EN ISO/IEC 17025:2005) 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 SN.
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 November 2005, and conflicting national standards shall be withdrawn at the latest by November 2005.
This document supersedes EN ISO/IEC 17025:2000.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO/IEC 17025:2005 has been approved by CEN and CENELEC as EN ISO/IEC 17025:2005 without any modifications.
SIST EN ISO/IEC 17025:2005
Reference numberISO/IEC 17025:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO/IEC17025Second edition2005-05-15General requirements for the competence of testing and calibration laboratories Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais
SIST EN ISO/IEC 17025:2005
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SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) © ISO 2005 — All rights reserved iii Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.2 3 Terms and definitions.2 4 Management requirements.2 4.1 Organization.2 4.2 Management system.3 4.3 Document control.4 4.3.1 General.4 4.3.2 Document approval and issue.4 4.3.3 Document changes.5 4.4 Review of requests, tenders and contracts.5 4.5 Subcontracting of tests and calibrations.6 4.6 Purchasing services and supplies.6 4.7 Service to the customer.6 4.8 Complaints.7 4.9 Control of nonconforming testing and/or calibration work.7 4.10 Improvement.7 4.11 Corrective action.8 4.11.1 General.8 4.11.2 Cause analysis.8 4.11.3 Selection and implementation of corrective actions.8 4.11.4 Monitoring of corrective actions.8 4.11.5 Additional audits.8 4.12 Preventive action.8 4.13 Control of records.9 4.13.1 General.9 4.13.2 Technical records.9 4.14 Internal audits.9 4.15 Management reviews.10 5 Technical requirements.10 5.1 General.10 5.2 Personnel.11 5.3 Accommodation and environmental conditions.12 5.4 Test and calibration methods and method validation.12 5.4.1 General.12 5.4.2 Selection of methods.13 5.4.3 Laboratory-developed methods.13 5.4.4 Non-standard methods.13 5.4.5 Validation of methods.14 5.4.6 Estimation of uncertainty of measurement.14 5.4.7 Control of data.15 5.5 Equipment.15 5.6 Measurement traceability.17 5.6.1 General.17 5.6.2 Specific requirements.17 5.6.3 Reference standards and reference materials.18 5.7 Sampling.19 SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) iv © ISO 2005 — All rights reserved 5.8 Handling of test and calibration items.19 5.9 Assuring the quality of test and calibration results.20 5.10 Reporting the results.20 5.10.1 General.20 5.10.2 Test reports and calibration certificates.20 5.10.3 Test reports.21 5.10.4 Calibration certificates.22 5.10.5 Opinions and interpretations.22 5.10.6 Testing and calibration results obtained from subcontractors.23 5.10.7 Electronic transmission of results.23 5.10.8 Format of reports and certificates.23 5.10.9 Amendments to test reports and calibration certificates.23 Annex A (informative)
Nominal cross-references to ISO 9001:2000.24 Annex B (informative)
Guidelines for establishing applications for specific fields.26 Bibliography.27
SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) © ISO 2005 — All rights reserved v 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 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 second edition cancels and replaces the first edition (ISO/IEC 17025:1999), which has been technically revised.
SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) vi © ISO 2005 — All rights reserved Introduction 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. The first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001:2000. Accreditation bodies that recognize the competence of testing and calibration laboratories should use this International Standard as the basis for their accreditation. Clause 4 specifies the requirements for sound management. Clause 5 specifies the requirements for technical competence for the type of tests and/or calibrations the laboratory undertakes. Growth in the use of management systems generally has increased the need to ensure that laboratories which form part of larger organizations or offer other services can operate to a quality management system that is seen as compliant with ISO 9001 as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory's management system. Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001. Conformity of the quality management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. The acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this International Standard and if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this International Standard. 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.
SIST EN ISO/IEC 17025:2005
INTERNATIONAL STANDARD ISO/IEC 17025:2005(E) © ISO 2005 — All rights reserved 1 General requirements for the competence of testing and calibration laboratories 1 Scope 1.1 This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. 1.2 This International Standard is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. This International Standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by this International Standard, such as sampling and the design/development of new methods, the requirements of those clauses do not apply. 1.3 The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard. 1.4 This International Standard is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. This International Standard is not intended to be used as the basis for certification of laboratories. NOTE 1 The term 'management system' in this International Standard means the quality, administrative and technical systems that govern the operations of a laboratory. NOTE 2 Certification of a management system is sometimes also called registration. 1.5 Compliance with regulatory and safety requirements on the operation of laboratories is not covered by this International Standard. 1.6 If testing and calibration laboratories comply with the requirements of this International Standard, they will operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001. Annex A provides nominal cross-references between this International Standard and ISO 9001. This International Standard covers technical competence requirements that are not covered by ISO 9001. NOTE 1 It might be necessary to explain or interpret certain requirements in this International Standard to ensure that the requirements are applied in a consistent manner. Guidance for establishing applications for specific fields, especially for accreditation bodies (see ISO/IEC 17011) is given in Annex B. NOTE 2 If a laboratory wishes accreditation for part or all of its testing and calibration activities, it should select an accreditation body that operates in accordance with ISO/IEC 17011. SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) 2 © ISO 2005 — All rights reserved 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 VIM, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML NOTE Further related standards, guides, etc. on subjects included in this International Standard are given in the Bibliography. 3 Terms and definitions For the purposes of this document, the relevant terms and definitions given in ISO/IEC 17000 and VIM apply. NOTE General definitions related to quality are given in ISO 9000, whereas ISO/IEC 17000 gives definitions specifically related to certification and laboratory accreditation. Where different definitions are given in ISO 9000, the definitions in ISO/IEC 17000 and VIM are preferred. 4 Management requirements 4.1 Organization 4.1.1 The laboratory or the organization of which it is part shall be an entity that can be held legally responsible. 4.1.2 It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard and to satisfy the needs of the customer, the regulatory authorities or organizations providing recognition. 4.1.3 The management system shall cover work carried out in the laboratory’s permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities. 4.1.4 If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest. NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard. NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities. 4.1.5 The laboratory shall a) have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures (see also 5.2); SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) © ISO 2005 — All rights reserved 3 b) have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work; c) have policies and procedures to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results; d) have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgement or operational integrity; e) define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services; f) specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations; g) provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results; h) have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations; i) appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources; j) appoint deputies for key managerial personnel (see Note); k) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system. NOTE Individuals may have more than one function and it may be impractical to appoint deputies for every function. 4.1.6 Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system. 4.2 Management system 4.2.1 The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. 4.2.2 The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following: a) the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its customers; b) the management’s statement of the laboratory's standard of service; c) the purpose of the management system related to quality; SIST EN ISO/IEC 17025:2005
ISO/IEC 17025:2005(E) 4 © ISO 2005 — All rights res
...
S L O V E N S K I SIST EN ISO/IEC 17025
STANDARD
julij 2005
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
General requirements for the competence of testing and calibration laboratories
(ISO/IEC 17025:2005)
Exigences générales concernant la compétence des laboratoires d'étalonnages et
d'essais (ISO/IEC 17025:2005)
Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien
(ISO/IEC 17025:2005)
Referenčna oznaka
ICS 03.120.20; 19.020 SIST EN ISO/IEC 17025:2005 (sl,en)
Nadaljevanje na straneh II in od 1 do 50
© 2006-05. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17025 : 2005
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17025 (sl,en), Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev, 2005, ima status slovenskega standarda in je enakovreden evropskemu
standardu EN ISO/IEC 17025 (en), General requirements for the competence of testing and
calibration laboratories (ISO/IEC 17025:2005), 2005.
NACIONALNI PREDGOVOR
Evropski standard EN ISO/IEC 17025:2005 je pripravil Odbor za ugotavljanje skladnosti CASCO v
sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/CLC TC 1 Merila za
organe za ugotavljanje skladnosti.
Slovenski standard SIST EN ISO/IEC 17025:2005 je prevod evropskega standarda EN ISO/IEC
17025:2005. Ob sporu zaradi besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski
standard v angleškem jeziku. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC UGA
Ugotavljanje skladnosti.
V prevodu je uporabljen izraz kalibracija (in izpeljanke), ki ga je po Mednarodnem slovarju osnovnih in
splošnih izrazov s področja meroslovja, 1999, mogoče zamenjati z istopomenskim izrazom umerjanje.
ZVEZA S STANDARDOM
S prevzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistega, ki je že sprejet v nacionalno standardizacijo:
SIST EN ISO 9001:2000 (sl,en) Sistemi vodenja kakovosti – Zahteve
Mednarodni slovar osnovnih in splošnih izrazov s področja meroslovja, Urad za standardizacijo in
meroslovje. Ljubljana 1999.
OSNOVA ZA PRIVZEM STANDARDA
– EN ISO/IEC 17025:2005
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17025:2002 (sl,en) Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev
OPOMBE
− Povsod, kjer se v besedilu standarda uporablja izraz »evropski standard« oziroma »mednarodni
standard«, v SIST EN ISO/IEC 17025:2005 to pomeni »slovenski standard«.
− Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
− Ta nacionalni dokument je enakovreden EN ISO/IEC 17025:2005 in je objavljen z dovoljenjem
CEN
Rue de Stassart 36
1050 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17025:2005 and is published with the
permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
II
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EVROPSKI STANDARD EN ISO/IEC 17025
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM maj 2005
ICS: 03.120.20 Nadomešča EN ISO/IEC 17025:2000
Slovenska izdaja
Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
General requirements for the Exigences générales Allgemeine Anforderungen an
competence of testing and concernant la compétence des die Kompetenz von Prüf- und
calibration laboratories (ISO/IEC laboratoires d'étalonnages et Kalibrierlaboratorien (ISO/IEC
17025:2005) d'essais (ISO/IEC 17025:2005) 17025:2005)
Ta evropski standard sta CEN in CENELEC odobrila dne 15. marca 2005.
Članice 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 voljo pri
CEN Management Centre ali pri članicah CEN ali 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 CEN
Management Centre, veljajo kot uradne izdaje.
Članice CEN in CENELEC so nacionalni organi za standarde oziroma nacionalni elektrotehniški
komiteji Avstrije, Belgije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Irske,
Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Slovaške, Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
Upravni center CEN Centralni sekretariat CENELEC
Rue de Stassart 36, B-1050 Bruselj Rue de Stassart 36, B-1050 Bruselj
© 2005 CEN/CENELEC Imetniki avtorskih pravic po vsem svetu so nacionalni člani CEN in CENELEC. Ref. št. EN ISO/IEC 17025:2005 E
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SIST EN ISO/IEC 17025 : 2005
VSEBINA Stran CONTENTS Page
Predgovor.4 Foreword.4
Uvod.5 Introduction .5
1 Področje uporabe . 7 1 Scope .7
2 Zveza z drugimi standardi . 8 2 Normative references .8
3 Izrazi in definicije . 8 3 Terms and definitions.8
4 Zahteve za vodenje . 9 4 Management requirements .9
4.1 Organizacija. 9 4.1 Organization .9
4.2 Sistem vodenja.11 4.2 Management system.11
4.3 Obvladovanje dokumentov. 12 4.3 Document control .12
4.3.1 Splošno. 12 4.3.1 General.12
4.3.2 Odobritev in izdaja dokumentov. 13 4.3.2 Document approval and issue.13
4.3.3 Spremembe dokumentov . 13 4.3.3 Document changes .13
4.4 Pregled zahtev, ponudb in 4.4 Review of requests, tenders
pogodb . 14 and contracts .14
4.5 Izvajanje preskusov in kalibracij 4.5 Subcontracting of tests and
pri podpogodbenikih . 15 calibrations.15
4.6 Naročanje storitev in nabava 4.6 Purchasing services and
materialnih sredstev . 16 supplies.16
4.7 Sodelovanje z odjemalci . 16 4.7 Service to the customer .16
4.8 Pritožbe . 17 4.8 Complaints .17
4.9 Obvladovanje neskladnega dela 4.9 Control of nonconforming testing
pri preskušanju in/ali kalibriranju . 17 and/or calibration work.17
4.10 Izboljševanje. 18 4.10 Improvement .18
4.11 Korektivni ukrepi . 18 4.11 Corrective action .18
4.11.1 Splošno. 18 4.11.1 General.18
4.11.2 Analiza vzrokov.19 4.11.2 Cause analysis .19
4.11.3 Izbira in izvedba korektivnih 4.11.3 Selection and implementation
ukrepov. 19 of corrective actions.19
4.11.4 Nadzor korektivnih ukrepov. 19 4.11.4 Monitoring of corrective actions .19
4.11.5 Dodatne presoje . 19 4.11.5 Additional audits.19
4.12 Preventivni ukrepi . 19 4.12 Preventive action .19
4.13 Obvladovanje zapisov .20 4.13 Control of records.20
4.13.1 Splošno. 20 4.13.1 General.20
4.13.2 Tehnični zapisi. 20 4.13.2 Technical records .20
4.14 Notranje presoje .21 4.14 Internal audits.21
4.15 Vodstveni pregledi . 22 4.15 Management reviews.22
5 Tehnične zahteve . 23 5 Technical requirements.23
5.1 Splošno . 23 5.1 General.23
5.2 Osebje . 23 5.2 Personnel .23
5.3 Prostori in pogoji 5.3 Accommodation and environmental
okolja .25 conditions .25
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5.4 Preskusne in kalibracijske metode 5.4 Test and calibration methods
ter validacija metod . 26 and method validation.26
5.4.1 Splošno. 26 5.4.1 General.26
5.4.2 Izbira metod.26 5.4.2 Selection of methods.26
5.4.3 Metode, ki jih je razvil laboratorij . 27 5.4.3 Laboratory-developed methods .27
5.4.4 Nestandardne metode. 27 5.4.4 Non-standard methods.27
5.4.5 Validacija metod.28 5.4.5 Validation of methods.28
5.4.6 Ocena merilne 5.4.6 Estimation of uncertainty of
negotovosti . 29 measurement.29
5.4.7 Obvladovanje podatkov . 30 5.4.7 Control of data.30
5.5 Oprema. 31 5.5 Equipment .31
5.6 Sledljivost meritev. 33 5.6 Measurement traceability.33
5.6.1 Splošno. 33 5.6.1 General.33
5.6.2 Posebne zahteve.33 5.6.2 Specific requirements.33
5.6.3 Referenčni etaloni in referenčni 5.6.3 Reference standards and reference
materiali. 35 materials .35
5.7 Vzorčenje . 36 5.7 Sampling .36
5.8 Ravnanje s primerki za preskus in 5.8 Handling of test and calibration
kalibracijo . 37 items .37
5.9 Zagotavljanje kakovosti rezultatov 5.9 Assuring the quality of test and
preskusov in kalibracij . 38 calibration results .38
5.10 Poročanje o rezultatih. 39 5.10 Reporting the results .39
5.10.1 Splošno. 39 5.10.1 General.39
5.10.2 Poročila o preskusih in certifikati 5.10.2 Test reports and calibration
o kalibraciji. 40 certificates.40
5.10.3 Poročila o preskusih . 41 5.10.3 Test reports .41
5.10.4 Certifikati o kalibraciji.42 5.10.4 Calibration certificates.42
5.10.5 Mnenja in razlage . 42 5.10.5 Opinions and interpretations .42
5.10.6 Rezultati preskušanja in kalibriranja, 5.10.6 Testing and calibration results
pridobljeni od podpogodbenikov. 43 obtained from subcontractors .43
5.10.7 Elektronski prenos 5.10.7 Electronic transmission of
rezultatov. 43 results .43
5.10.8 Oblika poročil in certifikatov. 43 5.10.8 Format of reports and certificates .43
5.10.9 Spremembe poročil o preskusih 5.10.9 Amendments to test reports and
in certifikatov o kalibraciji. 43 calibration certificates .43
Dodatek A (informativni): Primerjava z Annex A (informative): Nominal cross-
ISO 9001:2000 .45 references to ISO 9001:2000 .45
Dodatek B (informativni): Smernice za Annex B (informative): Guidelines for
pripravo razlag uporabe za posebna establishing applications for specific
področja . 47 fields .47
Bibliografija.49 Bibliography.49
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Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO – International Organization for Standardization) and IEC (the International
Standardization) in Mednarodna elektrotehniška Electrotechnical Commission) form the
komisija (IEC – International Electrotechnical specialized system for worldwide standardization.
Commission) tvorita specializiran sistem National bodies that are members of ISO or IEC
svetovne standardizacije. Nacionalni organi, participate in the development of International
člani ISO ali IEC, sodelujejo pri pripravi Standards through technical committees
mednarodnih standardov prek tehničnih established by the respective organization to
odborov, ki jih prva ali druga organizacija deal with particular fields of technical activity.
ustanovi za obravnavanje posameznega ISO and IEC technical committees collaborate in
tehničnega področja. Na področjih, ki so v fields of mutual interest. Other international
skupnem interesu, tehnični odbori ISO in IEC organizations, governmental and non-
sodelujejo med seboj. V delo se vključujejo tudi governmental, in liaison with ISO and IEC, also
druge vladne in nevladne mednarodne take part in the work. In the field of conformity
organizacije, ki se povezujejo z ISO in IEC. Za assessment, the ISO Committee on conformity
razvoj mednarodnih standardov in vodil s assessment (CASCO) is responsible for the
področja ugotavljanja skladnosti je odgovoren development of International Standards and
Odbor ISO za ugotavljanje skladnosti (CASCO Guides.
– Committee on conformity assessment).
Mednarodni standardi se pripravljajo v skladu s International Standards are drafted in
pravili iz Direktiv ISO/IEC, 2. del. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Osnutki mednarodnih standardov, ki jih sprejmejo Draft International Standards are circulated to
tehnični odbori, so posredovani nacionalnim the national bodies for voting. Publication as an
organom, ki o njih glasujejo. Za izdajo International Standard requires approval by at
mednarodnega standarda je potrebna odobritev least 75 % of the national bodies casting a vote.
vsaj 75 % nacionalnih organov, ki so oddali
svoje glasove.
Opozariti je treba na možnost, da so nekateri Attention is drawn to the possibility that some of
elementi tega dokumenta lahko predmet the elements of this document may be the
patentnih pravic. ISO in IEC ne odgovarjata za subject of patent rights. ISO shall not be held
prepoznavanje nobene oziroma nobenih takih responsible for identifying any or all such patent
patentnih pravic. rights.
Standard ISO/IEC 17025 je pripravil Odbor ISO ISO/IEC 17025 was prepared by the ISO
za ugotavljanje skladnosti (CASCO –
Committee on conformity assessment
Committee on conformity assessment). (CASCO).
Standard je bil razposlan v glasovanje It was circulated for voting to the national
nacionalnim organom ISO in IEC in sta ga bodies of both ISO and IEC, and was approved
odobrili obe organizaciji. by both organizations.
Ta, druga izdaja preklicuje in nadomešča prvo This second edition cancels and replaces the
izdajo (ISO/IEC 17025:1999), ki je tehnično first edition (ISO/IEC 17025:1999), which has
revidirana. been technically revised.
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Uvod Introduction
Prva izdaja (1999) tega mednarodnega The first edition (1999) of this International
standarda je bila izdelana na podlagi obsežnih Standard was produced as the result of
izkušenj pri uporabi vodila ISO/IEC 25 in extensive experience in the implementation of
standarda EN 45001, ki ju je nadomestila. ISO/IEC Guide 25 and EN 45001, both of which
Standard je vseboval vse zahteve, ki jih morajo it replaced. It contained all of the requirements
izpolnjevati preskuševalni in kalibracijski that testing and calibration laboratories have to
laboratoriji, če želijo dokazati, da imajo meet if they wish to demonstrate that they
vzpostavljen sistem vodenja, da so tehnično operate a management system, are technically
usposobljeni in da so sposobni pridobiti competent, and are able to generate technically
tehnično veljavne rezultate. valid results.
Prva izdaja se je sklicevala na ISO 9001:1994 The first edition referred to ISO 9001:1994 and
in ISO 9002:1994. Ta dva standarda je ISO 9002:1994. These standards have been
nadomestil ISO 9001:2000, zaradi česar je bilo superseded by ISO 9001:2000, which made an
treba uskladiti tudi ISO/IEC 17025. V tej, drugi alignment of ISO/IEC 17025 necessary. In this
izdaji so poglavja spremenjena ali dodana le, če second edition, clauses have been amended or
je bilo to v luči standarda ISO 9001:2000 added only when considered necessary in the
potrebno. light of ISO 9001:2000.
Akreditacijski organi, ki priznavajo Accreditation bodies that recognize the
usposobljenost preskuševalnih in kalibracijskih competence of testing and calibration
laboratorijev, naj bi uporabljali ta mednarodni laboratories should use this International
standard kot podlago za akreditacijo. V 4. točki Standard as the basis for their accreditation.
pa so opisane zahteve za dobro vodenje. V 5. Clause 4 specifies the requirements for sound
poglavju so navedene zahteve za tehnično management. Clause 5 specifies the
usposobljenost za vrste preskušanja in/ali requirements for technical competence for the
kalibriranja, ki jih laboratorij izvaja. type of tests and/or calibrations the laboratory
undertakes.
Vse širša uporaba sistemov vodenja je povečala Growth in the use of management systems
potrebo, da bi laboratoriji, ki so sestavni del generally has increased the need to ensure that
večjih organizacij ali ponujajo druge storitve, laboratories which form part of larger
lahko delovali po sistemu vodenja kakovosti, organizations or offer other services can operate
skladnem tako s standardom ISO 9001 kot tudi s to a quality management system that is seen as
tem mednarodnim standardom. Zato je bilo compliant with ISO 9001 as well as with this
poskrbljeno, da so v ta mednarodni standard International Standard. Care has been taken,
vključene vse tiste zahteve standarda ISO 9001, therefore, to incorporate all those requirements
ki so pomembne za obseg preskuševalnih in of ISO 9001 that are relevant to the scope of
kalibracijskih storitev, zajetih s sistemom vodenja testing and calibration services that are covered
laboratorijev. by the laboratory's management system.
Preskuševalni in kalibracijski laboratoriji, ki Testing and calibration laboratories that comply
delujejo v skladu s tem mednarodnim with this International Standard will therefore
standardom, bodo s tem delovali tudi v skladu z also operate in accordance with ISO 9001.
ISO 9001.
Skladnost sistema vodenja kakovosti, po Conformity of the quality management system
katerem laboratorij deluje, z zahtevami ISO 9001 within which the laboratory operates to the
sama po sebi še ne dokazuje usposobljenosti requirements of ISO 9001 does not of itself
laboratorija za pridobivanje tehnično veljavnih demonstrate the competence of the laboratory
podatkov in rezultatov. Prav tako pa dokazana to produce technically valid data and results.
skladnost s tem mednarodnim standardom še ne Nor does demonstrated conformity to this
pomeni skladnosti sistema vodenja kakovosti, po International Standard imply conformity of the
katerem laboratorij deluje, z zahtevami ISO quality management system within which the
9001. laboratory operates to all the requirements of
ISO 9001.
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Meddržavno sprejetje rezultatov preskušanja in The acceptance of testing and calibration results
kalibracije je lažje, če laboratoriji delujejo v between countries should be facilitated if
skladu s tem mednarodnim standardom in če laboratories comply with this International
pridobijo akreditacijo pri organih, ki so Standard and if they obtain accreditation from
podpisniki sporazumov o medsebojnem bodies which have entered into mutual
priznavanju z enakovrednimi organi v drugih recognition agreements with equivalent bodies in
državah, ki uporabljajo ta mednarodni standard. other countries using this International Standard.
Uporaba tega mednarodnega standarda bo The use of this International Standard will
pospešila sodelovanje med laboratoriji in facilitate cooperation between laboratories and
drugimi organi in pomagala pri izmenjavi other bodies, and assist in the exchange of
informacij in izkušenj ter pri usklajevanju information and experience, and in the
standardov in postopkov. harmonization of standards and procedures.
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SIST EN ISO /IEC 17025 : 2005
Splošne zahteve za usposobljenost General requirements for the
preskuševalnih in kalibracijskih competence of testing and calibration
laboratorijev laboratories
1 Področje uporabe 1 Scope
1.1 Ta mednarodni standard opredeljuje 1.1 This International Standard specifies the
splošne zahteve za usposobljenost za izvajanje general requirements for the competence to
preskusov in/ali kalibracij, vključno z carry out tests and/or calibrations, including
vzorčenjem. Standard zajema preskušanje in sampling. It covers testing and calibration
kalibriranje, ki se izvajata s standardiziranimi in performed using standard methods, non-
nestandardiziranimi metodami ter z metodami, standard methods, and laboratory-developed
razvitimi v laboratoriju. methods.
1.2 Ta mednarodni standard je uporaben za 1.2 This International Standard is applicable to
vse organizacije, ki izvajajo preskuse in/ali all organizations performing tests and/or
kalibracije. Vključeni so na primer laboratoriji calibrations. These include, for example, first-,
prve, druge in tretje stranke in laboratoriji, kjer second- and third-party laboratories, and
preskušanje in/ali kalibriranje sestavljata del laboratories where testing and/or calibration
kontrole ali certificiranja proizvoda. forms part of inspection and product
certification.
Ta mednarodni standard je uporaben za vse This International Standard is applicable to all
laboratorije ne glede na število osebja ali na laboratories regardless of the number of
obseg aktivnosti preskušanja in/ali kalibriranja. personnel or the extent of the scope of testing
Kadar laboratorij ne izvaja ene ali več and/or calibration activities. When a laboratory
aktivnosti, zajetih v tem mednarodnem does not undertake one or more of the activities
standardu, na primer vzorčenja in covered by this International Standard, such as
snovanja/razvoja novih metod, se zahteve teh sampling and the design/development of new
točk ne uporabljajo. methods, the requirements of those clauses do
not apply.
1.3 Opombe pojasnjujejo besedilo, navajajo 1.3 The notes given provide clarification of the
primere in usmerjajo. Ne vsebujejo pa zahtev in text, examples and guidance. They do not
niso sestavni del tega mednarodnega contain requirements and do not form an
standarda. integral part of this International Standard.
1.4 Ta mednarodni standard uporabljajo 1.4 This International Standard is for use by
laboratoriji pri razvoju svojih sistemov vodenja laboratories in developing their management
kakovosti ter pri upravnem in tehničnem system for quality, administrative and technical
delovanju. Uporabljajo ga lahko tudi odjemalci operations. Laboratory customers, regulatory
laboratorija, zakonodajni organi in akreditacijski authorities and accreditation bodies may also
organi pri potrjevanju ali priznavanju use it in confirming or recognizing the
usposobljenosti laboratorijev. Ta mednarodni competence of laboratories. This International
standard pa se ne more uporabljati kot podlaga Standard is not intended to be used as the
za certificiranje laboratorijev. basis for certification of laboratories.
OPOMBA 1: Izraz "sistem vodenja" v tem mednarodnem NOTE 1 The term 'management system' in this
standardu pomeni sisteme kakovosti, International Standard means the quality,
upravne in tehnične sisteme, s katerimi administrative and technical systems that
laboratoriji upravljajo svoje delo. govern the operations of a laboratory.
OPOMBA 2: Certifikacija sistema vodenja se včasih NOTE 2 Certification of a management system is
imenuje tudi registracija. sometimes also called registration.
1.5 Ta mednarodni standard ne zajema 1.5 Compliance with regulatory and safety
skladnosti z zahtevami zakonodaje in varnosti requirements on the operation of laboratories is
za delo laboratorijev. not covered by this International Standard.
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1.6 Če preskuševalni in kalibracijski laboratoriji 1.6 If testing and calibration laboratories
delujejo skladno z zahtevami tega comply with the requirements of this
mednarodnega standarda, pomeni, da imajo za International Standard, they will operate a
svoje dejavnosti preskušanja in kalibriranja quality management system for their testing
vpeljan sistem vodenja kakovosti, ki izpolnjuje and calibration activities that also meets the
tudi zahteve ISO 9001. V dodatku A so principles of ISO 9001. Annex A provides
navedene povezave med tem mednarodnim nominal cross-references between this
standardom in ISO 9001. Ta mednarodni International Standard and ISO 9001. This
standard zajema tudi zahteve za tehnično International Standard covers technical
usposobljenost, ki niso zajete z ISO 9001. competence requirements that are not covered
by ISO 9001.
OPOMBA 1: Mogoče bo treba določene zahteve tega NOTE 1 It might be necessary to explain or interpret
mednarodnega standarda pojasniti ali certain requirements in this International
razložiti, da bi zagotovili njihovo dosledno Standard to ensure that the requirements
uporabo. Napotki za uporabo na posebnih are applied in a consistent manner.
področjih, zlasti za akreditacijske organe Guidance for establishing applications for
(glej ISO/IEC 17011), so navedeni v specific fields, especially for accreditation
dodatku B. bodies (see ISO/IEC 17011) is given in
Annex B.
OPOMBA 2: Če želi laboratorij akreditacijo za vse svoje NOTE 2 If a laboratory wishes accreditation for part
preskuševalne in kalibracijske dejavnosti ali or all of its testing and calibration activities,
za njihov del, naj si izbere akreditacijski it should select an accreditation body that
organ, ki deluje skladno z ISO/IEC 17011. operates in accordance with ISO/IEC
17011.
2 Zveza z drugimi standardi 2 Normative references
V nadaljevanju navedeni dokumenti so za The following referenced documents are
uporabo tega dokumenta nujni. Pri datiranem indispensable for the application of this
sklicevanju se uporablja samo navedena izdaja; document. For dated references, only
...
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