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)
ISO/IEC 17025:2005 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.
It 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.
ISO/IEC 17025:2005 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 ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2005 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. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.
Compliance with regulatory and safety requirements on the operation of laboratories is not covered by 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)
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
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
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.
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
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ii © ISO 2005 — All rights reserved
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 a
...
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.
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
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
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
SIST EN ISO /IEC 17025 : 2005
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
SIST EN ISO/IEC 17025 : 2005
Predgovor Foreword
Mednarodna organizacija za standardizacij
...
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