1、 ANSI/ISO/IEC 17025-205 AMERICAN ATIONAL STANDARD General requirements for the competence of testing and calibration laboratories AMERICAN SOCIETY FOR QUALITY P.O. BOX 305 MILWAUKEE, WI 53201-305 ANSI/ISO/IEC 17025:205(E) AMERICAN ATIONAL STANDARD General requirements for the competence of testing a
2、nd calibration laboratories Approved as an American National Standard by: ASTM International American Society for Quality NCSL International An American National Standard Approved August 2005 American National Standards: An American National Standard implies a consensus of those substantialy concern
3、ed with is scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he or she has aproved the standard or not, from anufact
4、uring, purchasing, or using products, proceses, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This American National Standard may be revised or withdrawn at any time. The
5、procedures of the American National Standards Institute require that action be taken to reafirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive curent information on al standards by caling of writing the
6、American National Standards Institute. 205 by ASQ Copyright Protection Notice for the ANSI/ISO/IEC 17025:205 Standard. This standard is subject to copyright claims of ISO, ANSI, ASQ, ASTM, and NCSL. Not for resale. No part of this publication may be reproduced in any form, including an electronic re
7、trieval system, without the prior writen permision of ASQ. Al requests pertaining to the ANSI/ISO/IEC 17025:205 Standard should be submited to ASQ. Note: As used in this document, the term “International Standard” refers to the American National Standard adoption of this and other International Stan
8、dards. ASQ wil consider requests for change and information on the submital of such requests regarding this Standard. Al requests should be in writing to the atention of the Standards administrator at the adres below. ASQ Mision: The American Society for Quality advances individual and organizationa
9、l performance excelence worldwide by providing oportunities for learning, quality improvement, and knowledge exchange. Published by: ANSI/ISO/IEC 17025:205(E) Also available from ASQ uality Pres: A Laboratory Quality Handbok of Best Practices and Relevant Regulations Donald C. Singer, (editor) The M
10、etrology Handbok Jay Bucher, editor Failure Mode and Efect Analysis: FMEA From Theory to Execution, Second Edition D. H. Stamatis Managing the Metrology System, Third Edition C. Robert Penela Glosary and Tables for Statistical Quality Control, Fourth Edition ASQ Statistics Division The Quality Tolbo
11、x, Second Edition Nancy R. Tague To request a complimentary catalog of ASQ uality Pres publications, cal 80-248-1946, or visit our Web site at htp:/qualitypres.asq.org. (This page is intentionally left blank)ANSI/ISO/IEC 17025:205(E) ii Contents Page Foreword.v Introductionvi 1 Scope1 2 Normative re
12、ferences2 3 Terms and definitions.2 4 Management requirements.2 4.1 Organization2 4.2 Management system.3 4.3 Document control4 4.3.1 General.4 4.3.2 Document aproval and isue.4 4.3. Docuent changes.5 4. Review of requests, tenders and contracts.5 4.5 Subcontracting of tests and calibrations6 4.6 Pu
13、rchasing services and suplies.6 4.7 Service to the customer.6 4.8 Complaints.7 4.9 Control of nonconforming testing and/or calibration work7 4.10 Improvement7 4.1 Corective action.8 4.1.1 General.8 4.1.2 Cause analysis.8 4.1.3 Selection and implementation of corective actions8 4.1.4 Monitoring of co
14、rective actions8 4.1.5 Aditional audits.8 4.12 Preventive action.8 4.13 Control of records9 4.13.1 General.9 4.13.2 Technical records9 4.14 Internal audits.9 4.15 Management reviews.10 5 Technical requirements.10 5.1 General10 5.2 Personel1 5.3 Acomodation and environmental conditions12 5.4 Test and
15、 calibration methods and method validation12 5.4.1 General12 5.4.2 Selection of methods.13 5.4.3 Laboratory-developed methods.13 5.4. Non-standard methods13 5.4.5 Validation of ethods14 5.4.6 Estimation of uncertainty of measurement14 5.4.7 Control of data15 5. Equipment.15 5.6 Measurement traceabil
16、ity17 5.6.1 General17 5.6.2 Specific requirements17 5.6.3 Reference standards and reference materials18 5.7 Sampling19 ANSI/ISO/IEC 17025:205(E) iv 5.8 Handling of test and calibration items19 5.9 Asuring the quality of test and calibration results.20 5.10 Reporting the results20 5.10.1 General20 5.
17、10.2 Test reports and calibration certificates20 5.10.3 Test reports21 5.10.4 Calibration certificates.2 5.10.5 Opinions and interpretations2 5.10.6 Testing and calibration results obtained from subcontractors23 5.10.7 Electronic transmision of results23 5.10.8 Format of reports and certificates.23
18、5.10.9 Amendments to test reports and calibration certificates.23 Anex A (informative) Nominal cross-references to ISO 9001:2000.24 Anex B (informative) Guidelines for establishing aplications for specific fields26 Bibliography.27 ANSI/ISO/IEC 17025:205(E) v Foreword ISO (the International Organizat
19、ion for Standardization) and IEC (the International Electrotechnical Comision) 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 comites established by the respective o
20、rganization to deal with particular fields of technical activity. ISO and IEC technical comites colaborate 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 asesment,
21、 the ISO Coite on conformity asesment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in acordance with the rules given in the ISO/IEC Directives, Part 2. Draft International Standards are circulated to the national bodies for vot
22、ing. Publication as an International Standard requires aproval by at least 75% of the national bodies casting a vote. Atention is drawn to the posibility that some of the elements of this document may be the subject of patent rights. ISO shal not be held responsible for identifying any or al such pa
23、tent rights. ISO/IEC 17025 was prepared by the ISO Comite on conformity asesment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was aproved by both organizations. This second edition cancels and replaces the first edition (ISO/IEC 17025:199), which has ben tech
24、nicaly revised. ANSI/ISO/IEC 17025:205(E) vi Introduction The first edition (199) of this International Standard was produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 4501, both of which it replaced. It contained al of the requirements that testing and c
25、alibration laboratories have to met if they wish to demonstrate that they operate a management system, are technicaly competent, and are able to generate technicaly valid results. The first edition refered to ISO 901:194 and ISO 902:194. These standards have ben superseded by ISO 901:200, which made
26、 an alignment of ISO/IEC 17025 necesary. In this second edition, clauses have ben amended or aded only when considered necesary in the light of ISO 901:200. Acreditation bodies that recognize the competence of testing and calibration laboratories should use this International Standard as the basis f
27、or their acreditation. 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 generaly has increased the ned to ensure that lab
28、oratories which form part of larger organizations or ofer other services can operate to a quality management system that is sen as compliant with ISO 901 as wel as with this International Standard. Care has ben taken, therefore, to incorporate al those requirements of ISO 901 that are relevant to th
29、e scope of testing and calibration services that are covered by the laboratorys management system. Testing and calibration laboratories that comply with this International Standard wil therefore also operate in acordance with ISO 901. Conformity of the quality management system within which the labo
30、ratory operates to the requirements of ISO 901 does not of itself demonstrate the competence of the laboratory to produce technicaly valid data and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality management system within which the laboratory o
31、perates to al the requirements of ISO 901. The aceptance of testing and calibration results betwen countries should be facilitated if laboratories comply with this International Standard and if they obtain acreditation from bodies which have entered into mutual recognition agrements with equivalent
32、bodies in other countries using this International Standard. The use of this International Standard wil facilitate coperation betwen laboratories and other bodies, and asist in the exchange of information and experience, and in the harmonization of standards and procedures. ANSI/ISO/IEC 17025:205(E)
33、 1 General requirements for the competence of testing and calibration laboratories 1 Scope 1. This International Standard specifies the general requirements for the competence to cary out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard method
34、s, non-standard methods, and laboratory-developed methods. 1.2 This International Standard is aplicable to al 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
35、inspection and product certification. This International Standard is aplicable to al laboratories regardles of the number of personel 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
36、Standard, such as sampling and the design/development of new methods, the requirements of those clauses do not aply. 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 Thi
37、s International Standard is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and acreditation bodies may also use it in confirming or recognizing the competence of laboratories. This Inter
38、national 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 syste
39、m is sometimes also caled 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 wil operate a q
40、uality management system for their testing and calibration activities that also mets the principles of ISO 901. Anex A provides nominal cros-references betwen this International Standard and ISO 901. This International Standard covers technical competence requirements that are not covered by ISO 901
41、. NOTE 1 It might be necesary to explain or interpret certain requirements in this International Standard to ensure that the requirements are aplied in a consitent maner. Guidance for establishing aplications for specific fields, especialy for acreditation bodies (se ISO/IEC 1701) is given in Anex B
42、. NOTE 2 If a laboratory wishes acreditation for part or al of its testing and calibration activities, it should selct an acreditation body that operates in acordance with ISO/IEC 1701. ANSI/ISO/IEC 17025:205(E) 2 2 Normative references The folowing referenced documents are indispensable for the apl
43、ication of this document. For dated references, only the edition cited aplies. For undated references, the latest edition of the referenced document (including any amendments) aplies. ISO/IEC 1700, Conformity asesment Vocabulary and general principles VIM, International vocabulary of basic and gener
44、al terms in metrology, isued by BIPM, IEC, IFC, 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 giv
45、en in ISO/IEC 1700 and VIM aply. NOTE General definitions related to quality are given in ISO 900, whereas ISO/IEC 1700 gives definitions specificaly related to certification and laboratory acreditation. Where diferent definitions are given in ISO 900, the definitions in ISO/IEC 1700 and VIM are pre
46、fered. 4 Management requirements 4.1 Organization 4.1. The laboratory or the organization of which it is part shal be an entity that can be held legaly responsible. 4.1.2 It is the responsibility of the laboratory to cary out its testing and calibration activities in such a way as to met the require
47、ments of this International Standard and to satisfy the neds of the customer, the regulatory authorities or organizations providing recognition. 4.1.3 The management system shal cover work caried out in the laboratorys permanent facilities, at sites away from its permanent facilities, or in asociate
48、d 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 personel in the organization that have an involvement or influence on the testing and/or calibration activities of the laborat
49、ory shal be defined in order to identify potential conflicts of interest. NOTE 1 Where a laboratory is part of a larger organization, the organizational arangements should be such that departments having conflicting interests, such as production, comercial marketing or financing do not adversely influence the laboratorys 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 personel are fre from any undue comercial, financial
