ISO 17025

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.

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 These standards have been superseded by ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary.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 ofISO 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.

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 (seeISO/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.

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.

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Bibliography

[1]	ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1 General principles and definitions
[2]	ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
[3]	ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
[4]	ISO 5725-4, Accuracy (trueness and precision) of measurement methods and results — Part 4: Basic methods for the determination of the trueness of a standard measurement method
[5]	ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
[6]	ISO 9000:—1), Quality management systems — Fundamentals and vocabulary
[7]	ISO 9001:2000, Quality management systems — Requirements
[8]	ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2000 to computer software
[9]	ISO 10012:2003, Measurement management systems — Requirements for measurement processes and measuring equipment
[10]	ISO/IEC 17011, Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies
[11]	ISO/IEC 17020, General criteria for the operation of various types of bodies performing inspection
[12]	ISO 19011, Guidelines for quality and/or environmental management systems auditing
[13]	ISO Guide 30, Terms and definitions used in connection with reference materials
[14]	ISO Guide 31, Reference materials — Contents of certificates and labels
[15]	ISO Guide 32, Calibration in analytical chemistry and use of certified reference materials
[16]	ISO Guide 33, Uses of certified reference materials
[17]	ISO Guide 34, General requirements for the competence of reference material producers
[18]	ISO Guide 35, Certification of reference materials — General and statistical principles
[19]	ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons — Part 1: Development and operation of proficiency testing schemes
[20]	ISO/IEC Guide 43-2, Proficiency testing by interlaboratory comparisons — Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
[21]	ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems — General requirements for operation and recognition
[22]	ISO/IEC Guide 65, General requirements for bodies operating product certification systems
[23]	GUM, Guide to the Expression of Uncertainty in Measurement, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML
[24]	Information and documents on laboratory accreditation can be found on the ILAC (International Laboratory Accreditation Cooperation): www.ilac.org

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1) To be published. (Revision of ISO 9000:2000)