Test and calibration laboratories.

The first edition (1999) of this International Standard was the result of the extensive experience gained in the implementation of ISO/IEC Guide 25 and EN 45001, which it replaced. It contains all the requirements that testing, and calibration laboratories have to meet if they wish to demonstrate that they have 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 These standards have been replaced by ISO 9001:2000, which made it necessary to align ISO/IEC 17025. In this second edition, sections have been modified or added only to the extent necessary in the light of ISO 9001:2000.

It is desirable that accreditation bodies that recognize the competence of testing and calibration laboratories rely on this International Standard for their accreditations. Chapter 4 sets out the requirements for sound management. Chapter 5 sets out requirements for technical competence in the types of tests or calibrations that the laboratory carries out.

The increasing use of management systems has created a growing need to ensure that laboratories that are part of larger organizations or that offer other services can operate in accordance with a quality management system that is considered to be compliant with ISO 9001 as well as with this International Standard. Care has therefore been taken to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services covered by the laboratory’s management system.

Therefore, testing and calibration laboratories complying with this International Standard will also operate in accordance with ISO 9001. Conformity of the quality management system implemented by the laboratory with the requirements of ISO 9001 does not in itself constitute proof of the laboratory’s competence to produce technically valid data and results. On the other hand, demonstrated conformity to this International Standard does not mean that the quality management system implemented by the laboratory meets all the requirements of ISO 9001.

Acceptance of test and calibration results between countries should be facilitated if laboratories comply with this International Standard and obtain accreditation from bodies that have signed mutual recognition agreements with equivalent bodies using this International Standard in other countries.

The use of this International Standard will facilitate cooperation between laboratories and other bodies and assist in the exchange of information and experience, as well as the harmonization of standards and procedures.

Compliance with regulatory and safety requirements related to the operation of laboratories is not covered by this International Standard.

If testing and calibration laboratories comply with the requirements of this International Standard, they shall operate under a quality management system for their testing and calibration activities that also complies with the principles of ISO 9001. Annex A provides nominal cross references between this International Standard and ISO 9001.

This International Standard covers requirements for technical competence that are not covered by ISO 9001.

• NOTE 1: It may be necessary to explain or interpret certain requirements of this International Standard in order to ensure that the requirements will be applied consistently. Guidelines for establishing applications for specific fields are given in Annex B (see ISO/IEC 17011).
• NOTE 2: If a laboratory wishes to be accredited for all or part of its testing and calibration activities, it should select an accreditation body operating in accordance with ISO/IEC 17011.