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ISO 17025 : 2005 – NABL Accreditation Consultancy

ISO/IEC 17025 – Laboratory Quality System

Laboratories play an important role in company quality systems. The ISO/IEC 17025 (1) can be used as a standard to develop and establish a quality system for a laboratory and also for assessment by laboratory clients or third parties. The standard can also be used as a criterion for laboratory accreditation. Working according to global standards is especially important for laboratories to ensure validity and global comparability of test and calibration results. One of the goals of using global standards is to reduce the number of tests required in national and international trading.

The first edition of the “International Standard General Requirements for the Competence of Testing and Calibration Laboratories” was produced as a result of extensive experience in implementing ISO/IEC Guide 25 and EN 45001; it replaced these earlier standards in 1999. This new standard contains all 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.

Management requirements in the first edition refer to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an update of ISO/IEC 17025 necessary. In the second edition of ISO/IEC 17025, released in 2005, clauses were amended or added only when considered necessary in the light of ISO 9001:2000

Testing and calibration laboratories that comply with ISO/IEC 17025 will therefore also operate in accordance with ISO 9001. Accreditation bodies that recognize the competence of testing and calibration laboratories use ISO/IEC 17025 as the basis for their accreditation.

ISO/IEC 17025 is divided into five clauses, two annexes, and one bibliography section:

Clause 1: Scope
The standard covers the technical activities of a laboratory as well as the management and organizational aspects to perform the technical activities in a competent way.

Clause 2: Normative References

Clause 3: Terms and Definitions

Clause 4: Management Requirements Most of the requirements are similar to those specified in the ISO Standard 9001:2000.

Clause 5: Technical Requirements Most of the requirements come from the ISO Guide 25.

Annex A: Cross References to ISO 9001:2000

Annex B: Guidelines for Establishing Applications for Specific Fields

Bibliography

The most important clauses are clause 4 and 5, describing management and technical requirements. In addition to official requirements, these clauses also include notes with further explanations and recommendations