Posted on: March 7, 2011 Posted by: Diane Swarts Comments: 0

ISO/IEC 17025 is the main standard for testing and calibration laboratories, with commonalities to ISO 9001, but requiring certain managerial competencies.

Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organisation for Standardisation in 1999.

There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds the concept of competence to the equation, relevant to organisations that produce testing and calibration results.

Since its initial release, a second release was made in 2005 after it was agreed that it needed to have its quality system words more closely aligned with the 2000 version of ISO 9001.

The standard was first published in 2001 and in May 2005 the alignment work of the ISO committee responsible for it was completed with the issuance of the revised standard.

The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with customers.

Contents

ISO/IEC 17025 standard comprises five elements; Scope, Normative References, Terms and Definitions, Management Requirements, and Technical Requirements.

Management requirements are primarily related to operation and effectiveness of a quality management system in the laboratory.

Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.

Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an Accreditation Body.

Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.

A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.

Development

Some national systems like UK UKAS M10, were the forerunners of ISO/IEC 17025: 1999, but could sometimes be exceedingly prescriptive.

ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but an auditor may require the laboratory to justify using a particular method.

In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Regular internal audits are expected to indicate opportunities to make the test or calibration better than it was.

Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.

Unlike most ISO standards for systems, third party auditing and appraisal of the laboratory is not usually carried out by a certification body, but by the national organisation responsible for accreditation.

Laboratories are therefore “accredited” under ISO/IEC 17025, rather than “certified” or “registered” as in the ISO 9000 series.

Accreditation differs from “certification” by adding the concept of a third party, attesting to technical competence within a laboratory in addition to its adherence and operation under a documented quality system, specific to a Scope of Accreditation.

Third party accreditation

In order for accreditation bodies to recognise each others’ accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 – which became ISO/IEC 17011).

Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional co-operations to manage the work needed for such mutual recognition.

These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

Accreditation bodies typically encompass accreditation programs for Management Systems, Product Certification, Laboratory, Inspection, Personnel and others.

The first laboratory accreditation bodies to be established were NATA in Australia (1947) and TELARC in New Zealand (1973).

Most other bodies are based on the NATA/TELARC model and include UKAS, FINAS in Finland and Danak in Denmark to name a few.

In India, there is a National Accreditation Board For Testing and Calibration Laboratories (NABL) under the Ministry of Science and Technology.

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