What is EN ISO 17025?

This is the international standard defining how a test or calibration laboratory should be managed. It fundamentally looks for accurate and repeatable measurements to be made and recorded. The standard contains a number of rules to help laboratories avoid making erroneous measurements.

Why Should I Get My Laboratory ISO 17025 Approved?

Organisations and companies purchase formal testing and calibration to demonstrate to users that their products or services deliver what they claim. Therefore, they require professional laboratories to perform tests, and ISO 17025 accreditation provides evidence of professional testing or calibration competence.

Government and other authorities also require professional testing to demonstrate that suppliers are delivering according to specified requirements. Product safety, EMC testing and other conformity assessment activities commonly rely on competent testing laboratories.

Research laboratories working at the leading edges of technology also use ISO 17025 as a foundation for their laboratory management systems to support reliable testing and calibration.

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History of ISO/IEC 17025

Before the release of ISO 17025:2017, there was hardly any globally acceptable standard for laboratory quality management systems that could provide an internationally accepted source for accreditation.

Accreditation was historically based on national standards and national standards body guidelines. ISO Guide 25 helped create a foundation of principles for laboratory accreditation systems and encouraged greater consistency between requirements established in different countries.

ISO 17025 was developed from ISO Guide 25 and transformed the guidance into an internationally recognized standard for testing and calibration laboratories. The standard was also developed with consideration for compatibility with ISO 9001 quality management principles.

The 2017 revision accounts for market changes, technological developments and developments in quality management practices, helping ISO/IEC 17025 remain globally relevant.

Who is ISO/IEC 17025 For?

ISO/IEC 17025 is useful for any organization that performs testing, sampling, or calibration and wants reliable results.

This includes laboratories owned and operated by government, industry or other organizations. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies requiring testing, sampling or calibration.

International Recognition

Accreditation of laboratories has generally been carried out by national accreditation bodies. These bodies assess laboratories against the applicable version of ISO 17025.

Global recognition of accreditations awarded by national bodies is supported through Mutual Recognition Agreements (MRAs). These arrangements help laboratories achieve wider acceptance of their accredited results.

Regional accreditation cooperation helps support mutual recognition and consistency between accreditation bodies in different parts of the world.

Selection of Accreditation Body

A major consideration when choosing an accreditation body is to ensure that its accreditation is recognized in the context in which the laboratory's data needs to be used.

Where a laboratory operates purely in a domestic market, a suitable national accreditation body may be sufficient. However, laboratories servicing exporters that need to present data internationally should carefully consider whether the accreditation body is recognized by relevant importing countries.

Laboratories should therefore establish the relevant Mutual Recognition Agreements held by the accreditation body and determine which countries recognize its accreditation.

Coverage of Accreditation Scope

ISO 17025 is a relatively generic standard covering different types of laboratory practices. However, a particular laboratory may have only some of its methods included within its accreditation scope.

Accreditation bodies expect a comprehensively operating quality management system, and assessments focus on the scope of methods, personnel and equipment used to deliver laboratory services.

Rather than referring simply to an "accredited laboratory", it is more accurate to identify a laboratory as being accredited for a specific list of methods.

Applicability & Relation Between ISO 9001 and ISO 17025

ISO 9001 is the general standard specifying requirements for a quality management system. Laboratories that meet the requirements of ISO 17025 operate according to relevant quality management requirements for testing and calibration activities.

Organizations holding ISO 9001 certification may use an ISO 17025-accredited laboratory as a supplier of test data without necessarily carrying out their own audit of the laboratory's quality system.

Laboratories should be accredited against ISO 17025 for testing and calibration activities rather than relying on ISO 9001 alone for laboratory accreditation.

Main Benefits of Correctly Implemented ISO/IEC 17025

Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides several important benefits, including:

• Access to more contracts for testing and/or calibration.
• Improved national and global reputation and image.
• Continually improving data quality and laboratory effectiveness.
• Having a basis for most other quality systems related to laboratories.

Conclusion

If the credibility of the laboratory is the concern, ISO 17025 accreditation provides a structured approach to demonstrating laboratory competence.

Although it is a rigorous process, ISO 17025 helps laboratories understand requirements, responsibilities, measurement accuracy and the consequences associated with inaccurate results.

Ascent INSPECTA Consultants are highly trained and experienced in fulfilling the requirements of ISO 17025, including the additional requirements of accreditation bodies in different regions.

The 2017 revision of ISO/IEC 17025 accounts for market changes, technological developments and developments in quality management, helping ensure that the standard remains relevant and globally applicable.