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 you avoid making erroneous measurements.

Why should I get my laboratory EN ISO 17025 approved?

Organisations and companies purchase formal testing and calibration to demonstrate to the user their products or services deliver what they say they do. Hence they want professional laboratories to perform the tests and so ISO 17025 accreditation is evidence of professional testing or calibration.

Government and other authorities also want professional testing to demonstrate those suppliers are delivering to a requirement. A well-known example of this is National Weights and Measures in India. It is common for product safety or EMC to be tested in ISO17025 approved laboratories.

There are research laboratories that are working at the leading edges of technology and so want excellent testing or calibration and hence use ISO 17025 as the foundation of their laboratory management systems.

If you want to discuss this, then contact Ascent INSPECTA.

ISO 17025 CERTIFICATION PROCESS

History

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 used to be based on national standards and national standards body guidelines. Nevertheless, there was a sizable degree of consistency between the requirements articulated in these different standards due to the presence of ISO Guide 25, a document that was established by the ISO Council Committee on Conformity Assessment (CASCO) against a request by the International Laboratory Accreditation Cooperation (ILAC) held in Auckland, New Zealand, in October 1988. The declared intent of ISO Guide 25, as taken from it, is to create a foundation of principles that "third party accreditation systems [for laboratories] should, as far as possible, be based on globally agreed standards and procedures". ISO guides are intended to be used by local standard organizations when preparing their individual national standards. Thus, it is expected to achieve a higher degree of compatibility between standards established in different countries, so as to facilitate bilateral and multilateral recognition arrangements. (Captured from the foreword to ISO Guide 25, 3rd Edition.)

The document currently known as ISO 17025 was born as an amendment of the III edition of ISO Guide 25. As part of the revision process, it was decided to transform the guide into a standard, thus facilitating a global foundation for accreditation. The new standard was developed keeping compatibility between ISO 17025 and the generic quality management system standard ISO 9001, which was also under amendment at the same time. The idea was to construct a logical relationship between ISO 9001 and ISO 17025 such that the former could serve as a master standard with ISO 17025 being a specific application of that standard to the discipline of testing and calibration laboratories. ISO 17025:2017 was endorsed by the subscribing countries and came into effective usage at the beginning of 2017. The standard was accepted by countries after its adoption as a national standard by most countries around the world. The new version of ISO 9001:2015, however, was accepted at a later date. The program intended to harmonize ISO 17025 and ISO 9001 was later regarded as not-too-perfect, especially in the context that ISO 9001 had a higher inclination on continual improvement in the effectiveness of QMS. This was included in ISO 17025, but its significance as a part of the standard was not robustly emphasized. As a response to this situation, an amendment to ISO 17025 was undertaken, which led to the emergence of ISO 17025:2017.

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 all types of laboratories, whether they be owned and operated by government, industry, or, in fact, any other organization. The standard is also useful to universities, research centers, governments, regulators, inspection bodies, product certification organizations, and other conformity assessment bodies with the need to do testing, sampling, or calibration.

International recognition

Accreditation of laboratories has generally been carried out by national accreditation bodies. These bodies provide assessment services to laboratories in their respective countries against the valid version(s) of ISO 17025. They also respond to requests to perform assessments in other countries, especially when the requesting laboratory is in a country that doesn't have its own national accreditation body. In instances where a national accreditation body exists within the country and a laboratory seeks to use an accreditation body from another country of its choice, the incoming accreditation body normally seeks consent from the resident accreditation body before operating within the country. As a choice, a laboratory may have a preference to use an accreditation body other than the domestic one when the latter has limited or no international recognition or where it is deficient in recognition in parts of the globe relevant to the laboratory’s operations.

Global recognition of accreditations awarded by nationalized bodies is based on the conclusions of Mutual Recognition Agreements (MRAs) between nationalized bodies. To recognize each other’s accreditations, the nationalized bodies generally audit each other’s operations against ISO 17011 Conformity Assessment (General requirements for accreditation bodies accrediting conformity assessment bodies). ISO 17011 is the international standard to which accreditation bodies are expected to demonstrate their conformity. The nature of the MRAs could be multi-lateral (involving more than two accreditation bodies). This method is being rationalized through regional laboratory accreditation conferences linked through ILAC. Regional accreditation bodies assess the nationalized bodies for demonstrated conformity and arrange mutual recognition. Major regional groups include the Asia Pacific Accreditation Cooperation (APLAC), the European Cooperation for Accreditation of Laboratories (EAL), and the Southern Africa Development Community in Accreditation (SADCA).

Selection of Accreditation Body

Based on previous discussions, the major issue in choosing an accreditation body is to ensure that it has recognition in the context in which the laboratory’s data needs to be used. Where a laboratory operates purely in a domestic market and where the data is used only within the country, for example for local food safety or environmental protection, a national accreditation body, even one with no international recognition, will normally be entirely suitable. However, if the laboratory is servicing exporters who need to present its data internationally, it is critical that the accreditation body is recognized by importing countries. Hence the laboratory needs to establish the range of MRAs held by the accreditation body and especially which other countries will recognize accreditation awarded by it.

Coverage of accreditation scope

ISO 17025, being a relatively generic standard, covers all types of laboratory practices performed by laboratories. However, in practical scenarios, a particular laboratory may have only some of its methods included in the scope of accreditation. Accreditation bodies expect a comprehensively operating QMS, and the audit focuses on the scope of methods, personnel, and the equipment used to deliver them. The term ‘accredited laboratory’ is inaccurate. Rather, we should refer to it as a laboratory accredited for a specific list of methods.

Applicability & relation between ISO 9001 and ISO 17025

As discussed above, ISO 9001 is the general standard specifying the requirements for a quality management system. Laboratories that meet the requirements of ISO 17025 also operate in accordance with the relevant ISO 9001 requirements for calibration and testing activities. What this means in practice is that an organization holding ISO 9001 certification may use a laboratory accredited against ISO 17025 as a supplier of test data without needing to carry out its own audit of the laboratory’s quality system. However, laboratories should be accredited against ISO 17025, not ISO 9001, for testing and calibration activities.

Main Benefits of Correctly Implemented ISO/IEC 17025:

Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides benefits such as:

• 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 is the solution. Although it is a more rigorous process than ISO 9001 application, it helps the laboratory understand requirements, responsibilities, and the possibilities of inaccuracy and the consequences therein. Ascent INSPECTA Consultants are highly trained and experienced in fulfilling the requirements of the ISO 17025 standard, including the added requirements of accreditation bodies in different regions.

The recent revision of ISO/IEC 17025 in 2017 accounts for market changes, technological developments, and the latest version of ISO 9001. This helps ensure that the standard remains up to date and globally relevant.

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