Iso Iec 1702

[Virgil Gardiner]

ISOIEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles.[1] Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.[2] Material in the standard also forms the basis for accreditation from an accreditation body.

There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. The 2005 release also aligned more closely with the 2000 version of ISO 9001 with regards to implementing continuous improvement.[3]

Some national systems (e.g. UKAS M10 in the UK) were the forerunners of ISO/IEC 17025:1999 but could also be exceedingly prescriptive. ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but require the laboratory to justify using a particular method.

In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.

In common with other accreditation standards of the ISO 17000 series (and unlike most ISO standards for management systems), assessment of the laboratory is normally carried out by the national organization responsible for accreditation. Laboratories are therefore "accredited" under ISO/IEC 17025, rather than "certified" or "registered" by a third party service as is the case with ISO 9000 quality standard.

In short, accreditation differs from certification by adding the concept of a third party (Accreditation Body (AB)) 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.

In order for accreditation bodies to recognize each other's accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO/CASCO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, regions such as the European Community, the Asia-Pacific, the Americas and others, established regional cooperations 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 African Development Community Cooperation in Accreditation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

The first laboratory accreditation bodies to be established were National Association of Testing Authorities (NATA) in Australia (1947) and TeLaRC in New Zealand (1973).[4][5] Most other bodies are based on the NATA/TELARC model include UKAS in the UK, FINAS in Finland and DANAK in Denmark to name a few.

In the U.S. there are several, multidisciplinary accreditation bodies that serve the laboratory community. These bodies accredit testing and calibration labs, reference material producers, PT providers, product certifiers, inspection bodies, forensic institutions and others to a multitude of standards and programs. These ILAC MRA signatory accreditation bodies carry identical acceptance across the globe. It does not matter which AB is utilized for accreditation. The MRA arrangement was designed with equal weight across all economies. ABs include:

The accreditation of calibration laboratories is the shared responsibility of the Standards Council of Canada (SCC) Program for the Accreditation of Laboratories-Canada (PALCAN), and the National Research Council of Canada (NRC) Calibration Laboratory Assessment Service (CLAS). The CLAS program provides quality system and technical assessment services and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System.

In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for management systems, product certification, laboratory, inspection, personnel and others:

ISO/IEC 17025 is the international standard for testing and calibration laboratories. It sets out requirements for the competence, impartiality, and consistent operation of laboratories, ensuring the accuracy and reliability of their testing and calibration results.

This standard is vital for laboratories as it enhances the credibility of their testing and calibration work, fostering trust among clients and regulatory authorities. Compliance with ISO/IEC 17025 demonstrates a laboratory's commitment to quality, technical proficiency, and scientific rigor.

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It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

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 centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.

The last version of ISO/IEC 17025 was published in 2005 and, since then, market conditions and technology have changed. The new version covers technical changes, vocabulary and developments in IT techniques. It also takes into consideration the latest version of ISO 9001.

ISO/IEC 17025 has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001.

Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the competence of laboratories.

The use of this document will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures. The acceptance of results between countries is facilitated if laboratories conform to this document.

ISO/IEC 17025 requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.

Laboratories in need of assistance in learning and comprehending the changes in the new ISO/IEC 17025:2017 standard may explore A2LA training opportunities on the training page and 2018 training calendar.

Laboratories may be happy to know that while they are busy dissecting the changes to the ISO/IEC 17025 standard, A2LA will also be busy dissecting and implementing the changes to the newly approved and released ISO/IEC 17011:2017, the standard with which A2LA must maintain compliance. ISO/IEC 17011:2017 was also approved and released on November 29, 2017 and similarly with ISO/IEC 17025, ILAC has also mandated a 3-year transition for all Accreditation Bodies to become compliant with the new standard. A2LA just happens to have our regularly scheduled ILAC/APLAC/IAAC re-evaluation scheduled for May 2018 and have already alerted the Evaluation Team Leader that A2LA is requesting to be evaluated to the new standard.

ISO/IEC 17025:2017 Standard is applicable to all laboratories engaged in Calibration, Verification, Sampling or Testing and applies to all small, medium, large, government or privately-owned Laboratories and other entities engaged in activities of Testing, and Calibration. ISO/IEC 17025 has established the requirements necessary to demonstrate ability to provide accurate and consistent results of tests and measurements performed.

ISO/IEC 17025 Standard and ISO 15189 Medical Laboratory Standard are used for laboratory accreditation for testing / calibration and medical testing. These two standards are Laboratory Accreditation Standards for generic testing / calibration and medical testing.

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