ISO/IEC 17025

Last updated

ISO/IEC 17025General 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.

Contents

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]

The 2005 version of the standard comprises four elements:

  1. Normative References
  2. Terms and Definitions
  3. Management Requirements - related to the operation and effectiveness of the quality management system within the laboratory
  4. Technical Requirements - factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.

The 2017 version comprises eight elements:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. General Requirements - related to the organization of the laboratory
  5. Structural Requirements -related to the organization of the laboratory
  6. Resource Requirements - cites issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results
  7. Process Requirements - the heart of this version of the standard describes the activities to ensure that results are based on accepted science and aimed at technical validity.
  8. Management System Requirements -steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results

Predecessors

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.

Accreditation bodies

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.

USA

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:

Canada

In Canada, there are two accreditation bodies:

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.

Other countries

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:

See also

Related Research Articles

<span class="mw-page-title-main">Metrology</span> Science of measurement and its application

Metrology is the scientific study of measurement. It establishes a common understanding of units, crucial in linking human activities. Modern metrology has its roots in the French Revolution's political motivation to standardise units in France when a length standard taken from a natural source was proposed. This led to the creation of the decimal-based metric system in 1795, establishing a set of standards for other types of measurements. Several other countries adopted the metric system between 1795 and 1875; to ensure conformity between the countries, the Bureau International des Poids et Mesures (BIPM) was established by the Metre Convention. This has evolved into the International System of Units (SI) as a result of a resolution at the 11th General Conference on Weights and Measures (CGPM) in 1960.

<span class="mw-page-title-main">International Organization of Legal Metrology</span>

The International Organization of Legal Metrology, is an intergovernmental organisation that was created in 1955 to promote the global harmonisation of the legal metrology procedures that underpin and facilitate international trade.

Accreditation is the independent, third-party evaluation of a conformity assessment body against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks.

<span class="mw-page-title-main">Product certification</span> Performance and quality assurance

Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.

IEC 61508 is an international standard published by the International Electrotechnical Commission (IEC) consisting of methods on how to apply, design, deploy and maintain automatic protection systems called safety-related systems. It is titled Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems.

The Standards Council of Canada (SCC) (French: Conseil canadien des normes (CCN)) is a Canadian crown corporation with the mandate to promote voluntary standardization in Canada. The SCC is responsible for:

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212. ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff. While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

The International Laboratory Accreditation Cooperation or ILAC started as a conference in 1977 to develop international cooperation for facilitating trade by promoting the acceptance of accredited test and calibration results. In 1996, ILAC became a formal cooperation with a charter to establish a network of mutual recognition agreements among accreditation bodies that would fulfil this aim.

The South African National Accreditation System (SANAS) is the official accreditation body for South Africa. Founded in 1996, SANAS is headquartered in Pretoria, South Africa. SANAS accreditation certificates are a formal recognition by the Government of South Africa that an organisation is competent to perform specific tasks.

The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body recognised by the British government to assess the competence of organisations that provide certification, testing, inspection and calibration services. It evaluates these conformity assessment bodies and then accredits them where they are found to meet relevant internationally specified standards.

External quality assessment ('EQA), or external quality assessment schemes(EQAS) is a challenge of the effectiveness of a laboratory's quality management system, typically referring specifically to medical laboratories. The term external refers to the fact that that the laboratory's results are assessed by a third party. The most common EQA process is proficiency testing, in which an organization sends samples to a group of different laboratories and results are compared among the group. Retesting of the same sample by different laboratories and on-site visits to evaluate laboratory processes may also be part of an EQA scheme.

ISO 10012:2003, Measurement management systems - Requirements for measurement processes and measuring equipment is the International Organization for Standardization (ISO) standard that specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.

Forensic metrology is a branch of metrology applied to forensic sciences. Metrology has evolved various techniques for assessing the margin of error or uncertainty associated with measurements. Forensic laboratories and criminalistic laboratories perform numerous measurements and tests to support criminal prosecution and civil legal actions. Examples of forensic metrology include the measurement of alcohol content in blood using breathalyzers, quantification of controlled substances, and length measurements of firearm barrels. The results of forensic measurements are used to determine if a person is charged with a crime or may be used to determine a statutory sentencing enhancement. Other examples of forensic metrology includes tests that measure if there is a presence of a substance, latent print examination, questioned documents examination, and DNA analysis.

<span class="mw-page-title-main">National Accreditation Board for Testing and Calibration Laboratories</span> Indian accreditation organisation

National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories) in India. NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC 17025, ISO 15189, ISO/IEC 17043 & ISO 17034:2016 Standards. It has Mutual Recognition Arrangement (MRA) with Asia Pacific Accreditation Cooperation (APAC), International Laboratory Accreditation Cooperation (ILAC).

<span class="mw-page-title-main">HCT Co., Ltd.</span>

HCT Co., Ltd. is a South Korean compliance testing and equipment calibration company that also develops particle counters and antennas. Founded in 2000 as Hyundai Calibration & Certification Technologies Co., the company is a spin-off from Hyundai Electronics, the world's second-largest memory chipmaker. HCT has testing and calibration sites in Korea, the United States, and China.

IEC 62443 is a series of standards that address cybersecurity for operational technology in automation and control systems. The series is divided into different sections and describes both technical and process-related aspects of automation and control systems cybersecurity. The series is also known as ISA/IEC 62443 in recognition of the fact that much of the initial development was done by the ISA99 committee of the International Society for Automation.

<span class="mw-page-title-main">Runningland</span> Chinese laboratory company

Founded in 2009, "Runningland Metrology & Testing (Shanghai) Co., Ltd" is a Shanghai-based accredited third party laboratory that specializes in instruments metering, condition monitoring, calibration and testing petrochemical products. The company was founded by David Zhou, who is an active member of STLE ASTM D2 Committee, and SAE, and co-founded by Ti Zhou who is a member of Shanghai Lubrication Trade Association. As a commercial third party laboratory, the organization also collaborates with educational institutions and research associations across China. Oil analysis is still a relatively developing idea and has become an increasingly important concept in The People's Republic of China. Because the oil analysis market in China is growing, Runningland has developed a lab that specializes in grease testing. In 2015, STLE has published a report indicating its previous activities and plans to expand into the China market by organizing the China Advisory Council, which consists of 15 prominent members of China's lubrication industry including David Zhou, Chairman and Co-founder of Runningland.

BA 9000 Body Armor Quality Management System Requirements were established by the National Institute of Justice as a quality standard for body armor. It specifies the construction and assembly requirements of personal armor for federal, state, tribal and local law enforcement and corrections agencies; the requirements of BA 9000 are voluntary.

The National Association of Testing Authorities (NATA) is the recognised national accreditation authority for analytical laboratories and testing service providers in Australia. It is an independent, not-for-profit organisation, governed by a board of directors that has representation from NATA members, industry, government and professional bodies.

<span class="mw-page-title-main">Standardisation Testing and Quality Certification</span> Science and technology agency of the Government of India

Standardisation Testing and Quality Certification (STQC) Directorate, established in 1980, is an authoritative body offering quality assurance services to IT and Electronics domains.

References

  1. ↑ "Principles behind ISO/IEC 17025" (PDF). Canadian Association for Laboratory Accreditation (CALA). Archived from the original (PDF) on 11 August 2019. Retrieved 27 March 2018.
  2. ↑ Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". Journal of AOAC International. 86 (5): 1038–1044. doi: 10.1093/jaoac/86.5.1038 . PMID   14632407 . Retrieved 28 February 2012.
  3. ↑ "ISO/IEC 17025 Comparison - 1999 to 2005". SAI Global Limited ABN. Archived from the original on 2011-04-10. Retrieved 28 February 2012.
  4. ↑ "NATA - NATA Field and Program Accreditation Criteria - ISO-IEC 17025 Laboratory Accreditation (Applicable to all ISO/IEC 17025 fields)". www.nata.com.au. Retrieved 2017-04-28.
  5. ↑ "Testing Laboratory Registration Council Of New Zealand" (PDF). Archived from the original (PDF) on 2019-08-11. Retrieved 2017-04-28.
  6. ↑ "About ANAB". American Association for Laboratory Accreditation. Retrieved 30 August 2022.
  7. ↑ "About A2LA". American Association for Laboratory Accreditation. Retrieved 28 February 2012.
  8. ↑ "ISO/IEC 17025:2005 – Laboratory Accreditation Program- PJLA" . Retrieved 29 May 2015.
  9. ↑ "About IAS | The International Accreditation Service" . Retrieved 29 May 2015.
  10. ↑ "ASCLD-LAB home page". American Society of Crime Laboratory Directors-Laboratory Accreditation Board. Retrieved 12 July 2012.
  11. ↑ "CALA" . Retrieved 29 May 2015.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.