ISO/IEC 17025

Case studies, Research and Supporting Materials tagged as ISO/IEC 17025.

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The Ministry of Industry, Investment and Commerce, recognises the accreditation of the Pesticide Research Laboratory (PRL) of the University of the West Indies (UWI), as critical to strengthening Jamaica’s quality infrastructure and improving service standards.

The accreditation plays an important role in the facilitation of trade, particularly as it relates to export promotion in the agricultural sector, while supporting the country’s food safety policy.

Results are now well placed to be accepted on a global basis, thus facilitating export of local as well as regional products. Accreditation is a critical component of a strengthened National Quality Infrastructure (NQI), is valuable to the development of a logistics-centred economy, and allows for realisation of the full benefits of the National Export Strategy.

Further information is available on the Jamaican Government website.

 

Regulation 37 Standards for testing

For the purposes of section 16(3)(a) of the Act the prescribed standards for the testing, analysis and diagnostic examination of any sample or specimen for the purpose of determining whether it is infected with a disease are:

  1. the standards relevant to that disease in the Australian and New Zealand Standard Diagnostic Procedures as approved by the Primary Industries Standing Committee as amended and in force from time to time;
  2. in any other case, the standards relevant to that disease in the Australian Standard Diagnostic Techniques for Animal Diseases as published by the Standing Committee on Agriculture and Resource Management in 1993 as amended and in force from time to time.

For the purposes of section 16(4) of the Act the prescribed standard of accreditation for the facilities and operational practices of veterinary diagnostic laboratories is accreditation in accordance with ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.

Further information is available on the Victoria State Government website.

Energy-Efficiency (EE) standards are procedures and regulations that prescribe the energy performance of manufactured products e.g. electronic equipment, refrigerators, air conditioners and water heaters.

Mexico implemented a policy to establish a fund to facilitate the reduction of emissions in energy consumption by replacing incandescent light bulbs with compact fluorescent light bulbs and the project of energy-efficient refrigeration to reduce energy consumptions. This policy was supported by standards. Mexico mandates for EE standards to come from the Federal Law on Metrology and Standardization (LFMN – Ley Federal sobre Metrología y Normalización), which established a list of specific and generic public and private organizations for implementing the Standards’ Programme. The LFMN lists in Article 3 the responsible parties for developing voluntary (NMXs) and mandatory standards (NOMs).

The National Commission for Energy Efficiency (CONUEE) is responsible for developing EE standards. It is a decentralized, administrative agency of the Secretary of Energy, with technical and operative autonomy to promote energy efficiency.

When a Ministry in Mexico issues technical regulations, these are mandatory, so all products, processes, methods, facilities, services or activities must comply with the Mexican Official Standards that are published in the Official Gazette (DOF). There is a detailed list of current EE standards in Mexico.

To demonstrate compliance with mandatory standards, products such as refrigerators, air conditioners, laundry machines or water heaters shall be certified. The certification and related testing shall be performed by accredited third parties. Private organizations that participate in this EE conformity assessment system in Mexico are:

  • Testing laboratories: independent or operated by manufacturers. When accredited to ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories, the laboratory does the tests under NOMs requirements and issues the results’ report.
  • Calibration laboratories: accredited to ISO/IEC 17025 give traceability to the measurement instruments of testing laboratories.
  • Certification bodies: accredited to ISO/IEC 17065 and approved by corresponding ministries to certify compliance with EE standards (NOMs). The certification bodies only recognize test reports of accredited laboratories.
  • Accreditation bodies: ensures technical competence of certification bodies, testing laboratories and calibration bodies. A competent accreditation body complies with the requirements of ISO/IEC 17011 Conformity assessment – General requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs).

There are other systems that exist on the Mexican market, such as the Electric Power Saving Trust Fund (FIDE) label, a voluntary label that identifies energy-efficient products. It certifies that products meet specified standards and identifies them as FIDE certified energy-efficient products. FIDE also requires conformity assessment bodies to be accredited to issue its certificates.

FIDE label covers the products listed below and its targets to increase coverage to 7700 products across 85 companies:

  • Electric three phase induction motors
  • Lamps, ballasts and luminaries
  • Water pumps
  • Commercial refrigerators
  • TV sets and monitors
  • Air conditioners

Regarding EE voluntary standards, Mexico also promotes the use of ISO 50001 – Energy management systems, that supports organizations in all sectors to use energy more efficiently and improve environmental performance, through the development of an energy management system (EnMS).The Certification Bodies seeking accreditation on Energy Management Systems program shall comply with ISO/IEC 17021: Conformity assessment – Requirements for bodies providing audit and certification of management systems.

The Egyptian Ministry of Trade and Industry has issued Decree No. 43/2016 with references the ILAC MRA and IAF MLA. The Decree was issued on 30 December 2015 and enters into force on 1 March 2016.

If, as part of the requirements of the Decree, manufacturers and importers require their products to be tested or inspected under the ILAC MRA, they should contact the accreditation bodies that are a signatory to the ILAC MRA for testing using ISO/IEC 17025 or inspection using ISO/IEC 17020. The accreditation bodies will be able to provide a list of testing laboratories and inspection bodies that they have accredited to undertake the testing or inspection as required. The online directory of accredited laboratories and inspection bodies is also available from the accreditation body’s website.

For further information, please contact the Egyptian Ministry of Trade and Industry or the Egyptian General Organization for Export and Import Control (GOEIC) directly.

Under Title 47 of the United States Code of Federal Regulations, the FCC requires that a laboratory that has been accredited (to ISO/IEC 17025) with a scope covering the required measurements shall be deemed competent to test and submit test data for equipment subject to verification, Declaration of Conformity, and certification under the Equipment Authorization Procedures.  In addition, the FCC also requires that to be designated as a TCB (Certification Body) under this section, an entity shall, by means of accreditation, meet all the appropriate specifications in ISO/IEC Guide 65 (now ISO/IEC 17065) for the scope of equipment it will certify.

Since 2002, the FCC Equipment Authorization Program has experienced a 13% growth rate each year, and in 2014, the product certification bodies recognized under this program processed over 21,000 grants of equipment certification.  The US Customs and Border Patrol Agency receive over 1 million filings per month, requesting importation of these certified devices – whose compliance to FCC rules is reliant upon accredited conformity assessment activities.

More information regarding FCC requirements for test laboratories and product certification bodies under the Equipment Authorization Program can be found at:

TCB Program Roles and Responsibilities

 

In criminal courts in The Netherlands, DNA-based evidence will only be admissible if the DNA tests have been performed by a laboratory with an ISO/IEC 17025 accreditation. Obviously, the consequences of mistakes in DNA-based evidence can be enormous. With accreditation, the government creates extra guarantees for the integrity of the judicial system and the interests of the Dutch citizens.

Further information on this area of Dutch Law is available here. (In Dutch)

The U.S. General Services Administration requires star of life ambulances procured by the U.S. government to be tested by an independent laboratory accredited in accordance with ISO/IEC 17025 by an accreditation body that is a signatory to the ILAC MRA.

All of the GSA’s ambulance standards are used to validate that their contractors are producing a quality product, and the MRA is one tool among many in their assessment of quality. They accept accreditation from MRA signatories but still perform source inspections on each ambulance ordered and procured for federal agencies under a GSA contract.

The agency still does its own inspection but has confidence that the critical components of the ambulance have been tested by competent laboratories.

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In the UK, Lancashire Constabulary set a precedent by being the first Police Force outside of the Metropolitan Police Service (MPS) to set up their own in-house Forensics Service, thereby saving over £500,000 a year.

To ensure compliance to ISO/IEC 17025, the Forensics Lab has achieved UKAS Accreditation for a number of tests enabling it to run crime scene investigations and demonstrate its capability for forensic provision equals that of external providers and private companies. (UK)

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In July 2003, the Records and Identification Bureau of the Phoenix Police Department, Arizona, became the first law enforcement unit in the United States to certify its quality management system to ISO 9001. This case study describes the pioneering implementation of the standard in an “industry” where life-altering decisions are made 24/7 – 24 hours a day, seven days a week and resulted in savings of $11 million. (USA)

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The National Service of Customs in Chile specifies that the testing of fine copper and copper concentrates must be carried out in an accredited laboratory. (Chile)

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Similarly, in Serbia the Serbian Directorate of Measures and Precious Metals (DMDM), part of the Serbian National Metrology Institute, has implemented ISO/IEC 17025 to ensure international recognition of its national measurement standards, measurement and calibration results, and calibration certificates issued by DMDM. (Serbia)

DNA testing carried out by the Royal Canadian Mounted Police must be tested in an accredited laboratory. The National DNA Data Bank conforms with the requirements of ISO/IEC 17025 and is recognized as an accredited testing laboratory for specific tests listed in the scope of accreditation approved by the Standards Council of Canada. (Canada)

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IANZ (International Accreditation New Zealand) accreditation is applicable to all organisations providing medical examinations, including community laboratories and those in the public hospital system. With accreditation, medical laboratories receive formal recognition of the organisation’s technical competency after assessment of their processes, resources, facilities, staff and other key factors and skills which relate to, and impact on the quality of the service provided.

Most medical testing laboratories in the private sector and in hospitals around the country are accredited by IANZ, giving assurance that tests essential for human health are carried out accurately and competently.

Accreditation is based on ISO 15189 Medical laboratories – Requirements for quality and competence. This standard is based upon ISO/IEC 17025 and ISO 9001. (New Zealand)

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Health Authority in Dubai (DHA) requires that to be licensed all clinical laboratories are required to be accredited by any accreditation agency such as ISO: 15189 Medical Laboratory Standards adopted by Dubai Accreditation Center (DAC). (Dubai)

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Chief Inspector of UK Hospitals releases Policy Statement outlining how existing accreditation schemes can help to inform Care Quality Commissions programme of inspections.

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Accredited certification has been embraced by a variety of public sector organisation in Mauritius. Twenty Departments within many ministries in Mauritius have accredited certification to ISO 9001 granted by the Mauritius Standards Bureau, including the Ministry of Labour, Industrial Relations and Employment, the Mauritius Meteorological Services and the Mauritius Revenue Authority.  Three secondary schools have accredited certification to ISO 9001 as well as the Willougby Primary Government School. The National Blood Transfusion Service of the Ministry of Health and Quality of Life in Mauritius also has accredited Certification to ISO 9001 granted by the Mauritius Standards Bureau and the Passport and Immigration Office has accredited certification to ISO/IEC 27001. The Forensic Science Laboratory of Mauritius is itself accredited to ISO/IEC 17025. (Mauritius)

 

The Norwegian Maritime Authority (NMA) has been certified to quality management system standard ISO 9001. The Director General of the NMA Olav Akselsen has a clear view of certification’s role in improvement, “Certification alone, however, does not mean the job is done. We will work continuously to evaluate and refine our internal processes according to the standard, focusing on service and quality that will benefit our end users.”

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Various governmental entities in Abu Dhabi are also accredited to improve their performance, including the Food Control Department, Municipality Clinical Laboratory, Municipality Animal Laboratory. The Digital Forensic Laboratory of Abu Dhabi Police is certified to ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories. (Abu Dubai)

 

In order to have a better quality operation of key activities and more efficient management of its processes, the Serbian Directorate of Measures and Precious Metals (DMDM), the Serbian National Metrology Institute, has accredited certification for ISO 9001, ISO 14001, and OHSAS 18001. Moreover, they are ISO/IEC 17025 accredited (one testing laboratory and one calibration laboratory). (Serbia)

 

Ireland’s National Car Testing Service has achieved accreditation to ISO/IEC 17020 Conformity assessment – Requirements for the operation of various types of bodies performing inspection to ensure that it improves car safety and deliver its services with impartiality and consistency. (Ireland)

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In Eritrea, the National Blood Bank is certified to ISO 9001. Set up in 1999 as a center, the NBTS is a blood supply centre through out the country. Working in accordance with the internationally accepted management systems enables the NBTS run its activities effectively to the level of utmost excellence. Eritrea has now met the international standards of blood management system and gained international recognition to be certified by South African Accreditation body known as South African Bureau of Standards, SABS. (Eriteria)

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In the Canadian province of Newfoundland and Labrador, the Department of Environment and Conservation has stipulated that any laboratories that provide proficiency testing and environmental data to their department must be have a ‘Recognized Form of Laboratory Accreditation’. This means Accreditation obtained from an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Agreement and based on ISO/IEC 17025.

The policies state ‘The Department of Environment & Conservation shall contract only those commercial laboratories which have a recognized form of laboratory accreditation to perform the required’ and ‘The Department of Environment & Conservation shall contract only those commercial laboratories which have a recognized form of laboratory accreditation to perform the required analyses (except in limited instances). This has been done ‘to ensure that environmental information produced by and provided to the Province is comparable, of known quality, and adequate for its intended purpose’. (Canada)

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The issue of radioactive contamination in food caused by the Great East Japan Earthquake, March 11, 2011, has raised the importance of laboratory accreditation against international standards more than before.

Accreditation of laboratories under ISO/IEC 17025 is the system to accredit the laboratory with the technical competence to the international compliance. Test reports issued by the laboratory accredited by accreditation body as the signatory to the ILAC Multilateral Recognition Arrangement (MRA) supports the smooth logistics and can make a contribution to the export of agriculture products or food.

For the measurement and analysis of radioactive materials in food, the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) issued the notification that laboratories accredited under ISO/IEC 17025 are reliable analysis organizations for the analysis and presentation of this data.

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The Ministry of Agriculture, Forestry and Fisheries (MAFF) in Japan have also used accreditation as part of the process to valididate the safety of meat and eggs exported to Hong Kong, helping to deliver safe food across international borders.

 

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In New Zealand a 2007 amendment to the 1956 Health Act stipulated that drinking water for domestic consumption must be tested in labortories ‘accredited by International Accreditation New Zealand or any other prescribed body for the purposes of this section’ or conforming to the ISO/IEC 17025 standard. (New Zealand)

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Under the New Public Drinking Water Supply Program, the Government of Nova Scotia, Department of Environment require drinking water quality testing is to be completed by approved laboratories in accordance with the Policy for the Accreditation of Laboratories. (Canada)

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As part of the New Zealand Government’s support of their food industry’s export drive, the Ministry for Primary Industries states that all animal products for export (dairy products, as well as meat, fish, shellfish, honey etc.) must be tested in an accredited laboratory. (New Zealand)

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SERNAPESCA, the National Fishing Service in Chile, relies on accredited laboratories and inspection bodies to ensure the safety of seafood. Accredited testing laboratories are required to carry out activities such as sampling of seafood products, testing of process water and marine sediments. (Chile)

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The Food Control Department in Dubai requires that food sector companies including manufacturing companies, food storage/warehousing companies and 4 & 5 star hotels should be certified for ISO 22000 (Food safety management systems – Requirements for any organization in the food chain)/HACCP by accredited certification bodies. This scheme helps the local regulator to regulate the food market in better way. (Dubai)

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SAG, the Agriculture and Livestock Service in Chile, relies on accredited testing laboratories, product certification bodies, and inspection bodies to manage the quality of livestock and food production. (Chile)

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The Department of Agriculture, Food and the Marine requires its Virology division to be accredited in order to fulfil its objectives to provide laboratory support for disease control and eradication programmes, and to perform tests for statutory and import / export purposes. The Virology Division is accredited for a range of tests to ISO/IEC 17025.(Ireland)

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Lancashire Constabulary set a precedent by being the first Police Force outside of the Metropolitan Police Service (MPS) to set up their own in-house Forensics Service, thereby saving over £500,000 a year.

Lancashire Constabulary improved their own provision by keeping a number of services in-house. To ensure compliance to ISO/IEC 17025, the Forensics Lab has achieved UKAS Accreditation for a number of tests enabling it to run crime scene investigations and demonstrate its capability for forensic provision equals that of external providers and private companies (UK)

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