ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. In the field of conformity assessment, ISO and the International Electrotechnical Commission (IEC) develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO).
An ISO 17025 accredited laboratory is a laboratory that has been certified by an accredited body for its competency in conducting testing, calibration, and sampling. This accreditation ensures that a laboratory adheres to the ISO 17025 standard, which was developed by the International Organization for Standardization (ISO). The standard outlines key requirements that a laboratory must meet in order to demonstrate technical competence, impartiality, and consistent operational quality. ISO 17025 is recognized globally and assures stakeholders that the laboratory is capable of producing accurate, reliable, and traceable results.
Key Requirements of ISO 17025
- Quality Management: Laboratories that conform to ISO 17025 will also operate generally in accordance with the principles of ISO 9001. The laboratory must implement a comprehensive system for managing processes, documentation, and records. This ensures that all activities are systematically controlled, enabling consistent operations and transparency in laboratory functions. The quality management system also emphasizes continual improvement, ensuring the laboratory remains responsive to changes and improvements in testing and calibration practices.
- Technical Competence: To achieve ISO 17025 accreditation, a laboratory must ensure its staff is highly skilled and well-trained. Qualified personnel are critical in ensuring that testing and calibration procedures are conducted correctly and reliably. Additionally, the laboratory must possess appropriate equipment that is calibrated and maintained according to the required standards. Having up-to-date, suitable facilities and equipment ensures that all measurements and tests are precise and meet established benchmarks.
- Traceability: Measurement results must be traceable to internationally recognized standards or references. This principle is essential because it ensures that the laboratory’s results can be compared to others globally. Traceability also helps in verifying the accuracy of measurement instruments and maintaining the consistency of results over time. It links the laboratory’s operations to a broader network of recognized global standards, which is crucial in maintaining the integrity of the data produced.
- Impartiality: The laboratory must operate free from bias or influence from external pressures. Impartiality ensures that the results produced are objective and trustworthy, irrespective of the interests of any external parties. This is particularly important for maintaining credibility with regulatory authorities, clients, and the public, as well as for preserving the integrity of the testing and calibration processes.
- Risk-based thinking: ISO 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.
Importance of ISO 17025 Accreditation
ISO 17025 accreditation is widely regarded as a standard for excellence in laboratory testing and calibration. It is often a requirement in industries such as pharmaceuticals, environmental testing, food safety, forensic analysis, and manufacturing, where accurate and reliable results are critical. Laboratories seeking ISO 17025 certification must meet a comprehensive set of requirements, which not only assures that they are qualified to perform high-quality testing but also provides reassurance to regulatory bodies, customers, and the public that the laboratory adheres to international standards.
ISO 17025 certification 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 ISO 17025.
Accreditation provides a competitive edge for laboratories, as it helps build trust with clients, ensure compliance with international standards, and ultimately contribute to better decision-making processes in industries relying on precise data. Moreover, it aids in addressing rising concerns related to antibiotic resistance, food safety, environmental monitoring, and product quality. As ISO 17025 is recognized globally, it ensures that the laboratory’s testing services are accepted in international markets, promoting greater collaboration and business opportunities.
Institutions Offering ISO 17025 Accreditation
ISO 17025 accreditation is provided by national accreditation bodies and international organizations that are recognized by the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF). These bodies evaluate laboratories to ensure they meet the high standards outlined in ISO 17025. Below are some of the prominent accreditation bodies that offer ISO 17025 certification in various regions:
1. International Accreditation Forum (IAF): IAF is a global organization that facilitates the international recognition of accreditations, including ISO 17025. While IAF does not directly offer accreditation, it works with national bodies that do.
2. United States:
– ANSI National Accreditation Board (ANAB): ANAB provides ISO 17025 accreditation in the U.S. and is a member of both ILAC and IAF.
– American Association for Laboratory Accreditation (A2LA): Another prominent accreditation body in the U.S. that offers ISO 17025 certification.
3. United Kingdom: United Kingdom Accreditation Service (UKAS) is the national accreditation body for the UK and offers ISO 17025 accreditation for laboratories in the country.
4. European Union: European Cooperation for Accreditation (EA): EA facilitates the coordination of national accreditation bodies in Europe. Some of the prominent European accreditation bodies include
– Deutsche Akkreditierungsstelle (DAkkS) in Germany
– COFRAC in France
– Accredia in Italy
5. Canada: Standards Council of Canada (SCC): SCC is the body responsible for providing ISO 17025 accreditation in Canada.
6. Australia: National Association of Testing Authorities (NATA) is the national accreditation body for Australia offering ISO 17025 accreditation
7. India: National Accreditation Board for Testing and Calibration Laboratories (NABL) provides ISO 17025 accreditation in India.
8. Other Countries: Other countries typically have their own national accreditation bodies, which are recognized by ILAC. These bodies adhere to ILAC’s guidelines and offer ISO 17025 accreditation to laboratories that meet the required standards of technical competence and quality management.
In conclusion, ISO 17025 accreditation is essential for ensuring that laboratories meet the highest standards of competence, impartiality, and quality in testing, calibration, and sampling. It serves as a guarantee that laboratories produce reliable, accurate results that are traceable to international standards. As such, the importance of ISO 17025 cannot be overstated, particularly in industries where precise data is critical for safety, regulatory compliance, and decision-making. The rigorous process of obtaining ISO 17025 accreditation provides laboratories with a competitive edge, building trust with clients and ensuring that their operations meet international standards. Accreditation bodies around the world, recognized by ILAC and IAF, play an essential role in maintaining and ensuring the quality of laboratory services globally. Through these efforts, ISO 17025 contributes significantly to advancements in science, technology, and public health, enabling better outcomes in various fields of industry and research.
References
The following sources have been used for compiling this excerpt:
- “ISO/IEC 17025 Testing and calibration laboratories” from ISO Website (https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html)
- “What is ISO 17025 Accreditation?” From CAMPBELL SCIENTIFIC CANADA Website (https://www.campbellsci.ca/why-is-iso17025-calibration-important)
- Based on content of the international organization for accreditation bodies website (https://ilac.org/) and the international accreditation forum (https://iaf.nu).
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