What is ISO/IEC 17025?
Editorial Team - EMC Directory
ISO 17025 is the primary international standard that outlines the competency criteria for testing and calibration laboratories. It empowers laboratories to showcase their competence in generating accurate and dependable results, thereby instilling trust among customers across the globe.
The ISO/IEC 17025:1999 was the first version of this standard followed by ISO/IEC 17025:2005, and ISO/IEC 17025:2017 which were published in 2005 and 2017 respectively.
The 2017 edition of the accreditation includes five main sections:
· General Requirements: This section focuses on the essential requirements of impartiality and confidentiality, crucial elements in maintaining the trust and confidence of users relying on laboratory testing and calibration services. Impartiality ensures that the laboratory's commitment to quality remains uncompromised by commercial or financial pressures. It addresses and resolves internal issues, conflicts of interest, and personal relationships. Confidentiality, on the other hand, mandates that the laboratory keeps all results and information strictly private.
· Structural Requirements: This section establishes the fundamental organizational components of a laboratory, outlining its scope of activities and commitment to an effective management system. It specifies that an accredited laboratory must either be a standalone legal entity or part of a legal entity, assuming responsibility for its testing and calibration endeavours.
· Resource Requirements: Comprising six clauses, this section addresses the laboratory's obligation to possess the requisite personnel, facilities, equipment, systems, and support services essential for conducting laboratory activities effectively.
· Process Requirements: This section encompasses eleven core processes aimed at enhancing efficiency. It commences with the Review of Requests, Tenders, and Contracts. The Selection, Verification, and Validation of Methods are emphasized as one of the most technically intricate and significant aspects of the standard. It encompasses aspects such as sampling, handling of test items, and technical record-keeping. Ensuring result validity encompasses quality monitoring and control functions within the laboratory, including listed monitoring tools and requirements for proficiency testing.
· Management System Requirements: Within this section, eight key activities are addressed, comprising various aspects of Quality Management System (QMS) documentation. These activities encompass the formulation of policies and objectives, control of documentation and records, identification and management of risks and opportunities, continuous improvement initiatives, and the implementation of corrective action when necessary. Ultimately, the section concludes with the vital components of internal audit and comprehensive management review processes.
The journey towards ISO/IEC 17025 began with ISO 9000, the initial competence standard issued in 1979. However, ISO 9000 lacked the comprehensive focus on procedure verification necessary for testing and calibration laboratories. Recognizing this need, the standard evolved into the ISO/IEC 17025 quality management system, incorporating specific requirements tailored to laboratories engaged in testing and calibration activities. The management system model offered by ISO/IEC 17025 is not only applicable to testing and calibration laboratories but also beneficial to any organization seeking reliable results through testing, sampling, or calibration procedures.
ISO/IEC 17025 accreditation is equally applicable to independently owned and operated laboratories as well as those embedded within larger organizations. This all-encompassing accreditation extends its reach to both regulated government and public sectors, alongside non-regulated sectors. Notably, ISO/IEC 17025, in conjunction with ISO 9001, forms the foundation for ISO 15189, a specialized framework outlining the specific requirements for competence, quality, and accreditation of medical laboratories. This integration underscores the pivotal role of ISO/IEC 17025 in ensuring excellence within the realm of healthcare diagnostics and testing services.