17025

ISO/IEC 17025 is an international standard published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It specifies the general requirements for the competence of testing and calibration laboratories and the specific technical requirements to demonstrate that a laboratory can produce technically valid results. The standard is widely used as a basis for accreditation by national and international bodies, supporting confidence in laboratory results across borders.

Scope and purpose: The standard applies to laboratories performing testing and/or calibration, including sampling associated with measurement results. It provides a framework for managing technical competence and ensuring the accuracy, reliability, and traceability of results, with the aim of facilitating mutual recognition of laboratory capabilities through accreditation.

Structure and main requirements: ISO/IEC 17025 is organized into management requirements and technical requirements. Management requirements cover the laboratory’s quality management system, document control, internal audits, management reviews, corrective and preventative actions, and subcontracting. Technical requirements address personnel competence, premises and environmental conditions, equipment and metrological traceability, measurement uncertainty, validation and verification of methods (including non-standard methods), sampling, handling and storage of samples, data integrity, software validation, reporting and records, confidentiality, and the control of nonconforming work.

Accreditation and use: Laboratories are assessed against ISO/IEC 17025 by accreditation bodies. Successful accreditation signals technical competence and reliability of results and is often recognized internationally through ILAC Mutual Recognition Arrangements (MRA) and the IAF Multilateral Recognition Arrangements. The 2017 edition aligns with the ISO 9001 high-level structure, promoting integration with broader quality management systems.

Relationship to other standards: ISO/IEC 17025 is specific to laboratories, whereas ISO 9001 is a generic quality management standard for organizations. Many laboratories implement both, using 17025 to address technical competence and ISO 9001 to manage overall organizational quality.