ISO/IEC 17025 is the international standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It sets the benchmark for laboratories to demonstrate technical proficiency and reliability in producing accurate and valid test and calibration results.
The standard is critical for ensuring laboratory quality, enabling confidence among clients, regulators, and accreditation bodies by confirming that laboratories operate competently and generate trustworthy data. It applies to all types of laboratories, regardless of size or the scope of testing and calibration activities.
Key aspects of ISO/IEC 17025 include:
Competence requirements: Laboratories must have qualified personnel, proper equipment, validated methods, and a quality management system to consistently produce valid results.
Impartiality and confidentiality: The standard mandates mechanisms to ensure unbiased operations and protect client data.
Management system: Integration of quality management principles such as document control, corrective actions, internal audits, and continuous improvement.
Technical requirements: Proper handling of test and calibration procedures, traceability of measurements to international standards, and validation of methods.
Risk-based thinking: Emphasis on identifying and mitigating risks that could affect test results.
The latest edition, published in 2017, includes updates on information technology use, an enhanced focus on management responsibilities, and aligns with other ISO management system standards to facilitate integration.
Learn more:
https://www.iso.org/standard/66912.html