The NF EN ISO/IEC 17025 standard, or simply ISO 17025, is an international reference for testing and calibration laboratories. It is used to assess competence and ensure the quality of laboratories worldwide. The standard was updated in 2017 to incorporate new concepts and requirements related to risk and opportunity management. It also strengthened its focus on impartiality and confidentiality.
Impartiality is a key principle of ISO 17025. It requires laboratories to avoid any conflicts of interest and maintain objectivity in all their activities. To ensure impartiality, laboratories must identify and regularly assess risks related to their impartiality. They must also implement strategies to minimize these risks.
ISO 17025 also obliges laboratories to preserve the confidentiality of information obtained during their activities. This requirement extends to all laboratory personnel. Laboratories must inform their clients of any information they intend to make public. Furthermore, they are required to keep confidential any information obtained from sources other than the client.
Competence of personnel
The competence of personnel is another key element of ISO 17025. All personnel, internal and external, who can influence laboratory activities must be competent. Laboratories must document the required competencies for each activity and ensure that personnel possess these competencies before assigning them a task.
Control of facilities and environmental conditions
ISO 17025 mandates laboratories to control their facilities and the environmental conditions in which tests and calibrations are performed. The conditions must not compromise the validity of the results. Influencing factors must be identified, and the test conditions must be controlled.
Management of laboratory equipment
ISO 17025 also outlines requirements for the management of laboratory equipment. These requirements cover all types of equipment that could influence the results, including measuring instruments, software, reference materials, and even consumables such as reagents.
ISO 17025 presents specific requirements regarding metrology. It requires laboratories to perform regular calibrations to ensure result accuracy and metrological traceability.
Process of conducting activities
ISO 17025 demands that laboratories establish specific processes to manage client requests, proposals, contracts, and the selection and validation of methods.
ISO 17025 requires laboratories to establish, document, implement, and maintain a quality management system. This system must include document and record control, as well as actions to manage risks and opportunities.
Internal audit and management review
Finally, ISO 17025 mandates laboratories to conduct regular internal audits to verify compliance with the standard and their own requirements. They must also perform a management review to evaluate the effectiveness of their quality management system.
In summary, ISO 17025 is a critical reference for ensuring the competence, reliability, impartiality, and operational excellence of testing and calibration laboratories.