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====== ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
ISO/IEC 17025 is an international standard that sets out the general requirements for the competence of testing and calibration laboratories. During an ISO/IEC 17025 assessment, various topics are evaluated to determine the compliance and effectiveness of a laboratory's quality management system. Some of the key assessment topics include:
1. Management System: Assessment of the laboratory's quality management system, including its documentation, policies, procedures, organizational structure, and responsibilities.
2. Personnel Competence: Evaluation of the competence and qualifications of laboratory personnel, including their education, training, skills, and experience relevant to the testing and calibration activities.
3. Equipment and Calibration: Assessment of the laboratory's equipment, calibration procedures, and traceability to national or international standards. This includes verifying that the equipment is fit for purpose and properly maintained.
4. Measurement Uncertainty: Evaluation of the laboratory's understanding and application of measurement uncertainty, including the estimation, calculation, and reporting of measurement uncertainty associated with test results.
5. Sampling: Assessment of the laboratory's sampling procedures to ensure they are appropriate, representative, and documented.
6. Test and Calibration Methods: Review of the laboratory's test and calibration methods to ensure they are valid, reliable, and fit for purpose. This includes verifying that the methods are properly documented, validated, and implemented.
7. Quality Control: Examination of the laboratory's quality control procedures, including the use of reference materials, proficiency testing, inter-laboratory comparisons, and internal quality control measures.
8. Reporting of Results: Assessment of the laboratory's procedures for recording, analyzing, approving, and reporting test and calibration results. This includes checking for accuracy, completeness, and traceability of results.
9. Complaints and Non-Conformities: Evaluation of the laboratory's procedures for handling customer complaints, non-conformities, and corrective actions. This includes reviewing the effectiveness of the laboratory's corrective and preventive actions.
10. Data Management: Review of the laboratory's data management procedures, including data integrity, confidentiality, protection against loss or damage, and backup processes.
11. Facilities and Environment: Assessment of the laboratory's physical facilities, environmental conditions, and safety measures to ensure they are suitable for the intended testing and calibration activities.
12. Internal Audits: Verification of the laboratory's internal audit program, including the frequency and effectiveness of internal audits, as well as the follow-up on identified non-conformities.
These are some of the main topics that are assessed during an ISO/IEC 17025 evaluation. The specific assessment areas may vary depending on the scope of accreditation and the nature of the laboratory's activities.