ISO 17025 Requirements: A Guide to Laboratory Excellence
1. Range and Utilization
ISO 17025 is applicable to all businesses that perform laboratory operations, regardless of the size of the workforce or the scope of testing and calibration activities performed. Owing to the standard's flexibility, labs of all sizes and shapes can effectively implement its requirements.
2. Management Conditions
The management requirements of ISO 17025 focus on the overall management system of the laboratory. This includes several critical elements:
Organization and Management Structure: Laboratories must have a clear organizational structure, defining the responsibilities and authorities of personnel involved in the management and performance of tests and calibrations.
Document Management: Laboratories must establish and maintain procedures for controlling documents, ensuring that all documents are reviewed, approved, and updated as necessary.
Control of Records: Records must be accurately maintained and easily retrievable to demonstrate compliance with the standard and the laboratory’s own policies and procedures.
Internal Audits: Regular internal audits are required to verify that the management system is effectively implemented and maintained.
Evaluations of Management: Top management must periodically review the management system to ensure its continuing suitability and effectiveness.
3. Technical prerequisites
Technical requirements address the competence of staff, the testing and calibration methods, equipment, and the quality and reporting of test and calibration results. Key elements include:
Employee Proficiency: Laboratory personnel must have the appropriate qualifications, training, and experience for their assigned tasks. Ongoing training and evaluation are essential to maintain competence.
Environment and Facilities: The laboratory setting needs to be appropriate for the tasks being carried out, with the right facilities and ambient conditions to avoid contamination or interference.
Equipment: Laboratories must have access to all necessary equipment for sampling, measurement, and testing. Equipment must be properly maintained and calibrated to ensure accurate results.
Test and Calibration Methods: Methods must be appropriate and validated for their intended use. Laboratories must document all methods and procedures, ensuring consistency and reliability in their operations.
Measurement Traceability: Calibration of equipment must be traceable to international or national measurement standards. If such standards are not available, laboratories must use accepted methods to ensure traceability.
Handling of Test and Calibration Items: Proper procedures must be in place for the transportation, receipt, handling, protection, storage, and disposal of test and calibration items to prevent deterioration, contamination, and damage.
Assurance of Quality in Outcomes: Laboratories must have quality control procedures to monitor the validity of tests and calibrations. This includes participation in interlaboratory comparisons or proficiency testing.
Reporting Results: Test and calibration results must be reported accurately, clearly, unambiguously, and objectively. Reports must include all necessary information to enable the interpretation of results.
4. Continuous Improvement
ISO 17025 emphasizes how important continuous improvement is.
Laboratories must establish rules and procedures in order to identify
and apply improvements to their technical processes, management
system, and overall performance. This means giving regular feedback
and taking corrective and preventive action in order to address any
non-conformities and enhance the quality of operations.
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