- ISO/IEC 17025 is an international standard that specifies general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. This standard provides a comprehensive framework for laboratories to demonstrate their ability to generate valid results and operate a quality management system.
- General requirements focus on impartiality and confidentiality. Laboratories must conduct their activities impartially, manage conflicts of interest, and ensure confidentiality of client information. The standard emphasizes the importance of maintaining objectivity and protecting proprietary information.
- Structural requirements define how laboratories should organize themselves to meet the standard’s objectives. This includes clear definition of legal status, organizational structure, management responsibilities, and the scope of laboratory activities. The structure must support quality operations and maintain impartiality.
- Resource requirements cover personnel, facilities, equipment, systems, and support services. Personnel must be competent and properly qualified for their roles. Facilities and environmental conditions must be appropriate for testing activities. Equipment must be properly maintained and calibrated.
- Process requirements detail how laboratories should handle specific activities, including review of requests, selection of methods, sampling, technical records, evaluation of measurement uncertainty, and reporting of results. These requirements ensure consistent and reliable laboratory operations.
- Management system requirements can follow either Option A (detailed management system requirements within the standard) or Option B (laboratories implementing ISO 9001). Both options ensure proper documentation, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits, and management reviews.
- Method validation requirements ensure that laboratories use appropriate methods and demonstrate their capability to properly perform these methods. This includes verification of standardized methods and validation of laboratory-developed methods.
- Quality control procedures are essential components, including regular use of control samples, proficiency testing participation, and monitoring of results. These procedures help ensure the ongoing validity of results and maintain measurement quality.
- Documentation requirements specify the need for controlled documents, including quality manuals, procedures, and technical records. The system must ensure that current versions are available and obsolete documents are properly managed.
- Record keeping requirements ensure that laboratories maintain appropriate records of all relevant activities, including original observations, derived data, and sufficient information to establish an audit trail.
- Measurement uncertainty must be evaluated for all calibrations and testing methods. Laboratories must have procedures for estimating uncertainty and apply these procedures consistently.
- Equipment management includes requirements for calibration, maintenance, and performance verification. Laboratories must maintain records of equipment status and ensure that equipment meets specifications.
- Sampling requirements apply when laboratories perform sampling activities. This includes sampling plans, methods, and procedures for recording relevant data.
- Training and competency requirements ensure that personnel are qualified for their assigned tasks. Laboratories must maintain records of personnel qualifications, training, and ongoing competency evaluations.
- Customer service aspects include requirements for communication with customers, handling complaints, and obtaining customer feedback. Laboratories must have procedures for addressing customer needs and concerns.
- Internal audit requirements ensure regular evaluation of laboratory operations against the standard’s requirements. Audits must be conducted by trained personnel and findings must be addressed through appropriate corrective actions.
- Corrective action procedures address nonconforming work and implement changes to prevent recurrence of problems. The system must include root cause analysis and effectiveness verification.
- Risk management requirements emphasize the need to identify and address risks and opportunities related to laboratory activities. This includes both technical and business risks.
- Continuous improvement mechanisms ensure that laboratories regularly evaluate their operations and implement improvements. This includes using feedback from various sources to enhance services and processes.
- Accreditation processes verify compliance with ISO/IEC 17025 through independent assessment by accreditation bodies. This provides formal recognition of laboratory competence and impartiality.
