BS EN 17025: General Requirements for the Competence of Testing and Calibration Laboratories is a standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It is widely used by laboratories to ensure their operations are of high quality and meet international standards. Here are the key details and requirements:
1. Scope
- BS EN 17025 applies to all organizations performing testing and/or calibration, regardless of their size or the type of testing they perform (e.g., chemical, mechanical, electrical).
- The standard is used to ensure laboratories can demonstrate their competence to carry out specific tests or calibrations.
2. Key Requirements
The standard is structured around several key areas:
A. General Requirements
- Impartiality and Confidentiality: The laboratory must be impartial and must not be influenced by external interests. Confidentiality of results is critical.
- Management System: Laboratories must establish and maintain a management system that ensures they meet the requirements of the standard and the needs of their clients.
- Quality Assurance: The laboratory must have a documented system for quality control, including procedures for ensuring the accuracy of test or calibration results.
B. Structural Requirements
- Organizational Structure: Clear definition of roles and responsibilities.
- Facilities and Environment: The laboratory must maintain an environment suitable for testing, such as adequate space, equipment, and safety conditions.
- Equipment: Laboratories must ensure equipment is fit for its intended use, properly maintained, calibrated, and serviced.
C. Resource Requirements
- Personnel Competence: Personnel involved in testing and calibration must have the necessary qualifications, training, and experience.
- Equipment and Calibration: Laboratories must use equipment that is properly calibrated and verified. It must be appropriate for the tests being conducted.
D. Process Requirements
- Methods and Procedures: The laboratory must use validated methods and procedures, ensuring that they are appropriate for the tests and calibrations performed.
- Handling of Test and Calibration Items: Clear procedures must be in place for handling, storing, and disposing of items being tested or calibrated to avoid contamination or damage.
- Measurement Traceability: The results of tests and calibrations must be traceable to international or national standards, ensuring they are accurate and reliable.
E. Management Requirements
- Document Control: All documentation related to laboratory operations must be properly controlled and regularly reviewed.
- Internal Audits and Management Reviews: Regular internal audits should be performed to ensure the system is working as expected, along with periodic management reviews.
- Non-conformities and Corrective Actions: Laboratories must have a system in place to identify non-conformities and take corrective actions to resolve them.
3. Competence
Competence is the cornerstone of the BS EN 17025 standard. Laboratories must demonstrate their ability to carry out testing and calibration with consistent, reliable, and accurate results. This involves:
- Maintaining an up-to-date competence assessment system for personnel.
- Ensuring that staff are continuously trained and qualified.
- Using standardized, validated methods for performing tests and calibrations.
4. Accreditation
- Laboratories that meet the requirements of BS EN 17025 can seek accreditation from a national accreditation body (such as UKAS in the UK or ANSI in the US).
- Accreditation is a formal recognition that the laboratory has met the standard and is competent to perform specific tests or calibrations.
5. Importance of BS EN 17025
- Confidence: Clients can trust that laboratories adhering to this standard provide reliable and consistent results.
- International Recognition: BS EN 17025 is recognized globally, facilitating trade and ensuring that laboratories’ results are acceptable internationally.
- Continuous Improvement: Laboratories must continuously evaluate and improve their performance to remain in compliance with the standard.
6. Relation to Other Standards
- BS EN 17025 is aligned with other international standards like ISO/IEC 17025, which applies to the same type of laboratories but may be updated differently in various countries.
- It is also used in conjunction with ISO 9001 (Quality Management Systems) in some laboratories.
7. Documents and Records
- Laboratories must maintain accurate records of test and calibration results, quality control activities, maintenance, audits, and staff qualifications.
- Documents should be regularly reviewed and updated to ensure compliance.
8. Conclusion
BS EN 17025 ensures that testing and calibration laboratories operate efficiently, competently, and in compliance with international standards. It is a key standard for laboratories that wish to demonstrate their ability to produce valid and reliable results, ensuring confidence among clients and stakeholders.
