Overview
ISO/IEC 17025 is the main standard used by testing and calibration laboratories, which originally known as ISO/IEC Guide 25, ISO/IEC 17025. The official title of this standard is: BS EN ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories. It was produced by Technical Committee ISO/CASCO in collaboration with Technical Committee CEN/CLC/TC 1.
ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. And it applies directly to those organizations that produce testing and calibration results.
The standard was first published in 2001 and on 12th May 2005 the alignment work of the ISO committee responsible for it was completed with the issuance of the revised standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer. Besides, it was agreed that it needed to have its quality system words more closely aligned with ISO 9001:2000.
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. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.
There are two main sections in ISO/IEC 17025 standard - Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of staff, methodology and test/calibration equipment.
The complete and usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard is as below
1. Introduction
2. Scope
3. Definitions and terminology
4. Management requirements
4.1. Organization
4.2. Quality system
4.3. Document control
4.4. Review of contracts
4.5. Subcontracting
4.6. Purchasing
4.7. Service to the client
4.8. Complaints
4.9. Control of non-conforming work
4.10. Improvement
4.11. Corrective actions
4.12. Preventive actions
4.13. Control of quality records
4.14. Internal audits
4.15. Mangement review
5. Technical requirements
5.1. General
5.2. Personnel
5.3. Accomodation
5.4. Test methods and validation
5.5. Equipment
5.6. Measurement traceability
5.7. Sampling
5.8. Test items
5.9. Quality control
5.10. Reports / calibration certificates
Useful Links for More Detail Info
ISO/IEC 17025 is the main standard used by testing and calibration laboratories, which originally known as ISO/IEC Guide 25, ISO/IEC 17025. The official title of this standard is: BS EN ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories. It was produced by Technical Committee ISO/CASCO in collaboration with Technical Committee CEN/CLC/TC 1.
ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. And it applies directly to those organizations that produce testing and calibration results.
The standard was first published in 2001 and on 12th May 2005 the alignment work of the ISO committee responsible for it was completed with the issuance of the revised standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer. Besides, it was agreed that it needed to have its quality system words more closely aligned with ISO 9001:2000.
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. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.
There are two main sections in ISO/IEC 17025 standard - Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of staff, methodology and test/calibration equipment.
The complete and usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard is as below
1. Introduction
2. Scope
3. Definitions and terminology
4. Management requirements
4.1. Organization
4.2. Quality system
4.3. Document control
4.4. Review of contracts
4.5. Subcontracting
4.6. Purchasing
4.7. Service to the client
4.8. Complaints
4.9. Control of non-conforming work
4.10. Improvement
4.11. Corrective actions
4.12. Preventive actions
4.13. Control of quality records
4.14. Internal audits
4.15. Mangement review
5. Technical requirements
5.1. General
5.2. Personnel
5.3. Accomodation
5.4. Test methods and validation
5.5. Equipment
5.6. Measurement traceability
5.7. Sampling
5.8. Test items
5.9. Quality control
5.10. Reports / calibration certificates
Useful Links for More Detail Info
- http://en.wikipedia.org/wiki/ISO_17025
- http://www.17025-standard.com/
- http://www.quality.co.uk/custpage.htm#iso-17025
