ISO 17025 standard is an International Standard (published by the International Organization for Standardization) that specifies the general requirements for the competence to carry out tests and/or calibrations.
Description of ISO 1702 standard
These include: first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. There are 15 management requirements and 10 technical requirements. These requirements outline what a laboratory must do to become accredited. ISO 9001 is a generic management standard that can be applied to any business enterprise, public administration, or government department. Growth in the use of management systems generally has increased the need to ensure that laboratories can operate to a quality management system that is seen as compliant with ISO 9001 as well as demonstrate technical competency.
Therefore, 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. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories. Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.
History of ISO 17025 standard
ISO 17025 was first published in 1999 as a replacement to ISO Guide 25. ISO 17025 was revised and reissued in May 2005. ISO Guide 25 was a well used document published by ISO, but did not have all the management requirements that were outlined in ISO 9001. ISO 17025 includes all the requirements of ISO 9001. Then ISO 9001 was revised and reissued in 2000. ISO 17025:2005 now includes all the management requirements that were incorporated into the new ISO 9001:2000 standard.
Contents of ISO 17025
The ISO 17025 standard itself is comprised of 5 elements:
- 1. Scope
- 2. Normative References
- 3. Terms and Definitions
- 4. Management Requirements
- 5. Technical Requirements
Elements 4 and 5 contain the actual accreditation requirements.
Management Requirements in ISO 17025 norm
- Quality system
- Document control
- Review of requests, tenders and contracts
- Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to client
- Control of nonconforming testing and/or calibration work
- Corrective action
- Preventive action
- Control of records
- Internal audits
- Management reviews
Technical Requirements indicated in ISO 17025 norm
- Accommodation and environmental conditions
- Test and calibration methods and method validation
- Measurement traceability
- Handling of test and calibration items
- Assuring the quality of test and calibration results
- Reporting the results
- Honsa, J. D., & McIntyre, D. A. (2003). ISO 17025: Practical benefits of implementing a quality system. Journal of AOAC International, 86(5), 1038-1044.
Author: Arkadiusz Kowalczyk