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
Advantages of ISO 17025
ISO 17025 is a widely recognized standard for testing and calibration laboratories, providing a number of advantages for organizations that successfully implement it. The following are some of the key benefits of ISO 17025:
- Greater credibility: Obtaining ISO 17025 accreditation demonstrates a laboratory's competency, impartiality, and trustworthiness, which can help to increase a laboratory’s reputation and credibility.
- Improved consistency and quality of work: Adopting the procedures laid out in ISO 17025 helps to ensure greater consistency and quality of work, leading to more accurate and reliable results.
- Increased customer satisfaction: By producing results that meet the required standards, customers are more likely to be satisfied, leading to greater customer loyalty.
- Reduced risk: Implementing ISO 17025 can help to reduce the risk of errors and non-conformities, leading to fewer complaints, less wastage, and greater efficiency.
- Increased staff motivation and morale: Following a standardized system will help to reduce stress and lead to greater job satisfaction for laboratory staff, increasing motivation and morale.
Limitations of ISO 17025
ISO 17025 is a comprehensive standard for testing and calibration laboratories, but there are certain limitations that should be noted. These include:
- The scope of the standard is limited to the aspects of technical competence, management system, and accreditation. It does not address elements such as laboratory design, personnel qualifications, or data management and reporting.
- ISO 17025 does not provide any guidance on how to define the scope of accreditation for a laboratory. It is up to the laboratory and the accreditation body to decide on the scope of accreditation.
- It does not provide any guidance on how to deal with conflicts of interest, including financial conflicts.
- ISO 17025 does not cover the validation of test methods, which is required in some cases.
- It does not provide any guidance on how to ensure the integrity of the data collected by a laboratory.
- ISO 17025 does not address issues of personnel qualifications, training and competency.
In conclusion, while ISO 17025 is a comprehensive standard, it is important to note that it has certain limitations that should be taken into account when a laboratory is being accredited.
ISO 17025 is an International Standard that specifies the general requirements for the competence to carry out tests and/or calibrations. There are several other approaches related to this standard that organizations can consider, such as:
- Risk-based thinking: This approach requires organizations to consider the risks associated with their activities and take proactive steps to manage them.
- Continuous improvement: This approach encourages organizations to identify areas for improvement and take steps to address them.
- Quality management system: ISO 17025 requires organizations to have a quality management system in place to ensure consistent results.
- Accreditation: Organizations must undergo accreditation to demonstrate their competence and be recognized as compliant with ISO 17025.
In conclusion, ISO 17025 is an International Standard that specifies the general requirements for the competence to carry out tests and/or calibrations. Organizations should consider several related approaches, such as risk-based thinking, continuous improvement, quality management system and accreditation, in order to demonstrate their competence and be compliant with ISO 17025.
|ISO 17025 — recommended articles|
|Accreditation — Certification and accreditation — Certificate of quality — Certificate of conformance — Certificate of approval — Krzysztof Wozniak — Standard — General specification — Internal audit|
- 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