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Would it be best practice to integrate the ISO17025 requirements in the ISO13485 QMS or make a separate ISO17025 QMS for the labs?
In my experience it all depends on the management structure of the laboratory. If you have different people responsible for the different standards implementation and maintenance, then keep them separate, at least to start with and then integrate to a practical extent later. Otherwise if you try and do this upfront, it could slow down the adoption of ISO 17025.
It is however, unnecessary to reinvent the wheel, so use the current process and strategies already implemented in 13485 for common ISO 17025 activities, wherever possible. Examples a document control and dealing with complaints and nonconforming work.
I suggest you do a gap assessment of what is in place for ISO 13485. List the current processes and documentation in place for ISO 13485 which are applicable to ISO 17025, and then list the additional required by or needing customisation for ISO 17025. The project plan is a handy tool to use. This way you can track your progress.
For more information, the following may be of interest:
The whitepapers
- Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
- Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025
Free implementation resources at https://advisera.com/17025academy/free-downloads/ including
- Project Plan for ISO/IEC 17025 implementation
- Project Checklist for ISO 17025 implementation
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Dec 15, 2021