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17025 vs 13485

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Guest user Created:   Dec 14, 2021 Last commented:   Dec 15, 2021

17025 vs 13485

First of all, thanks for having this platform, very helpful! My question is around how 17025 interacts with 13485. We have an ISO13485 QMS and we want to get accredited to ISO17025 for one of our labs, multiple in the future. Our core business is medical devices and 13485 is the heart of that, with a relative small part for calibration activities (internal use) where we want 17025 accreditation for. Would it be best practice to integrate the ISO17025 requirements in the ISO13485 QMS or make a separate ISO17025 QMS for the labs? Many thanks in advance.
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Dec 15, 2021

You asked

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

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 14, 2021

Dec 15, 2021

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