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Certifying a family of products under ISO13485 when company is ISO 9001 compliant

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Guest user Created:   Feb 18, 2019 Last commented:   Feb 18, 2019

Certifying a family of products under ISO13485 when company is ISO 9001 compliant

Hello, Currently we are certified under ISO9001:2015, however in the next months we pretend to certify a family of products under ISO13485.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Feb 18, 2019
What do you recommend me in terms of elaborate an implementation plan?

Answer:

The first step of the implementation plan is to adapt your current company’s QMS to the type of medical devices that your organization will be dealing with such as the inclusion of medical device files, design and development file, software validation and sterilization process just to name a few.

Here are the steps to successful implementation of ISO 13485:
1) Get management support.
2) Identify requirements.
3) Define the scope.
4) Define processes and procedures.
5) Implement processes and procedures.
6) Deploy training and awareness programs.
7) Choose a certification body.
8) Operate the QMS / Measure the system.
9) Conduct internal audits.
10) Conduct a management review.
11) Take corrective action.
12) Perform the stage 1 certification audit.
13) Stage 2 certification audit.

For more information, please refer to:

-ISO 9001 vs. ISO 13485
https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

- List of mandatory documents required by ISO 13485:2016
https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

-Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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Feb 18, 2019

Feb 18, 2019