Integrating ISO 13485 and ISO 27001 & GDPR
Hello, I would like an advice from an expert regarding integration of ISO 13485 and ISO 27001 + GDPR. We have purchased two documentation toolkits from Advisera:
- ISO 13485 & ISO 14971 Premium Documentation Toolkit
- EU GDPR & ISO 27001 Integrated Documentation Toolkit
We have already completed implementation of ‘ISO 13485 & ISO 14971’ toolkit, and we got the ‘EU GDPR & ISO 27001’ toolkit only recently. The question I would like to ask is how would you recommend connecting the two management systems (ISO 13485 and ISO 27001)? Would you recommend setting up an Integrated Management System? Or perhaps would you recommend keeping both systems separately and just referencing the ISMS in the QMS?
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ISO 27001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 27001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 27001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
You can use the following documents for both ISO 13485 and ISO 27001 because they are practically the same:
- Internal audit procedure
- Procedure for document and record control
- Corrective action procedure
All the other documents are different because they fulfill requirements specific to each standard, so these other documents cannot be integrated.
This way you can have an integrated system and reduce your administrative effort.
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Oct 23, 2019