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?