We are a small company and we have a subcontracted production as well as a subcontracted R&D. Can we exclude from our QMS 6.3 infrastructure and 6.4 work environment and contamination control ?
Is it required by the standard to have a coding system for your documentation? Before we started our ISO 13485 certification, we would organize the documents by folders and name the documents according to their contents, then revisions and sometimes dates. For example, "1 Quality (Folder) > Quality Manual Rev 03.docx (Document name). Will this be satisfactory for our organization and control of documents?
To obtain the MDSAP certification, should we have both ISO 13485 AND 9001, or just ISO 13485?
Requirements for infrastructure
Regarding the ISO 13485:2016 PR 05 Procedure for Infrastructure and Work Environment: 95% of our business is repair of surgical drills and saws. The other 5% of our business is contract manufacturing for OEM surgical device makers. We do not manufacture complete medical devices in our facility. We do not have clean rooms, and we don't test our air quality for microbiological or particulates. What all is actually required in our procedure as far as the standard is concerned?
How to start ISO 13485 implementation project
How to start the project of ISO 13485 after getting the management approval?
Content of the medical device file
Setting up the medical device file under the new 13485 have added ISO certs and Manufacturers Instructions is there anything specific I should be adding to it.
Software validation for raw material supplier
Declaring compliance without certificate
Software validation in medical device
We are sitting for our ISO 13485:2016 shortly, and wish to know how we can validate our software for inventory management? Thanks in advance for the feedback.
My question is about the similarities of ensuring the ISO 13485 is applied on the AS NZS 3551.