Re: Meeting ISO 9001:2015 7.1.6 Organizational Knowledge Requirements
Demonstration with confidence and assurance is the way to go. As a document, I would double up a good process validation document and record for this purpose, where the validation team members are named.
Thanks for the comments. I think that I am going to keep this is as simple as possible and the competence angle captures the knowledge the guys who build things need to have to produce acceptable quality product. We keep a design library for technical design elements, and as new technology becomes available, we identify the knowledge we need to integrate into our designs and this gets added to the design library.
Is it wise to document how we go about it? i.e. how do we identify, obtain, store, maintain, review and communicate the knowledge required by the company, or just demonstrate that we do it.
Is it wise to document how we go about it? i.e. how do we identify, obtain, store, maintain, review and communicate the knowledge required by the company, or just demonstrate that we do it.