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Evaluating risks
I want to evaluate my risk register.Please help me. -
Transition from 2008 to 2015 of ISO 9001
I would want to seek advice how to do documentation on the transition to ISO 9001:2015. We are a certified ISO 9001:2008 firm. -
Process owners
Do we have to have owners for our processes? We are a very small company and there are only maybe 3 people that we would be able to use for that. Can the Quality Manager be the owner of all the processes? -
IO 9001:2015 and production process
Hi.. -
Lean and ISO 9001
In reality, given the nature of modern business needs to be multi-skilled and innovative, is there really a difference between Quality and Lean? Or just two group of consultants trying to make money (albeit legitimately)? -
Preparing for certification audit
I have a new company ( less then 1 year) and going to get a certification 9001:2015. What I should to prepare for auditors visit? It would be preview before external auditor (representative from certification body). For documentation and work in company we use electronic systems: HR, CRM, PM. What I should represent in paper or electronic forms: as per standard requirements there`re a lot of clauses but clarification isn`t so clear. -
Meaning of "ISO"
What is the meaning of "iso"? -
Inspection and traceability of implantable devices
What are the specific requirements for inspection and traceability for implantable devices? -
Implementation of ISO 13485
How do i start implementation for ISO 13485?