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Updating Quality Manual to match ISO 9001:2015
I was wondering if our quality manual should follow the same structure (use the same clause titles) as the ISO standards. The link you sent me says the structure is up to us so I guess it doesn't have to follow the same format. -
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?