4.2 Documentation Requirements
General
A quality system must include:
A written quality policy and quality objectives - not necessarily anywhere specifically A quality manual
Yes you still need a quality manual and the policies need to be all the more bespoke for your company and everyone needs to understand them. Objectives must be coherent and in place for most individuals / teams / processes and should be used as a method of managing the businessDocumented procedures as required by ISO 9001:2000
This is better you only need a very few procedures documented as you will find out as you progress through this standardA set of plans laid out in the previous section press your back button to remind yourself Various records Quality Manual
Your quality manual must include a scope including justification of exclusions (so if you don't design or have no measuring equipment for example). Either your procedures / processes or at least reference to them (normally a reference or hyperlink is the most effective to keep a quality manual down in length), plus your description of process flow.
Control of Documents
You need a procedure that defines controls for:
Approving documents Reviewing and updating documents Changes to documents are identified Ensuring relevant versions of documents are available at point of use and not old ones Ensuring documents remain legible and identifiable - in most case printed or electronic copies makes this obvious but you need to state it. Ensuring documents from outside the company are controlled Preventing unintended use of obsolete documents (all the above) This is one of your documented procedures - you must have this one Control of Quality Records
Quality records (these are your working forms or other records) are used and kept (safely) to prove the system is functioning properly.
This can be made part of the same procedure as above split into two sections, one for documents, one for records
You asked:
Chamaiporn
- I would like to see the sample of other quality manual as a guide line. I saw you web site quite interesting but I could not found the sample of QM. Do you have any recommendation to give me?As we say on our website - we do not sell template documents - you mentioned sample - well that sounds to me like a template document that is free. The reason is that no two systems should be alike - it should reflect your business and not anyone else's. Templates sidestep this and lose all their value and no-one takes any notice of them once they are introduced - an expensive and pointless exercise. There are plenty of sites that will sell you full templated systems, I think ours is one of the few that still do not.
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