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 business. It needs to include a scope
  • Documented procedures as required by ISO 9001:2015
    In the 2008 stanhdard you needed a minimum of 6 procedures covering doument and record control, problem handling and auditing. Now no procedures are required, but in their absence you will have a hard time convincing auditors you are in control of the process.
  • A set of plans laid normally laid out as a series of agenda items in the management review process, risk assessment and a strategic directions document.
  • 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.

 

  • 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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