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ISO9001 QMS: Quality Manual Examples & Templates

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Steven Hudson, Sep 20, 2021.

  1. Steven Hudson

    Steven Hudson New Member

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    I am looking for some help and was hoping some of the members here can provide some assistance...it will be hugely appreciated. I need to create a Quality Manual for a procurement / services business where we outsource the manufacturing for our customers. Both with project and serial based production with customer IP, and serial production for our own IP.

    - Does anyone have editable example documents of a Quality Manual / QMS they could share with me please or able to advise where I can source some?
    - I am also interested in specific sections or Level 2 Procedures & Level 3 Templates and Work Instructions for:
    1. Non Conformities Process, Root Cause Analysis and CAPA's
    2. Reclamation / Claims handling
    3. Supplier Audit Process, Template and Actions / Reporting
    - Can anyone recommend any partners that I could work with in delivering ISO9001 certification i.e. training and support?
     
    Steven Hudson, Sep 20, 2021
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome, Steven:

    I am sure there are many templates etc for the documentation, including many I have myself. However, before we go that route, you are asking for things which are a) not required by ISO 9001:2015 and b) are "old fashioned" and may be accomplished in other ways.

    As far as "partners" go, where are you located? That helps...
     
    Andy Nichols, Sep 20, 2021
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  3. Steven Hudson

    Steven Hudson New Member

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    Thanks Andy!
    Its something I have been asked to create as the company does not have any QMS. So its the start point just to get to grips with current process manuals / procedures they have today and to assess gaps in some of the processes I mentioned. ISO9001 will come later as I need something in place before the end of the year...
    I am in Finland but open to any remote support as and when required for 9001 training and implementation.
     
    Steven Hudson, Sep 20, 2021
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Finland? Wow. I was hoping for something closer to home!

    I'd suggest that the starting point is deciding if having documentation is of value to the organization (see the Context, Knowledge and Process Control requirements of ISO 9001). Without your management team all on the same page, you won't get any buy-in to the difficult tasks which come later.

    Simply taking what others have done and YOU doing it all is the kiss of death when it comes to creating a documented QMS. Sure, you'll get some hapless auditor to give you a recommendation for a Certificate, but that's a low bar. WHat you are looking for is ownership. Trust me, it'll become an albatross around your neck.
     
    Andy Nichols, Sep 20, 2021
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  5. pkfraser

    pkfraser Active Member

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    Steven

    What do you/they have now? It sounds as though there is some documentation in place, but is it up-to-date/used/useful? I would start from the point of view of what you would give a new start - do you have something that will tell them how things are done now? 9001 and CBs can come later, once you have your system description in place and communicated to everyone.
     
    pkfraser, Sep 20, 2021
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  6. Steven Hudson

    Steven Hudson New Member

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    There are some process manuals / Procedures and templates for each segment...I have to compile a 'checklist' of what they have, and then also read through to see quality of the content and any gaps in the procedures ref in my post. I need a basic system that functions this year with what they already have including refinements...
     
    Steven Hudson, Sep 20, 2021
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Surely, they have that in place already? The organization is satisfying (customer) requirements? Why don't the process owners do the reading? Why do you have to tell them? I'm guessing that you are assessing this against ISO 9001 requirements, which will be fairly easy. The checklist is a list of what they have vs what ISO says? You might come up a bit short, since the requirements for documentation don't exist like they did. A QMS can function based on what management say what happens - as long as that can be demonstrated (and there's usually a record)
     
    Andy Nichols, Sep 20, 2021
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  8. Steven Hudson

    Steven Hudson New Member

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    Thanks and good advice Andy...I will not be owning peoples processes. But I will be reviewing them to firstly to understand current state, then give feedback on any refinements, understand gaps and to help me also create / improve standards that I will own such as auditing and NC's for example.
     
    Steven Hudson, Sep 20, 2021
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Excellent!

    A technique I have found works well - a "template" is to have the leadership make assignments as Process Owners (this is a naturally occurring thing, just never made "formal" in many cases). Give the Process Owners the following homework:

    Know the Requirements! Customer, regulatory and ISO 9001
    Know the Process! This will include inputs/outputs controls and resources needed (and any documentation the organization has for the process)
    Know the Performance! To include the goals/objectives, metrics and results currently seen compared to the goals
    Know the Improvements! This includes what needs correcting and if it's working well, what to improve.

    This is all directly linked to running their bit of the business, too.
     
    Andy Nichols, Sep 20, 2021
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  10. pkfraser

    pkfraser Active Member

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    Steven
    I can recommend SQMC ( see https://www.sqmc.co.uk/) who run online training courses and also offer consultancy assistance. As it happens they contacted me today to tell me that they are now running courses in Aberdeen, but I guess that online would suit you better... You could give them a shout and see if they can help.
     
    pkfraser, Sep 20, 2021
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  11. pkfraser

    pkfraser Active Member

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    Steven

    Did you make any progress with this?
     
    pkfraser, Nov 1, 2021
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