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Guidance on creating a manual

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rebecca Ervin, Nov 2, 2015.

  1. Rebecca Ervin

    Rebecca Ervin New Member

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    Hello,
    New to the forum not quite sure how to post a new question maybe you can help. This has been approved by out external auditor. We are a small company but we are broken into two parts. I have been told that both companies can be combined into one manual. Still a little confused on what this would like I would like to get this right the first time. I am having no luck at all finding and example. Any suggestions:)
     
  2. tony s

    tony s Well-Known Member

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    Hi Rebecca. May I know the nature of your organization?
     
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  3. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    Hello Rebecca, and welcome here,

    Events seem to indicate that you managed to post your first question, so that is one obstacle overcome... ;) Ok, over to your question:

    Agreed, there is no reason not to combine both parts of the company in the same description. I just wonder if maybe you were audited acc. to ISO 9001:2008, as ISO 9001:2015 does not require a manual per se as previous versions of the standard did? At any rate, nothing in the new version of the standard prevents you from having a document called a manual, so no worries there. As for examples of the setup you mention, I am afraid I have none at hand, but if you regard the two parts as one and describe it that way, everything should work out. That would show how the two parts of the company fit together (scope, processes and so on).
     
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  4. RoxaneB

    RoxaneB Moderator Staff Member

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    Further to Claes's statement, one document that outlines what both parts do is great, but if there are aspects of a system that they do differently, I would suggest you clearly outline those, as well.

    "Company XXX and Company YYY (herein referred to as the Organization) have developed and implemented a quality management system that....

    Corrective Action

    The Organization has a corrective action process that focuses on...

    Company XXX tracks all applicable corrective actions in system123...

    Company YYY tracks all applicable corrective actions in system456..."
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If I may add - and hopefully a clarification - a "Quality Manual" for a small company doesn't need any details about much more than information like scope and so on (ISO 9001:2008 tells us) for each organization. As Claes says, ISO 9001:2015 doesn't even require a manual and...a manual based on the clauses of the standard isn't helpful (in many cases). It's pretty common for two organizations to share a QMS with the differences in process/responsibilities/methods either taken care of with notes in the documentation (using different fonts, text colors etc) or even work instructions.
     
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  6. tony s

    tony s Well-Known Member

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    If I will combine two affiliated companies in one Quality Manual, the manual will have:
    • separate descriptions of the QMS scope - (ISO 9001:2008 clause 4.2.2a);
    • separate sets of exclusion statements - (ISO 9001:2008 clause 4.2.2a);
    • separate or combined high-level process maps - I'm assuming that management processes (e.g. management review, internal audit, business planning, etc.) and support processes (e.g. documents and records control , human resources management, infrastructure management, etc.) are shared - (ISO 9001:2008 clause 4.2.2c);
    • brief narrative descriptions of the separate or combined process maps with referencing on their individual and common documented procedures - (ISO 9001:2008 clause 4.2.2b)
     

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