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Quality Manual: Long and informative vs. Basic and Minimal?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rick Schellenberg, Dec 23, 2019.

  1. Rick Schellenberg

    Rick Schellenberg Member

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    I am reviewing a new internal draft of our Quality manual which is 37 pages. It is very comprehensive and goes into depth on every section of the ISO 9001:2015 standard. In some ways, it is almost like a Quality Manual AND a training manual.

    Is this a mistake to make the manual so comprehensive? Does it open too many cans of worms? Does it expose us to issues with auditors in the future? Or should we strive to keep the manual as short and to the point as possible?

    Any comments or suggestions would be appreciated. Thanks
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Good day Rick,

    As ISO 9001:2015 no longer requires a quality manual, if you keep one it should be for a good reason. Do customers and/or regulators require it? Is it needed to help employees navigate the QMS documentation?

    If it repeats information defined in procedures/work instructions, then yes it could open a can of worms because duplicating information invites risk of one or the other not keeping up with change.

    If that is the case in your organization, I suggest simplifying if you keep it at all. I have seen quality manuals that are little more than QMS Scope and Policy statements (both of which need to be documented) and a table of contents listing key procedures by subject.

    So in the end, as always the answer is "That depends" ... what is useful/needed by your organization?
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In some cases, yes. To parrot the standard it is a mistake. I use a "Quick Start Guide" as a model for the Quality Manual. Just like you get when you buy an item of electrical equipment, for example. If you pm me your details, I'll email you the template.
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    I prefer as short and sweet as possible. The bulk of our manual is made up of a cross reference between the standard and where we address the standard in our system. Went from a worthless recitation of the clauses to something actually useful. Good luck.
     
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  5. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Rick Schellenberg ;
    As others have stated, it will likely become a burden/liability to create an maintain the document you describe.

    THIRTY SEVEN PAGES? ! , would be my typical response to such a description.

    Be selfish. The ultimate goal of 9001 is to ensure that the organization is operating in a framework that addresses the defined needs of an organization and its customer(s). Create only documentation that is beneficial to the organization. Ensure that the management system is constructed in manner that will allow it to sustain and thrive even if/when key members of the team leave. Don't EVER create or do anything for the auditor. For each document being considered, as the questions...
    1- How will this benefit the organization"?
    2- Is what we are doing being done in a manner that meets the requirements of the standard?

    Hope this helps.
    Be well
     
  6. tony s

    tony s Well-Known Member

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    Since ISO 9001:2015 does not require a quality manual, I make use of the 2008 requirements should I need to prepare one.

    4.2.2 Quality Manual
    The organization shall establish and maintain a quality manual that includes
    a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
    b) the documented procedures established for the quality management system, or reference to them, and
    c) a description of the interaction between the processes of the quality management system.
    If you follow the above statement, it is very clear that you don't need to explain how your organization satisfies each clause of the standard. Even the Introduction of ISO 9001:2015 stated this:

    It is not the intent of this International Standard to imply the need for:
    — uniformity in the structure of different quality management systems;
    alignment of documentation to the clause structure of this International Standard
    The quality manual provides a general description of your organization's QMS and the various processes employed within the scope. It would add value by helping the process owners to understand their roles within the entire QMS. So, create a manual that is more user-friendly than auditor-friendly.
     
  7. leyladonmez

    leyladonmez Member

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    Hello
    İ am working in a group company. And group sends us signed policy. Does it need to be signed again by our general manager
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No.
     
  9. hogheavenfarm

    hogheavenfarm Well-Known Member

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    As tony pointed out, the 2015 does not require any, but in my experience, customers frequently do. I just finished a "desk audit" from a Tier 1 customer that not only requires the latest version of our QM, but then included about ten pages of direct "yes/no, state where that requirement is in your manual" questions regarding our quality system. Of note, several questions asked for the "required process documents" for the main categories in 9001:2008. The very first question was "Does your company have a quality manual?" before it proceeded to ask for all the "required documentation". I answered yes, (because we do), then wrote right across the question "ISO 9001:2015 does not require a quality manual!". Customers seem to always be the last to keep up with current changes in ISO. I still get these audits asking questions directly from the 2000 version.
    As a result, we have stayed with our current (2008) manual, but have added some changes reflecting our adoption of the 2015 version, (ie "thou shalt not audit thine own work", and our interpretation of "emotionally protective workplace", etc.
    Customers seem to be happy with an "expanded" QM, seems to be what they expect, so depending on your needs, you can have "none", "minimal", or "throw the book at them" sizes.
     
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  10. leyladonmez

    leyladonmez Member

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    Thank you
     
  11. Guy Léger

    Guy Léger Member

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    According to ISO 10013:2001, a quality manual depend on the size of an organization. In 4.4.1 of ISO 10013, the quality manual content should be " Title and scope, Table of content, Review, Approval and Revision, Quality Policy and Objectives, Organization, Responsability and Authority, References, Quality Management System Description (ISO 9001 of courses), Appendices,...
    According to ISO 19011:2018, auditors must determine whether the documented information provides correct information which content conforms to other reluable standards...and ISO 10013: 2001 defines Guidelines for Quality Management System Documentation...
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Which tells us a lot about the interest in documentation... It's old fashioned and, largely, a bureaucracy-creating guide
     
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  13. pkfraser

    pkfraser Member

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    2001: almost 20 years ago - ah, those were the days! We need to save the trees. After all, people like to look at trees - not so sure about quality manuals...
     
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  14. Guy Léger

    Guy Léger Member

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    Honestly, I am also waiting for a new revision...

    Sincerely,
     

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