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Help with 2008 to 2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Phil Sparano, Feb 27, 2018.

  1. Phil Sparano

    Phil Sparano New Member

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    I am new to the forum and also the quality department and I have a stupid question. We just had our re-cert audit and it went pretty well, my question is the auditor recommended that we update our quality manual to reflect the 9001:2015 numbering system and title wording such as 4.1 Quality Management System in 9001:2008 is now 4.4 Quality Management System and its processes in 9001:2015. I also read somewhere this was not actually a requirement but we would like to go ahead and do it anyway. So I found several Correlation Matrix's online. My question is that in the matrix for 9001:2015 they list several title and numbers that correlate to the old which is just 1. (9001:2008 4.2.2 Quality manual 9001:2015 4.3 Documenting the scope of the quality management system 7.5.1 general or 4.4 Quality management system and its processes) Do you pick the best match or use all 3? Also do they need to be in numerical order in the entire manual? I know these are stupid questions but i'm just trying to get everything in order with the least hassle possible. Thanks in advance for your help!
     
  2. Qualmx

    Qualmx Well-Known Member

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    Starting
    It is not a requirement to have a manual, but...If is useful for you, you could renumber clauses, if is little change, is ok.
    Hope this helps
     
  3. Golfman25

    Golfman25 Well-Known Member

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    I would refrain from any numbering system which atempts to reflect the standard. Your number system should be process based instead. You may have more than one process or procedure which addresses each element. For example, for the leadership requirements you may use both business planning and management review to comply.
     
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  4. Phil Sparano

    Phil Sparano New Member

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    Thanks for the help guys! We did decide to use a Quality manual even though it was not a requirement, I did read that re-numbering to the new standard was not necessary
    but thought about doing it for ease in the future when discussing anything with other companys etc. Thanks again!
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    My own preference is to create a document that is numbered/structured in a way that is appropriate to my organization, not the standard. But to help those auditors who are unable to make the link between your Corrective Action section in your manual and the Corrective Action section of the Standard, you could include an appendix with a matrix that shows how your manual aligns with the Standard. This way, for future numbering changes, you just need to update that matrix.
     
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  6. tony s

    tony s Well-Known Member

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    Tell your auditor that ISO 9001:2015 standard has the following statements:
    • 0.1 General says "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 use of the specific terminology of this International Standard within the organization."
    • A.1 Structure and terminology says:
      "There is no requirement in this International Standard for its structure and terminology to be applied
      to the documented information of an organization’s quality management system.
      The structure of clauses is intended to provide a coherent presentation of requirements, rather than a
      model for documenting an organization’s policies, objectives and processes."
    If he/she still wants a quality manual that has the same number and title as the standard's clauses, tell him/her to Go Home.;)
     
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  7. Maggie123

    Maggie123 New Member

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    New to ISO also... I just came in to this company where I need to do the transition 2015. In the QM, can I just replace the old clause with the new ones (#) ?
     
  8. RoxaneB

    RoxaneB Moderator Staff Member

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    Welcome, Maggie.

    As we've mentioned, there is no requirement in ISO 9001:2015 to have a quality manual.

    With regard to the numbers, I'm tempted to say no...because some of the clauses might also be different. Why not write a manual in a way that reflects your organization's culture and language, and then throw in a matrix that shows how your manual aligns with the standard. This might make the document more meaningful to your organization...if you're going to keep it.
     
  9. Maggie123

    Maggie123 New Member

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    Sounds good, thanks Roxane !