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An organization must follow its own procedures

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Phil Scott, Nov 6, 2018.

  1. Phil Scott

    Phil Scott Member

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    I'm sure there is a requirement that an organization must meet the requirements of ISO 9001:2015 and, as part of that, must also meet the requirements of its own QMS procedures. I just can't seem to find it in the standard. Please, take pity and rub my nose in the clause/subclause. THANKS!
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Phil Scott ;
    Yes, you are correct. The "requirement" is laced throughout the standard. (e.g. 4.3 "The organization" 'shall determine the boundaries....scope;, 4.4 "The organization shall establish...management system, ...processes needed.."; 5.1.1 "ensuring ...the resources"; ensuring ...meets intended results...etc..etc..etc…

    However, I assume what you are referring to is

    9.2 Internal audit


    9.2.1 The organization shall conduct internal audits at planned intervals to provide information on


    whether the quality management system:


    a) conforms to:


    1) the organization’s own requirements for its quality management system;


    Hope this helps.

    Be well.
     
  3. tony s

    tony s Well-Known Member

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    There is no categorical statement, but, in my own views, here are some related requirements:
    • 4.4.1c - "determine and apply the criteria and methods..." - if the procedure contains the criteria and method;
    • 8.1d - "implementing control of the processes in accordance with the criteria" - if the procedure contains the criteria;
    • 8.5.1a.1 - "the availability of documented information that defines... the activities to be performed" - perform the activities as defined in the procedure;
    • 8.6 - "release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed" - if the procedure contains the planned arrangements, it must be satisfactorily completed;
    • 9.2.1a.1 - "conforms to... the organization’s own requirements for its quality management system" - if the procedure contains the requirements, then the auditee need to demonstrate conformance during internal audit.
     
  4. Phil Scott

    Phil Scott Member

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    Thanks John!
    Phil
     
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  5. Phil Scott

    Phil Scott Member

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    Thanks for the guidance Tony. I think the 9.2.1a1 citation has the language I remember.
    Phil
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's not in the standard! There's simply no mention of procedures, so it can't make it a requirement to follow them...(I don't agree with my friends above!);)

    However, it DOES state, in 4.4.1 "the organization shall establish, IMPLEMENT, maintain and continually improve a quality management system, including the processes needed..."

    It's up to the organization to decide whether procedures are necessary to accomplish this.
     
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  7. John C. Abnet

    John C. Abnet Well-Known Member

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    As @Andy Nichols nichols accurately pointed out @Phil Scott , there is indeed no longer a requirement for actual "procedures". I was somewhat presumptuous in my initial response to you. Yes, the organization must ensure...

    a) conforms to:

    1) the organization’s own requirements for its quality management system;


    , however, it is true that there is no requirement for these "organization’s own requirements" to be in a "procedure".

    Be well.
     
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  8. Phil Scott

    Phil Scott Member

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    Right. I understand there are limited procedural requirements, but if an organization has seen fit to issue a procedure to control some aspect of its QMS it must follow said procedure.
    Peace.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can I ask why it is you're questioning this salient point? Why are you looking for something in the standard to tell people to "follow procedure"?
     

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