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ISO 9001 Implementation

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Nasha, Feb 7, 2021.

  1. Nasha

    Nasha Member

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    Hi,

    For the ISO 9001:2015 implementation is it doable to implement (run awareness and start documenting) in parts or should implementation start at the end of document completion?

    There is a couple of different views within the organization I work with so I would appreciate the help.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Nasha, that's a very difficult question to answer, other than in very general terms. In many cases, an organization is doing many of the requirements of ISO 9001, (for example, the quoting/sales ordering process) so the implementation may precede any documentation which is created. On the other hand, some requirements, such as internal audits, (which are not usually in place before adopting ISO 9001) then the documentation will need to come before implementation.
     
    John C. Abnet likes this.
  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Nasha ;
    There is no one, or "right" way to approach this, however, I would advise the following...

    1- DEFINE; what it is your organization is trying to achieve by implementing ISO 9001. Define the INTENT.
    NOTE: Remember the Scope of ISO 9001 = (paraphrased)...
    a) consistently provide products and services that meet customer requirements
    b) improve customer satisfaction


    2- IDENTIFY; current gaps. Perform a gap analysis of your current actual conditions vs your organization's intent and the requirements of ISO 9001.

    3- DON't; create documentation for the sake of standard or what you think an auditor may "want".

    4- CONSIDER; what your organization ALREADY does. If your organization is an existing and functioning organization, then it is likely that your organization is
    already "meeting" many/ (most?) of the requirements of ISO 9001.

    After you have completed all I identify above, then simply "fix" the gaps that your organization has identified.

    Hope this helps.

    Be well.
     
    Andy Nichols likes this.
  4. Golfman25

    Golfman25 Well-Known Member

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    You can implement as you go. If you're an ongoing business, you're 80% of the way there anyway. Just make your tweaks and move forward. Start with a process, document and implement. Then move on to the next process. Good luck.
     
  5. tony s

    tony s Well-Known Member

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    I'm assuming here that you are referring to the documented procedures, not the records. The standard allows the organization to decide for themselves if they need to document a procedure for a particular process or not. In clause 4.4.2, the standard mentions "to the extent necessary". So, in establishing the necessity for documenting procedures resides with the organization - not the standard nor the auditors. In addition, the ISO 9000 vocabulary clarified that "Procedures can be documented or not". So, there's should be no issue with the standard if you document first then implement, or vice versa, or omit documenting a procedure at all.
     
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  6. Eric Twiname

    Eric Twiname Well-Known Member

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    Hello Nasha,
    I'm about to say the same thing that John and Tony and Golfman said...just in different words.

    If you are an ongoing business with a reasonable management you already have (80% per Golfman, I would say 95%) already "implemented".
    Do not implement ISO9001...implement the processes that make your business work, document them for the business future success...which will then comply with ISO9001.
    ISO is a check/standard/revisit to make sure you have all the bases covered.

    Any compliance to ISO9001 should be in the light of "didn't we already do this?"...and implementing those things you haven't done...which may be only documentation of stuff you already do.
    If you haven't done stuff (BCP, documenting lessons learned, considering risks, etc.)...ISO is a great tool to remind you that these are important too.

    ISO9001 is not in charge...it is a measure of whether or not someone is in charge well.
    HTH
     
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  7. Nasha

    Nasha Member

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    Thank you Eric
     

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