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Multi-site ISO9001:2015 Certification

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Lokiboy, Sep 26, 2016.

  1. Lokiboy

    Lokiboy New Member

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    My organization is global with all sites being ISO9001:2008 certified. I've been tasked with implementing 1 quality assurance program globally. I was thinking of setting it up with a corporate manual to define the purpose of 1 global quality program and then defining the organization (Of course their will be site-level processes and procedures/work instructions that will be maintained at each location):
    4.0 Context of the Organization
    Defined globally of the organization
    5.0 Leadership
    Quality Policy
    Vision Statement
    Mission Statement
    Organizational Chart (Titles only)
    Strategic Direction
    6.0 Planning
    Change Management Procedure
    Site-Level Risk/Opportunity Matrix
    Corporate KPI's identified
    7.0 Support
    Corporate procedures for Document Control, Nonconformity, Audits, and Performance Reviews
    8.0 Operation
    Site-level processes identified
    Site-level work instructions
    9.0 Performance Evaluation
    Conducted at site-level
    Conducted at corporate level
    10.0 Improvement
    Conducted at site-level
    Conducted at corporate level
    Am I on the right track?
    Thanks for the help!
     
  2. tony s

    tony s Well-Known Member

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    Since there's no requirement for the structure of a quality manual. Having your corporate manual outlined against the 2015 clauses should not cause your organization problems concerning documenting a manual. Though there is no requirement in 2015 to include the scope of the QMS, you may consider including it in your corporate manual.
     
    RoxaneB and keivan farzan like this.
  3. MCW8888

    MCW8888 Well-Known Member

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    Does your Organization have a website where all the missions, vision and business plans are defined? I suggest you start off by conducting a gap analysis to ISO9001:2015. Then develop a project plan and timeline.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is it your intent to have one certificate covering all sites? How many sites have you and what does each site do? Similar products? Different? Are there "divisional" groupings around regions/products/markets served etc?

    In my experience, trying to write one quality manual for a large organization is a big task and, as Tony says, structuring it on ISO 9001:2015 is simply doing what we know doesn't work! I'd suggest taking a long hard look at other examples first. You may end up with a much smaller quality document which points to other manuals.
     
  5. askartsolutions

    askartsolutions Member

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    Since you already have global certification to ISO 9001:2008 for all your sites, I suggest the following:
    1. Do a gap analysis, as others have suggested to ISO 9001:2015
    2. Update your Quality Manual (QM) for the missing requirements. There is no need to change your clause numbering or terminology to the new standard unless you have a good reason to. It was confusing enough before and the new terminology is even more confusing now and it might cause some confusion within your organization. Just add the missing requirements as new clauses at the end of your QM and update existing clauses for changes to them.
    3. Create a simple matrix referencing the way your QM is structured to the new numbering scheme in ISO 9001:2015. There are plenty of such matrices available on the internet. Just do a Google search "compare ISO 9001:2008 to ISO 9001:2015 matrix".
    4. Implement the new requirements globally for all sites as identified by your Gap Analysis. Be careful of contextual and related risk issues as they will likely be specific to each site.
    5. When you're done implementing and have accumulated 3-4 months of performance data to your updated system, do your internal audits, make your corrective actions and your all set for your registration audit to the new standard.
    Cheers.
     

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