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Other sites not in Scope of ISO9001

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Lkong, Feb 15, 2019.

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  1. Lkong

    Lkong New Member

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    Dear all,
    My company is a semiconductor company has a few locations in US and Asia (Site A, B, C). Only one site (say site A) in US is ISO9001_2015 certified. This site (site A) has all ISO9001 processes: Development, Sales/Marketing, production, testing/inspection, shipping/receiving, QA, outsourcing, planning, etc.
    Some staff located in site B and C also support work on the product & process of Site A. However site B & C are not ISO9001 Certified and not in the scope of the certification. Although they follow the same quality system and subjected to yearly internal audit.
    How should we refer to these two sites? As external service provider? and how should we control it according to ISO9001_2015? Thank you for your attention!
     
  2. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    I suppose as you already do internal audits on site B and C, that should suffice as how you manage the support provided to Site A.
     
  3. Lkong

    Lkong New Member

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    Thanks for respond! Yes, we did every year! But the scope of the certification is site A only. When we mention site B & C, how should we refer to it? Internal Supplier? Or external service provider? ....
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How did you address this in the section 4.0 Context of the Organization requirements? It clearly states in 4.3 that the scope has to be determined, a) to c) and also the boundaries etc. We cannot tell you how to address it. That's WHY this section (4.3) is there - for YOUR organization to do this. I'm guessing you need to go and take another look at this.
     
  5. Lkong

    Lkong New Member

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    We clearly define that the scope of the QMS covers Site A. With no mention of Site B & C. Although respective functional groups has staff in other sites. And they follow the same QMS.
    I am not clear how we should refer to these sites and activities. And in which QMS documents we should mention.
     
  6. tony s

    tony s Well-Known Member

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    Do sites B and C cater other organizations? Do they have customers other than their parent site A? Do they offer products/services to other customers and can have a stand-alone certification outside of site A? If you answer Yes to all these questions, then sites B and C are considered "external providers" to site A. Control them as per clause 8.4.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This makes no sense. For clarification, I don't mean the scope of certification, I mean the scope of the QMS. If sites B & C follow the same QMS, then they ARE within the scope.

    How have you defined processes? If site B & C are involved in carrying out processes within the QMS, how can they NOT be in the QMS?
     
  8. storyqh

    storyqh New Member

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    I'm working for seoul semiconductor in Vietnam,
    If SITE B,C need to get ISO 9001 certificate, you should clearly in Quality manual and Certificate location.
    Process and procedures relate three SITE shall declare SITE B,C how are relate/ What are relate/...
    Internal audit/ Risk/ BCP / Management review/... normal conduct but include SITE B,C.
     
  9. Siddarth

    Siddarth New Member

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    Dear All

    Even i have the same issue like lkong said ,

    the site B & C does job's for site A only in that case does B & C should have ISO Certified ,

    If ISO is not required for B & C what are considered as ....?

    And if we should include in Manual where & as what we should include ,

    Some of the customers ask's for ISO certification for all sites what should we do & how to explain them ........?
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think you are confusing things here. You need to be clear that you IMPLEMENT a QMS for the good of the customer - to provide product which meets their needs - and make the organization some money. Each site has the same objective.

    Which site gets a certificate is YOUR choice and doesn't have to include all of them. But you'd have to ask yourself, why and what the perception of the customers is going to be...
     

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