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The scope of the QMS

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Leonid, Dec 19, 2019.

  1. Leonid

    Leonid Well-Known Member

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    Why shall the organization consider the external and internal factors and the requirements of relevant interest parties when determining the scope of the QMS?
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Leonid ;
    Good question.

    Before I explain, let me first emphasize that in my experiences , COTO- Context Of The Organization (and specifically clauses 4.1 and 4.2) are often misunderstood and misapplied.

    Keep in mind where clause 4 falls in the PDCA cycle (plan) and what level of leadership would be wise to be involved at establishing.

    To help companies understand and address this, I ask them to think of COTO as determining...

    WHO are we?
    WHAT do we do?
    WHO cares?
    WHAT do they care about?

    Once we have addressed this within the framework of 4.1 (Internal and External issues....i.e. WHAT) and 4.2 (interested parties...i.e. WHO), then I think it becomes clear as to why 4.1 and 4.2 need considered when developing the scope (4.3). In other words, without understanding ...

    WHO are we?
    WHAT do we do?
    WHO cares?
    WHAT do they care about?

    ...how can we establish the boundaries and applicability of all that which is to follow?

    Hope this helps.

    Be well.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Are you asking because you don't know? Or to discuss why it's in there?
     
  4. Leonid

    Leonid Well-Known Member

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    The meaning of this requirement is really unclear to me. Let's take an organization being a producer of pumps which decided to establish a QMS to ISO 9001. It determined the sources of threats and opportunities (4.1) and relevant requirements of interested parties (4.2). Now it needs to determine the scope for its QMS (4.3). But it is already known. The scope is "production of pumps". It will be stated on the certificate. The scope is applicable within a boundary which encompasses all elements of the organizational structure which are involved directly and indirectly in activities at various stages of the pumps life cycle.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Ah, but if we understand the market place, if we understand customers' needs and expectations, maybe we can also provide repair services (which are often like the original manufacturing). Perhaps, the customer would like installation services. Maybe, there's an opportunity to provide service replacement parts. Should the QMS apply to these?
     
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  6. Leonid

    Leonid Well-Known Member

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    These are indeed a possibility. Also possible is that some threats to the particular scope will be recognized.

    But strictly speaking 4.2 requires defining those issues which affect the ability to achieve intended results (objectives) of the QMS. And these results concern pump production. New options like services do not fall into the intended results.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe you don't think so... I'd suggest you're looking at this in a binary manner. If an organization is truly customer focused, they will understand there are risks and opportunities in doing MORE than just pump production. ISO 9001 is steering the organization to look at more than what's happening NOW as your post tends to suggest. If indeed, it is so, they might decide to plan (section 6) to develop a service parts process. If you are thinking it's JUST about section 4. you may wish to revisit your understanding of the standard.
     
    Last edited: Dec 20, 2019
  8. tony s

    tony s Well-Known Member

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    Sometime in 2007, with the intent of improving public services, the national government of my country gave a directive for all government agencies to get certification against ISO 9001 standard. To motivate agencies, certification was incentivized i.e. those who get the certificate receive monetary bonus. Due to this, many were certified against the 2000 and the 2008 versions. However, most were certified on limited QMS scopes. For examples: a light rail agency with certification on train drivers administration; a public high school with certification on its enrollment process; a city office certified only on its business permit services; an electric company certified for its human resource management; etc. As long as any agency has something they want easy certification, the CBs were just very happy to oblige.

    It's a good thing that the 2015 version has a statement to consider first the organization's context in determining the QMS scope. Now if a government agency (national or local) in my country would seek ISO 9001 certification, it should ensure that the QMS scope is aligned to its mandate. This, I believe, will have a greater impact to my country's stakeholders.
     
  9. Leonid

    Leonid Well-Known Member

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    Any organization which wants to create or update its QMS to ISO 9001:2015 has definitely a well-established scope of supply. Therefore, it does not need to DEVELOP the scope of the QMS. What it might need is to REDUCE the scope due to threats to performance or to EXTEND the scope in order to realize opportunities. In other words, the organization shall REVIEW its scope of supply based on consideration of 4.1, 4.2.
     
  10. Mayor

    Mayor Member

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    Hello, I'm new to this forum and I have some enquiries to make as regard ISO 9001, but I don't know to post my comment. Can anyone put me through? Thank you.
     
  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome Mayor! Please see the instructions I posted in Simple instructions for QFO posting.
     
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I can't agree! Experience shows that there are plenty of rubbish scopes out there - I encounter then almost weekly - and it's worth revisiting it. Secondly, anyone new to certification has likely ZERO clue about what a "scope" is an needs to think about these things BEFORE establishing their system. Don't overlook that some organizations don't give a hoot about certification, too!
     
  13. Dobis

    Dobis Member

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    Should the organisation include repair and installation services in the scope when it is an intention (resulting from its review of 4.1 ad 4.2) and not actual operation being carried out at the moment?
     
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Dobis, the QMS scope typically includes operations that are actually being carried out. The planning, product/process design, verification and validation of these operations are undertaken while the intended processes are being developed. Once this is completed, these operations can be included in the QMS scope.
     
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  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If your management have identified these two services as risks/opportunities, then people should be assigned to develop the required process, as part of the Quality Management System (in accordance with section 6)
     
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