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"The organisation shall consider"

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Vincent, Aug 7, 2015.

  1. Vincent

    Vincent New Member

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    Hi All,

    Interested to have you take on "the organisation shall consider" which appears all over the DIS.

    For example:
    "
    4.3 Determining the scope of the quality management system.

    The organisation shall determine the boundaries and applicability of the quality management system to establish its scope.

    When determining this scope, the organisation
    shall consider:

    (a) The external and internal issues referred to in 4.1;

    (b) The requirements of relevant interested parties referred to in 4.2;

    (c) The products and services of the organisation."


    So when the auditor sits down with sharpened pencil, and says " show me how you considered the external and internal issues referred to in 4.1", what shall we be showing him?

    Initial thoughts would be that "to consider" would mean that we have addressed the item in a risk assessment perhaps?, so then I would be thinking that wherever we see shall consider in the standard, we should have a formal record of a risk assessment addressing the items noted in that clause for 'consideration'.

    (Or maybe I'm overdoing it on analysing the concept?)

    Whats your take?
     
  2. Eric Twiname

    Eric Twiname Well-Known Member

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    I have not seen the full revised standard, so I'm making some assumptions regarding what 4.1 and 4.2 are...

    In light of those assumptions:
    #1. Seems to me that considering those three items is a "duh" moment...Of course you would consider them...it is like saying "To determine how to apply a QMS to your business you shall consider your business"
    The only way this would start being an issue is if you were trying to limit the scope of the QMS to exclude things you didn't want to put up with audits on.

    #2. If you aren't consciously trying to limit the scope, a single high level governing document...possibly the Quality Manual, possibly some other similar doc... noting that consideration was given to these three items when determining the scope pretty much covers it.
    Something like "In determining the scope of the QMS, consideration was given to external and internal factors such as ___, the products and services offered, and requirements such as ____. The scope of the QMS includes but is not limited to the following departmental functions: xxx and excludes the following departmental functions xxx. The scope of the QMS will be reviewed yearly/quarterly/whatever and records of that review will be kept in the minutes of Management review meetings.

    HOW you considered them is up to you...THAT you considered them is the requirement.

    Again, I haven't seen the rest of the requirement...doing so may change things a bit...
     
  3. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    I got my hands on the document some five minutes ago, and just like Eric I will have a peek at it before I say too much... :D ...but until then I agree with him.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You're making an assumption about the auditor asking "show me". It's not always the case and you don't have to have a document to "show"...
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    When reviewing the definition of the word "consider" I can see we are in for some of the same confusion as demonstrating RBT. But I think you are on the right track Vincent.

    That said, the element you are referring to is about scope. What types of forces can impact you, so you need to keep controls and minimize the likelihood of unexpected outcomes? Your organization will need (I selected #4 from the list) To take into account; bear in mind (a), (b) and (c) when establishing your system. We've always (hopefully) been addressing (a), and (c); and (b) is including regulatory bodies as is currently mentioned in 4.1 of the 2008 version. The new thing is the 2015 version asking to extend the recognition of potential interested parties, decide which are relevant, and include them.

    Sure, you can list them somewhere but an astute auditor should be able to recognize this is happening, and question only if he/she has direct understanding and recognizes a gap such as failing to include FDA when producing medicines, or Underwriters Laboratory if you are producing smoke alarms.

    I hope this makes sense!
     
    Last edited: Aug 7, 2015
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  6. Ackack-DC

    Ackack-DC Member

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    First, I apologize that this ended up being quite verbose. I re-read through and realized I just kept writing a few really long sentences.

    Second, I would suggest purchasing the new 9000 when it comes out when you go over the 9001:2015. This will be very helpful to review much of the new wordings and phrases being used so that the organization can better get a handle on what the new 9001 is requiring.

    Third, that's not the entire wording of the clause.

    Fourth, and please someone definitely correct me if I'm wrong on this because I'm new to these changes: For this particular part of the clause that includes the A,B, and C, that first sentence is The Deal (what they are trying to say, the overall statement), and the "shall considers" are explicitly the least amount of how the organization must go about to doing The Deal.

    These are less for auditors to check boxes either that you considered something or didn't consider it. Auditors who only like to audit on the front side of things want all of the requirements to be checkboxes; These A,B, and C requirements instead requires auditing throughout and coming back around to verify. These "shall considers" are not something that an auditor can check yes/no and move on. Perhaps in a cursory way to make sure the organization admits they covered A,B, and C.

    However, unless the organization retains documented information explicitly to show all of this (which is what I think you are suggesting but it's not required so that's the organization's choice to retain this documented information of A,B, and C), these "shall considers" are one of those requirements where nonconformities are found after the fact. Further downstream in the audit that, with enough objective evidence leads a reasonable person to conclude for example: "hmmm after reviewing my audit notes and finding this, this, and this, I'm afraid my evidence reveals that the organization did not consider 4.3C when originally determining the scope of their QMS."

    Does that make sense? Or does that sound about right? Or both? Or neither?
     
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  7. Ackack-DC

    Ackack-DC Member

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    Yes! What Jennifer said! I like that!
     
  8. Gray Warner

    Gray Warner Member

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    The auditor challenges become very apparent as you apply the considerations to a system that does not require a quality manual or management representative, and at the same time emphasizes executive participation. These considerations will not be grouped into a tidy little list. The considerations will be contained in the various departments and fully understood by the department heads. The auditor will be challenged to dialogue with a broader base of personnel to determine how the organization has considered the various aspects of the organization and interested parties.
     
  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I fully agree, Gray. We could argue that from here the onus of verifying conformance is placed on the auditor and not the auditee. That will no doubt prove to be a challenge for many.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not exactly in agreement, but I believe it'll change (or should) the emphasis that (some) auditors have of expecting to see a document of some kind (Lord knows what they were taught in LA course). I believe it also will place the responsibility on management to develop a "story" of how they meet these requirements (and not look to the MR to answer for them)
     
  11. Randy

    Randy Member

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    Consider = "Yeah, we thought about it but,......"
    That's what consider means
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Seems good to me!
     
  13. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    Amen to that. I have been asked for documents showing all sorts of things, including statements saying that we indeed aim to accomplish what the standard in question requires us to do, in spite of being able to show written procedures and functioning processes clearly aimed at achieving precisely that.:confused: The Doh! factor is high sometimes... :rolleyes:

    Amen to that as well. Just maybe this will convince a few hard case managers that they actually have to take part in making the system tick.
     
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  14. Mikishots

    Mikishots Member

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    I'm in agreement with that. Not everything needs to be documented, but in many cases, it's helpful to be able to show to some degree that you looked at the impact of the process and made a determination of if/how you would address it. I'm thinking that the "show me" phrase that was mentioned earlier is just a way of saying "describe to me your analysis.' This situation is kind of like making a root cause statement without showing the analysis of how you got there.
     

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