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Context of organization less complex

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Eline Boonk, Sep 7, 2020.

  1. Eline Boonk

    Eline Boonk New Member

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    As an organization, we are ISO 9001:2015 certified. We do not yet know whether we are properly addressing paragraph 4 of the standard 'context of the organization'.

    At this point, management has made the following:
    - an external analysis, using the PESTEL analysis.
    - an overview of stakeholders and their interests
    - an internal analysis, using the McKinsey 7S Model.

    The output of this results are in an Action-oriented SWOT.


    Once a quarter, this information is gone through to look at the status from the SWOT and once a year it is checked whether all documentation is still up-to-date.

    All this is quite a lot of work.

    Are there organizations that approach this more easily?
    How?

    (I have already seen more questions regarding this subject, but not yet an unambiguous answer with concrete examples.)
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Most of what should be considered in the Context are items to discuss at Management Review. Are you doing this Context information at a different time??
     
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  3. Eline Boonk

    Eline Boonk New Member

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    Hello Andy,
    Thank you for your feedback.
    At the management review we check whether all documentation is still up-to-date. The SWOT we check one a quarter.
    I notice that management thinks it is only large documents, which must be worked through.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why? This isn't a requirement. Also, your internal audits should be doing this.
    I wouldn't think this needs checking that frequently. Typically SWOT is a strategic look at the organization.
     
  5. tony s

    tony s Well-Known Member

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    4.1 and 4.2 are inputs to other requirements of the standard. For example, if the organization understands the needs and expectations of their interested parties (e.g. customers, employers, employees, regulatory bodies, etc.) they can easily determine appropriate objectives at relevant functions, levels and processes (6.2). They can easily identify risks/opportunities that might cause difficulties in fulfilling the needs and expectations (6.1).

    If the organization understands the internal and external issues, it will give them a good reference for identifying risks/opportunities. Positive issues can be used as the basis for identifying opportunities, while negative issues for risks.

    Don't need to complicate the approach in satisfying the requirements in 4.1 and 4.2.
     
  6. Eline Boonk

    Eline Boonk New Member

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    Sorry, we don't check all documentation at the management review.
    We do indeed have internal auditors for this.
    We check the external analysis, the overview of the stakeholders and their interests and the internal analysis.
    We don't have a SWOT, but a action-oriented SWOT. It contains actions that must be carried out.
     
  7. Eline Boonk

    Eline Boonk New Member

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    Do you have a concrete example of what this looks like in an organization. You will have to record this and review it regularly?

    What would be the simplest approach?
     
  8. tony s

    tony s Well-Known Member

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    There is no requirement about documentation on 4.1 and 4.2. However, on those requirements that use them as inputs like 4.3, 6.1.1, 6.2 and 9.3, documentation will need to be retained or maintained.
     
  9. NISHITH NEEMA

    NISHITH NEEMA New Member

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    As an organization, we are ISO 9001:2015 certified. We do not yet know whether we are properly addressing paragraph 4 of the standard 'context of the organization'.
    Answer
    The standard, and requires the organization to determine all internal and external issues that may be relevant to the achievement of
    the objectives of the QMS. Hence the organisation should first determine all the customer internal and external parties which are your customer and determine their expectation from you.
    Remember clause 4 is Context of the organization which is further divided in
    4.1 Understanding organization and its context
    4.2 Understanding needs and expectations of interested parties
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    there are more than customers the organization has to take care of. The internal and external issues are also not necessarily anything to do (directly) with a customer. Think more broadly.
     
  11. Rustle

    Rustle Member

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    I prepare a combined SWOT / Risk Register which is then reviewed at least annually during management review. This ticks the box without much effort. Also would have an overview of organisational context which references the SWOT / Risk Register and interested parties register and have never had any issues with this clause in audits.
     
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