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Section 4.1 and 4.2 on Context of the Organisation Visual Representation, any Examples??

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by ISO GURU, Nov 21, 2015.

  1. ISO GURU

    ISO GURU Member

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    Hi I am currently looking at more ways to be visual in documenting a QMS.

    1. I aM using turtle diagrams for use in visually describing the process in the business which I think will work very well - its simple and works well in demonstrating # of areas of compliance with the standard.

    however the context of the organisation for compliance with clauses 4.1 and 4.2 I am struggling a bit with. Any thought on a diagram layout? or should this be left to as part of a strategic review document used by top management.

    Comments/feedback welcome.
     
    Last edited by a moderator: Nov 23, 2015
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe you might be looking at this the wrong way. There's no requirement and it's not intended that the context be documented as part of the qms. The idea is that having identified your interested parties, your management define a number of things - policy, objectives and so on. The context of your organization, when understood, sets a framework for other things to be defined and then documented. I tend to look at this as being like asking the question "What do we want to be in the customers' eyes?"

    Now, where this discussion etc can be recorded is in management review records. That seems to me to be the most logical place for the discussion, defining any actions etc. Perhaps a look here might help: https://www.nqa.com/en-us/resources/blog/november-2015/why-the-context-of-the-organization
     
  3. ISO GURU

    ISO GURU Member

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    Hi Andy,

    Thanks for the feedback, and the link - definitely food for thought - I read the standard extensively this afternoon and noticed since posting this thread that the no mandatory requirement to document the context.

    The pyramid diagram really brings it home as to what this version of the standard is trying to do.

    It makes the auditing of company's QMS more slightly more challenging in some ways, but more interesting in others - but more importantly the audit should be (if conducted properly) more relevant and added value for the client.
     
    Last edited by a moderator: Nov 22, 2015
  4. Stacey

    Stacey Member

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    Hello!

    I am brand new to the ISO process, so I really don't know anything about this. We are trying to implement it in the company that I work for and I need help. :) Are we supposed to be entering statements for 4, 4.1, 4.2, 4.3 and 4.4? Is the Context of the Organization to be one sentence? 4.2 are we to list the internal and external issues? and so on? Thanks!
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Stacy and welcome!

    Great questions! The idea behind this requirement is that management (your leadership) is supposed to consider what their business is actually about - in considering those "interested parties". You might care to read this blog article I wrote back in November, to answer such a question: https://www.nqa.com/en-us/resources/blog/november-2015/why-the-context-of-the-organization

    Once you've taken a look, come back and let us know if you need anything else!
     
  6. MCW8888

    MCW8888 Well-Known Member

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    To follow-up Andy's comment, I might suggest you have a meting with management of your organization (include supervisors and employees and brainstorm the Strength, Weaknesses, Opportunities and Threats of your organization's business. Forget ISO for a while. Analyze your SWOT and you can identify the Internal and External parties that could influence the success of your organizations business. Analyze the risk of these internal and external processes because you need to control them to mitigate a negative impact to the success of your QMS. From there you can develop a strategy for a successful strategy and scope out the processes. You will end up with the scope of your QMS and the processes that needs to be monitored periodically for effectiveness. Hope this helps.
     
  7. Stacey

    Stacey Member

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    I did take a look at that actually before I posted my question :) I just don't get what needs to be listed. I am terrible at creating new documents without having an actual sample. I will need lots of help :(

    Thank you for help and the welcome!!!
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Nothing! Stacy, the best "venue" for recording the considerations of the context etc is the management review records ("retained information") which will show that there was discussion about your "interested parties, what your organizations does (or aspires to do) for those interested parties, what the quality policy and objectives are and so on. No need to create a document, per se, but certainly "minute" the discussions your leadership had to reach consensus (or not!)
     
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  9. Somashekar

    Somashekar Moderator Staff Member

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    This is a small piece of fantastic information not only to the OP. but to everyone who wants to understand the ISO9001:2015 and its implementation. How sad that the standard in its Annex does not state the intent and objective of every clause / subclause to clear the air and give the users some typical applications of process interactions viz the context and management review and documented information.....
     
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  10. Stacey

    Stacey Member

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    Ok so now I am even MORE confused! We are not ISO compliant and we want to be. This was all started with the 2008 guidelines, so there are some things created, but it appears, to me, that most of what was done is kind of irrelevant. I am trying to figure out what it all means and what needs to be put down for all the "categories" 1. Scope, we have to state the Scope of the business, correct? 2. Normative References..we only use this if we reference documents? 3. Terms and Conditions....not real sure what to do here. 4 through 10.2 WHAT NEEDS TO BE LISTED????? I am so lost!!!!!

    Am I making any sense as to what I need help with?

    Thanks in advance.

    Stacey
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Stacey: I completely understand. Please feel free to give me a call if you are in the USA - 248-681-9665, I can give you some pointers and then maybe find a class on ISO 9001 or even a consultant.
     
  12. MCW8888

    MCW8888 Well-Known Member

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    I suggest that you give Andy a call. He can give you direction because he wrote the book. I am in the same situation as you do.
     
  13. Stacey

    Stacey Member

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    Super!! When would be a good day/time to call?
     
  14. Stacey

    Stacey Member

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    Super!! When would be a good day/time to call?
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Any time between 8.00am and 5.00pm EDT (US)
     
  16. Stacey

    Stacey Member

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    Hello Andy!

    Would it be ok if I call you now? If not, what time would work?

    Thanks!
    Stacey
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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  18. Stacey

    Stacey Member

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    Just tried to call, got answering machine, please let me know when to try again. Thanks!
     
  19. MCW8888

    MCW8888 Well-Known Member

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    Try the SIPOC instead of turtle diagram.
     
  20. Stacey

    Stacey Member

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    Andy,

    May I try to call again?

    Stacey
     

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