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Context of the Organization-ISO9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by MCW8888, Sep 5, 2015.

  1. MCW8888

    MCW8888 Well-Known Member

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    I would like to invite anyone to critique my first attempt to define the context of the organization. I appreciate everyones feedback.
     

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  2. Somashekar

    Somashekar Moderator Staff Member

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    I am sorry, but I do not see anything about your organization context in this.
    Like who are you, where are you (where all) , What you do, Which industry you serve , Who all are your customer industries, Are you local or global provider, What standards and regulations governs your product and your existence, Who supplies you , What are your internal issues like employees, union, affiliations, stake holders etc etc to later consider all there interests., etc etc ....
    It can never be as general as it looks in the pptx
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I agree with Soma. I can't tell much about your organization, other than a big flow chart. Can I ask if YOU came up with this or did you work with your management team to define the context? If you did it on your own, that's not the best place to start...
     
  4. MCW8888

    MCW8888 Well-Known Member

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    OK I appreciate all your feedback. This flow chart was an adaptation of the process flow chart from ISO9001:2008. Did I not address section 4.3 of the new ISO standard.
     
  5. Somashekar

    Somashekar Moderator Staff Member

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    MCW .. do not get locked into the contents and flow chart diagrams in standard. Rather do not attempt it on your organization also. As an exercise try it on a simple establishment which you can create in your mind, like for example your own Beauty Parlor in your locality. Draft your context from what the standard says. See how much clarity you can get in the context as you make. It can be in text form of table form or any other that is convenient to you to draft the context information.
     
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  6. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    What is supposed to be the purpose of this so-called "Context of the Organization"? Again that big, elusive WHY (this document)?
     
  7. Somashekar

    Somashekar Moderator Staff Member

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    You do not have to write anything at all ... if you can consider your context in all its perspective and plan support and operate what you intend to do to meet customer requirements and sustain the same over time ~~~~~
    The purpose is to set up the PLAN for your QMS Planning
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It is outlining internal and external customers, parties who could be affected by the organization's success, and an introspective look at the culture for the purpose of knowledge management and extending awareness and involvement to the process level.

    Culture is important but has not always been clearly considered. Group of some types of people behave differently and are motivated by different forces than others.
     
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  9. MCW8888

    MCW8888 Well-Known Member

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    Thank you for your feedback. At this point ion time I could not elaborate the type the nature of my company. I have already drafted a FMEA to identify the internal and external issues and their risks. Some of these boxes in the flow chart are support processes conducted at other location. The flow diagram came from the FMEA.
     
  10. MCW8888

    MCW8888 Well-Known Member

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    At this point I would not be confident of facing an auditor without anything written down. A forum expert has suggested to do FMEA and I have done that. And from that FMEA my team agreed to a scope. No exemption was identified. Perhaps after I complete the first audit to ISO9001:2015, I will throw away the manual because its not needed anyway. Thanks.
     
  11. MCW8888

    MCW8888 Well-Known Member

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    Thank you Jennifer for mentioning the culture thing as we could not justify any issue around culture and society. I work in a very diverse environment. I am motivated by all thefeedback from this forum. It was your suggestion to develop the FMEA for the Risk based thinking process.
     
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The context of the organization is simply management asking themselves what the organization they run is supposed to be doing! In other discussions, people equate "quality" with ""excellence", for example. If you have management having the same erroneous thoughts, then the organization is going to have a problem.

    I'm concerned, MCW8888, when you say "I've done this or done that". This is, in my experience, one of the reasons a QMS fails to work correctly. You should, IMHO, be engaging your management in the risk discussion. One person CANNOT effectively create an FMEA - look at the traditional (and correct way) to create an FMEA - it's done with a cross functional team. It's not the place of one person, that's why there's no requirement for a management representative any more! One person can't be responsible if the system is to be an effective, integrated way of managing the customers needs. And certainly it's NOT your call to throw away the manual, when in fact it might be rewritten to be helpful and someone else on the management team suggests that customers expect you to have one!
     
  13. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    There is a Policy; there are Objectives, long term and short term, in alignment with the Policy; there are identified processes that are put in place to achieve the Objectives in the direction set by the Policy; there is an Organization to execute these process and manage them. Is "Context", cluster of all these? Having not gone through the 2015 version, I might be missing something.
     
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Consider this: Are there fast food restaurants? Are there high-end cuisine restaurants? Each has its "context", doesn't it? As a result, each has objectives, processes, competencies and so on. Do they both work for the customers they've identified? Sure! McDonald serves millions of fast food meals. It isn't high end cuisine. Are its "interested parties" happy? You bet! On the other side, would you expect a meal at a high end restaurant to be served in 4 minutes? Order from a menu with pictures? Have your food prepared by someone with possibly only a day of training? Dressed in a uniform? Ask, when you order a chateaubriand, "Do you want fries with that?"
     
  15. MCW8888

    MCW8888 Well-Known Member

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    I appreciate your concern Andy. I will remember your advice. I know that FMEA is a multi-functional team effort. I am starting a team of Management Reps to start the transition planning to ISO9001:2015. We are actually developing a new Quality Manual to prepare for this transition. Even if there isno requirement for Management Representative, Top Management has assigned some focal points to train in the new standard and start the transition. Stage gate for this transition process will be reviewed by Top Management.
     
  16. MCW8888

    MCW8888 Well-Known Member

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    Ganesh, by sharing my limited knowledge of this standard, I am able to learn from the experts. Remember, they are helping us. We will eventlually succeed in the transition journey. Some of the comments that Andy has are really good- especially the one where multi-functional team is required for the Risk Analysis. I have preached that to the choir, but nobody listens. My company is still hitting their target goals. Stay with this forum.
     
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  17. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I want to stress the importance of culture in the QMS as the 2015 version of the standard is concerned.

    What is culture? Things people do, and why... varying motivations among employees with less, or more education and expertise. Members of a society who expect more/less of their leadership than "Left-foot, right-foot" types of direction. As the standard claims we should engage our employees, it also asks that we know our employees. That is the basis of the Context requirement referenced here.
     
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  18. MCW8888

    MCW8888 Well-Known Member

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    Hello Jennifer,
    I will remember the importance of culture in ISO9001:2015. But how do we audit this in light of Context of the organization. Can you share an example of what to look for, or what type of question to ask? Thank you.
     
  19. Somashekar

    Somashekar Moderator Staff Member

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    In the "my context" attached here as a pdf., I have attempted to consider external and internal issues., my purpose and strategic direction., positive and negative factors., used the note 2 and note 3 of the 4.1 FDIS., needs and expectations of the interested parties., ... I hope I can go over to the QMS scope now, and further move forward.
    Read it to have a good laugh ~~~ Do comment also
     

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  20. MCW8888

    MCW8888 Well-Known Member

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    Thank you for sharing this model of "Context" with me. Now I know why this new standard is very user friendly to small business. You did a great job defining the business. The Risk-based thinking is embedded throughout the document. Are there any
    OK I read the whole context with a wide open mind. I made some comments on the document. Basically the acommments are around mitigation of risk to ensure that the business is not shut down before it even takes off to realize its future vision. But I got the message. My context is more comprehensive than this one but it's because I still have a limited knowledge of this standard.
     

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