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Forming QMS documents

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by danis, Jan 4, 2016.

  1. danis

    danis New Member

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    Hello,

    I'm happy to find that this forum lives after the great and legendary Elsmar forum disappearance.
    Thanks to the founder.

    Further to my inquiry,
    For some reasons, basing on abandoned and un-well structured QMS ISO 9001:2008 documents, my company decided to keep a complete set of hard copy of QMS documents and currently I'm trying to form a complete set of QMS ISO 9001:2015 documents.

    The objective is to provide well structured, easy to manage and user-friendly QMS documents that satisfy all ISO 9001:2015 requirements. As the initial step, I have mapped the documents then connecting it with a gap analysis.

    I have little knowledge on QMS ISO 9001 and actually am in a doubt whether the attached map and gap analysis "looks good" and will achieve the objective. So, would like to hear the expert's comment and also would like also to get advice on the next step. Thanks in advance.
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    MCW8888 and Atul Khandekar like this.
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi and welcome to QFO! Before you go too far, the new ISO 9001 standard gives an opportunity to stand back from "documentation" and ask yourself - the organization that is - "what do we want?" Before you attempt to map documents to ISO requirements, you have a chance to draw a line in the dirt and discover if there's any benefit to having the stuff you've got - by studying the understanding the "context of the organization".

    In addition, if this job has fallen to you, I'd also get quickly up to speed in all things ISO 9001 so you don't jump into learning this from the wrong point of view (from documentation). ISO isn't "do what you say, say what you do" - certainly not now...
     
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  3. danis

    danis New Member

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    Hi Andy,
    In fact we are confusing our self if should we have no a clear procedure then how we expect to control the process, train our new member, let our internal auditor understanding the process of the area being audited and so on. We're a kind of traditional company, especially in managing the QMS system and still believe a written procedure is a useful and powerful tool to set the process boundary to prevent "un-necessary creative action" that can lead to negative impact. Also, bringing some paper and display it on some areas of the company is a lot easier than bringing a laptop or provide an online procedure to the certain structure of the company.

    We do have a set of QMS ISO 9001:2008 documents but almost all of the users found it not user-friendly and they even difficult to find applicable procedures to their department. That's why we decide to refresh and simplify the documentation.

    I found "the context of the organization" is a hot topic. After reading some quality articles (unfortunately in English :(), I can tell you that I'm the one that still not fully understand this clause. :D
    This job has fallen to me so am preparing the project plan and the proposal. Forming the documentations is a part of the project.
    OOT, I'm still enjoying this journey and all of the challenges.
     
  4. MCW8888

    MCW8888 Well-Known Member

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    We are all in the same boat. If you tell us that you understand WTO with the Context of the Organization I could say you are not one of us. If your procedures are controlling the processes, then keep them. But if they do not add value, archive them. For 4.1, do a SWOT analysis of your organization. 4.2 Who are the internal and External parties that could affect the QMS. Clauses 4.1 and 4.2 should input into the 4.3 scope of your QMS. The output of the scope is the QMS processes 4.4. In 6.1 you are going to revisit the SWOT analysis of 4.1 and do a Risk Analysis of your processes identified in 4.4. Your weaknesses and Threats are to b classified as either High or medium risks and the Opportunities are to be implemented to strengthen the weaknesses and eliminate the threats. I hope this helps.
     
  5. danis

    danis New Member

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    Thank you for the valuable addition MCW8888!
    Related to your addition, I found useful toolkit posted by Jennifer.
    But come back to my question, what do you think about the design of attached QMS framework in my first post? Is it good?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Danis: Is this so? Your organization didn't do a good job BEFORE implementing ISO 9001?(2008). Documentation isn't always needed for the reasons you describe - one of the reasons why ISO 9001:2015 no longer specifies that (some) documents are mandatory. Once again, I'd suggest you get some help to understand the context of your organization, interested parties etc and then have the various process owners take a good, hard look at what documents exist and a) if they are necessary and b) if they are needed, if the documents are any good (a badly written document may be worse than not having one)
     
  7. MCW8888

    MCW8888 Well-Known Member

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    The design is OK but the Context of the organization is NEW. there is no equivalent matrix in 2008 that will match that. SWOT should be the first one you need to do in 4.1; In 4.2 you do the interested parties, 4.3 scope and 4.4 is your QMS and the processes. Somewhere in this forum there was a posting of documents that Shall be maintained and documents that shall be retained. Those are the ones that you need to keep for auditing purposes. Only keep the documents that you use to control the process that is described in 4.4. Section 6.1 is the Risk analysis which you will make reference to your SWOT when you do the risk. In the Resource part of this site there is a template for Risk Assessment which is nice to use if you do not have one in your organization. This has to be done by a multi-functional team.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I can't tell what your organization does from looking at this. I can't therefore say the "design" is any good. I'd ask you to put it in front of your management team and ask them if it's any use to them. Making up a matrix without knowing the context of your organization isn't sufficient for anyone to say whether what you've done is "good" or "bad"...
     
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  9. danis

    danis New Member

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    Ah..
    Now I can see the point why you keep stressing about the context of the organization. It's like a requirement to understand my self and where I am, what is the applicable rule then basing on that I will know what I need, what is right or wrong when trying to go to the desired destination.

    I'll work with my team and management on this, and come back again.

    You know Andy, previously I thought you and MCW8888 are on the opposite pole, but now I know you're just in the different way in helping people :D
    Thank you.
     
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  10. tony s

    tony s Well-Known Member

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    Yeah. That's why I love this forum.:D
     

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