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Order of implementation

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Graham Thorpe, Feb 10, 2019.

  1. Graham Thorpe

    Graham Thorpe Member

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    I have been out the game for a while but have been asked to guide a company through the 2015 revision. Its a small outfit designing high spec electronics for industry.
    I had a quick look and they seem ( well have) the ethos of a company in control and aware of where they are and what they do. There are some great (but not robust ) systems in place for design. Change notes, formal signed of specifications, engineering drawings, purchasing specs, etc. All systems are electronic and no paper in sight.
    Before I went to see them I bought and read the standard, well read it a few times.

    So what are your thoughts on the order I do things in. Initially my plan was define Context of Organisation, then Scope and Quality Policy and move into the detailed stuff later. Now I am beginning to think that I should really formalise the bits they have in place first as they are the bits that are valuable to them with or without Certification.
     
  2. judegu

    judegu Well-Known Member

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    Hi Graham. I am not the professional here. However I have read about the order of establishing the QMS in some book and also learned a lot from this forum. Here is my idea about it.
    As you said, this company has already had some great but not robust processes in the first place. So I highly recommend you to formalise these processes first. And when formalising these processes, taking the requirements of ISO 9001:2015 for these processes into consideration is also crucial. In another word, it would be great if you make these processes conform to the relevant requirements of the standard in the process of formalising them. After formalising, you could do the other things step by step. IMO QMS should be developed based on the current already-existing business flows instead of from scratch. What is more, if we developed the QMS by your first mentioned order, there would be a risk that the processes being built for 2015 version would finally go against the current work flows.
    Looking forwards to others` opinions.
     
  3. tony s

    tony s Well-Known Member

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    My understanding is that context of the organization is a vital input when an organization need to define their scope and set their objectives. So I will start first by establishing the scope but I need to mull over the following:
    • what products and services should be covered?
    • should we include everything within the scope?
    • can we have a limited scope?
    • what issues will affect the coverage of the scope?
    • will the scope address the needs and expectations of interested parties?
    Then, I will establish the organization's strategic goals but need to deliberate on the following:
    • what issues should be considered and/or will affect my strategic goals?
    • do the strategic goals address the needs and expectations of interested parties?
    • what are risks that can adversely affect the achievement of our goals?
    • are there opportunities that can help us in achieving our goals?
    Then, the Quality Policy, next the measurable Quality Objectives at relevant functions and levels (but, again, issues, needs and expectations are to be considered and risks/opportunities are determined)
     
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  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Graham Thorpe and welcome to the forum.

    You have already received some good council.

    Please allow me to provide some additional consideration…

    The ISO gods have done a nice job (my strong opinion) in constructing the standard and it follows a generally linear path.

    If you look at/simply each clause as I have attempted below, it may help. Within, I have also highlighted some of the connections between the various clauses.

    4- Context of the organization
    Identify the following: Who are you (your organization) , WHAT do you do, WHO cares, and WHAT do they care about

    5- Leadership
    Identify responsibilities (ensuring Top Management takes ultimate responsibility)

    6- Planning
    Considering what was identified in "4", plan to achieve ..(including establishing goals and objectives and identifying any RISKS, which could prevent you from achieving those goals and any OPPORTUNITIES which would help you.)

    7- Resources
    Gather what and who you need to achieve the plans you've identified in "6" and ensure all are properly equipped.

    8-Operation
    Do what you do and do it under controlled situations. (i.e. Utilize what/who you gathered in "7" to meet the goals identified in "6")

    9- Performance evaluation
    Measure how well you did. (i.e. did what you do in "8" achieve the plans and goals you established in "6" ?)

    10- Improvement
    Fix what's broke and continue to raise the bar on what you do.
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I agree - somewhat - with John. The "somewhat" is that Leadership should be the first requirement. Some of the Context feeds the Planning (6) requirements, which in turn reflect back into section 4, so it's not quite a linear progression, but pretty close...
     
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  6. Graham Thorpe

    Graham Thorpe Member

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    I think the Standard had made a great leap forward in this edition. It sure is not the same as the first one I did in 1989.

    I think I am lucky that the company I am going to do this for is owned by a man who knows what Leadership is. I am really looking forward to the challenge and I guess it will be interesting to see if assessments have changed much in the years since I did my last system.

    I appreciate all comments from you guys who ave gone through :2015 or are going through it.

    Graham
     
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  7. John C. Abnet

    John C. Abnet Well-Known Member

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    Yep...you only need to spend a little time in the IATF standard (the mess specific to automotive specific industry) to really appreciate how ISO structures and approaches their standards.

    Great to hear you have such good leadership in your organization.

    Be well.
     
  8. Golfman25

    Golfman25 Well-Known Member

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    Why does what they have need "formalizing?" I would start with a gap analysis to see how what they have is applicable to the standard. Once you have that, you can start from the beginning -- I'll bet they are 80%+ of the way there. It is likely they have some "context" stuff already, if not written down at least inside the guy's head. So you just tidy that up - section 4 - and then move to section 5 tying up loose ends, on on to sec. 6 etc.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I hope, Graham, you're doing a LOT of research. If you don't know the different approaches Certification Bodies are using now (re your other post about stage 1 and stage 2), you're going to find out (and your client will too) that things are significantly different since 89! Trust me - I was in the UK when BS 5750 became ISO 9001 and today the standards are totally different. OK, some terminology is the same, but the actual deployment is quite, quite different. I'd hate for you not to be aware in guiding your client and have you fall foul at the certification - experience shows the consultant gets thrown under the bus...
     
  10. Graham Thorpe

    Graham Thorpe Member

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    Andy, I am indeed researching, an awful lot. Whatsapp is getting a lot of use phoning friends around the world who have done the 2015 version and we are looking at systems in place at our customers and suppliers.

    Thanks for your comments, keep them coming.

    Graham
     

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