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ISO 9001:2015: Need the List of documents required

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Darren, Sep 20, 2016.

  1. Darren

    Darren Member

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    Hi all, I have been reading through website after website, post after post but just cannot wrap my head round this all..

    I am very new to quality management systems so please bear with me.

    I work for a small building services consultants and we are going for ISO certification, being the document control manager I have been tasked with it.

    I've purchased a copy of the standard and have been reading it through but was wondering if there is a definitive list of documents which are required - or if anyone has any pointers?

    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Darren, welcome! You are in good hands!
    There's no list which is applicable - it's up to your management to decide - in consideration of some factors which may influence your choices - what number/type/style of documents you might need.
     
  3. Darren

    Darren Member

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    Thanks Andy,

    I currently have a
    -policy statement
    -quality objectives
    -QMS scope

    But it's just trying to figure out what clauses and records of documented information is specifically required
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you have a copy of the standard?
     
  5. Darren

    Darren Member

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    Yeah I have a copy of the standards, but if I'm honest that's more confusing then it helps ha!
     
  6. David Bradley

    David Bradley Active Member

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    One of the difficult parts is 7.5.1 b) which states: "documented information determined by the organization as being necessary for the effectiveness of the quality management system." This means what documentation that is required for one company, might not be required for a different company. For example, your company might not need any documentation at all to control purchasing, but my company might need 2 separate procedures and 15 different forms.

    My advice is to determine what documents and records your company needs to prevent pain, or optimize your processes. Also look at parts where the standard requires you to either maintain or retain documented information. That should be your list.
     
  7. Darren

    Darren Member

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    Great that's a super help
     
  8. Pancho

    Pancho Active Member

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    Hi Darren,

    One very useful document when you're first starting out is a list of the "key processes". This is the set of things that your team does in order to have happy clients. In our company it includes sales, design, purchasing, fabrication and installation.

    Then describe how each of those key processes are carried out. But don't do that yourself. Have the person responsible for each process do it. They can do it with text, flow charts, outlines, or whatever is easiest. The result will be your company's main procedures. As your team describes them, compile and list those other docs that you need or produce when doing the work.

    You will then need procedures for maintaining and improving your quality. These are what the standard prescribes: Document control, training, continuous improvement, etc.

    Soon you'll have the list of docs that you seek. But keep in mind that the list will change as your system improves. And, if your system is working, that will be often.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    To David's point, you can add other considerations, the ISO 9001:2015 requirements point to: Organizational Knowledge and Internal and External Issues and your Interested parties. Any form of documentation is going to be useful in terms of retaining knowledge where the tribal version is tenuous. Add to that competency requirements, customer expectations, consistency of process/product controls and so on and you start building a picture of why documentation is a necessary thing, and not because "ISO-says-So"...
     
  10. Darren

    Darren Member

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    Thanks everyone for the help, one thing I'm struggling to determine is what could be determined as a process - I work in a building services consultants so would I be right in thinking that a process would be:
    Design process - we take the clients requirements and design the systems to comply with the clients requirements and the regs.
    Review & compliance process - we act oh behalf of a client to ensure a designed system is compliant to the regs.

    Am I on the right track?
     
  11. Pancho

    Pancho Active Member

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    Seems to me like you are on the right track. The delivery of different services may indeed each be a distinct process.

    But you may also want to think about another possibility: cutting up the services in another direction. Different processes are often led by different folks or done by different departments. That could be one clue about what the processes are.

    Say, for example, your Design Service could involve "Preliminary Design", "Detail Design", "Design Review", "Contract Management", "Invoicing and collection", etc. In this case, the "Design Review", "Contract Management" and "Invoicing and collection" processes could apply to both your "Design" service and your "Review & Compliance" service.
     
  12. MCW8888

    MCW8888 Well-Known Member

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    Welcome aboard QFO.

    I think this attached document came from a moderator of this forum. I hope they do not mind if I share this with you.
     

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

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  13. askartsolutions

    askartsolutions Member

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  14. Julius UGWALA

    Julius UGWALA New Member

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    Any useful template regarding QMS? Thanks in advance.
     
  15. Joe Ganim

    Joe Ganim New Member

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    A great way to determine needs is to go through the Standard and highlight anyplace it says "Shall" - that is everything you need to do & document, to the extent that your company needs it and to the extent your external auditors say you need to have.
     
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sorry Joe, but this really isn't the way the standard is set up to be used. Firstly, the external (CB) auditors have NO say in what an organization should have documented. The need for documentation comes (solely) from understanding "interested parties", "internal and external issues", the "context of the organization" and the design of the resulting QMS. I recently had a client "fail" their stage 1 for not having "defined" their internal audit process - which I had performed. With more than 25 years of auditing experience, I (for one) don't need a procedure to tell me how to do an audit. I had planning forms etc. and the CB auditor never interviewed me about the process, so how can it be reported the process isn't "defined"? I'd ask you rethink your ideas about why documents might be necessary...
     
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  17. MCW8888

    MCW8888 Well-Known Member

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    ISO9001:2015 document specifies SHALL "MAINTAIN DOCUMENTS= Mandatory Documents" and "RETAIN DOCUMENTS= Mandatory Records". These are the "definitive list" of documents and records that are AUDITABLE, You determine what other documents and records you must keep to control your own processes. I hope this helps.
     
  18. Joe Ganim

    Joe Ganim New Member

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    I definitely hear you Andy, thank you, but the issue is when the external auditors come in to do the audit, if you don’t have what you do documented they will ask you questions on ‘how’ you address all those ‘shalls’.
    The "shall's" in the 2015 Standard do not lay down any auditing instructions or requirements, they are a roadmap for better leadership, planning, support, operation, evaluation and improvement.
     
    Last edited: Oct 28, 2016
  19. RoxaneB

    RoxaneB Moderator Staff Member

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    An auditor - internal or external - who is competent knows that not everything is documented...nor is it always feasible, practical and/or value-added to have everything documented. An auditor would look for consistency...or would look to see that your organization assesses consistency of processes (and results). Just because a process is documented is no guarantee that it's done as outlined. Observation is vital to the auditing process.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed, Joe, however protocol for dealing with external auditors - even when they can be considered as "interested parties" - isn't criterion for determining the need for documentation, IMHO. A better strategy is to know how to answer why it was determined that a document isn't needed by reference to interested parties etc.
     

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