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Required Documents

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by KyleG, Jan 30, 2019.

  1. KyleG

    KyleG Active Member

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    I would first like to start by saying thank you for all of your help, you all have helped me so much with developing my QMS and have stopped me a few times from setting myself up for failure.
    I would also like to apologize for all of my ridiculous questions that are blatantly obvious to most of you.

    I am creating and implementing a brand new QMS to be certified by the end of the year, i have recently purchased the ISO book in plain english.
    What required documents do i have to have for and ISO 9001:2015 certification,
    So far i have:
    Control Of documents
    Control of Records
    Corrective/preventive Actions
    Internal Audit
    Work Instructions
    Standard Operating Procedure
    These are the documents i have finished. They are not implemented yet. I should also add i have reached out to an ISO consulting Company.

    Any advice is always appreciated.
    Thanks,
    Kyle
     
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, no question is ridiculous - we all started off like you!

    Secondly, when you post "I am creating", it worries me. I need to understand if you have decided these are necessary and have been writing them or something else. An effective QMS isn't about single-handedly creating documents. If you and your management team haven't signed up for this, agreed to the format and other aspects, you are headed down the wrong street and it's one-way (you are going against the traffic too)
     
    Last edited: Mar 11, 2019
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  3. KyleG

    KyleG Active Member

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    I am the Document Control manager, I am in charge of creating all procedures policies work instructions etc. when i say "i am creating" i have other management involved in the creation process im just the person physically doing the work. As of now the policies and procedures we (I) am creating are what we plan to implement at a later date, mid year, Our plan is to get the documentation together and then slowly roll out new items to the operations team. We have also started talking with the operations team and giving them information about what is to come with standard work and competence training and associate development. Sorry for the confusion.
    Also, my company is rather small we have buy in from senior and executive management there is zero push back with what we need/want to accomplish in 2019 as far as ISO certification.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK - cool - wanted to check!
     
  5. tony s

    tony s Well-Known Member

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    There are documents that are required to maintain, required to retain, and as necessary. Here's a matrix of those clauses with such requirements for documented information:
    upload_2019-2-2_14-55-24.png
     
  6. Suraiya Ramkissoon

    Suraiya Ramkissoon Member

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    Thanks a lot this is very helpful.
     
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  7. Yukon

    Yukon Well-Known Member

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    ISO9001:2015 unfortunately does not require you to have any documentation. That being said if you do creat documents they must comply with the requirements of the standard. It's up to you how many and what type of document you chose. The CB can't tell you what documents you must have. You tell the CB. ( you do need records)
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What mustn't be overlooked is that instead of being TOLD what to do, when it comes to documentation, most CEOs won't do it because "ISO-SAYS-SO". After all, it's not like ISO 9001 is on the MBA list of top reads is it? In fact, I know of no entrepreneur who does anything because they are told to! (nope, not even pay taxes!)

    This latest version of the standard did something quite innovative. It gives the organization an opportunity to decide if and what documents might be needed. Instead of myopically viewing a clause to determine what document might be "required", the section 4 "Context of the Organization" takes management through a step by step rationale of why a document might be a good thing. By understanding "interested parties" and also their "needs and expectations", especially when viewed against the requirements for identification of "internal and external issues" affecting the QMS and it's ability to function as intended, it can be seen that the need for documents - of some kind - make good business sense. Top management get that! Doing stuff because ISO-SAYS-So, doesn't...

    This makes the 2015 version so much more compelling as a tool in the toolbox. Sadly too many people don't get this important point, since they lack the understanding of leadership. And, added in edit, it does make a couple of things mandatory to be in a document (the term is "maintained documentation", rather than "retained documentation" - which was records in the past) like policy, objectives, scope and justification I seem to recall.
     
    Last edited: Mar 11, 2019
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  9. Yukon

    Yukon Well-Known Member

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    Kyle,
    There are no formal requirements for developing and maintaining documents in the ISO 9001:2015 version of the standard. The standard requires that you formally maintain "documented information" (records, mentioned approximately 41 times). It is up to the organization to determine how many, if any, documents will be needed or used. One of the "risks" an organization to an organization already registered to ISO 9001:2008 is that they and their CB will apply Clauses 4.2.2, & 4.2.3 to ISO 9001:2015.
     
  10. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Yukon. May I inquire as to why you describe this as "...unfortunately..."

    Thanks in advance.
     
    Last edited: Mar 11, 2019
  11. tony s

    tony s Well-Known Member

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    I'm not sure on the above statements. But ISO 9001:2015 have these statements:

    Clause 4.3: "The scope of the organization’s quality management system shall be available and be maintained as documented information".
    Clause 5.2.2: "The quality policy shall... a) be available and be maintained as documented information"
    Clause 6.2.1: "The organization shall maintain documented information on the quality objectives"

    These are just those that are required to be maintained - and there are those that are required to be retained.
     
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  12. Yukon

    Yukon Well-Known Member

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    "Documented information" refers to records. There are no requirements for any other type of document, only "documented information" ( records).
     
  13. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Yukon ;
    I believe your previous statement implies that "documented information" is limited to "records". Obviously 9000:2015 (section 3.8.6) is much more inclusive in its definition of "documented information" (i.e management system, processes, information created in order for the organization to operate, etc...)

    You may wish to reconsider .

    Hope this helps.

    Be well.
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I thought there's a clear distinction made, John, between "maintained" and "retained" documented information. Isn't it clear? I certainly don't see any confusion. The standard hasn't actually changed very much in this respect (I'm writing a blog regarding this very topic)
     
  15. Yukon

    Yukon Well-Known Member

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    John,
    Thank you for the comments, however the ISO 9001:2015 version of the quality management standard no longer requires any specific procedures (documents), as was required in the previous version (ISO 9001:2008). There are only three pieces of documentation required none of which are considered to be procedures. They are as follows:

    • Scope of the quality system (4.3) - addressed in the Registration Scope statement and includes multiple site registrations and any site-specific scopes
    • Quality Policy (5.2.2) - must provide the framework for the quality objectives; usually posted at strategic locations throughout the facility; usually signed by the CEO or President
    • Quality Objectives (6.2.1) - must be consistent with the quality policy; usually posted on bulletin boards as KPI's; mandatory that the quality objective trends be addressed at Management Review
    There are numerous places on the www where you can confirm my claim. Here is one that I hope you can link to:

    www.qualitysystems.com/support/learning/the-six-required-procedures-of-iso-9001

    I audit (since 2002) for one of the largest, and most respected CB's in the world (QMI/SAI Global). Our instructions are clear for ISO 9001:2015 - auditors cannot issue a NC for the absence of procedural documentation (assembly/test/sales/procurement/design/etc/etc) but NC's do apply for the absence of required "documented information" (records).
     
    Last edited: Mar 12, 2019
  16. John C. Abnet

    John C. Abnet Well-Known Member

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    Agreed. ..no requirement for procedures. Who said it did? I'm simply pointing out that your statement " 'Documented information' refers to records" is inaccurate.

    Hope this helps.

    Be well.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'll put it more straightforwardly: maintained documented information ISN'T records. Retained documented information IS records. Quality Policy, Quality Objectives, Scope of the QMS ISN'T records.

    A.6 in ISO 9001:2015 makes it very clear. "Where ISO 9001:2008 used specific terminology such as "document" or "documented procedures".... this edition... defines requirements to "maintain documented information". A similar statement, regarding "quality records" and "retained documented information" appears just below it on page 23.

    Posters who continually post their "interpretations" on this matter may have their posts deleted as #fakenews :D
     
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  18. Yukon

    Yukon Well-Known Member

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    In my opinion ISO 9001:2015 is extremely weakened in comparison to previous versions. I also believe it was weakened purposely by the TC176 committee. Men like R Shaughnessy former TC176 chair would have never allowed the standard to be "de-structured" as it has been - change for the sake of change, too make money.
     
    Last edited: Mar 12, 2019

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