Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Required Documents

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

  1. KyleG

    KyleG Active Member

    Joined:
    Nov 7, 2018
    Messages:
    92
    Likes Received:
    59
    Trophy Points:
    17
    Location:
    Reno Nevada
    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
     
    Andy Nichols likes this.
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,701
    Likes Received:
    1,370
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    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
    John C. Abnet likes this.
  3. KyleG

    KyleG Active Member

    Joined:
    Nov 7, 2018
    Messages:
    92
    Likes Received:
    59
    Trophy Points:
    17
    Location:
    Reno Nevada
    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.
     
    Andy Nichols likes this.
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,701
    Likes Received:
    1,370
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    OK - cool - wanted to check!
     
  5. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    885
    Likes Received:
    662
    Trophy Points:
    92
    Location:
    Laguna Philippines
    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

    Joined:
    Nov 30, 2018
    Messages:
    43
    Likes Received:
    15
    Trophy Points:
    7
    Thanks a lot this is very helpful.
     
    tony s likes this.
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,701
    Likes Received:
    1,370
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    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
    Suraiya Ramkissoon and KyleG like this.
  8. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    243
    Likes Received:
    141
    Trophy Points:
    42
    Good day @Yukon. May I inquire as to why you describe this as "...unfortunately..."

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

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    885
    Likes Received:
    662
    Trophy Points:
    92
    Location:
    Laguna Philippines
    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.
     
    KyleG and John C. Abnet like this.
  10. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    243
    Likes Received:
    141
    Trophy Points:
    42
    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.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,701
    Likes Received:
    1,370
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    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)
     
  12. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    243
    Likes Received:
    141
    Trophy Points:
    42
    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.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,701
    Likes Received:
    1,370
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    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
     
    RoxaneB, tony s and John C. Abnet like this.

Share This Page