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What documents need to be controlled in ISO 2015?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Jan 3, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all.

    Considering that the current standard doesnt require too much documented records.
    how do you manage the next issue?

    in a procedure its is mentioned a document which is an evidence that one product is available in the storage.

    But this document is not included in the QMS, (not in the list of documents, nor list of records) is somewhat informal, but anyway gives you traceability of such product.

    Do all the documents mentioned into the procedures should be registered into the QMS?

    Please give your input
     
    Qualmx, Jan 3, 2018
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Records are records - there is no "next issue". What ever you were doing for ISO 9001:2008 is fine for ISO 9001:2015.
     
    Andy Nichols, Jan 3, 2018
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  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    There is no need to "register" documentation. We control documents based on the risk of getting things wrong when they are not up-to-date. That includes forms.

    There is no requirement for a list of controlled documents, in 2008 or 2015 versions. It does seem worthwhile to reference them in a procedure, so as to provide users with guidance on what record to use.

    In addition to the clauses in the standard that require retained documented information (call it a record if you like) the records you should keep are those that help keep your QMS effective and customers happy.
     
    Jennifer Kirley, Jan 4, 2018
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  4. tony s

    tony s Well-Known Member

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    I presume your using a register of documents as part of the controls on documented information. The answer to your question will depend on the requirements specified in your procedure for document control. The standard does not specifically require a list or register of documents, same with the list of internal/external issues or interested parties, but if your procedure requires registration then you have to conform with it.
     
    tony s, Jan 10, 2018
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  5. Daniel Padilla T

    Daniel Padilla T Member

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    If I use a spreadsheet to measure on time delivery, would it be necessary to control this file? I will use it to create some descriptive statistics such as: % of shipments on time, % of incomplete shipments, and things like that.
     
    Daniel Padilla T, Jul 19, 2019
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you alone use it?
     
    Andy Nichols, Jul 19, 2019
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  7. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Qualmx ;
    This topic (particularly the title of your OP), comes up a lot. A search on this forum will provide you with some past conversations.

    Here is an excerpt from a response I gave previously to a similar question....
    The term I use ..."wrong or gone" is a term I developed years ago to help my teams determine if a document needed controlled (or not). The goal is to ask the question...,
    If a document is "Wrong or Gone" can this contribute to a nonconformance? If the answer is "no", then likely no formal method of document control is needed.
    However, if the answer is "yes", then the question would by, "Why shouldn't it be controlled." My professional opinion, if the answer is "yes", then it should be controlled.

    Hope this helps.

    Be well.
     
    John C. Abnet, Jul 19, 2019
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  8. Daniel Padilla T

    Daniel Padilla T Member

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    Yes, I am the only one who uses it. The result of the analysis of this spreadsheet, would be in the form of an indicator (on time delivery).
     
    Daniel Padilla T, Jul 19, 2019
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Don't "control" it. It's just like a piece of paper with squares on it.
     
    Andy Nichols, Jul 19, 2019
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  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It sounds like a tool, not a controlled document. Controlling it with a formal method would be too constraining, as you may want to frequently alter the tool to measure something new or differently, fix a formula, etc. I once fended off an automotive auditor who ask how I controlled my corrective action log, given it is a record. I said "No, this is a tool. The record of corrective action is in the audit report." He had no choice but to accept that.

    That said, there are different types of control. A spreadsheet that contains important information can be password protected to help ensure it is not inadvertently changed, and kept in a networked file with backups to help prevent loss.
     
    Jennifer Kirley, Jul 20, 2019
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  11. Pushpender Sharma

    Pushpender Sharma Member

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    i have this list if it helps ....
     

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

    Pushpender Sharma, Aug 12, 2019
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  12. Nitish Bhatia

    Nitish Bhatia Member

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    I have not much time to to prepare .
    Please let me know the main points and documents for which the external auditor will be looking for.
    Procedures, manuals and policies are all documented and implemented.
     
    Nitish Bhatia, Sep 18, 2019
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    We cannot tell you. Who knows what auditor "think" you should have. What do you have? What do you have compared to what's required by ISO 9001:2015?
     
    Andy Nichols, Sep 18, 2019
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  14. tony s

    tony s Well-Known Member

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    As a minimum, try to find all the "documented information" statements in the ISO 9001. Other documents will depend on your organization's need (e.g. quality manual, documented procedures, etc.)
     
    tony s, Sep 19, 2019
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  15. Nitish Bhatia

    Nitish Bhatia Member

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    All the working processes are being documented and controlled. is that enough
     
    Nitish Bhatia, Sep 19, 2019
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What are these? Please define.
     
    Andy Nichols, Sep 19, 2019
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  17. Nitish Bhatia

    Nitish Bhatia Member

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    For QA-Documented information procedures, practice for non confirmities, training plans, internal audit plan, organisational structure, role and responsibilities,Risk assessment, Quality manual, Quality policy,Objectives, MRM
    For procurement- Procurement manual, vendor development, rating scoring , comparative price sheets, etc.
    For all other departments their working is documented as per the real work flow as used formats and checksheets
    For documenteing all thesse procedure and use documented one practice is aslo made"practice to develop standard documents"
     
    Nitish Bhatia, Sep 19, 2019
    #17