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Referencing ISO Clauses in QMS documentation ?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Suraiya Ramkissoon, Feb 8, 2019.

  1. Suraiya Ramkissoon

    Suraiya Ramkissoon Member

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    Hi guys,

    i was wondering, is there a specific way in which you reference ISO Clauses? See snip below of how I chose to reference 8.4, does this seem ok?

    upload_2019-2-8_11-30-27.png

    feedback appreciated.

    Suriaya
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In your QMS documentation? No need to reference anything ISO.
     
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  3. Suraiya Ramkissoon

    Suraiya Ramkissoon Member

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    are you sure? don't you reference which clause this procedure is applicable to? so it shows overall how you comply with the requirements?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Complying with requirements isn't achieved by referencing a clause in the standard. You can put any number in a document you want, doesn't mean it complies. No-one who reads your procedures is interested in ISO clauses. I'd suggest YOU make a matrix for reference for your CB auditor (if you want to help them) and so you know which document relates to which requirement.
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    Just imagine the workload, Suraiya, if/when the standard changes and/or your organization decides to pursue registration to other standards. Every single one of your documents will need to be revised, approved, released. Every. Single. One. If you only have a handful of documents not a big deal, but still unnecessary work for a bunch of people.

    A skilled auditor is able to figure it out pretty quickly - a procedure about suppliers probably goes with any requirements about suppliers - but if you feel like being nice, providing coffee, lunch, and a handy matrix to your auditor may go a long way. ;)

    Such a matrix may also help in the planning of internal audits, but, there is no need to reference the clause in the document.

    Your organization demonstrates compliance to the requirements by actually doing what they said they do, doing what they should be doing, and achieving what they should be achieving...and doing all of that consistently.
     
  6. tony s

    tony s Well-Known Member

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    Andy and Roxane are right. Don't reference your QMS documents to ISO 9001 clauses. A good auditor doesn't need them. The users/implementors of the documented procedure don't need them either. Better reference the other documented procedures that are interrelated to a specific procedure (e.g. reference Corrective Action Procedure with Internal Audit Procedure or with Complaints Handling Procedure). In this way, any change in one can trigger an update on another.
     
  7. Suraiya Ramkissoon

    Suraiya Ramkissoon Member

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    Thank you everyone for helping me to see the light.... I was indeed being too "nitty gritty" and it is unnecessary work. What I will do is start developing my Macro Compliance matrix.
     
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  8. tony s

    tony s Well-Known Member

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    Organizations who wanted to demonstrate conformity with the standard's requirements, IMHO, should not complicate their system/documentation to make it auditor-friendly but efforts should be expended to make it user-friendly.
     
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  9. KyleG

    KyleG Active Member

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    I just use a matrix something like this
     

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  10. tony s

    tony s Well-Known Member

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    Why can't SAI do that for themselves? Can't SAI identify the clauses relevant to the processes they will audit? I'm surprised.
     
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  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The matrix is very nice, but identifying the clause numbers is not necessary for that either.

    The only useful reason I have seen for cross referencing clauses and processes is to do audit planning. The matrix method Yukon referenced is also included in Bureau Veritas's ISO 9001:2015 Lead Auditor course.
     
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    But that's an external audit concern, to meet accreditation requirements. I wouldn't advocate it for internal audits, however, as a planning tool. Maybe on the corner of a napkin, in case a not yet competent CB auditor asks "How do you know you've covered all the clauses?" - which isn't something they should even ask, but do...
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Because, in part, contract auditors can't be trusted to do the paperwork properly and they have odd interpretations of requirements. Only recently I discovered an auditor who was so far off on their interpretation, that it showed they have zero clue what they were actually talking about! By making the client do the work, the CB can avoid the issue of admitting they chose an incompetent auditor. Sadly, no one can tell these types of auditors they are wrong.
     
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    What better way to help ensure the entire standard gets covered during internal audits?

    Note I was the only 3rd party in my class at BV.
     
  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Who do you think is doing these matrixes at the CB? Contract auditors.
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Which CB are you talking about?

    Which means? It's a simply truth: CBs don't spend money on ensuring competency. Experience shows they wait until someone (like me, who knows what to expect) complains. I have complained directly to management about some auditors, and to the oversight bodies about others and will continue to do that, while I am still involved in this industry.
     
  17. tony s

    tony s Well-Known Member

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    Here are some of the bases (from the statements in the standard) why we need to demonstrate conformity with the relevant requirements:

    4.4.1 - The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard
    5.1.1c - Top management shall demonstrate leadership and commitment with respect to the quality management system by... ensuring the integration of the quality management system requirements into the organization’s business processes
    5.1.1f - Top management shall demonstrate leadership and commitment with respect to the quality management system by... communicating the importance of effective quality management and of conforming to the quality management system requirements
    5.2.1c - Top management shall establish, implement and maintain a quality policy that... includes a commitment to satisfy applicable requirements
    5.3a - Top management shall assign the responsibility and authority for... ensuring that the quality management system conforms to the requirements of this International
    Standard

    9.2.1a.2 - The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system... conforms to... the requirements of this International Standard

    Methods to easily identify the requirements relevant to each QMS process may include:
    • referencing the relevant clauses in the sections of the quality manual;
    • referencing the relevant clauses in each documented procedures;
    • process vs clauses correlation matrices;
    • indicating the clauses, among other criteria, to be covered per process in the audit plan or schedule;
    • inclusion of the relevant clauses, again, among other criteria, in the audit checklist
     
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  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Mine. While I (and some of my peers) do give customers a copy of a matrix and invite them to complete it, the end result seldom supports the process audit method nor acknowledges how often certain requirements (like documented information) should be included in a given audit. To be clear, methods for completing the matrix (now a part of our audit reports) also vary among auditors. There is no clearly defined expectation to point to.
    It means in a class of 12, I was the single participant in a 3rd party auditor role. All 12 of us received instruction on using the matrix as a simple, high level tool for identifying clauses to include with process audits. The other 11 people were 1st party auditors, several of whom were their organization's Lead Auditors. It makes sense that they receive more comprehensive information than is included in an Internal Auditor training.

    While practices vary, CBs do have a requirement to ensure competency as per accreditation rules and do spend money on it. Naturally, the individuals' behavior may vary while on site and naturally some may not agree with us. Your viewpoint on auditors' lack of competency is rightfully shared, but direct customer complaints are more likely to get a result.
     
  19. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The industry seems to be moving to contract auditors instead of employees. Exceptions are for high demand disciplines like automotive, aerospace, medical instruments etc. I am a contract auditor, and have been since 2012. For us, qualification requires personal internal witnessing over a period of days. Accreditation requirements include training us all to the updated standards. I do wish more were clearly directed to the ISO/TC 176/SC2 Auditing Practices Group. I send my own trainees to that site, as well as customers.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "Seems"? It's been that way since CBs arrived in the USA and discovered that clients wouldn't pay for 2 days of travel for a 2 day audit. That's the most significant reason.
     

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