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Newbie Audit schedule & cross reference

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by mike whittingham, Jan 9, 2020.

  1. Leonid

    Leonid Well-Known Member

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    Any audit includes interviews with levels and functions responsible for the QMS and its processes. A time schedule of related visits shall be prepared accordingly and provided to the auditee in advance. Relevant clauses of the standard are often indicated in the schedule for each level and function to be audited. Each requirement of the standard shall be audited at leasе once per audit cycle.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This isn't a requirement for internal audits.
    Why would you do that? If an organization has a 4 year development cycle for their new product, what's the point in trying to audit product validation every year? It might not happen until year 3 or 4!


    Again, not a requirement. I hope you, as a third party auditor, don't go around imposing these things on your audits... This is the type of mythology which proves many (CB) auditors aren't in touch with reality.
     
    Last edited: Jan 12, 2020
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  3. mike whittingham

    mike whittingham Member

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    The audits i have been involved in so far have seen the UK CB ask for evidence of a schedule. I guess this is something that they seem to think is the norm with other businesses and the way they construct their audits? I would find it easier myself if I provided evidence of monthly audits being performed and evidence the senior management have taking a pro active approach to all non-conforms raised with completed corrective action pushing the business forward.

    Mike
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Ah, but don't forget, the auditor isn't there to impose requirements and your job is to keep management happy, not a once-a-year visitor who cares not about how much work you have to do 51 other weeks of the year.

    If you can talk to why and when you do audits and you'll plan them based on the need for verification that the processes are performed as required, don't let them bulldoze their agenda. Let's not also overlook that most CB auditors don't have a clue about internal audits. And, even if they part-time as a consultant, they do the same thing to their clients! Trust me on this one.

    In a previous post you can see evidence of such an approach.
     
  5. mike whittingham

    mike whittingham Member

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    Thanks Andy.
    I am not going to get hung up about the CB auditors as I don't think anyone can predict how they will audit on the day , I don't think they even know!! All the help I'm getting will put me on the path of a foot sure approach to how I perform my audits and in turn make the management happy :cool:

    Mike
     
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  6. Leonid

    Leonid Well-Known Member

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    In general case, the fulfillment of EACH element of the Standard shall be audited as per 9.2.

    In specific case (e.g. 4 year product development cycle) validation can be done in year 4. That is why this element shall be excluded, until completion of development, from the scope of the QMS as per 4.3. Production of the new product will be included in the scope only when it is carried out.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not if it isn't applicable.
    This has nothing to do with the scheduling of audits on an annual basis. In a previous post you stated everything has to be audited annually. It's simply NOT required.
     
  8. Leonid

    Leonid Well-Known Member

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    I never said "annually" or similar. I spoke about an audit cycle. The cycle is often annual with the audits conducted with annual intervals. But annual frequency is not required by the standard. I met with the 3-year cycle when planned intervals are three years. My point is: each standard requirement within the QMS scope shall be audited at least once within the planned interval. If not, the requirement of 9.2.1 a)2 will not be fulfilled.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I see nothing which indicates this. I think you are confusing the CB rules, defined in ISO/IEC 17021 with ISO 9001:2015 requirements.
     
  10. Leonid

    Leonid Well-Known Member

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    Sorry, I do not understand you.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This is not a requirement of internal audits, is my comment. It may be (I don't have my copy of ISO/IEC 17021 to hand) that a CB has to cover a client's whole QMS vs the applicable requirements of the Certification Criteria (ISO 9001 et al) but that's got nothing to do with internal audits under 9.2. Let's NOT overlook that an organization can implement ISO 9001:2015 without being certified by a CB and, therefore, the organization is at liberty to audit to meet the requirements.

    Maybe the issue is in understanding what "planned intervals" means, but I can assure you that it doesn't mean any rigid calendar which constrains what must be audited and when. Internal audits are defined by the scope and criteria applicable and timed to be of benefit to management in returning a report on the implementation of the QMS. Indeed, a previous version of ISO 9004 gave excellent guidance about the timing of audits which, in basic terms, stated that what you should be flexible about what you audit next.

    One of the biggest mistakes I see is that organization create an arbitrary calendar of audits through a whole year and neglect the "results of previous audits" or only use previous non-conformities (which is what a CB does).
     
    Last edited: Jan 14, 2020
  12. tony s

    tony s Well-Known Member

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    What evidences would you expect to see for this?
     
  13. Golfman25

    Golfman25 Well-Known Member

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    I think some auditors skip right to the chase and ask for the document they expect to see to satisfy the requirement. So since many people use a schedule of some sort, that's what they ask for instead of asking the open ended question - "how do you plan audits."
     
  14. Leonid

    Leonid Well-Known Member

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  15. Leonid

    Leonid Well-Known Member

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    According to 9.2.1 a)2, any organization shall conduct internal audits at planned intervals to provide information on whether the QMS conforms to THE requirements of this International Standard. "THE" indicates all 132 requirements of ISO 9001. These requirements are stated in 64 numbered sections. To reflect the planned/audited requirements auditors use matrices (mandatory in many CB) or spider diagrams.[/QUOTE]
     
  16. mike whittingham

    mike whittingham Member

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    I agree, that is why the last 2 quality managers here have produced a annual audit plan but as the wise words pointed out to me by Andy they have been auditing all the clauses and not the processes. At the moment I am trying to put the processes in some kind of structure and as attached in #10 i have to whittle down 28 processes that have been thrown at the business. Also there are 14 procedures to tackle once this has been done. Thing i have been thrown into the deep end i am on a learning curve at the moment so i am taking all comments and wise words from you guys to help me gain valuable knowledge.

    Mike
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, but there are many ways of doing this and the CB auditors' is ONLY one way. If the QMS is initially determined as compliant with ISO 9001:2015, why would an audit be necessary, within any period, to determine otherwise? In a year, a lot could happen in some organizations. In others, not much might happen. As I have stated copious times, selecting some arbitrary timeframe and force fitting audits into that is NOT what the standard requires. This might help shed light: https://www.the-center.org/Blog/May-2019/No-Time-for-ISO-9001
     
  18. tony s

    tony s Well-Known Member

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    When attempting to obtain documented evidences of conformity with the "shalls" of the standard, auditors should give more attention on "documents stating results achieved or providing evidence of activities performed". The reason why the definition of audit evidence specifically mentioned "records". Matrices and schedules don't fall under these documented evidences. They are planning documents, not evidentiary documents. To obtain evidence/s that the QMS and its processes were audited against the relevant shalls, auditors should look into the accomplished audit checklists/notes and audit reports.
     

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