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No project to audit during 2020

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Kodirl, Jan 11, 2021.

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  1. Kodirl

    Kodirl Member

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    Hi everyone.

    Hopefully someone can shed some light for me on the following....

    I work in the construction industry and last year we had a construction project that we had started to work on but was shelved after only two months due to Covid-19 and will not be re-starting.

    We are due to have our annual ISO surveillance audit next month and are only now mobilising personnel on another project.

    Is it mandatory that we have performed a processes/systems audit during a calendar year for ISO certification? We have put our management review that was due to take place in December on hold until after we have completed our first audit on the new project, which will most likely be in March but then we cannot show evidence in next months audit that management review has taken place.

    Any advice welcome on the above.
     
    Kodirl, Jan 11, 2021
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "Mandatory" comes from only 2 places. The standard and your own QMS. It certainly doesn't say anything even remotely like that in ISO 9001, so what does your own QMS state?
     
    Andy Nichols, Jan 11, 2021
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  3. Kodirl

    Kodirl Member

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    Our QMS states "The internal audit programme is prepared to ensure a complete audit of all elements within the Quality System during a twelve month period"..........
     
    Kodirl, Jan 12, 2021
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why was that put into the QMS? It's not a requirement of ISO 9001! Sadly you will attract a non-conformity. When you write things into the QMS which are a) not in the standard, b) not a customer requirement and/or c) not a contractual CB requirement (why would you?) then you attract opportunities to be held to things which cause problems.

    Scheduling of internal audits has never been about a calendar or some other time-based criteria. It's about events, changes, poor performance and such like. Those don't happen on a regularized basis.

    Make a change to the text in your QMS, because of COVID-19 and use event-based audit programming.
     
    Andy Nichols, Jan 12, 2021
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  5. Kodirl

    Kodirl Member

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    Thank you Andy. Also, thanks for recommending joining the mentoring program for CQI/IRCA it has been very helpful!
     
    Kodirl, Jan 12, 2021
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  6. tony s

    tony s Well-Known Member

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    9.2.1 may have mentioned "to provide information on whether the quality management system conforms to the requirements of this International Standard". But don't schedule the audits based on the elements to be covered. Schedule the audit as Andy suggested. Cover only those elements relevant to the area/function/process being audited, if necessary.
     
    tony s, Jan 14, 2021
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  7. Pamvvietnam

    Pamvvietnam New Member

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    Clause 9.6.2.2 ISO 17021 (a): internal audit and management review
    And 9.2.2 (a)...plan, establish, implement and...an audit programme including the frequency (Scheduling of internal audits has never been about a calendar or some other time-based criteria. It's about events, changes, poor performance and such like)
    Hi @Andy Nichols . How does the organization prove this is conformity if Internal audit?
     
    Pamvvietnam, May 22, 2021
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Which are you asking about?
     
    Andy Nichols, May 22, 2021
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  9. Pamvvietnam

    Pamvvietnam New Member

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    Sorry. Surveillance activities: Clause 9.6.2.2 ISO 17021 (a): internal audit and management review.
    How does the organization prove this is conformity if CB review Internal audit report
     
    Pamvvietnam, May 27, 2021
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Under the Certification Body "rules" (in ISO/IEC 17021) a certified organization must have, at each surveillance event, an audit of key indicators of the maintenance of their QMS - which includes internal audits and management review. The certified organization must provide evidence that their audits and management review complies with the requirements of 9.2 and 9.3. Typically, for internal audits this means audit planning, preparation of checklists, auditor notes, audit reports and so on. For management review, it often includes meeting planning (if the review is held as a meeting), preparation of QMS data, minutes of discussions and action items assigned etc.
     
    Andy Nichols, May 27, 2021
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  11. Pamvvietnam

    Pamvvietnam New Member

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    Thank you @Andy Nichols
    In Vietnam, We generally comply with CB .'s Surveillance activities regulations
    most organizations internal audit a calendar year for QMS ( (once a year).
     
    Pamvvietnam, May 28, 2021
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Which doesn't comply with the requirements stated in 9.2!
     
    Andy Nichols, May 28, 2021
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  13. Leonid

    Leonid Well-Known Member

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    IMHO the internal audit and management review are not the main issue. In the absence of activities within the QMS scope, the Certification Body cannot maintain the certification.
     
    Last edited by a moderator: May 30, 2021
    Leonid, May 30, 2021
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can you cite any authoritative reference?
     
    Andy Nichols, May 30, 2021
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  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Nothing in ISO 9001:2015 specifically states that every process must be audited every calendar year. It does say audits will be planned based on status, performance and results of previous audits. If a process is not active in a scheduled year, nothing in the standard forbids you to reschedule. I usually see a note in the schedule explaining the change. Such a note exhibits the specific language of 9.2 "...changes affecting the organization..." because changes includes the circumstances that impacts the process. Those are among the issues referred to in 4.1.

    CBs will likely expect to see all of the QMS audited within the 3-year certification period, and if there are multiple shifts they will expect to be covered too.
     
    Jennifer Kirley, May 31, 2021
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  16. Leonid

    Leonid Well-Known Member

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    Afraid to say ISO 9001 does not say so.
     
    Leonid, Jun 2, 2021
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  17. Leonid

    Leonid Well-Known Member

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    Please refer to ISO 17021-1:2015:
    9.6 Maintaining certification
    9.6.1 The certification body shall maintain certification based on demonstration that the client continues to satisfy the requirements of the management system standard.
    9.6.2.1.2 Surveillance activities shall include on-site auditing of the certified client’s management
    system’s fulfilment of specified requirements with respect to the standard to which the certification is
    granted.
    9.6.2.2 Surveillance audits are on-site audits, but are not necessarily full system audits, and shall be planned
    together with the other surveillance activities so that the certification body can maintain confidence
    that the certified management system continues to fulfil requirements between recertification audits.

    How can the CB maintain confidence if no activities within the QMS scope were conducted?
     
    Leonid, Jun 2, 2021
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  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed. However, you may be also overlooking the fact that the IAF has permitted alternative approaches under IAF ID-3 for such events as the pandemic etc.
     
    Andy Nichols, Jun 2, 2021
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  19. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Okay, it says "...shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits."
     
    Jennifer Kirley, Jun 3, 2021
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  20. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    If your QMS is too confining, why not change it?
     
    Jennifer Kirley, Jun 3, 2021
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