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  1. Richard Billings
    Post

    What's the purpose?

    The Internal Audit process should identify weaknesses or strengths in specific QMS processes.
    Post by: Richard Billings, Apr 10, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  2. Richard Billings
    Post

    Difference between clause 8.7 and 10.2

    It may not fit the title of 'Keep it simple' but it will help making sure they are 'consistently correct'.
    Post by: Richard Billings, Apr 10, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  3. Richard Billings
    Post

    7.5 documented information

    Issue and/or revision numbering is the best way to control documents of any type all traceable to a Master listing.
    Post by: Richard Billings, Apr 10, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  4. Richard Billings
    Post

    Management Review - Is attendance by top management required?

    Hogheaven, The Top Manager at your location should be in attendance at MR meetings he should also be involved in the objective setting exercise....
    Post by: Richard Billings, Apr 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  5. Richard Billings
    Post

    Management Review - Is attendance by top management required?

    If Top Management does not (shall) review the QMS as specified in clause 9.3.1 then it would be very difficult to defend his absence from the MR...
    Post by: Richard Billings, Apr 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  6. Richard Billings
    Post

    Clause 10:Demonstrate Continual Improvement

    Breakthrough Change and/or Innovation? You guys are making this more difficult than it really is. Why not just focus on the Risks and...
    Post by: Richard Billings, Apr 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  7. Richard Billings
    Post

    Responsibilities under ISO 9001

    If you have an organization chart whomever is designated as the senior manager for Design is accountable for the process - usually a Director or...
    Post by: Richard Billings, Apr 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  8. Richard Billings
    Post

    Management Review - Is attendance by top management required?

    Our VP of Operations 'lives for quality' he has always attended the MR meetings and everyone knows it. His buy-in, complete buy-in, is the number...
    Post by: Richard Billings, Apr 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  9. Richard Billings
    Post

    9.2 QA activities Outsourced Internal Audit to be conducted BEFORE or AFTER Management Review?

    It's not odd it's smart audit management.
    Post by: Richard Billings, Apr 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  10. Richard Billings
    Post

    Management Review - Is attendance by top management required?

    The risk is that the CB could raise a NC and we would have to hold a Management Review with Top Management in attendance. I don't know why some of...
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  11. Richard Billings
    Post

    Difference between clause 8.7 and 10.2

    I establish the parameters.
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  12. Richard Billings
    Post

    ...risk levels established by the laboratory.

    Our auditor's audit our procedures - are they being followed?
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 17025 - Calibration and Test Laboratories
  13. Richard Billings
    Post

    9.2 QA activities Outsourced Internal Audit to be conducted BEFORE or AFTER Management Review?

    I think I indicated in an earlier post that it really doesn't matter if the auditor makes a mistake and identifies a NC as an OFI because...
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  14. Richard Billings
    Post

    Difference between clause 8.7 and 10.2

    A root-cause will be completed only if we discover it is worthy of RC. That is why we are inspecting the POs - to determine the defect trend
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  15. Richard Billings
    Post

    9.2 QA activities Outsourced Internal Audit to be conducted BEFORE or AFTER Management Review?

    I don't know how many people you have doing Internal Audits but read some of their reports concentrate in particular on OFIs and see how many are...
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  16. Richard Billings
    Post

    ...risk levels established by the laboratory.

    Our auditors are fully trained and experienced. There's always the chance of being uncertain. We do classify the difference between OFI and NC.
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 17025 - Calibration and Test Laboratories
  17. Richard Billings
    Post

    Management Review - Is attendance by top management required?

    Clause 9.3.1 clearly states that 'Top Management shall review the QMS at planned intervals'. We hold what I call 'mini" MRs throughout the year....
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  18. Richard Billings
    Post

    Management Review - Is attendance by top management required?

    clause 9.3.1 "Top Management shall review...QMS at planned intervals..." It really is quite clearly defined.
    Post by: Richard Billings, Apr 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  19. Richard Billings
    Post

    Difference between clause 8.7 and 10.2

    Many POs have numerous sections that must be completed and many times these are not filled in. During an audit seeing numerous POs incomplete...
    Post by: Richard Billings, Apr 7, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  20. Richard Billings
    Post

    Clause 10:Demonstrate Continual Improvement

    Identify process weaknesses, and determine what needs to be done to improve a spefic process. Assign an owner, determine the time-line for...
    Post by: Richard Billings, Apr 7, 2019 in forum: ISO 9001:2015 - Quality Management Systems
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