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  1. BufferMess
    Post

    Addressing Clause 4.1 and 6.2

    You might not need to assess or rank your risks and opportunities but you still need to assess potential impact of the determined risks and...
    Post by: BufferMess, Nov 25, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  2. BufferMess
    Post

    Audits/Checklist

    The OP already has a verification plan for food safety system but she wants to make it simple for monthly audits (inspections?). Audits are not...
    Post by: BufferMess, Apr 18, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  3. BufferMess
    Post

    Audits/Checklist

    For a mini/monthly audit, process audits are more than enough to verify the processes are efficient at delivering conforming outputs. For food...
    Post by: BufferMess, Apr 17, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  4. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    I appreciate your point of view. I supposed the thread was about continual improvement. My explanation of continual improvement is too...
    Post by: BufferMess, Apr 16, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  5. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    I think there is a confusion between the requirements for "continual improvement" in ISO9001:2008 and ISO9001:2015. Many auditors and...
    Post by: BufferMess, Apr 15, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  6. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    I don't think so. "breakthrough change" causes some degree of disruption. It does not fit the requirements in clause 10.3 and PDCA cycle is not...
    Post by: BufferMess, Apr 14, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  7. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    I don't mean the SixSigma is not allowed. An organisation must improve efficiency of processes and effectiveness of the QMS in a frequently...
    Post by: BufferMess, Apr 13, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  8. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    Arguable. The QMS is not a methodology like SixSigma. No matter how an organisation improves customer satisfaction, the effectiveness can not be...
    Post by: BufferMess, Apr 12, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  9. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    According to google, continual (adjective) - forming a sequence in which the same action or event is repeated frequently. There are few articles...
    Post by: BufferMess, Apr 11, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  10. BufferMess
    Post

    Clause 10:Demonstrate Continual Improvement

    Sorry but breakthrough change and innovation is not what ISO9001 actually requires with Continual Improvement. Continual Improvement is not...
    Post by: BufferMess, Apr 10, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  11. BufferMess
    Post

    Quality Management System and its Processes.

    Procedures are different than processes in many ways. Usually in a QMS where a QMR is active, he or she is the one preparing the procedures and TM...
    Post by: BufferMess, Feb 27, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  12. BufferMess
    Post

    Calibrated equipment

    @senior. Your company failed to verify calibration status of the new measuring equipment. "prior to use" pretty much defines the NC...
    Post by: BufferMess, Jan 23, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  13. BufferMess
    Post

    Strategic Direction

    @KyleG. Strategic direction shapes your context, quality policy and objectives. The QMS of your organization needs to be in alignment with the...
    Post by: BufferMess, Jan 23, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  14. BufferMess
    Post

    Process Validation - Injection Moulding Process

    Perfect. You are on the right direction. You actually employed both - initial validation study and subsequent verification of the validated model.
    Post by: BufferMess, Jan 23, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  15. BufferMess
    Post

    Calibrated equipment

    The standard specifically requires to calibrate measuring equipment used for the conformity of products. It is not about all measuring equipment....
    Post by: BufferMess, Dec 28, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  16. BufferMess
    Post

    Identifying Risk

    Hi KyleG. You should elaborate on "works better" when considering a change in the process. Which parameters will work better if you change the...
    Post by: BufferMess, Dec 11, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  17. BufferMess
    Post

    The difference between quality objectives and process performance.

    We still need top management, allocation of resources and responsibilities for setting an objective to a lower level, function or process.
    Post by: BufferMess, Nov 20, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  18. BufferMess
    Post

    The difference between quality objectives and process performance.

    Process KPIs are set at process level. Quality objectives are set at organizational level. Process effectiveness is measured to evaluate process...
    Post by: BufferMess, Nov 19, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  19. BufferMess
    Post

    7.1.5.2 Measurement Traceability

    No, surveys, calculations, estimations, observations and such do not count. You should consider only measuring devices.
    Post by: BufferMess, Nov 16, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  20. BufferMess
    Post

    7.1.5.2 Measurement Traceability

    "equipment" was replaced with "resources" in ISO9001:2015. The requirements are similar. You should have your measurement devices approved for the...
    Post by: BufferMess, Nov 15, 2018 in forum: ISO 9001:2015 - Quality Management Systems
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