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  1. Leonid
    Post

    Management Review

    @xrat86 Please refer to ISO/TS 9002:2016 "Quality management systems - Guidelines for the application of ISO 9001:2015". Its section 9.3...
    Post by: Leonid, Jun 7, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  2. Leonid
    Post

    No project to audit during 2020

    Totally ageee. Under the pandemic the CB can implement an appropriahte alternatve approach, for instance to postpone the forthcoming surveilance...
    Post by: Leonid, Jun 4, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  3. Leonid
    Post

    No project to audit during 2020

    The words “consider” or "take into consideration" mean it is necessary to think about but can be excluded, whereas “take into account” means it is...
    Post by: Leonid, Jun 4, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  4. Leonid
    Post

    No project to audit during 2020

    Please refer to ISO 17021-1:2015: 9.6 Maintaining certification 9.6.1 The certification body shall maintain certification based on demonstration...
    Post by: Leonid, Jun 2, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  5. Leonid
    Post

    No project to audit during 2020

    Afraid to say ISO 9001 does not say so.
    Post by: Leonid, Jun 2, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  6. Leonid
    Post

    No project to audit during 2020

    IMHO the internal audit and management review are not the main issue. In the absence of activities within the QMS scope, the Certification Body...
    Post by: Leonid, May 30, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  7. Leonid
    Post

    That old chestnut that is 8.3 Design & Development

    We are discussing the case being not informed what is the scope and how the nonconformity is formulated.
    Post by: Leonid, May 10, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  8. Leonid
    Post

    That old chestnut that is 8.3 Design & Development

    The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision...
    Post by: Leonid, May 10, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  9. Leonid
    Post

    That old chestnut that is 8.3 Design & Development

    @Steve Morris: Strength of the containers seems to be important for preservation of conformity of the materials during transportation. Are the...
    Post by: Leonid, May 10, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  10. Leonid
    Post

    Top Management Review but Not Plan?

    In my humble opinion the Top management’s role in QMS planning is mentioned clearly enough. To plan the QMS one needs to have quality objectives...
    Post by: Leonid, May 8, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  11. Leonid
    Post

    What does "Opportunity" mean in ISO 9001's "Risk and Opportunity"?

    @Tony: These are two different "sometings". Doing the QMS makes it posible to improve it. Favorable cirumstances often occur in the external...
    Post by: Leonid, May 8, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  12. Leonid
    Post

    What does "Opportunity" mean in ISO 9001's "Risk and Opportunity"?

    Good day, @Andy Nichols. Long time no act. Hope, the quotations below make the issue clear. It should be «The organization shall determine the...
    Post by: Leonid, May 7, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  13. Leonid
    Post

    difference between Process performance and product conformity vs Monitoring and measurement results

    Good day @Rex Freeman. With reference to terms definitions in ISO 9000:2015: Process performance is the measurable results of the process. It...
    Post by: Leonid, May 6, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  14. Leonid
    Post

    Are KPI required under ISO9001:2015 or can you show Trend Analyes

    Good day @Jacquie Collins66 ISO 9001 requires to determine and apply the criteria and methods (including monitoring, measurements and related...
    Post by: Leonid, Feb 13, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  15. Leonid
    Post

    Risk based thinking

    ISO 9001 doesn't mention anything about neither operational nor strategic risk. Nonetheless it implicitly addresses both: (1) The organization...
    Post by: Leonid, Feb 9, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  16. Leonid
    Post

    What outcomes are expected from the consideration?

    Auditor validates effectiveness regardless it is good or bad. This will become clear after the validation.
    Post by: Leonid, Jan 28, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  17. Leonid
    Post

    What outcomes are expected from the consideration?

    I did not get "however". In addition to the conformity issue the internal audit shall provide information whether the quality management system...
    Post by: Leonid, Jan 27, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  18. Leonid
    Post

    What outcomes are expected from the consideration?

    There is no such requirement in the standard. 14k and 45k clarify in section A.3 “The word “consider” means it is necessary to think about the...
    Post by: Leonid, Jan 26, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  19. Leonid
    Post

    What outcomes are expected from the consideration?

    According to 9.2.1 internal audits shall provide information on whether the quality management system is effectively implemented and maintained....
    Post by: Leonid, Jan 26, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  20. Leonid
    Post

    What outcomes are expected from the consideration?

    Audit results indicated worsening the effectiveness of processes. Root causes were considered and a combined corrective action plan was approved....
    Post by: Leonid, Jan 23, 2020 in forum: ISO 9001:2015 - Quality Management Systems
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