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  1. Artem
    Post

    Unmet objective - is it a nonconformity?

    Hi Tony Failing to meet an objective is a non conformity for a company itself (something went wrong with either planning or implementation). But...
    Post by: Artem, Nov 24, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  2. Artem
    Post

    Unmet objective - is it a nonconformity?

    Normally at audits in order to establish the situation with the objectives i would compare objectives of the last year and... one but last :)...
    Post by: Artem, Nov 23, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  3. Artem
    Post

    9.3.2 evidences for Auditor

    Often auditor would ask within „changes“ a) if you track changes in applicable regulation (do you do this by the way) b) list of corrective...
    Post by: Artem, Nov 13, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  4. Artem
    Post

    A few questions about ISO 9001:2015 8.5.6 and 7.5.3

    Wow... „since 1987“, „one or two experiences“. I thought we are talking about quality here, not quantity. P.S. good that you draw a perfectly...
    Post by: Artem, Oct 18, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  5. Artem
    Post

    A few questions about ISO 9001:2015 8.5.6 and 7.5.3

    Non conformity per se is not only audit topic, but ok...
    Post by: Artem, Oct 17, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  6. Artem
    Post

    A few questions about ISO 9001:2015 8.5.6 and 7.5.3

    Who gave „best“ practice?! I gave a „good“ only. Why you never read my posts with attention Andy? ;) For medical products you need to preserve...
    Post by: Artem, Oct 17, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  7. Artem
    Post

    A few questions about ISO 9001:2015 8.5.6 and 7.5.3

    Hi Davin, I have drafted a small explanation of the changes process (attached). Please note that 8.5.6 is not a documentation changes clause....
    Post by: Artem, Oct 17, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  8. Artem
    Post

    6.2.1 c) The organization shall establish quality objectives

    Hi, As i was analyzing what to answer I also though about a collision of the word Objective with Tolerances, Targets, etc. if we consider a...
    Post by: Artem, Oct 3, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  9. Artem
    Post

    6.2.1 c) The organization shall establish quality objectives

    Hi Andy, Please read the flow again - besides such environmental words as „toxic“ there are words like „purchasing process“, „line cleaning“,...
    Post by: Artem, Oct 3, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  10. Artem
    Post

    6.2.1 c) The organization shall establish quality objectives

    Hi, I hope you are from a manufacturing company and my illustration attached will help. If you find it illustrative enough - ask your questions...
    Post by: Artem, Oct 3, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  11. Artem
    Post

    8.3 Design and development

    Hi Dennis, Do you think it is possible to show us the process as it was before the audit? Or at least a simulation of a part of it? I think we...
    Post by: Artem, Sep 28, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  12. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    Well I definitely like the discussion around this post :) What shall I answer to you? As you gave a „stick“ saying at the end of your answer I...
    Post by: Artem, Sep 28, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  13. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    Oh this is for sure - I never claimed it to be sufficient, did I :) I am a great fan of iso 9001 as a standard, but I am great opponent of...
    Post by: Artem, Sep 28, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  14. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    Following your logic - sampling and measurement of produced goods is not a control - it is a confidence gaining for a production manager and...
    Post by: Artem, Sep 28, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  15. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    Is control not made by sampling in principle? An audit is a control mechanism. And you entrust this mechanism first of all to certified suppliers...
    Post by: Artem, Sep 27, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  16. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    Always willing to help :) Basically this is as easy as with any control. You set a criteria (have an iso 9001 certified qms) and make sure this...
    Post by: Artem, Sep 27, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  17. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    Some things to consider: - you can exercise control in any form. Be it sneaking into LinkedIn profiles of suppliers employers or making sure that...
    Post by: Artem, Sep 27, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  18. Artem
    Post

    Are our outsourcing organizations and suppliers must ISO 9001 certified?

    There is no such requirement. You need only to exercise control over them. One way of controlling MAY be that YOU require them to get certified....
    Post by: Artem, Sep 27, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  19. Artem
    Post

    5.3 Organizational Roles, Responsibilities, and Authorities

    Hi, I assume this is not an ISO clause but a requirement of a customer (auditor), right? The way it is formulated is clearly not out of any...
    Post by: Artem, Sep 26, 2018 in forum: ISO 9001:2015 - Quality Management Systems
  20. Artem
    Post

    Management Review acc. to ISO9001:2015 - example

    Hi Kristof Basically - this is about making sure that changes in environment, market, Regulation,etc (external ones) as well as changes in...
    Post by: Artem, Sep 25, 2018 in forum: ISO 9001:2015 - Quality Management Systems
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