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  1. Randy A. Kaczynski
    Post

    Do I need to have a SINGLE major risk?

    If you want to comply with ISO 9001:2015 and demonstrate RBT, just follow the 6.1 requirements. 'Nuff said! ;)
    Post by: Randy A. Kaczynski, Apr 13, 2017 in forum: ISO 9001:2015 - Quality Management Systems
  2. Randy A. Kaczynski
    Post

    Do I need to have a SINGLE major risk?

    I disagree with the prior statement --- All you are required to demonstrate is "risk based thinking". The requirements are in 6.1 (Actions to...
    Post by: Randy A. Kaczynski, Apr 10, 2017 in forum: ISO 9001:2015 - Quality Management Systems
  3. Randy A. Kaczynski
    Post

    Training management on new ISO 9001:2015

    The management system is no longer just the in the domain of the quality manager. The requirement to ensure that the QMS integrates with the...
    Post by: Randy A. Kaczynski, Mar 7, 2017 in forum: ISO 9001:2015 - Quality Management Systems
  4. Randy A. Kaczynski
    Post

    8.7 Conrtrol of Nonconforming Outputs VS 10.2 Nonconformity and Corrective Action

    Per ISO 9002:2016, 8.7.1 The intent of this subclause (8.7 Control of nonconforming outputs) is to prevent the unintended delivery or use of...
    Post by: Randy A. Kaczynski, Mar 7, 2017 in forum: ISO 9001:2015 - Quality Management Systems
  5. Randy A. Kaczynski
    Post

    Document revision for ISO9001:2015 preparation

    The one thing that top management cannot delegate is their accountability for the effectiveness of the QMS.
    Post by: Randy A. Kaczynski, Mar 6, 2017 in forum: ISO 9001:2015 - Quality Management Systems
  6. Randy A. Kaczynski
    Post

    Books on all ABout ISO 9001 2015

    I recommend this online training as one possible resource for you - http://qcaonline.com/mastering-iso-9001-sales-page
    Post by: Randy A. Kaczynski, Nov 11, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  7. Randy A. Kaczynski
    Post

    Management Review Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance"

    I have come to the conclusion that these two MR inputs are generally of the same type, with slightly different focuses, that is – 9.3.2.c.3...
    Post by: Randy A. Kaczynski, Sep 8, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  8. Randy A. Kaczynski
    Thread

    Management Review Inputs (9.3.2) - "monitoring and measurement results" vs. "process performance"

    Referring to this clause 9.3.2, what is the difference between "monitoring and measurement results" and "process performance"? 9.3.2 Management...
    Thread by: Randy A. Kaczynski, Sep 8, 2016, 5 replies, in forum: ISO 9001:2015 - Quality Management Systems
  9. Randy A. Kaczynski
    Post

    Does the phrase "take into consideration" mandatory?

    Your question is very interesting. In looking through ISO 9001:2015 I see that the phrase "shall consider" is used multiple times in other...
    Post by: Randy A. Kaczynski, Sep 1, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  10. Randy A. Kaczynski
    Post

    Processes vs manual

    Per ISO 9000:2015 - 3.8.8 quality manual specification (3.8.7) for the quality management system (3.5.4) of an organization (3.2.1) 3.4.1...
    Post by: Randy A. Kaczynski, May 16, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  11. Randy A. Kaczynski
    Post

    Difference between clause 8.7 and 10.2

    Yes. ISO TC 176 www.iso.org/tc176/sc02/public
    Post by: Randy A. Kaczynski, Apr 20, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  12. Randy A. Kaczynski
    Post

    Difference between clause 8.7 and 10.2

    Per ISO's "Correlation matrices between ISO 9001:2008 and ISO 9001:2015", 8.7, Control of nonconforming outputs (2015) <---> 8.3, Control of...
    Post by: Randy A. Kaczynski, Apr 13, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  13. Randy A. Kaczynski
    Post

    Monitoring and measuring devices

    Referring to ISO 9000:2015 -- 3.11.3 monitoring determining (3.11.1) the status of a system (3.5.1), a process (3.4.1), a product (3.7.6), a...
    Post by: Randy A. Kaczynski, Apr 13, 2016 in forum: ISO 9001:2015 - Quality Management Systems
  14. Randy A. Kaczynski
    Post

    Quality System Auditor Qualification

    Typically, we team a newly (externally) trained auditor with an experienced (lead) auditor to perform audits together to serve as continuing...
    Post by: Randy A. Kaczynski, Dec 1, 2015 in forum: ISO 19011 - Auditing Management Systems Guidelines
  15. Randy A. Kaczynski
    Post

    New ISO 9001... RBT seriously ... what could happen.

    Having local work instructions, etc., in the local language is a key requirement for communication, understanding and implementation; and is not a...
    Post by: Randy A. Kaczynski, Aug 19, 2015 in forum: ISO 9001:2015 - Quality Management Systems
  16. Randy A. Kaczynski
    Post

    Legal requirements compliance ... To keep OR keep away from QMS

    ISO/FDIS 9001:2015 reference to the "applicable statutory and regulatory requirements" refer only to the products and services provided, nothing else.
    Post by: Randy A. Kaczynski, Aug 19, 2015 in forum: ISO 9001:2015 - Quality Management Systems
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