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  1. Neo113016
    Post

    Context Of the Organisation

    No need to consider COTO as a process. You have already Strategic Planning and if your organization is regularly conducting SWOT Analysis, you...
    Post by: Neo113016, Mar 8, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  2. Neo113016
    Post

    Vendor Verification and Vendor Tracking

    Supplier Audit or Vendor Audit - this is conducted by organization to ensure that a supplier can provide the material and products meeting quality...
    Post by: Neo113016, Mar 1, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  3. Neo113016
    Post

    Vendor Verification and Vendor Tracking

    Try to conduct Supplier Audit in their premise.
    Post by: Neo113016, Feb 28, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  4. Neo113016
    Post

    Management Review that doesn't suck!

    Hi Arby! Visualize the whole organization as a patient and doing a regular consultation to a doctor (Top Management). Based on the data...
    Post by: Neo113016, Feb 22, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  5. Neo113016
    Post

    Quality System Auditor Qualification

    OK
    Post by: Neo113016, Jan 21, 2019 in forum: ISO 19011 - Auditing Management Systems Guidelines
  6. Neo113016
    Post

    Quality System Auditor Qualification

    I love the word "EMPATHY". And I agree that a lot of people lack this ability specially in internal auditing.
    Post by: Neo113016, Jan 11, 2019 in forum: ISO 19011 - Auditing Management Systems Guidelines
  7. Neo113016
    Post

    eAuditing......Taking It To The Next Level?

    Yes it is true, auditor being physically present at the site is what we have always done to ensure effectiveness of the activity. But considering...
    Post by: Neo113016, Jan 11, 2019 in forum: ISO 19011 - Auditing Management Systems Guidelines
  8. Neo113016
    Post

    eAuditing......Taking It To The Next Level?

    I totally agree Roxane. Virtual auditing will be the future of Quality Management System.
    Post by: Neo113016, Jan 10, 2019 in forum: ISO 19011 - Auditing Management Systems Guidelines
  9. Neo113016
    Post

    8.6.b) traceability to the person(s) authorizing the release.

    You should have an evidence to show who authorize the release.
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  10. Neo113016
    Post

    Using Job descriptions in Quality Manual

    No need to combine. As John have stated, an organizational chart should reflect the corporate intent.
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  11. Neo113016
    Post

    8.5.4 Preservation

    I agree with Qualmx, specifically the output of your Warehouse or Storage Area are preserved and damage free raw materials prior to use in the...
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  12. Neo113016
    Post

    Context of organisation

    If your organization is regularly conducting SWOT analysis, you have no problem with clause 4.1.
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  13. Neo113016
    Post

    9.3.2 evidences for Auditor

    It is clause 9.3.3 not 9.3.2. It is stated that "The organization shall retain documented information as evidence of the results of management...
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  14. Neo113016
    Post

    SOP/Work Instructions

    @KyleG Keep it simple. Always keep in mind to question "Why?" you need to document a SOP or work instruction.
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  15. Neo113016
    Post

    Multiple sites

    YES. Specify it in your SCOPE.
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  16. Neo113016
    Post

    An organization must follow its own procedures

    I agree with Andy on this one. @Phil Scott, there will be a lot of instances that an established procedure may not be followed step by step but...
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  17. Neo113016
    Post

    Change Control Process

    If your current processes are able to manage the changes to your key personnel, buildings, systems, equipment and other process then that is...
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  18. Neo113016
    Post

    Identifying Risk

    In your current process, have you establish targets or KPI? If yes, what are those things you think that can happen that will hinder your...
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  19. Neo113016
    Post

    Internal Auditor Certification

    The answer is No.
    Post by: Neo113016, Jan 9, 2019 in forum: ISO 9001:2015 - Quality Management Systems
  20. Neo113016
    Post

    5.3 Organizational Roles, Responsibilities, and Authorities

    If you have an updated organizational chart as well as job description for those personnel working under the HODs, then you have no problem.
    Post by: Neo113016, Jan 7, 2019 in forum: ISO 9001:2015 - Quality Management Systems
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