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ISO 9001:2015 Clause 8.3

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Ben Garcia, Jan 25, 2021.

  1. Ben Garcia

    Ben Garcia Member

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    What are the pros and cons of including clause 8.3? Our current company is evaluating the possibility of implementing it for our certification.
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Ben Garcia and welcome to the site.
    Is your organization...
    1- already certified to ISO 9001 with an "exclusion" claimed for 8.3 and you're considering removing the "exclusion" from your scope ?

    or...

    2- Pursing 9001 certification and considering whether or not to include/exclude 8.3 ?

    Please advise.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not sure what you mean about "pros and cons" of the product design requirements. An organization either does product design or it doesn't. Hence, if you implement and want to certify a QMS in compliance with ISO 9001:2015, there is no discussion, "pro" or "con" of including/excluding it.
     
  4. Ben Garcia

    Ben Garcia Member

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    Hi John,
    We are already ISO Certified with an exclusion for 8.3 and we are considering removing the exclusion from our scope. We want to know what would be the pros and cons?

    Thanks in advance,
     
  5. John C. Abnet

    John C. Abnet Well-Known Member

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    What @Andy Nichols said Ben.

    See also, Appendix A.5, which states...
    "The organization can only decide that a requirement is not applicable
    if its decision will not result in failure to achieve conformity of products and services."


    And also, clause 4.3, which states...
    "The organization shall apply all the requirements of this International Standard if they are applicable
    within the determined scope of its quality management system."


    ...and....

    "The scope shall state the types of products and services covered, and provide
    justification for any requirement of this International Standard that the organization determines is not
    applicable to the scope"


    ...which are all consistent with what @Andy Nichols said.

    Hope this helps.
    Be well.
     
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  6. Ben Garcia

    Ben Garcia Member

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    .

    We have the capability to design products base in customer requirements however, we want to design our own products.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In that case, once you have established the processes, then you should contact your CB and they will arrange for an "extension to scope" audit to be conducted, at your convenience (next surveillance or special visit).

    I'd suggest that you document & implement the whole, major change, through the following:

    • Discuss impending change at Management Review
    • Assign a Team, including a Process Owner, to develop the Product Design process, including compliance to the 8.3 requirements, timeline etc.
    • Develop the Process, including those affected, if not directly involved in product design (sales, marketing, manufacturing, service etc - don't forget key suppliers)
    • Ensure D & D personnel are competent.
    • Set and document D & D objectives and measurables (SMART objectives), communicate objectives etc.
    • Implement a New Product through the D & D process, measuring progress to objectives
    • Perform internal audits at key stages to ensure process is a) implemented as planned and b) effective
    • Perform a Management Review on the outcomes, rinse and repeat.
    • Revise scope of QMS, update Quality Manual (if used) etc.
    • Schedule CB audit of scope extension
     
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  8. John C. Abnet

    John C. Abnet Well-Known Member

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  9. Ben Garcia

    Ben Garcia Member

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    Thanks Andy, (I think a have tons of documentation to review and implement
     
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  10. John C. Abnet

    John C. Abnet Well-Known Member

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    A little concerned about this statement @Ben Garcia . What does your organization currently do to control activity related to design? "Documentation" should never be created for the auditor. What does your organization need? Always approach these things selfishly....i.e. do what is best for YOUR organization (in a manner which meets the requirements of the standard).

    Hope this helps.

    Be well.