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  • 1.  ISO 13485:2016: Clause 5.4.2(a) - Quality Management System Planning

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2021 16:45
    This message was posted by a user wishing to remain anonymous

    Hello RAC community,

    Can anyone provide examples or template or outline or information on how to comply with clause 5.4.2(a) in ISO 13485:2016?
    Should we prepare a plan on how we are going to implement the quality management system? or is Quality manual the plan?

    Thank You.

     



  • 2.  RE: ISO 13485:2016: Clause 5.4.2(a) - Quality Management System Planning

    Posted 19-Jul-2021 21:17
    Edited by Kevin Randall 19-Jul-2021 21:22
    I simply handle ISO 13485:2016 clause 5.4.2(a) by stating in the Quality Manual that:

    a) The organization has determined the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization. [Remember that those roles need to first be specified in an appropriate section of the Quality Manual.]

    b) This also includes planning the sequence and interaction of the QMS processes via the Quality Manual and the documented procedures included or referenced therein.

    c) Moreover, the organization applies a risk-based approach to the control of the appropriate processes needed for the quality management system as described in the corresponding subsection of the Quality Manual (e.g., see 'Risk-based approach' under 'Scope').

    d) The ultimate output of this planning is the Quality Manual and the procedures included or referenced therein.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: ISO 13485:2016: Clause 5.4.2(a) - Quality Management System Planning

    Posted 20-Jul-2021 01:09
    Hello Anon,

    Quality planning can encompass many different areas such as a Quality Plan for the organisation - "what are we doing" to a Quality Plan for a specific activity - "We are building a new cleanroom" - to a Quality Plan for a major event - "We are transitioning to EU MDR".  There are also many who create a quality plan for the product(s).  Or use their Quality Manual as a quality plan.  I would recommend reviewing ISO 10005 as this describes how quality planning can be used and also provides some examples.  Also do not think of a Quality Plan as just a document, but also consider it a process for how your organisation manages activities and events.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: ISO 13485:2016: Clause 5.4.2(a) - Quality Management System Planning

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jul-2021 08:31
    This message was posted by a user wishing to remain anonymous

    I have seen "quality plan" used generically to mean any project plan authored by the Quality department. Sometimes it's more specifically about a level of product quality the company is aiming for and the various activities being undertaken to get there.​
    Original Message


  • 5.  RE: ISO 13485:2016: Clause 5.4.2(a) - Quality Management System Planning

    Posted 20-Jul-2021 09:34
    Edited by Kevin Randall 20-Jul-2021 09:36
    I think it's important to remember that the general quality management system planning and set-up called for by ISO 13485 clause 5.4.2(a) is fundamentally distinct from clause 7.1's product/project/object/output-oriented planning.  If they were the same, then ISO TC/210 would not have separated and distinguished clauses 5.4.2(a) and 7.1.

    Clause 5.4.2(a) general quality management system planning is aimed at the more fundamental quality management system setup, implementation, and maintenance of clause 4.1.  By contrast, ISO TC/210 has traditionally maintained and currently maintains that a clause 7.1 "quality plan" is instead a product/project/object/output-oriented plan generated to support product realization.  Indeed, the scope and intent of ISO 10005 correlates with clause 7.1 quality plans (i.e., product realization plan, i.e., Widget XYZ realization plan, etc.) rather than clause 5.4.2(a) general quality management system planning.

    While an ISO 13485 clause 7.1 / ISO 10005 quality plan may indeed address the need for particular quality management system features specific to the object/output of the quality plan, it is nonetheless important that a clause 7.1 quality plan not be confused or equated with clause 5.4.2(a) general quality system planning.

    Another way to explain it is that the organization might have multiple clause 7.1 / ISO 10005 quality plans addressing the product realization requirements for various tangible Widgets, projects, or other product realization outputs, whereas clause 5.4.2(a) quality management system planning is a singular (yet ongoing) planning process.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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