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  • 1.  ISO 13485:2016 clause 4.1.4

    Posted 24-Oct-2018 14:08
    Hi Everyone,

    I am puzzled as to how address this requirements in our QMS.
    The clause 4.1.4 in ISO 13485:2016 says:

    " The organization shall manage these quality management system processes in accordance with
    the requirements of this International Standard and applicable regulatory requirements. Changes to be
    made to these processes shall be:
    a) evaluated for their impact on the quality management system;
    b) evaluated for their impact on the medical devices produced under this quality management system;
    c) controlled in accordance with the requirements of this International Standard and applicable
    regulatory requirements."

    I confused as all the processes are going to impact our quality system and devices in one way or the other.
    Any ideas on how to address this?

    Thanks,
    Sheemah

    ------------------------------
    Sheemah Kazi
    QA/RA coordinator
    Concord CA
    United States
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  • 2.  RE: ISO 13485:2016 clause 4.1.4

    Posted 25-Oct-2018 08:24

    The best approach is to break down the requirement for analysis.

     

    You must establish processes in your QMS. The processes come from two sources. One is the requirements in ISO 13485:2016. The second is the requirements from each regulatory region in you market products. For example, ISO 13485:2016 requires a process for advisory notices – look at 8.3.3. However, if you market devices in the US then the regulatory requirements are in Part 806. If you market in the EU, the regulatory requirements are in the MDD for a Field Safety Corrective Action.

     

    Assume the processes are set-up and running, but you want to make a change to one of the processes. For example, you could have a change that improves the efficiency of the process.

     

    First you must do some evaluations. Evaluation compares something against a requirement to make a decision.

     

    The first evaluation is whether the change impacts the QMS. The answer is almost certainly yes, but is the impact positive or negative. Presumably positive or you would not make it. There may be other elements in the evaluation. For example, if your QMS is based on EU-MDD Annex II, then paragraph 3.4 requires, "The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered." Use the NB's definition of substantial as one side of the evaluation, use your description of the change on the other side. The evaluation determines whether the change is substantial and must be reported to the NB.

     

    The second evaluation is whether the change has any impact on the devices produced under the QMS. Here it could be positive, negative, or none.

     

    The third point is control of the changes. Make sure you follow the requirements of the standard and any other regulatory requirements.

     

    In particular, create a quality record for each evaluation and the conclusion.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: ISO 13485:2016 clause 4.1.4

    Posted 25-Oct-2018 10:27
    Sheemah,

    I am working through similar questions as part of an annual review of the QMS documents.  These are General Requirements that are likely incorporated in a Management of Change procedure.  In the QSR preamble FDA describes control of change in this way, "While change is a healthy and necessary part of product development, quality can be ensured only if change is controlled and documented in the development process, as well as the production process."  

    My auditors ask these questions related to paragraph 4.1.4

    • How are changes to the QMS evaluated?

    • How is the impact to medical devices considered before changes are made?

    • How are changes to the QMS or products controlled?



    Respectfully,

    ------------------------------
    William Coulston
    Quality & Regulatory Affairs
    San Antonio TX
    United States
    ------------------------------

    Original Message


  • 4.  RE: ISO 13485:2016 clause 4.1.4

    Posted 25-Oct-2018 11:21
    As Dan stated, the processes are required by either the ISO or FDA requirements or a combination of both.  Each of your processes should be documented.  If you have a robust change control process you will be able to show documented evidence of the review to your product and quality system.  If your change control process does not include this, consider adding these to your process.  You can have a Yes/ No about the impact which will drive additional requirements to your change process. This alleviates extra, NVA non-value added requirements to simple changes to your system or documentation. As with most things, risk is always a factor...
    In addition, if these changes are deemed to be significant (either positive or negative) they should also be discussed during management review.
    Good Luck,
    ~Deb

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    Deb Hervieux
    Compliance & Regulatory Affairs Engineer
    Foxboro MA
    United States
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    Original Message


  • 5.  RE: ISO 13485:2016 clause 4.1.4

    Posted 25-Oct-2018 12:17

    ​Hi Sheemah,

    We have addressed this via management review. Every quarter I review if there are any new regulations, standards or guaidances and report back to the management team if they would impact our QMS or production of medical devices. If there is an impact, we set up appropriate actions, which is a control of changes under the standard.

    The big changes coming are MDR and IVDR if you selling in EU.

    Hope this helps,



    ------------------------------
    Vesna Janic
    Starfish Medical
    Victoria BC
    Canada
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    Original Message


  • 6.  RE: ISO 13485:2016 clause 4.1.4

    Posted 26-Oct-2018 08:57
    As mentioned you need to have a well-established change control system for not only changes to QMS procedures, but to product information as well.  I see a few companies that have a Engineering Change process that only addresses changes to components, assemblies, the product ... it does not address changes to processes.  There needs to be a change control process for when SOPs, procedures, work instructions, manufacturing plans, component specifications, assembly instructions etc. etc., are changed to determine the impact.  Now determining the impact is the key part because who makes that decision? What is a significant change? What change would require notification to a regulatory authority?  This is where a robust change control system needs to be implemented.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 7.  RE: ISO 13485:2016 clause 4.1.4

    Posted 27-Oct-2018 10:46

    My concern is that reporting upcoming changes at management review does not satisfy the clause 4.1.4 requirement. In 5.6.2.j management review input includes changes that could affect the quality management system.

     

    Clause 4.1.4 is about managing the QMS changes, not informing management.

     

    The QMS needs to satisfy both elements.



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    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


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