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Medical device Non-conformance based on ISO 14971 ?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by John C. Abnet, Nov 30, 2021.

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  1. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day QFO team...specifically those of you with ISO 13485 medical device expertise.

    I was in conversation with an organization today. They are certified to both ISO 13485 and ISO 9001.
    During an ISO 13485 audit, they received a nonconformance in regard to their lack of compliance to
    ISO 14971 (referenced in 13485 but not listed as a "normative reference")

    Does this make sense?

    Thank you.
     
    John C. Abnet, Nov 30, 2021
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  2. yodon

    yodon Well-Known Member

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    7.1 does require that the "organization shall document one or more processes for risk management in product realization" but to directly "require" compliance to 14971 is overstepping (unless they say that's how they comply with 7.1 somewhere else).

    Frankly, I would suggest that compliance to 14971 is their best path forward, anyway. They're going to run into all sorts of roadblocks and extra reviews otherwise.
     
    yodon, Nov 30, 2021
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Citing ISO 14971 is as bogus as citing ISO 31000 for an ISO 9001 certified company. From the ISO abstract:

    This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

    The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

    The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.

    It's a guide. Cite the part of ISO 13485 or go home, auditor...
     
    Andy Nichols, Dec 1, 2021
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  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Thanks for cutting to the chase (as always) @Andy Nichols !
    I assumed that was the position (thus this post), but wanted to make sure by tapping some of you more expert in this particular field.

    Thanks again Andy.

    Be well.
     
    John C. Abnet, Dec 1, 2021
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'll have you know I'm a nearly fully MedMAPP/MedAccred certified something or other and there aren't many of us in the country...:D
     
    Andy Nichols, Dec 1, 2021
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  6. John C. Abnet

    John C. Abnet Well-Known Member

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    O
    Of course. That's why I appreciate having you as a resource ;)
     
    John C. Abnet, Dec 1, 2021
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