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  • 1.  Quality Manual and device classification

    This message was posted by a user wishing to remain anonymous
    Posted 11 days ago
    This message was posted by a user wishing to remain anonymous

    Do you indicate your device classification in the Quality Manual?


  • 2.  RE: Quality Manual and device classification

    Posted 11 days ago
    No, that's not required, and if you have many devices in many jurisdictions, you may have many classifications, too, and the quality manual would be an awkward place to keep track of them.

    The quality manual just needs to cover the scope of activities that are relevant for your responsibilities for your device(s).


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    Anne LeBlanc
    United States
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  • 3.  RE: Quality Manual and device classification

    Posted 8 days ago
    The Quality Manual should most definitely indicate the device classification.  Here's some background showing why:

    In the context of ISO 13485 (or its various derivatives like EN ISO 13485) as amended, remember that it requires the organization to identify the applicable regulatory requirements, and to deliberately incorporate those into the quality management system (QMS).  Remember also 13485's prescription that, "regulatory requirements" specifically means the requirements for the QMS, and for device safety and performance.

    Consequently, the identification of the device classification is ultimately paramount to identifying the applicable regulatory requirements for the QMS in accordance with ISO 13485.  For example, certain jurisdictions enforce QMS scope based on device class, such as U.S. GMP-exempt device classification regulations.

    And since the Quality Manual is required by ISO 13485 to include the QMS scope and the details/justification for any exclusion or non-application (which are generally driven by device type and class, among other things), then the Quality Manual really does need to include a statement of the device class that establishes the basis for the QMS's scope.

    I had a prominent longstanding Notified Body declare my Quality Manual to be the best they'd ever seen.  That's not to brag, but instead to encourage you that you too can enjoy the same kinds of results by employing strategies like those I've modeled here in this thread.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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  • 4.  RE: Quality Manual and device classification

    Posted 7 days ago
    Or you can have that classification in a regulatory plan, with well thought out justification for class, applied rules, and based on device design/features in all applicable regions.

    Why clutter the Quality Manual ?  Just my two cents.




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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 5.  RE: Quality Manual and device classification

    Posted 7 days ago

    Hey Ginger. Ultimately, this topic can certainly be sliced and viewed different ways. And since, for example with ISO 13485, there is no direct normative / standardized requirement to state the device class in the Quality Manual, then we certainly can choose to not, as you say, "clutter" the Quality Manual with a few words identifying the device class(es). Yet it may be debatable whether such a few words would actually "clutter" the Quality Manual.  It could also be debatable whether we can truly realize an effective ISO 13485 Quality Manual without those few words. Either way, I'm thankful that ISO 13485, for example, and the FDA's 21 CFR Part 820, as another, allows us the flexibility to decide which approach we take.

    That said, my experience with ISO 13485 Registrars and Notified Bodies is that those few additional words about classification, in my opinion, actually bring continuity and coherence to an ISO 13485 Quality Manual's required QMS scope narrative and justification, and thus to the ISO 13485 QMS itself, since these are fundamentally driven by the device class. Indeed, for some folks or scenarios, it might actually be more cluttered if the Quality Manual's required QMS scope narrative and justification can't stand alone, where it instead is forced to rely on an additional separate QMS document(s) (e.g., a regulatory plan) maintained somewhere else, that oftentimes isn't needed at all, and that isn't a normative requirement.

    Here's a few other angles I've considered that seem to make it beneficial if the Quality Manual includes a few words identifying the covered device class(es):

    • ISO 13485:2016 brought a renewed emphasis on the requirement for the QMS to clearly identify and document the various applicable regulatory requirements (i.e., the laws, ordinances, regulations, etc.), along with the organization's specific "regulatory roles" played under those requirements. These, along with the related device class, are necessary in support of the Quality Manual's required QMS scope and justification narrative.  Therefore, it seems most succinct to state them in a simple supporting table and/or narrative in the Quality Manual so as to give basis for the QMS scope that must be asserted in the Quality Manual.

     

    • A longstanding rule of thumb is that it is most advisable to give a QMS auditor only the document that has been requested, or that is needed to answer the question. Accordingly, I'd rather not give a QMS auditor a regulatory plan / strategy document (and thus various unsolicited insights into other aspects of the QMS and organization) when the auditor is instead simply seeking to vet an ISO 13485 Quality Manual's required QMS scope and justification narrative.

     

    • It may not be possible to conform with ISO's traditional QMS documentation hierarchy pyramid (i.e., policy-level documents like the Quality Manual at the top in Tier I) followed later thereunder by corresponding records (i.e., Tier IV documents) such as a regulatory plan. Generating Tier IV records before generating the Tier I policies tends to conflict with the traditional ISO QMS documentation structure/hierarchy.

     

    In any event, as has been shared by Anne's, Ginger's, and Dan's great posts, there are a variety of alternative approaches that can work.



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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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  • 6.  RE: Quality Manual and device classification

    Posted 7 days ago
    You need to start with the role of the Quality Manual in your Quality Management System, QMS. Some companies view as a place to describe the whole system at a high level. This often results in a 20 or 30 page Quality Manual.

    When I'm asked to audit a QMS I always start at the Quality Manual. Invariably, the procedures that implement the activities in the QMS don't match the Quality Manual. Companies update procedures without ensure the change stays within the requirements of the Quality Manual. It is a rich source of audit nonconformances.

    My recommendation is to write a minimal Quality Manual and do all the work in the procedures. FDA QSR is the best, because it doesn't require a Quality Manual. ISO 13485:2016, 4.2.2 isn't too bad. The Quality Manual needs four things:
    • The scope of the quality management system, including details of and justification for any exclusion or non-application
    • The documented procedures for the quality management system, or reference to them
    • A description of the interaction between the processes of the quality management system
    • An outline of the structure of the documentation used in the quality management system

     In this minimalist approach, the class of your devices is at the wrong level for the Quality Manual.

    Someplace in your QMS a list of your devices and the class in each regulatory region is useful to help implement regulatory requirements. This should cover all the regulatory regions in which you market any device.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 7.  RE: Quality Manual and device classification

    Posted 7 days ago
    Edited by Kevin Randall 7 days ago
    Longstanding ISO precedent is that the organization may choose for the Tier I Quality Manual policies to be clerically paired in the Quality Manual with the corresponding Tier II implementing/operating procedures.  I don't generally recommend this approach, but it is nonetheless very much permitted by ISO and the FDA if that approach suits an organization.

    To expand upon Dan's great point about discrepancies between Tier II procedures located in the Quality Manual vs. redundant Tier II procedures simultaneously kept elsewhere, that nonconforming scenario is certainly common, but can easily be avoided by proper attendance to the traditional documentation hierarchy pyramid.  Specifically, an organization needs to either a) have the Tier II procedures wholly and exclusively encompassed only within the Quality Manual, or b) be sure that the Quality Manual is limited strictly to Tier I policy with no Tier II operating procedures, instead just referencing the Tier II procedures as is required by ISO and FDA.

    Finally, don't forget that FDA's Quality System Record (QSR) requirement in 21 CFR 820.186 is intended by FDA to be a requirement for a Quality Manual even though the Part 820 QS Regulation text uses the name Quality System Record instead of the "Quality Manual" terminology.  We know this to be true because, when FDA promulgated the 820.186 QSR requirement and published the corresponding preamble that FDA can use in court to show its intent, the agency did so for the fundamental purpose of echoing ISO's Quality Manual requirement.  In other words, when an FDA inspector asks us for our "Quality Manual" (I promise you they will use that terminology), and if we respond by declaring that there is no such FDA requirement, then that could easily become valid grounds for the FDA to issue a corresponding Form FDA 483 Observation.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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  • 8.  RE: Quality Manual and device classification

    Posted 6 days ago
    As you can see, there are a lot of different ways to cover this one. In  general, I lean to not having the classifications in the QM, for the following reasons:

    - if you have a lot of different SKUs in different classes and different rules, it either takes up a huge amount of space or requires reference to other documents anyway,
    - for a company that does business in a lot of geographies, with rules slightly different in differing geographies, these would need to be repeated for every SKU and every geography (ugh)
    - in principle, to me, the classification is part of the product documentation - much like design drawings etc are, and thus belong in the hierarchy which manages product configurations etc, not the highest level QS documents
    - if I change, gain/sell products etc, I have to update the QM. In most companies, everyone has to be trained on the QM, and I am not excited about surplus training tasks for busy employees just because we updated a product classification in some geography or other

    That said, if I was at a small company with only 1-2 products and very few geographies, I could be tempted to include in the QM rather than setting up another doc type for what then would hold only a couple "regulatory assessment" type documents. Plus, as Kevin points out, it makes it super easy to show you've assessed regulatory requirements in your QS.I still suspect I'd lean towards a separate landing spot, if only because to me it is way more scalable.

    Ginger



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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 9.  RE: Quality Manual and device classification

    Posted 6 days ago
    Thank you Ginger G. (and Ginger C. too!) for your insightful commentaries; very expert, informative, and helpful as always.

    I think the scalability piece is definitely important.  The way I've done that, even for diverse product portfolios, is via the same simple table I mentioned earlier.  After all, the entire universe of device classes is only three-to-four across all jurisdictions.

    And though each jurisdiction's three-to-four class scheme will have some unique relative aspects, they are nonetheless more similar than different.  Most often, for most scenarios, and maybe even for any scenario, the table will have only a few rows to state the organization's main device types/categories (e.g., like the standardized generic way it is stated by the Registrar on the QMS certificate itself, which doesn't list all the catalog numbers).  The device types/categories are directly linked to, and representative of, the device classes.

    As discussed earlier, ISO 13485:2016 has a pervasive fundamental intent that the applicable regulatory requirements for the QMS and product be seamlessly and organically woven into the very fabric of the QMS. Consequently, in an ISO 13485 QMS, the most succinct way to demonstrate that the organization actually understands, and has done this, is via the Quality Manual.  That is also an intrinsic goal of the ISO QMS Tier I level's documentation hierarchy.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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  • 10.  RE: Quality Manual and device classification

    Posted 5 days ago
    Not wanting to repeat all of the great methods, thoughts and suggestions already described, my addition would be to answer the question in the simplest terms. Include the context of your organisation in your Quality Manual.

    Address the organisation's role (e.g. Manufacturer, and intended markets) and the products included in the scope. On that latter point, I would refer to the generic types of devices and their key characteristics (e.g. are they to be supplied as sterile, are they implantable, are they active, are they MD/IVD/combination products). This high level context is then the basis for the details, which can be documented in all of the ways already described, and maybe more.

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    Edward Ball
    Manager, Intelligence & Innovation
    United Kingdom
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