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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Original Message:
Sent: 23-Nov-2022 09:33
From: Ginger Glaser
Subject: Quality Manual and device classification
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
Original Message:
Sent: 22-Nov-2022 16:19
From: Kevin Randall
Subject: Quality Manual and device classification
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.
Original Message:
Sent: 22-Nov-2022 10:34
From: Dan O'Leary
Subject: Quality Manual and device classification
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
Original Message:
Sent: 18-Nov-2022 13:55
From: Anonymous Member
Subject: Quality Manual and device classification
This message was posted by a user wishing to remain anonymous
Do you indicate your device classification in the Quality Manual?