ISO13485 Folder Structuring for Medical Device

[itsasupernova]

Hello,

I am a fresh grad working for a Medical Device (Class II) company that is a startup.
I don't have previous experience in organizing the folders such as QMS, DMR, DHF etc..

From your current or previous experiences, how have companies organized their documentation?

 

[blackholequasar]

Hello and best of luck with your endeavors!

I think that it's a bit subjective, based on the organization of the QMS and how it interprets the standard. The way that my current company works, they have an SOP for each section of the ISO cert, though they aligned it such that their documentation matches what the standard outline was. I do NOT recommend doing this as the standard is prone to edition and the numbering will change.

DMRs, DHF, inspection reports, ect are all kept in product folder on a server here (each product line has its own folder), but I have seen people successfully use Sharepoint. Again, it all depends on how you guys are doing things there - if they are paperless or want hardcopy documents.

 

[ChrisM]

"From your current or previous experiences, how have companies organized their documentation? "
Sometimes.... very badly.

Unfortunately, you need some experience of using "organised" folders to find out the good and bad ways.
The way of organising them can also depend to a large extend on the number of employees regularly using the folders/documents, how often they have to be amended (constant product improvements and hence change notes, or very infrequent changes) etc etc.

As an example, for QMS documentation if you have a very small company with 1 product and maybe 1 dozen employees maximum, you may find that one electronic folder will be sufficient to hold all your procedures and work instructions, whereas for a multi-site company with thousands of employees, you will need a totally different way of organising the documents with numerous folders

 

[Tidge]

I would first suggestion recognizing that the QMS, the DMR(s) and the DHF(s) all serve different purposes, and have different constraints, so I wouldn't presume that there is a common organizational methodology for them. There are features that they may share (i.e. the concept of 'revision history') and elements may be subject to common processes (e.g. 'change control') but they are IMO quite different things.

QMS: Typically these are arranged in a hierarchy, with something like a Quality Policy (that rarely changes) at the top, with subordinate system policies below it, each with their own subordinate work instructions (that can include forms and/or templates). The QMS and its structure is established (at the top, by executive management) and employees train on the diverse parts as their job requires. Elements of the QMS are subject to change control... there is required training, but there should be no material impact when QMS elements change. Superseded QMS elements are never used again.

DMR: This is the recipe for making your marketable device. These are product structures with the apex of the structure being the finished good. Work instructions (and inspection procedures) will be part of the product structure; these are NOT part of the QMS... rather they are (generally) required by the QMS. The elements of the DMR are subject to revision control as 'things' change... could be acceptance criteria, could be supplier information, could be part swaps, could be process changes... these are 'design changes' so the DMR structure has to be established in such a way that supports design changes. Superseded DMR changes have to be available for review, because products with them are still going to be in the field! Changes to DMR almost always have material impact.

DHF: The DHF is essentially the recorded narrative of how a device got to market in the first place. Elements of a DHF are NOT subject to change... it is true that a new revision of some DHF element (think:, 'Rev B of a development plan') could be approved, but the 'Rev A' doesn't get tossed. If you want a 'neutral third party' (would be a NRTL, NB, or a regulator) you are essentially sending them the DHF for review. The DHF is 'alive', but it preserves the entire history of the life, whereas the QMS and DMR are pretty much only snapshots of the currently 'alive' system/good. There needs to be a system that controls how information gets into the DHF, but there is no formal need to consider life-cycle activities for the records inside a DHF.

 

[John C. Abnet]

Hello,
I am a fresh grad working for a Medical Device (Class II) company that is a startup.
I don't have previous experience in organizing the folders such as QMS, DMR, DHF etc..
From your current or previous experiences, how have companies organized their documentation?

Good day @itsasupernova ;
The others have already provided you with some wise counsel.

If I may add another consideration....
Regardless of what your naming/structure is, I would recommend that your documents have a hierarchy and are established within unique "categories" . In other words, if your organization has....
- Procedures-
- SOP,s
- work instructions
- ES,s
- forms
- etc...etc...

I would recommend that your organization proceduralizes each of these categories by ...
a) DEFINING them (i.e. what is the purpose and application of each.
b) ESTABLISH a numbering scheme/naming convention for each.
e.g. may be SOP,s are number 4- ABC- 567, where ..
- "4" = the site/location
- ABC= the process
- 567 = numerical sequence.

Proceduralizing this prevents "creep" (i.e 'other' categories/types of documents are randomly created and undermine the intended structure/foundation, and assists with navigation through documents.
Likewise establishing a SCALABLE numbering scheme/naming convention ensures that a logical name/pattern is applied as new documents are introduced and also assists with navigation through documents.

Hope this helps.
Be well.

 

[FRA 2 FDA]

I was in your shoes a year and a half ago. I was tasked with setting up our QMS and had never worked with one before. I think the most important things are 1) to make sure that your released/ approved documents are very clearly segregated from your archived revisions and working drafts under edit and 2) as John said above, to organize your documents in folders that make sense. I have folders for forms, lists, SOPs, policy docs and templates as well as for CAPAs and DCNs. The other bit of wisdom I can share is that it's hard to know how something will be set up to be functional if you haven't used it yet. We have restructured our QMS and DMR 3 times because as we used them more and more and our processes became more mature and had more history, the way we needed to use these systems changed. Don't be afraid to try something to get started and adjust as you go. Assuming this start up you work for is small (both documentation and people), changing/adjusting should be relatively easy.