By: Steve Gompertz, QRx Partner
If you work in Medical Devices, you should already know that the FDA’s regulation 21 CFR Part 820 has been updated to mostly defer to ISO 13485 for Quality Management System requirements. Enforcement begins in February 2026, which will be here faster than it may seem. The changes and transition will not be particularly difficult or disruptive since most medical device companies are either already certified to ISO 13845 or based their QMS on it. For those that didn’t do either, one change will be the 13485 requirement to establish a Quality Manual that describes the QMS.
Enter the Consultants
Not surprisingly, there are already many posts online warning that the sky is falling, and you need expert help fast to ensure the compliance of your QMS. Some are even offering free Quality Manual examples or templates for purchase. As we also espouse in our postings on quality and regulatory topics, getting expert advice is always a good idea, so long as you remember that not everyone who claims to be expert, actually is. So it is regarding all this advice for Quality Manuals. I’ve looked at offerings from several consultants and eQMS vendors, and found an annoying trend; 40-page, overthought, non-value-added Quality Manuals
There’s Only 4 Requirements
In all of these cases, it seems that they’ve forgotten to check ISO 13485 or failed to understand its requirements. Clause 4.2.2 only establishes four requirements for a Quality Manual. So, why would it take 40 pages to address them? I actually had an Auditor ask me that once at a company where I had just become the head of quality. Too often, the answer is because that’s how we’ve always done it. I think we all know that’s never a good answer, but yet we so often continue to apply outdated, incorrect, and ineffective approaches.
In a nutshell, the four requirements are:
1. Establish the scope of the QMS
2. Reference the documented procedures
3. Describe the interaction between QMS processes
4. Outline the QMS documentation structure
What’s Being Done Wrong?
Notice that there is no mention of repeating the wording of regulations or standard. So many of the Quality Manuals I see are essentially a parroting of the standard. The standard cites, “The manufacturer shall establish a procedure for …”. So, the Quality Manual cites, “XYZ Corp. will establish a procedure for …”. Sometimes, they go in a slightly better direction by stating, “XYZ Corp. has established SOP-12345 for …”, but then goes on to add several paragraphs explaining what will be in that SOP (usually by parroting the standard). If you’re going to have a separate SOP, which is usually the case, it will contain all the details, and the Quality Manual doesn’t need to repeat them. Redundancy eventually leads to divergence. What I usually see is that two thirds to three quarters of the content is this unnecessary wording.
What’s Really Needed?
Looking back at the four requirements, what should jump out is that three of them can be easily accomplished through diagrams rather than words, and two of them can be the same diagram! The one that requires words, QMS scope, can actually be addressed by one or two sentences and a table. The sentences can concisely describe the organization’s role (Manufacturer, Relabeler, Contract Manufacturer, etc.) and what it produces, and the table can show what portions of the regulations and standards don’t apply; half a page at most.
The documentation structure is easily shown as the typical pyramid with four layers (Quality Manual, SOPs, Work Instructions, and Records). This is probably the one thing everyone gets right but see the next section for a possible improvement. Another half page, but maybe a full page if you include a brief explanation of each layer.
The two that can/should be combined into one diagram are process interaction and procedures references. This diagram is typically referred to as the Process Model. Its intent is to demonstrate that the QMS is based on a Process Approach per Clause 0.3; you know, the one no one reads. The mistake is that most often this diagram is copied as is from the outdated version of ISO 9000. Yes, that means your Quality Manual demonstrates that your organization is unaware that the standards have been updated. Regardless, the intent isn’t to copy that diagram, but to create a version that shows your organization’s process model. Basically, it’s a flow chart showing your QMS end to end. And each box in the diagram can include a reference to the applicable SOP(s). Boom, two requirements met with one diagram! This should all take up a single page.
If you’re keeping count, including a cover page, we’re up to just 3 pages, maybe 4, instead of 40!
Other Value-Added Content to Consider
Besides meeting the four requirements, there are a few other elements that can add value to a Quality Manual. Remember, just doing enough to be compliant should never be the goal.
The Quality Policy is always a good addition to the Quality Manual. I like to put it right on the cover page so that it’s the first thing readers see. That also means that it doesn’t add to the page count, employees don’t have to search for another document, and you have one less document to manage.
A Functional Organization Chart is useful in explaining how the organization covered by the QMS is structured. It can also be used to identify who comprises Top Management, who serves as Management Representative, and where Quality fits in (hopefully clarifying its independence). By functional, I mean no names or titles (except the CEO), e.g. – just Quality, Engineering, Marketing, Operations, etc. This can also be a good way to show how business units, division, and sites are connected, as well as showing any outsourced functions. A detailed organization chart can be established as a separate addendum to the Quality Manual.
A Process Layer is often overlooked. Remember Clause 0.3? A Process Model diagram gets that started, but often doesn’t go deep enough. One approach could be to add a Process Layer to the documentation pyramid and commit to establishing standalone documents (QSPs?) for each major process depicted in the Process Model, e.g. – Product Development, Quality Planning, Employee Competence, IT Management, Purchasing, etc. These QSPs can contain the next level of flowchart to show what activities comprise the process, and then there can be an SOP for each activity. Another approach is to incorporate the process-specific flowcharts into the Quality Manual so that there are fewer documents to manage, but the number of pages will go up (although since they’re mostly diagrams, the extra pages won’t deter the readers).
A list of Applicable Regulations and Standards is also a good idea, but if yours is extensive, or you want to make it a matrix to which SOPs address each requirement/clause, then consider making this a separate addendum as it may change often.
Building a Better Quality Manual
So, if we add all of the above and remove all the redundancies, we’re now looking at a Quality Manual of somewhere between 3 and maybe 8 pages! Which would you rather read, or consider referring back to periodically, a 40-page tome or a short, illustrated overview of the QMS? One last attempt to blow your mind; I’ve actually incorporated all of the above into a tri-fold brochure! And yes, it has passed FDA inspections and Notified/Certification Body audits at companies both small and very large. My favorite auditor response? “Finally!”
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