Last Updated on September 25, 2025 by Melissa Lazaro

Introduction: Why Document Control Can Make or Break ISO 13485

If there’s one thing auditors always check first in an ISO 13485 audit, it’s document control. And for good reason—if your procedures, work instructions, or forms aren’t properly controlled, the rest of your QMS starts to look shaky.

Here’s what I’ve noticed over the years: companies still trying to run document control on paper or shared drives almost always run into the same problems—outdated SOPs floating around, missing approvals, or multiple “latest” versions of the same file. It’s stressful, time-consuming, and almost guaranteed to raise nonconformities during an audit.

That’s why more and more medical device companies are moving to electronic document control systems (eDMS). Done right, an eDMS doesn’t just tick the compliance box—it saves time, reduces errors, and makes audits a lot smoother.

In this article, I’ll break down:

• What ISO 13485 actually requires for document control.

• Why electronic systems are becoming the go-to choice.

• The features you should look for in an ISO 13485-compliant eDMS.

• Best practices (and common pitfalls) when implementing one.

By the end, you’ll know exactly how to make document control a strength in your QMS instead of a weak spot.

What ISO 13485 Requires for Document Control

Before we dive into electronic systems, let’s clear up what ISO 13485 actually expects when it comes to document control. The requirements are spelled out in Clause 4.2.4, and they’re pretty straightforward:

• Approval before use – Every document (like SOPs, forms, and work instructions) must be reviewed and approved before it’s released.

• Version control – Only the current, approved version should be available at the point of use. Old versions need to be archived but not in circulation.

• Accessibility – Relevant staff must be able to easily access the right documents when they need them.

• Periodic review – Documents need to be reviewed and updated regularly to stay accurate.

• Change tracking – Every change should be recorded, with who approved it and when.

• Obsolete documents – Must be identified and prevented from accidental use.

Pro Tip: Auditors don’t care whether you use paper binders or a cloud-based eDMS. What they do care about is consistency. If someone on the production floor is using an outdated instruction, that’s an instant finding.

Common pitfall: Mixing up document control and record control.

• Documents tell you how something should be done (procedures, SOPs).

• Records prove that it was done (training logs, calibration certificates).
  Both are critical, but the control rules are different.

Bottom line: whether you’re paper-based or electronic, ISO 13485 requires a controlled, reliable system for managing your documents. An eDMS just makes it easier.

Why Move to an Electronic Document Control System (eDMS)?

Now that we’ve covered what ISO 13485 actually requires, let’s talk about why so many medical device companies are moving away from paper and shared-drive setups to electronic document control systems.

Here’s what I’ve noticed: paper systems and manual folders work fine when you’re small—but as soon as you scale, they become a nightmare. I’ve seen companies spend half an audit chasing signatures, digging through binders, or arguing over which SOP is the latest version. That’s wasted time and stress you don’t need.

An electronic document control system (eDMS) solves most of those problems by:

• Automatic version control – no more duplicate “final_v3_reallyfinal” files.

• Electronic signatures and approvals – compliant with FDA 21 CFR Part 11.

• Built-in audit trails – every change is timestamped and traceable.

• Faster retrieval – search and pull up any document in seconds.

• Integration – link SOPs directly to training, CAPA, or risk management modules.

Real-world example: I worked with a client who used to spend 10–15 minutes finding a single SOP during audits. After switching to an eDMS, the same request took less than 30 seconds. The auditor literally said, “That just saved us both a lot of time.”

Common pitfall: jumping into software too quickly. I’ve seen teams buy an expensive eDMS without aligning it to their existing QMS processes. The result? Confusion, frustration, and employees working around the system instead of with it.

Bottom line: ISO 13485 doesn’t force you to go electronic, but an eDMS makes compliance easier, faster, and a lot less stressful.

Essential Features of an ISO 13485-Compliant eDMS

Not every document control system is created equal. If you’re in the medical device space, your eDMS needs to support both ISO 13485 and, in many cases, FDA 21 CFR Part 11 requirements. From what I’ve seen, the best systems share a common set of features:

4.1 Access Control & Permissions

Only authorized people should be able to view, edit, or approve documents. This prevents accidental (or unauthorized) changes.

4.2 Version Control

An absolute must. The system should automatically archive old versions, clearly mark what’s current, and prevent outdated SOPs from being used.

4.3 Electronic Signatures

For FDA compliance, signatures must be secure, unique, and time-stamped. A simple typed name in Word doesn’t cut it.

4.4 Audit Trail

Every change should be logged: who made it, when, and what was changed. This is often the first thing an auditor checks in an eDMS.

4.5 Integration with Other QMS Processes

The most useful systems connect with training, CAPA, and risk management. Example: when a new SOP is approved, the system automatically triggers training assignments.

Pro Tip: When evaluating software, map each feature back to the relevant ISO 13485 clause. That way, you can confidently tell an auditor, “Here’s how our eDMS meets the requirement.”

Common pitfall: choosing a generic document management tool that isn’t designed for regulated industries. It might be cheaper, but if it doesn’t handle signatures, audit trails, or compliance workflows, you’ll pay for it in findings later.

Best Practices for Implementing eDMS in a Medical Device QMS

Switching to an electronic system can feel daunting—but done right, it’s one of the best investments you’ll make in your QMS. Over the years, I’ve seen both smooth transitions and painful failures, and the difference usually comes down to preparation.

5.1 Start with a Document Inventory

Before you migrate, know what you have. Clean up duplicate or obsolete SOPs and forms. There’s no point moving clutter into a shiny new system.

5.2 Train Your Team Early

An eDMS only works if people use it correctly. Don’t just train them on how to click buttons—train them on why compliance matters. If your staff understand that outdated SOPs create audit risks, they’re more likely to follow the process.

5.3 Define Workflows Clearly

Set up standardized workflows for document creation, approval, and review. Make sure responsibilities are crystal clear—who writes, who approves, who publishes.
👉 Pro Tip: Build in periodic review reminders. Many findings come from SOPs that haven’t been reviewed in years.

5.4 Pilot Before Full Rollout

Test the system with one department (like CAPA or Training) before going company-wide. This helps iron out issues without overwhelming everyone at once.

5.5 Make It Part of the Quality Culture

The biggest pitfall I see? Treating the eDMS as “just IT’s job.” If quality and operations leaders don’t champion it, employees will resist and find workarounds. Success comes when it’s embedded into daily routines, not treated as extra paperwork.

Real-world story: One company I worked with rolled out their eDMS in phases—starting with document control, then linking it to training and CAPA. Because the system was aligned with their workflows, employees actually liked it. By the time the auditor came, everything was smooth, and they passed with zero document control findings.

FAQs – ISO 13485 Electronic Document Control Systems

Q1. Is an electronic system mandatory under ISO 13485?

No—ISO 13485 doesn’t say you must use an electronic system. A paper-based setup is still acceptable. But here’s the catch: as soon as you grow, paper becomes difficult to control. That’s why most companies move to an eDMS—it makes compliance easier and audits smoother.

Q2. Can we still use a hybrid (paper + digital) approach?

Yes, but it can get messy fast. I’ve seen teams struggle because half their SOPs were on paper, while newer ones were digital. Auditors get frustrated when they can’t tell which system is “the source of truth.” If you do hybrid, document the rules very clearly.

Q3. How do we ensure an eDMS also meets FDA 21 CFR Part 11?

Make sure the system has:

• Secure, unique electronic signatures.

• Audit trails for every change.

• Proper access controls.
  If your eDMS vendor can’t show compliance with Part 11, you’ll run into problems in U.S. audits.

Conclusion: Smarter Document Control = Smoother Audits

At the end of the day, document control is one of those areas where you either impress your auditor—or give them a reason to dig deeper. ISO 13485 doesn’t force you to go electronic, but in my experience, an eDMS makes compliance far less painful.

With the right system in place, you don’t waste time hunting for documents, worrying about outdated SOPs, or scrambling for signatures. Instead, you show auditors a clean, consistent process that builds confidence in your QMS.

Here’s the takeaway:

• ISO 13485 requires control, accessibility, and traceability—whether you’re on paper or digital.

• An eDMS gives you built-in version control, audit trails, and electronic signatures.

• Success isn’t about buying software—it’s about aligning the system with your quality culture.

Next step: Download our free Document Control SOP Template to benchmark your current system, or explore eDMS options designed for medical device companies.