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Issues With Paper-Based QMS in ISO 13485 Compliance

Many MedTech development teams still stick to their tried-and-tested ways of quality management based on printed paper documents. The author of this post, Intland's Engineering Consultant with years of MedTech development experience, argues that such an obsolete environment means an unnecessary burden on product innovation teams that limits their performance. Read on to find out about the challenges of a paper-based QMS environment, and what strategies can help modernize your quality management!

Issues With Paper-Based QMS in ISO 13485 Compliance

About the author

Mate Harsing is an Engineering Consultant at Intland Software with a past in medical device manufacturing. Mate has years of experience working in an ISO 13485-compliant environment with paper-based QMS. Mate is also the co-creator of MedTech-specific industry templates for codebeamer X. 


Have you ever had to walk up the stairs to the sixth floor with a document that had to be signed by another department head – only to realize he’s walked down to your office to do the same because of miscommunication?

Well, I have. Having worked for a medical device manufacturer nurturing a paper-based QMS system, it was a common adventure to go on, getting documents signed all around the building. I’ve always wondered how much time I was spending doing this weekly and consequently, how much this was costing our company every week...

In a more and more regulated environment, like in medical device development, implementing quality management systems is a critical concern to guarantee compliance, particularly with the ISO 13485 standard. Whether you are a beginner in ISO 13485 or a veteran QMS expert, you’ll find that using a convenient, efficient, and accurate QMS solution that allows easy compliance with regulations is essential. However, that solution can take various forms: some use a set of homegrown tools and processes, others opt for dedicated eQMS tools, yet others integrate QMS in the development process via unified Application Lifecycle Management tools.

Learn all you need to know about ISO 13485:

Download Intland's Essential Guide to ISO 13485 Medical Devices Quality Management Systems

Common Quality Management Issues

There are various ways companies build the required Quality Management System, ranging from using traditional paper-based solutions to adopting modern, robust, electronic QMS software. If you are following paper-based or hybrid processes, making the switch to fully automated systems can dramatically improve the efficiency of your quality management efforts.

Related reading:

How to Ensure Patient Safety and Development Efficiency in MedTech Innovation?

Whether you are working for a startup or a mid-sized company that does not yet apply an electronic QMS, you’ll probably be familiar with the following 4 main issues. I’ve found that paper-based ISO 13485 compliance is not only cumbersome but close to impossible if striving for perfection, because of the following:

1) Audit-readiness & costs

Due to unannounced audits, every medical device company needs to be ready for an audit at any given moment. Paper-based systems make this virtually impossible. Every new sheet of paper added to the filing system means extra costs due to the staff handling it, storage costs for paper copies, and manual error that inevitably occurs because of the fundamental issues of a paper-based system.

Related reading:

Simplifying Regulatory Audits in Medical Device Development

If you take into account all of the processing that paper goes through as part of documenting your quality control, you can see just how expensive a paper-based document workflow can be. Additional costs for paper-based QA systems include manpower to track down signatures – as I noticed myself, the time spent reviewing documents, files that are lost, securing the papers, keeping them where they are easy to access, storing the superseded documents for the long-term, shredding, and disposing of documents all result in time, effort, and costs. Finally, let’s not even start talking about the environmental aspects of producing so much physical paper...

2) Transparency & traceability

Can you imagine frantically looking for a document that, as it turns out, doesn’t even exist? That’s right, this also happened to me. I made a typo when writing a document’s ID into the “trace” field of another document – then spent an hour physically looking for it before I realized what I’d done. Using an eQMS or other form of electronic quality management system can help you map the needed bidirectional trace links between your quality documents, so you can avoid that problem altogether.

Moreover, in the case of ALM tools, your development documentation and data are also housed in the same platform. An eQMS tool (usually a cloud-based platform), is designed to help streamline the full spectrum of quality management for life sciences organizations involved in the development, manufacturing, and distribution of pharmaceutical, medical device, and biotechnology products. This can either work in an ecosystem with your ALM tool or in the ALM software itself. If the right tool is used, it might even completely replace QMS. On paper, creating trace links is a labor-intensive and error-prone manual activity. Adequately selected eQMS or ALM tools can take this burden right off your shoulders.

Need help in selecting the right ALM tool? Access this free ALM evaluation guide:

How to Select the ALM Solution that Best Suits Your Needs

3) Access control

Have you ever happened to “accidentally” glance at a document that you shouldn’t have seen? Well, I’m sure you haven’t, of course, but let’s assume you know someone who has... There is an underlying problem with trying to grant or revoke permissions to documents unless you want to pay for staff and secure filing systems to be able to facilitate their upkeep. The same applies to users being able to make changes to paper documents unnoticed – no one will ever find out. The slightest chance of such an event taking place will raise any auditors’ eyebrows.

When managing these documents digitally, modern tools not only create an unerasable and unchangeable audit trail for each change, permission matrices allow for tighter control over who has read or write access to certain sensitive documents. 

4) Change control

Lastly, imagine following an SOP for months only to realize that it’s been superseded long ago. Paper-based document management is often considered a no-go by departments where this issue has caused trouble in the past. The creation and maintenance of documents that convey vital information, such as SOPs, Process Documents, Quality plans, Manuals, Training Records, and Policy Documents, can all be done digitally, whereas Work Instructions, Reference Charts, and Specifications may all be done using both digital and hard copies.

Things change once digital transformation is enabled and encouraged across the entire organization and workstations are equipped with devices that allow team members to systematically follow up-to-date work instructions, reference charts, and specifications instead of having to handle them physically. Operating this way reduces the margin for error and introduces a leaner way of working as a byproduct of digitalization. The prerequisite for this process to be streamlined is to have a centralized repository of documents where only active files are accessible – this is where an eQMS plays a crucial role.

Find out how successful companies efficiently comply with ISO 13485! Check out our webinar:

ISO 13485: Best Practices and Challenges of Modernizing Document-based QMS

Modernizing Your Quality Toolset

Stemming from not only, but including, the problems listed above, a system that keeps records up to date, provides easy access to documents, has best-practice workflows built-in, is compliant with medical device regulations, and makes verification effortless can be a source of competitive advantage. Thorough, compliant QA requires the right systems and tools, and paper-based processes are no longer sufficient in today’s ultra-competitive market. Instead of focusing on making sure the product and process quality of medical devices are first-class, companies are spending precious time and resources dealing with inefficiencies created by paper-based approaches.

Download Intland's Essential Guide to ISO 13485 Medical Devices Quality Management Systems

While QA professionals were once required (literally) to shuffle papers, now they have an opportunity to leverage digital tools to enable leaner, more efficient, and automated systems that better address growing complexity and risks. While dedicated eQMS systems are available, it has become a trend for medical device developers to integrate their QMS system into their development tools e.g. by using integrated Application Lifecycle Management, which results in a universal “single source of truth” all along the cascading process of product innovation.

For more information on a tool that can help you simultaneously conduct medical device development and quality management in a shared repository with seamless traceability between them, try codebeamer X!

Trusted by leading MedTech innovators, codebeamer X offers features specifically built to support product development and quality management in life sciences product innovation. Preconfigured process templates offer out-of-the-box compliance support for ISO 13485:2016 and FDA Title 21 CFR Part 820, and more. Interested in learning more? Book an online demo or start your free trial today!

Intland's MedTech Development and Compliance Templates

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