How to structure your QMS documentation for ISO 13485 compliance

How should you structure your documentation to meet the requirements of ISO 13485?

As your med tech company scales, the sheer volume of QMS documents you need to control will grow.

But without a structured approach to file management, critical information can be lost, teams can struggle with version control, and audits can become chaotic hours of tail chasing - threatening budgets, project time lines and compliance.

When systems bring structure

That’s why ISO 13485 (the quality standard for medical device design and development) mandates a structured approach to quality management system documentation.

Because, as the often repeated warning of quality managers around the world has it - “If it isn’t documented - it didn’t happen’.

Without systematic recording, ordering and indexing of your documentation, all your development work may count for nothing in the face of regulatory scrutiny.

Why ISO 13485 requires you to organise documentation

ISO 13485 doesn’t just require you to store documentation. It requires you to actively control it within a structured quality management system.

It demands your entire decision-making process is traceable and accountable from beginning to end - proving you are capable of delivering products to required levels of quality.

How ISO 13485 requires you to organise your documentation

To this end, ISO requires you to develop and define a documentation system that ensures:

• The entire document lifecycle is controlled – from creation and approval to modification, distribution, and obsolescence.
• Access and editing rights are clearly defined – preventing unauthorised changes and ensuring only qualified personnel can modify critical documents.
• Every stage of product development follows a repeatable documented process – ensuring consistency, quality, and regulatory compliance.
• Changes are fully traceable – version control, timestamps, and author identification prevent outdated or incorrect information from circulating.
• Regulatory bodies and auditors can easily verify compliance – providing structured, organized documentation that facilitates efficient audits and inspections.

Developing a scalable, well-structured digital system ensures your quality documentation works for you - keeping your product development process streamlined, audit-ready, and compliant.

How should you structure the documentation in your QMS?

ISO 13485 states:

"The quality manual shall outline the structure of the documentation used in the quality management system."

It should be noted the standard doesn’t specify exactly how this should be done. But many businesses adopt a QMS documentation hierarchy approach, which organizes documentation in a structured way to ensure clarity and consistency.

In this hierarchy, each layer of documentation guides the consistent production of the ones beneath:

At the top of this pyramid are the policy and quality manuals that summarize your approach and philosophy. The next layer includes documented procedures and SOPs that show your team who performs required functions, when, where, and in what way.

The next layer includes all the specifications, designs, drawings, and work instructions that are required to build your product. The final layer includes the records you generate as you build the product, which serve as evidence that you have built it as intended. These can include validation records, medical device technical files (including your Design History File and  Device Master Record).

A well-defined QMS documentation structure ensures that each document, from high-level policies to work instructions, is aligned with quality management system documentation requirements.

A document hierarchy cascades quality downwards

Effective control, review, and distribution of documentation at every level of this hierarchy ensure that consistency and quality cascade downwards throughout the product lifecycle, even as the volume of documents increases.

In this way, you can ensure you are producing good QMS documentation consistently, according to your documented procedures and in ways that match regulatory requirements.

How document controls maintain the document hierarchy

The production of each layer of documentation is subject to required controls and checks to ensure their integrity is maintained throughout an evolving project.

These controls ensure documents and records:

• Are approved prior to use (with the use of e-signatures if required).
• Can be approved by multiple stakeholders before they are published to trigger new phases of development.
• Are owned by a named individual, so they cannot be orphaned in a system.
• Are properly indexed for ease of auditing and retrieval.
• Have a trackable version history, showing their evolution and contributors.
• Cannot be changed or removed without authorisation.
• Are subject to continual review for accuracy and effectiveness.
• Can be automatically archived when obsolete or superseded.

They ensure the right documents are easily available to the right people at the right time and prevent the system from becoming cluttered with obsolete documentation. A well-structured document management approach ensures compliance with ISO standards while supporting efficient quality management processes.

How an electronic QMS helps you structure and control your documentation

Maintaining this level of consistency and control manually is a huge challenge. A quality management software solution like an electronic quality management system (eQMS) can help implement cycles of planning, execution, review, and improvement that protect the integrity of your documentation and quality processes.

The right digital tools can support your team as they create new documents in different formats, helping you approve and manage them over time in a structured way.

Support for different kinds of documentation

The documents and records you generate throughout the cycle will come in multiple formats, from Word documents to CAD files and video demonstrations. You need an eQMS flexible enough to store them all while making their contents visible and accessible.

Many critical resources might be in the form of flowcharts, images, or instructional videos. A robust QMS will allow you to control their version history, index them, and review them periodically.

Automation and control of information flow

You need the flexibility to create different workflows for different document types—defining access rights, approval mechanisms, and re-approval processes as needed.

Automation ensures that required processes happen consistently, reducing the risk of errors and omissions. Workflows can trigger new validation and development sequences, keeping projects moving through various states from planning, design, build, and testing.

In fact, systems like the Cognidox eQMS can allow you to develop graphical overlays to help your teams visualise the way your document approval and validation processes are structured.

As you progress through design stages, the right QMS software should help define document requirements for each phase, ensuring that required approvals are in place before documents are finalised and published.

Keeping it lean

The way documentation is structured and maintained can determine whether your quality system is efficient and supportive or cumbersome and difficult to navigate.

A well-designed eQMS will help you:

• Structure documentation to match business needs and regulatory requirements without unnecessary complexity.
• Define your processes, execute projects efficiently, and ensure compliance with minimal disruption.
• Automate document management to prevent bottlenecks and streamline approvals.

Through proper structure and automation, you can create a management system that supports your business, simplifies audits, and helps your team focus on innovation rather than paperwork.

How to build your med dev eQMS: Download our free eBook

Learn how an eQMS can help you structure and control your QMS documentation while ensuring compliance. Download our free guide below to see how a digital eQMS can streamline your processes and help you maintain regulatory standards.

Blog post updated on 11/03/2025