Documentation Requirements in ISO 13485 – Start with a QMS

By ETQ on June 8, 2018

When it comes to ISO certifications, one thing companies can count on is a mountain of documentation.

It’s especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products—and the effectiveness of their quality processes.

In today’s post, we’re examining ISO 13485:2016 documentation requirements to help manufacturers get organized as they transition to the latest standard version.

Quality Management System (QMS) Documentation

To earn your ISO 13485 certification, you’ll need a documented Quality Management System (QMS) that complies with the standard and all applicable regulatory requirements.

Aside from the documents you will need for your individual jurisdiction, ISO requires you to document elements like:

  • Quality policy and objectives: You’ll need written statements that describe not just your commitment to quality, but also the detailed objectives that will help you reach those goals.
  • Quality manual: Your quality manual should include QMS scope and references to documented quality procedures.
  • Computer software validation procedure: The U.S. Food and Drug Administration (FDA) requires medical device manufacturers to validate any software used in the design, manufacture, packaging, labeling, storage, installation and servicing of finished devices.
  • Quality procedures and records: These need to cover all processes, including procedures for document and record control.
  • Medical device file: This document refers to the device master record as well as its technical documentation.

Documenting Management Participation

One thing we’re seeing across the board in international standards is an increased focus on management accountability. What are ISO auditors looking for in terms of documenting management participation?

  • Clearly defining roles and responsibilities in your documentation.
  • Maintaining a schedule showing dates of QMS reviews and other planning activities.
  • Keeping records from planning meetings and reviews.

Employee Training Records

Manufacturers need a documented Employee Training program that includes steps to determine competence and awareness of team members. You’ll need records and other personnel information handy, which is easier with an integrated quality management system that can push and pull data from external systems like human resources (HR).

Infrastructure and Maintenance

ISO 13485 requires documentation of infrastructure requirements needed to ensure quality. A key focus here is documenting standardized maintenance procedures and keeping records of any maintenance work.

Contamination Control

To address issues of contamination, the standard requires medical device manufacturers to document elements such as:

  • How to prevent environmental conditions from affecting finished product quality.
  • Clothing or hygiene considerations for personnel.
  • Procedures for handling contaminated products.

Product Realization

Clause 7 of ISO 13485, dedicated to product realization, covers a number of documentation requirements. These cover areas that include:

  • Customer requirements review process and results.
  • Procedures for communicating with customers.
  • Design and development files, procedures, plans and outputs.
  • Verification of materials and outsourced products.
  • Traceability
  • Calibration and installation records.
  • Computer validation records.

Supplier Documentation

Medical device manufacturers typically work with a number of suppliers and contract manufacturers. Given the level of risk that suppliers can introduce to products, ISO 13485 includes requirements to proactively address supplier quality.

The standard specifically calls out written supplier quality agreements as a required. Supplier quality agreements are also a best practice recommended by the FDA, helping establish formal requirements for product specifications and supplier practices.

Documenting Measurement and Monitoring

Monitoring and analysis are central to the ISO approach, and this standard is no different. Clause 8 of ISO 13485 delves into a wide range of monitoring requirements, requiring documentation and records of processes like:

  • Complaint Handling and customer feedback.
  • Regulatory reporting.
  • Internal audits.
  • Nonconforming product.
  • Corrective and preventive action.
  • Reporting.

How an Automated Quality Management System Helps with ISO 13485 Documentation

Documentation is critical to achieving ISO 13485 certification. If you’re still using paper and spreadsheets, it can be a fairly complicated and time-consuming process to track down everything you need.

Conversely, automated Quality Management Software centralizes your documents, allowing you to apply best practices in documenting and recording critical processes addressed by the standard. These tools include:

  • Document Control to centralize documents and ensure a smooth change process.
  • Employee Training tracking tools to make sure all staff members have the necessary competence and awareness.
  • Audit Management capabilities to help you verify that documented procedures are followed.
  • Centralized Reporting tools to make sense of all the data and get a high-level picture of risk (not to mention easily access data at an auditor’s request).
  • Corrective and Preventive Action (CAPA) tracking to manage problems more efficiently and trigger any necessary changes to documents, procedures or quality requirements.

When you get down to it, the documents are the foundation of everything you do in medical device manufacturing. They’re also just the beginning of the journey, providing a starting place for ensuring quality and safety while continuously improving your process over time.


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