Mandatory documents required by ISO 13485

Updated: September 19, 2023.

The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016 documentation requirements are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to the medical device industry.

So, here is the list – below, you will see the mandatory ISO 13485 documents, but also keep in mind that the QMS (Quality Management System) documentation consists of not only the mandatory documents, but also other ISO 13485 documents specified by applicable regulatory requirements.

Some of the key ISO 13485 documentation requirements
  • Quality Manual
  • Responsibilities and authorities
  • Medical device file
  • Procedure for document control
  • Procedure for design and development
  • Procedure for validation


ISO 13485 documentation requirements

Here are the required ISO 13485 documents, categorized according to the clauses of the standard. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes related to ISO 13485 documentation requirements):

Some of the key ISO 13485 documentation requirements:

 

Standard clause 4. Quality management system

Standard clause 5. Management responsibilities

Standard clause 6. Resource management

Standard clause 7. Product realization

Standard clause 8. Measurement, analysis and improvement

The importance of documentation

The purpose of the documentation in the QMS is to ensure that critical processes, where you need to make sure that all employees consistently do the same thing, are understood and repeatable. To make this work, it is wise to have these processes as uncomplicated as possible and presented in the simplest manner to make them easy to understand. Often, using a graphical flow chart can suffice to relay all the relevant information quickly and easily. The less complicated the process documentation, the easier it will be to ensure that all employees can deliver repeatable, quality outcomes for the processes. In the long run, the adage is often right: “The simpler, the better.” And this is what the importance of ISO 13485 good documentation practices is all about.

Download a free preview of the ISO 13485 Documentation Toolkit to see the structure for each document mentioned above.

Advisera Strahinja Stojanovic
Author
Strahinja Stojanovic

Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.


Advisera Kristina Zvonar Brkic
Contributor
Kristina Zvonar Brkic
Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and the EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and as an auditor and assessor for the MDD.


The portfolio of medical devices for which she has approval is plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, different catheters, panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, and various dental materials.