ISO 13485 Templates – Medical Device Quality Management System

ISO 13485 Templates – Medical Device Quality Management System

USD $900.00

Do it yourself ISO 13485 or QSR 820 compliance


Built in Microsoft® Word for easy editing, these medical device QMS templates are the quick and easy way to build a Quality Management System (QMS) compliant with the ISO 13485 standard or QSR 820 regulations.


The medical device QMS templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.


Ideal for medical device companies who are preparing to commence manufacture of devices controlled by the FDA, TGA or any other regulatory authority.


Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.

SKU: iso13485-templates-2021 Category:


ISO 13485 templates: 2016 (latest version)

We are proud to announce the release of the ISO 13485:2016 template pack. Anyone who bought and downloaded the old 2003 version this year, can contact us for a free gap analysis and tracking spreadsheet on the gap between 2003 and 2016. In addition, anyone who purchased the 2003 pack after the 1st March 2016 will receive the 2016 pack free of charge.

What’s included in the Medical Device QMS template pack?

Pack of ISO 13485 templates includes quality management system templates for developing Policies, Standard Operating Procedures (SOPs) and Work Instructions for the following areas of your business:


product information, quotations and orders
product development
production and quality planning
purchasing and receiving
labelling, packaging, shipping and distribution
monitoring and measurement of products
monitoring and measurement of the Quality Management System
monitoring customer feedback and satisfaction management policies, planning and commitments
management review
human resources
plant, facility and equipment
information resources
measuring and monitoring devices
continual improvement
risk management
corrective and preventative actions (CAPA)

These areas are specified as being essential components of a medical device quality management system by the various regulatory bodies e.g. TGA, FDA.


Get a head start with 35 pre-written standard operating procedures

The ideal resource for a quick and easy do-it-yourself QMS implementation, the template pack includes 35 procedure templates, 15 form templates, 1 manual, 12 master templates & 1 register.

Get help from our regulatory compliance experts

Included in the price is two hours of support via telephone or email. Feel confident in the knowledge that if you have questions or get stuck then you can speak to a GMP compliance specialist to set you on the right path. Our consultants have many years of experience working in the medical device industry. You can benefit from their knowledge of what works and what doesn’t when creating and maintaining a quality management system for a medical device manufacturer.



The sample on the website really helped sell the templates to me. Me and a couple of other fellows run a consultancy here on medical devices, mostly musculoskeletal. I liked the emphasis on 13485 since most of the small companies we deal with will likely hit the world stage before the US stage. Looking forward to working with the tools.

ISO 13485 Template


I used your QMS pack to first “modernize” our QMS and then this year to update to 2016 standards. I found your QMS pack for 2016 to be very helpful and easy to use.

ISO 13485 Template


We are very satisfied with the template pack and used them for setting up our quality management system.

The documents are very good, readable and understandable and the structure is clear. Overall our impression is that the documentation pack is of a high quality and it was necessary for us to make fast progression. 100% value for money.

ISO 13485 Template