ISO 13485 Templates – Medical Device Quality Management System

ISO 13485 Templates – Medical Device Quality Management System

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$900.00 US

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.

SKU: iso13485-templates-2016 Category: Tag:


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
  • production
  • 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
  • validation
  • 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.

Take a preview – here’s an extract from the template pack

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.