OPEN QMS

Looking for templates or forms to use in your quality system?

OPEN QMS

What is a QMS?

A Quality Management System (QMS) is a collection of policies, procedures and processes that ensure an organization can consistently deliver products or services that meet customer and regulatory requirements.

Regulations require medical device developers establish quality management systems to help ensure safe and effective devices. The International Organization for Standardization (ISO) is an independent, non-governmental organization that develops and publishes international standards. ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) specific to the medical devices industry.

OpenQMS is a free resource provided by Archimedic to offer downloadable forms and templates commonly used during the medical device design and development process.

These resources are provided at no cost to give device developers a jump start on the rigorous documentation process associated with medical device development. Of course, if you need support, our expert team is available to guide you through the process.

JUST GETTING STARTED WITH QUALITY?

Find out what OpenQMS can do for you

While many of our templates can be applied in multiple phases of medical device development, we've outlined a general sequence to help organize your efforts.

Review the video and phase structure diagram below.

KNOW WHAT YOU NEED?

Follow the links below to access Archimedic's templates

Each link will contain a downloadable, editable file and some helpful tips on how to use the template. Please note that templates will appear in multiple phases as indicated by the phase diagram above.