Chat with us, powered by LiveChat

ISO 13485:2016 Documentation Templates

ISO 13485:2016 Quality Manual and Procedures
Building your QMS is a cornerstone of any successful ISO 13485 Registration. But why take the risk of starting from scratch? With our fully customizable Quality Manual and Procedures Package you will have all the processes and documents you need.

ISO 13485: 2016 FDA- QMS

This Quality Manual is designed for ISO 13485 and can accommodate the FDA Quality System Regulation (21 CFR 820 2016).
ISO 13485:2003 to 13485:2016 Quality Manual Upgrade Instructions
The QMS Upgrade Instructions will save you much time when transitioning your QMS from ISO 13485:2003 to 13485:2016.
ISO 13485:2016 and FDA QMS Upgrade for 2016
Integrate FDA.QSR (21 CFR 820) 2016 regulations into your existing ISO 13485:2016 quality management system.
ISO 9001:2015/ISO 13485:2016 Combined QMS Package
This QMS is for organizations (like Contract Manufacturers) who have ISO 9001:2015 and are looking to integrate ISO 13485:2016 QMS.
ISO 9001:2015 to ISO 13485:2016 Transition Instructions
This QMS is for organizations (like Contract Manufacturers) who have ISO 9001:2015 and are looking for instructions to integrate ISO 13485:2016.
13485:2016 Procedures Package
Our ISO 13485:2016 procedures are designed for you to use with your ISO 13485:2016 Quality Management System, as required by the ISO 13485:2016 Standard. Our easy-to-customize procedures relate directly to a section of the standard with time saving features…
ISO 13485:2016 Forms Package
A proper QMS should have forms referenced in the procedures. This package of ISO 13485:2016 Forms is a complete set of forms & tables to complete your ISO 13485 Quality Management System.
13485:2016 Flow Charts
ISO 13485:2016 flowcharts created in MS Visio© and SmartDraw©. These flowchart templates can be exported to MS Word©, PowerPoint©, Excel©.
ISO 13485:2016 Procedures Individual Packages
Our ISO 13485:2016 procedures are designed for you to use with your ISO 13485:2016 Quality Management System, as required by the ISO 13485:2016 Standard. Our easy-to-customize procedures relate directly to a section of the standard with the following features…