ISO 13485:2016 Documentation Templates

ISO 13485:2016 Quality Manual and Procedures
Save time, save money, and simplify certification with the right QMS!
13485:2016 Procedures Package
Our ISO 13485 procedures are designed for you to use with your ISO 13485 Quality Management System, as required by the ISO 13485 Standard.
13485:2016 Flow Charts
Flowcharts, software & training to help you understand your business.
ISO 13485:2003 to 13485:2016 Quality Manual Upgrade Instructions
Save the time and resources required to design and document an ISO 13485 Quality Management System. ISO 13485 Store has created most of it for you.
ISO 13485:2016 and FDA QMS Upgrade for 2016
This instruction / checklist is intended for use in upgrading your Quality Management System and integrating the FDA.QSR (21 CFR 820) regulations quality management systems used by organizations involved in the medical devices industry.
ISO 13485:2016 Forms Package
This package of ISO 13485 Forms is a complete set of forms & tables to complete your ISO 13485 Quality Management System.
ISO 13485:2016 Procedures Individual Packages
Our ISO 13485 procedures are designed for you to use with your ISO 13485 Quality Management System, as required by the ISO 13485 Standard.
ISO 9001:2015/ISO 13485:2016 Combined QMS Package
This QMS is for organizations (like Contract Manufacturers) who want ONE QMS for both ISO 9001:2015 and ISO 13485:2016.
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 transition to ISO 13485:2016

ISO 13485: 2016 FDA- QMS

This Quality Manual is designed for ISO 13485 and can accommodate the FDA Quality System Regulation (21 CFR 820).