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. The above Quality Management Systems are compatible with each other and have common requirements.

In ISO 13485:2016, the requirements are described in (4) main clauses:

• Clause 4 Quality management system
• Clause 5 Management responsibility
• Clause 6 Resource management
• Clause 7 Product Realization
• Clause 8 Measurement, analysis and improvement

In QSR (21 CFR 820), the requirements are described in (15) main parts; Subpart A through Subpart O, covering General provisions to Statistical techniques. CFR Title 21, Part 820 (e-CFR May 26, 2016), represents the US (FDA) Food and Drug Administration’s current good manufacturing practices (CGMP) and it is not fully harmonized with ISO 13485. This document provides instructions on how to customize your ISO 13485 QMS to meet these requirements.

You have the 2016 version in place and now have the objective of upgrading the system to the FDA-QSR 2016 version. The good news is that since you are familiar with formal management systems, this initiative will be relatively straightforward where documented information for the QMS sets the stage for an understanding of the requirements and of the international standard as a whole.

The documentation will need to be reviewed, upgraded and implemented. The first step is to assign a person responsible for the QMS, such as with a Management Representative, to become familiar with the changes for 2016 versions of the FDA regulations and of the ISO 13485:2016 standard. Visit the http://13485store.com/ for training materials, resources and information on quality management systems requirements.

The following table, with detailed instructions, focuses on the areas of the documentation required for the integrated quality management system. As you undertake the task of upgrading your quality management system, note that in the left hand column of the instructions, all the ISO 13485:2016 clauses are shown and in the 4th column of the table, corresponding, or related requirements, or no correspondence in QSR (21 CFR 820), are indicated in Italics. The table outlines the changes to your ISO13485 QMS documentation to align it with the Quality System Regulation, 21 CFR 820, as current with the e-CFR data of May 26, 2016.