Each company selling medical devices in the U.S. must implement a quality management system that fulfills the requirements of 21 CFR 820, known as the Quality System Regulation. Selling in Canada, in the countries of the European Union, and in an increasing number of other countries around the world also means implementing the requirements of the ISO 13485:2003 quality standard, as well as special requirements for particular countries.
Quality Management Systems: Structure Options
A company may choose to organize its quality management system according to a structure suggested by the FDA’s approach to the Quality System Regulation (Figure 1).
Figure 1. FDA Quality System Inspection Technique (QSIT) model.
Alternatively, a company may choose to organize its quality management system to fit more closely the model used by the ISO 13485: 2003 standard (Figure 2).
Figure 2. ISO 13485:2003 process model.
Either structure – or a tailor-made structure – can provide all the pieces needed to fulfill worldwide requirements.
Quality Management System: Critical Documentation Features
A quality manual that presents overall quality management system requirements in language that speaks to all employees.
A second level of documentation of two dozen or so procedures that make clear the principles and strategies for key company processes.
A third level of documentation describing in detail how to carry out all the requirements for the business.
A fourth level of supporting documentation, including records.
Quality Management System: Reminders
Our goal is good products meeting customer needs.
Good processes are needed to design and produce good products.
Good people are what make the processes work.
The Quality Management System needs to bring all the pieces together in an effective, efficient manner.