The purpose of this field guide is to assist the reader, step-by-step, in implementing a Quality Management System (QMS) in conformance with ISO 13485:2003. What separates this field guide from most other books on ISO 13485:2003 and its implementation are the flow charts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. The flow charts can be overwhelming when you first look at them, for this reason, a box appears with each flow chart that explains pertinent facts and/or what the flow chart represents and how it is to be used.
The ISO 13485:2003 QMS your organization implements must meet the needs of its users—you and the rest of your organization’s employees, from senior management to the most junior employee. So the QMS you create using this field guide will not only satisfy ISO 13485:2003’s requirements, but will provide a set of processes that suits your organization and will foster improved use of the system and improvement in the processes of the organization as it matures.