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A Practical Field Guide for ISO 13485
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.
