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.
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Quality Management System
Measurement Analysis and Improvement
2003 Documented Requirements by Section
Sources of Information
Other editions - View all
13485 The organization 5.0 Management Responsibility 7.0 Product Realization 8.0 Measurement 8.2 Monitoring 9004 Recommends achieve actions taken activities Analysis and Improvement appropriate continual improvement corrective action customer and regulatory customer property customer satisfaction delivery design and development design and/or development documented procedure effectiveness and efficiency ensure environment Establish evaluate field guide Finish The Standard flowchart follow-up actions implementation infrastructure Internal Audit Questions Keep records management representative management should consider Management Summary measuring and monitoring medical device Monitoring and Measurement needs and expectations nonconforming product objective evidence organization identified performance personnel planning process Preservation of product preventive action Product Realization 7.3 product requirements Production and Service purchased product purchasing information quality management system quality objectives quality policy quality records Record Internal Audit regulatory requirements responsibilities and authorities risk management Service Provision specifications subclause suitability supplier throughout the organization Top management traceability validation verification Verification and Validation written procedure