Chapters cover:
o Quality Standards in Research and Development
o Building Blocks of the Design Control System
o How to Approach Design Control
o The Process of Research and Development
o The Relationship Between ISO 9001 and Total Quality
Management
o Other Requirements of ISO 9001 in Research and Development
o Audit and Certification
o Beyond ISO 9001: Good Practices
o Beyond ISO 9001: Regulatory Requirements
o Conclusions
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