Pre-Production Quality Assurance for Healthcare Manufacturers: 1st Edition (Hardback) book cover

Pre-Production Quality Assurance for Healthcare Manufacturers

1st Edition

By G. William Hough, David A. Rawlings, Michael F. Turner

CRC Press

292 pages

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Hardback: 9781574910452
pub: 1997-06-30
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Description

The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.

Table of Contents

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

Subject Categories

BISAC Subject Codes/Headings:
BUS070080
BUSINESS & ECONOMICS / Industries / Service Industries
MED000000
MEDICAL / General
MED002000
MEDICAL / Administration
MED071000
MEDICAL / Pharmacology