A veteran of quality in medical device and pharmaceutical industries, Steinborn updates again the guide he first wrote in 1984. He details what quality control and quality assurance measures are needed in those industries above and beyond those required in other industries, because of product liability and regulatory conditions. He describes the basic tools needed to perform compliance audits, and the various audit types. Manufacturers of finished products are his main concern, but for suppliers to companies in the industry, he also explains what to expect when a quality audit is anticipated. Most of the book and all of the disk are devoted to detailed audit questionnaires and checklists, which can be copied and used directly. There is no index. No information is provided about subsequent volumes. Loose-leaf bound.

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