ISO 13485 : a complete guide to quality management in the medical device industry /: a complete guide to quality management in the medical device industry. (2012)

• Record Type: Book
• Further Information: Note: Itay Abuhav.
• Other Names: Abuhav, Itay
• Contents: Scope; General; Application; ; Normative References; ; Terms and Definitions Requirements ; ; Quality Management System; General Requirements; Documentation Requirements; ; Management Responsibility; Management Commitment Requirements; Customer Focus; Quality Policy; Planning; Responsibility, Authority, and Communication; Management Review; ; Resource Management; Provision of Resources; Human Resource Requirements; Infrastructure Requirements; Work Environment Requirements; ; Product Realization; Planning of Product Realization; Customer-Related Processes; Design and Development; Purchasing; Production and Service Provision; Control of Monitoring and Measuring Device Requirements; ; Measurement, Analysis, and Improvement; Measurement, Analysis, and Improvement—General Requirements; Monitoring and Measurement; Control of Nonconforming Products; Analysis of Data; Improvement
• Publisher Details: Boca Raton : Taylor & Francis
• Publication Date: 2012
• Extent: 1 online resource (xiii, 350 pages), illustrations
• Subjects: 610.284; Medical instruments and apparatus industry -- Quality control -- Standards -- Handbooks, manuals, etc; Medical instruments and apparatus -- Standards -- Handbooks, manuals, etc; MEDICAL -- Instruments & Supplies; Equipment and Supplies -- standards; Equipment Design -- standards; Manufactured Materials -- standards; Quality Control; Electronic books
• Languages: English
• ISBNs: 9781439866122; 1439866120
• Related ISBNs: 9781439866115
• Notes: Note: Includes bibliographical references.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.