Practical Field Guide for ISO 13485

by Myhrberg, Erik V.

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Title Statements

Full title :Practical Field Guide for ISO 13485.

Edition Statements

Publication Date:©2013.

Publication Statements

Publisher(s):ASQ Quality Press
Place of Publication:Milwaukee
Language:eng
Publication Date:©2013.

The Physical Object

Description:1 online resource (145 pages)

Edition Identifiers

oclc:on1371448458
LC Classification:R856.15 -- .M947 2013eb
Dewey Decimal:610.28/4

Intro -- Title Page -- CIP Data -- Contents -- Introduction -- How to Use This Field Guide -- ISO 13485 Overview -- Section 4: Quality Management System -- 4.1 General Requirements -- 4.2 Documentation Requirements -- Section 5: Management Responsibility -- 5.1 Management Commitment -- 5.2 Customer Focus -- 5.3 Quality Policy -- 5.4 Planning -- 5.5 Responsibility, Authority and Communication -- 5.6 Management Review -- Section 6: Resource Management -- 6.1 Provision of Resources -- 6.2 Human Resources -- 6.3 Infrastructure -- 6.4 Work Environment -- Section 7: Product Realization -- 7.1 Planning of Product Realization -- 7.2 Customer-Related Processes -- 7.3 Design and Development -- 7.4 Purchasing -- 7.5 Production and Service Provision -- 7.6 Control of Monitoring and Measuring Devices -- Section 8: Measurement, Analysis and Improvement -- 8.1 General -- 8.2 Monitoring and Measurement -- 8.3 Control of Nonconforming Product -- 8.4 Analysis of Data -- 8.5 Improvement -- ISO 13485:2003 Documented Requirements by Section -- Sources of Information.