ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel

This workbook contains a general orientation course on ISO 13485 (EN46000) quality systems. It is intended for training personnel in companies that either operate an ISO 13485 quality system or are implementing it and preparing for certification. The course explains what the standards are, how the quality systems works, and how everyone should prepare themselves and their work areas for the certification audit. The workbook is intended for distribution to all personnel for self–study or group training, and it includes a short multiple-choice test and a certificate of completion. This course satisfies ISO 13485 (EN 46000) requirements for training personnel in understanding and operating the quality management system. Table of contents is provided in the Book Information menu on the left side of this page.