ISO13485 medical device industry standard course training
Course introduction:
ISO13485: 2003 "medical equipment quality management system for regulatory requirements" standard is to ISO9001:2008 standard based, used in medical devices on a dedicated independent standard, emphasized to meet the medical device regulatory requirements, on July 15, 2003 release. The State Food and drug administration has converted to industry standard YY/T0287-2003 by the principle of equivalent. This course will be a thorough explanation of the medical device industry certification requirements, so that you fully grasp the relevant requirements of the 13485:2003 ISO, effective system of internal audit work. Improve the quality management level of medical device manufacturers, enhance the international competitiveness, and promote the standardized management of medical device industry.
Curriculum outline:
First day:
Foundation of quality management system for medical device industry
The background and principle of ISO13485:2003 standard revision
Standard requirements and understanding of the main points
System requirements of ISO13485 quality system for medical devices used for regulatory purposes
The characteristics of ISO13485 in the application of specific enterprise
the second day:
Implementation process and requirements of internal quality audit
ISO13485 internal audit planning
Audit skills upgrading
Training object:
All people who want to know about ISO13485:2003 standards.
Personnel who will use the ISO13485:2003 standard for audit
To the existing quality management system (ISO9000: 2008) to enhance the ISO13485:2003 standard of company general manager, tube generation, quality manager, MBA staff
Training time: 2016 (a month, a total of three days, Friday to Sunday, the specific time, please call or mail)
Training fee: RMB 1300 yuan / person (including training fee, certificate fee and material fee, lunch fee, etc.).
Training location: Shanghai, Qingdao, Chongqing, Wuhan, Guangzhou, Beijing, Changchun,, Zhengzhou, Hangzhou, Changsha and other major cities have. Specific telephone consultation.
Registration Advisory customer service phone 400-613-8218