ISO 13485:2016 Medical Devices Quality Management Systems Foundation Course – For Medical Devices Industry

DESCRIPTION

This program is designed to provide attendees with the tools and knowledge necessary to upgrade their quality system to an international recognized medical device standard.

In addition to providing the requirement for compliance with the latest standard - ISO 13485:2016, attendees will learn how to prepare, manage and successfully complete an inspection by the certification bodies.
 
COURSE OUTLINE:
Personnel attending this program will have an opportunity to learn how to prepare for an ISO 13485 audit, what to expect during interaction with auditors and how to respond to the findings.

Additionally, this course provides compressive review on the latest ISO 13485:2016 which including the new requirements in version 2016 and its relationship with ISO 9001:2015.

This course is a good refresher for all personnel involved in the medical device business and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format.  A test will be arranged during the course. 

PROFESSIONAL TRAINER:
Tutor with more than 10 years of working experiences in auditing the medical device and electronic appliance industry. Experiences across R&D, Production Technique, Quality Assurance & Quality Management System. (SGS Hong Kong Ltd. reserves the right of final tutor arrangement.)

CERTIFICATION (Attendance: 100%):
Delegates who successfully completed the course and passed the test will be issued a certificate by SGS Hong Kong Limited.
 
GENERAL INFORMATION:
Venue: T.S.T. / Wan Chai / Sheung Wan Training Centre / HKSTP / TBC 
Medium: Cantonese supplemented with English materials

* Early Bird Price will be offered to participant whose enrolment is made one month prior to the course or online booking

AUDIENCE

This course is directed toward those who are responsible for research, development, manufacture, marketing, quality, and/or regulatory compliance involved in one or more stages of the life-cycle of medical device.

The course will benefit individuals whose job functions include operations governed or overseen by various regulations including personnel involved in preparing for, participating in and responding to medical device inspections.