Public Training
Public Training
ABOUT THE ISO 13485:2016 Internal Audit for Medical Device Quality Management System
Date: 29-31 May 2024
Duration: 3 days instructor-led training
Time: 9 am - 4.30pm ICT
Fees: Early bird rates available
To keep quality management system standards relevant to the community of users, ISO 13485:2016, the internationally recognised quality management system standard for the medical devices industry, underwent significant changes by the Standard Body, and the revised medical standard ISO 13485:2016 was published on February 25, 2016, and continuing effectively.
This three-day training, including a practical workshop and case study, is designed to help participants understand the requirements from an experienced trainer’s interpretation. Additionally, the workshop case study will help participants gain more insight into preparing for internal audits, either as the internal auditor or auditee, against this ISO 13485:2016 standard.
WHAT YOU’LL GAIN FROM This course?
This course is specially designed for:
After completion of the 3-day program, at the end of the courses. All participants will have to take the examination generated from content summarised from those 3 days. The participants must achieve a 70% score result in order to get the recognised certificate from TÜV SÜD. This reassures potential employers about your skills and knowledge as an auditor for ISO 13485:2016.
As an ISO 13485:2016 internal auditor, you may work in the following industries:
It is a possible pathway towards a lead auditor role in the medical devices industry.
Mr. Parawee Dolsook, Manager, Medical Health Service Certification
Khun Parawee currently contributes to and leads the Medical Health Service Division in TÜV SÜD Thailand; he is responsible for the contribution of division strategic management and growth of TÜV SÜD’s market share for Medical Health Services. He is a recognised Lead Auditor for various schemes, including ISO 9001, ISO 13485, MDD, MDR, and MDSAP.
He has a keen sense of business acumen and well-honed leadership skills, with over a decade of industry experience in manufacturing, research & and development under his belt. Khun Parawee started his career with Molnlycke Health Care (Thailand) Ltd., where he was responsible for the quality assurance leader of medical device products being manufactured by the company. He ensured that the product conformed to the desired requirements and quality attributes. He has a great career path during the work experience in the company in promotion to work globally in a Research and Development Department in the role of Assistant Product Care Manager to contribute to the new medical device implementation project launch to the market. Khun Parawee holds a master's in business administration, a Major in Marketing Management (MBA), and a bachelor’s degree in science, Major in Public Health in Occupational and Safety (B.Sc.), Petrochemical and Polymeric materials (B.Sc.).
Ms. Piyachat Maneewisetcharoen, Lead Auditor, Medical Health Service Certification
Khun Piyachat is currently the Lead Auditor of the Medical Health Service Division at TÜV SÜD Thailand. She is responsible for being the Lead Auditor for Medical Device ISO13485, Quality Management System ISO9001, MDD, MDR, and MDSAP. She is also an assessor for sterilisation methods such as Steam and Irradiation. Khun Piyachat holds a master’s in business administration from Kasetsart University, and a bachelor's in pharmacy from Srinakharinwirot University.
