ISO 13485:2016
Medical Devices Quality Management System Internal Auditor Course
PRICE
SGD$850
[Subject to 8% GST]
DURATION
2 Days
LANGUAGE
English
CODE
MM-70621
SGD$850
[Subject to 8% GST]
2 Days
English
MM-70621
WHO SHOULD ATTEND
Medical device quality professionals, Individuals interested in conducting first-party or second-party audits, Management Representatives, Quality Manager, Internal Auditors, Individual responsible for establishing, implementing, maintaining ISO13485:2016
Medical device quality professionals, Individuals interested in conducting first-party or second-party audits, Management Representatives, Quality Manager, Internal Auditors, Individual responsible for establishing, implementing, maintaining ISO13485:2016
This course aims to equip participants with principles and concepts of ISO13485:2016 and competency to conduct an effective internal audit on ISO13485:2016 requirements.
Downloadable Resources
Course Content
Day 1
- Introduction to Quality Management Systems
- Overview of ISO 13485:2016 requirements
– Section 4: Quality Management System
– Section 5: Management Responsibilities
– Section 6: Resources Management
– Section 7: Product Realization
– Section 8: Measurement, Analysis, and Improvement
Day 2
- Audit planning and preparation
- Audit execution
- Non-conformity reporting
- Closing meeting
- Audit report preparation
- Audit follow-up
– Section 4: Quality Management System
– Section 5: Management Responsibilities
– Section 6: Resources Management
– Section 7: Product Realization
– Section 8: Measurement, Analysis, and Improvement
