ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor Course – Complying with Requirements

Description

COURSE OUTLINE:

1. Quick review of ISO 13485:2016 version
2. Process approach
3. Management process and supporting process - Quality Management System
4. Responsibilities and duties of lead auditor, auditor
5. Audit planning and preparation
6. Objectives collection and analysis of evidence
7. lReview, report and follow-up
8. Test

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: 80%):
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 material

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

Remark: This course doesn’t cover interpretation of ISO 13485:2016 requirements. Delegates who are not familiar with the requirements should attend ISO 13485:2016 Foundation Training Course first.

Objectives

• Fully understand and successfully interpret the ISO 13485:2016 requirements
• Familiar with the latest update for ISO 13485:2016
• Understand how to audit using the process approach
• Ask audit questions that get results
• Identify and document nonconformities
• Audit to the ISO 9001:2015 Quality Management Systems
• Quality additional staff to conduct internal audits
• Provide critical knowledge for your management staff
• Gain insight into the ISO 13485:2016 audit requirements to augment/sustain your existing program
• Gain knowledge to help manage a successful ISO 13485:2016 implementation project
• Provide professional credentials to your internal auditors
• Provide critical knowledge for your staff and management

Audience

The ISO 13485 Internal Auditor Course includes the in-depth interpretation of ISO 13485 requirements, auditing skills and case studies to ensure thorough implementation of ISO 13485 and audit skills within the organization.