Course Duration
16 hours (2days)
Course Fees
S$850 + GST, Per Participant
Venue
Main Office (Bendemeer)
20 Bendemeer Road, #04-06 BS Bendemeer Centre, Singapore 339914
Course Overview
Learners will be able to:
• Understand the requirements of ISO 13485:2016
• Define the audit scope, criteria, frequency, methodologies, responsibilities and requirements
• How to carry out documentation review, interviews and site inspection during an audit
• Be able to plan, prepare and execute integrated management system internal audit effectively
• Develop the skills of evaluating the significance of audit findings and developing appropriate corrective/preventive measure
• Preparation of an audit report
• Accredited as a certified internal auditor for ISO 13485:2016
Course Content
• Introduction – requirements of ISO 13485:2016.
• Understanding quality control for medical device and continual improvement in organizations
• Define the audit scope, criteria, frequency, methodologies, responsibilities and requirements
• How to carry out documentation review, interviews and site inspection during an audit
• Be able to plan, prepare and execute integrated management system internal audit effectively
• Develop the skills of evaluating the significance of audit findings and developing appropriate corrective/preventive measure
• Preparation of an audit report
Course Completion
• Participants will need to attend 100% of the course. A certificate will be awarded after successful course completion.
Target Audience
• All staffs of an organization who are responsible for planning and scheduling an internal audit on ISO 13485:2016.
• Participants who desire to have the knowledge and skills of conducting an internal audit on ISO 13485:2016 in an organization.
Company Sponsored Form (More than 1 participant)