Courses

ISO 13485:2016 - Quality Management System for Medical Devices - Internal Auditor Training Course

Course Duration
16 hours (2days)

Course Fees
$ 750.00/- (Inclusive of GST)

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.

No Entry Requirements.
Classes
Schedules

Weekdays

Day 1 – 2 : 08:30:00 – 17:30:00


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