MMD-102    ISO 13485:2016 Internal Auditor Training

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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Certify your quality management system for medical devices with ISO 13485.
 
ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.

On completion of this training, participants will be able to:

• Understand the requirements of ISO 13485:2016 clauses
• Determine the principles of Quality Management system
• Interpret ISO 13485:2016 requirements in the context of an audit
• Evaluate their organisation’s status with regard to ISO 13485:2016 implementation
• Describe the roles and responsibilities of auditors and lead auditor.
• Improve the skill of auditing
• Plan and conduct an audit in accordance with ISO 13485:2016 audit plan

Day 1

• Section 1: Briefing of Fundamental concept of Internal Audit 
• Section 2: Audit scheduling and planning activities
• Section 3: Adequacy, Compliance and Effectiveness (ACE concept)

​Day 2:

• Section 4: Mock Audit Activity: Hands-on Experience
• Section 5: Audit report writing  
• Section 6: : Audit Presentation, discussion and evaluation​

This course is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Internal Auditors and others who would like to develop judgment and decision-making in ISO 13485:2016 and learn the auditing process for first, second, and third party auditors.

This is a 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.