MMD-102 ISO 13485:2016 Internal Auditor Training
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.
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:
- Explain the structure and scope of ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
- Identify the principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct informal opening and closing meetings
- Conduct an audit based on process identification, sampling and questioning
- Provide verbal and written feedback
- Document concise nonconformities
- Effectively report on an audit
- Follow-up on corrective actions
Day 1
Day 2:
- Review of key concepts and skills learned
- Section 1: Introduction to ISO 13485:2016
- Section 2: Introduction to Internal Auditing
- Section 3: Systematic Approach to Conducting Audit
Day 2:
- Section 4: Audit Process
- Section 5: Audit Reporting
- Section 6: Corrective Action and Follow-Up
- Mock Audit Activity: Hands-on Experience
- Review of key concepts and skills learned
- Section 7: Q&A session
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.
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.
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.
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