Quality is always the result of excellent work without compromise.
MMD-102 ISO 13485:2016 Internal Auditor Training
Schedule and Hours
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:
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
Overview of EN ISO 13485 standard including definitions and terms
Cross linking to other regulations
The types of audits
Preparing an Audit Schedule
Identification of key auditor skills and Auditing Techniques
Planning a process based audit including resources and timings
Checklists – development and uses
Evaluating the significance of audit findings
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.
We are HRD Corp (Human Resource Development Corporation) Registered Training Provider. All of our training modules are claimable under HRD Corp.