ISO 13485:2016 Medical Devices Lead Auditor

This ISO 13485:2016 Lead Auditor training course will enable you to conduct effective audits in any auditing situation. It provides you with the skills to plan, conduct, lead and report audits for first party (within your own organisation), second party (suppliers) and with third party organisations.

It will provide you with the knowledge to understand implement and evaluate Medical Device- Quality Management Systems. It also assists you in understanding the interpersonal and communication skills required for Auditors and Audit team leaders. The course involves a high level of participant involvement through discussions, role plays and case studies that are used to reinforce the concepts and to provide practice in applying them

Why you should take this course?

-This course suitable for any professional who is responsible for developing and implementing Medical Device - Quality Management Systems based on ISO 13485:2016

-Auditors and lead auditors who are required to conduct internal/external audits.

Note: Professionals may choose to do this course in their own pace by opting to do the Individual competencies Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL at different times as per the training schedule.

Program Benefits

Explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).

Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011

Identify the purpose and benefits of an ISO 13485:2016 QMS

Skills you will gain

On successful completion of the course assessment, participants will be issued with a ‘Certificate of Attainment’, covering the competencies of Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL.

This certificate enables successful candidates to apply to Exemplar Global (formally RABQSA International) for certification as a provisional auditor.

Those participants who choose not to submit the assessment will be issued with a ‘Certificate of Attendance’

What will you learn?

Understand the intent and requirements of the ISO 13485:2016 Standard in the context of a quality management system audit

Understand the relationship between the applicable regulatory requirements and ISO 13485

Explain the concepts of the process approach, Plan-Do-Check-Act, process-based activities and associated inputs, outputs, controls, and resources

Understand how to evaluate the effectiveness of an entire quality management system, including process, customer focus and improvement to meet regulatory requirements

Evaluate, using risk-based thinking, the effectiveness of an entire quality management system as applied to medical devices

How to manage an audit program including the scope, objectives and criteria for the audit, and selecting an appropriate audit team

Perform all aspects of a management systems audit in accordance with ISO 19011, from preparation through to conducting follow-up

Evaluate evidence collected during the audit and prepare reports of conformity and nonconformity to the audit criteria, including writing a formal audit report

Practice effective team leadership and communication skills

Throughout the course a series of activities will provide the opportunity for attendees to demonstrate the knowledge they have gained

The course uses a detailed medical devices case study to conduct the practical in-class activities