Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. Over 5 days, you will gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. You will acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
Learning Objectives:
Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance.
Conduct an effective audit based on process identification, sampling and questioning
Plan an internal audit
Identify the key principles of auditing and auditor responsibilities
Conduct an effective audit based on process identification, sampling and questioning
Determine if corrective action has been effectively implemented
Who Should Attend?
Management representatives
Quality directors, managers, and engineers
Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
Consultants
Lead Auditors
Pre-requisite:
It is recommended that trainee attending this route shall have adequate expertise of ISO 9001 Standards and a few prior information of QMS auditing.
It is likewise conveyed that no prior knowledge as above may lead to unsuccessful of completion of this route and the gaps in this information may not be covered all through this path.