MD-QMS ISO 13485:2016 (Medical Device – Quality Management System) Lead Auditor

The aim of this course is to provide learners with the knowledge and skills required to perform first, second and third party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011 and ISO/IEC 17021. All references to standards are to the current versions, unless stated otherwise. In detail the course will provide students with the basis for becoming a competent Lead Auditor by teaching amongst others the following knowledge and skills:

• Purpose and benefits of an MD-QMS
• Role of an auditor to plan, conduct, report and follow up a quality management system audit
• Plan, conduct, report and follow up an audit of an MD-QMS to establish conformity (or otherwise) with ISO 13485 via exercises and role play
• Generating Audit Findings
• Plan-Do-Check-Act cycle and its application to medical device framework
• Differences between first-party, second-party and third-party certification audit
• Benefits of third-party accredited certification
• Terminology defined in the standard
• Requirements for MD-QMS documented information
• Verify the effectiveness of the design and development process
• Verify the control of procedures and records and the effective documentation
• Verify the competence of MD-QMS personnelnd differences between first party, second-party and third-party certification audit of management systems

Successful completion of the course (including examination) will result in the issue of a certificate which may be used to support an application to become registered as an IRCA auditor. Being certified as an IRCA auditor is a clear statement that you are a recognized, qualified and capable auditing professional.

• The number of participants is limited to max. 10 people.
• Online Examination.