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 personnel

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