ISO 13485:2016 Lead Auditor Training Course

MD-QMS ISO 13485:2016 Lead Auditor Training Course (2583)

This course aims 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.


Course Details

In detail the course will provide students with the basis to become a competent Lead Auditor, amongst others via the following:

  • 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
  • verification of requirements in processes involved and key personnel

Successful completion of the course (including examination) will result in issuance 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.

Recommended prior Knowledge

Knowledge of the requirements of ISO 13485 is recommended as well as the knowledge about MD MS audit, in particular the principles and conceptsof the Plan, Do, Check, Act (PDCA) cycle; the relationship between ISO 13485 and applicable international regulatory requirements for medical devices; commonly used quality management terms and definitions within ISO 13485 and ISO 9000; the process approach used in MD-QMS. 

A working knowledge of risk-management principles related to the design of a medical device, for example ISO 14971 should be available. Furthermore a working knowledge of medical device regulatory process applicable to countries of course attendance is expected for proper discussions of examples during the course. 

Having the prior knowledge will support the successful completion of the course. Learners without sufficient prior knowledge might participate in a foundation course of the respective discipline first.

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