Dates and Venues

Learn how to audit a complete quality management system against the requirements of ISO 13485 and associated regulations.

This ISO 13485 Lead Auditor training course provides in-depth knowledge and hands-on experience in auditing Medical Device Quality Management Systems (MD-QMS).

The 5-day course is designed to provide learners with the knowledge and skills required to perform 1st, 2nd and 3rd-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.

Through a series of exercises, activities and case study scenarios, delegates will learn how to:

  • assess the documentation of the QMS against ISO 13485 requirements
  • prepare a risk-based audit plan, create effective checklists and sampling plans, and incorporate risk considerations
  • systematically sample and gather evidence to test the conformance and effectiveness of processes and the interaction between the processes of the QMS
  • balance the rigour of evidence-based auditing with the ability to engage auditees, building an open and supporting audit environment that adds value, promotes discussion and drives improvement.

Central to the course is a case study based on a medical device manufacturer, marketing its products in UK and Europe.

This course is suitable for those with a wide range of job roles and tasks, including:

  • individuals involved in internal, supplier, or certification audits of medical device quality management systems
  • managers responsible for leading or managing audit teams
  • management representatives or those developing or implementing an MD-QMS
  • individuals aspiring to become IRCA-certified MD-QMS auditors

Before attending the course, an understanding of ISO 13485 and awareness of related regulations is required. For those new to ISO 13485, we suggest pairing this course with our Introduction to ISO 13485 training course, available at a discounted rate when booking both courses together.

Course topics include:

  • fundamentals of auditing and the audit process
  • PDCA cycle and application to a medical device quality management system
  • processes included in a medical device quality management system
  • role of the auditor
  • documentation and records requirements
  • auditing medical device software
  • IEC/ISO 606601 standards
  • IMDRF Medical Device Single Audit Program
  • planning, conducting, reporting and follow up of an audit
  • risk-based audits
  • auditor responsibilities

This typical course agenda offers a good indication of how the topic will be approached through discussion, case studies and regular knowledge reviews as the course progresses.

Pre-course

  • Questions and sources of information to help ensure delegates have sufficient prior knowledge of ISO 13485 and relevant regulations.

Day 1

  • WELCOME
  • Course introduction
  • Introduction to auditing
  • Management systems and ISO 13485
  • Processes and process auditing
  • ISO 13485 documentation requirements
  • Overview of the audit process
  • Auditor roles and responsibilities
  • Audit meetings
  • Stage 1 audit
  • Case study: Introduction to the case study
  • CLOSE
  • Evening work

Day 2

  • Learning review
  • Case study: Pre audit activity
  • Case study: Stage 1 document review
  • Stage 2 audit, risk-based audit planning
  • Case study: Prepare a stage 2 audit plan
  • Audit checklists and sampling plans
  • Case study: Checklist and sampling plan preparation
  • CLOSE
  • Evening work

Day 3

  • Learning review
  • Performing the audit and audit skills
  • Case study: Top management interview
  • Case study: Internal communication
  • Evaluating audit evidence
  • Audit reporting and nonconformities
  • CLOSE
  • Evening work

Day 4

  • Learning review
  • Corrective action
  • Following up and close out corrective actions
  • Case study: Tasks and simulated audits making use of MD-QMS materials and information representative of those that auditors can expect to find in real audits of MD-QMS which are based on ISO 13485
  • CLOSE
  • Evening work

Day 5

  • Learning review
  • Planning routine surveillance audits
  • Case study: Using a risk-based approach, produce a plan for surveillance audits
  • Case study: Present audit conclusions and recommendations to the auditee
  • Course review and exam preparation
  • Exam
  • CLOSE

By the end of the ISO 13485 Lead Auditor training course, delegates will have learned how to:

  • explain the purpose, requirements and business benefits of a medical device quality management system (MD-QMS)
  • plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity or nonconformity with ISO 13485 and applicable medical regulations
  • explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit