ISO 13485:2016 Auditor/Lead Auditor

Medical Devices Monitor ImageISO 13485:2016 Auditor/Lead Auditor
5 Days

CQI & IRCA Certified 
No. 1764
CQI IRCA Certified Course

You need this ISO 13485:2016 Auditor/Lead Auditor course if...

  • you want to audit Quality Management Systems against ISO 13485 requirements
  • you are an Auditor or Quality System Manager working in the medical devices sector and want to add to your credibility with a widely accepted qualification

You will learn …

  • the purpose of a QMS based on ISO 13485 and the ISO 9000 principles of quality management
  • essential definitions to help you interpret and audit ISO 13485 requirements
  • to analyse ISO 13485 clauses and suggest examples of evidence that would show conformance with these requirements
  • the roles and responsibilities of an auditor and lead auditor
  • to plan and conduct an interview with top management and evaluate an organization’s quality policy and objectives
  • to prepare an on-site audit plan that establishes effective audit trails across processes and between members of an audit team
  • how to audit processes for conformance and effectiveness, including any specific quality objectives
  • to prepare thoroughly for audit and produce process based checklists
  • to gather objective evidence through observation, interviewing and reviewing documentation
  • how to evaluate objective evidence and correctly identify conformance and non-conformance with requirements
  • to report findings accurately against requirements of ISO 13485, write and grade non-conformity reports and evaluate proposals for corrective action
  • how to relate your audit findings to the policy and objectives of the organization and present your overall evaluation to top management

You will need …

  • knowledge and understanding of ISO 13485 and experience of auditing
  • ideally to have attended our ISO 13485 Appreciation and Interpretation course
  • to understand the basics of how organizations work and the role of top management
  • to have good knowledge of ISO 13485 and possess knowledge of the quality management principles and concepts: the Plan, Do, Check, Act (PDCA) cycle; the relationship between quality management and customer satisfaction; commonly used quality management terms and definitions and the 7 Quality Management Principles as given in ISO 9000; the process approach used in quality management; the Model of a Process Based Quality Management System; the structure and content of ISO 13485.
  • Complete approximately 3 hours of pre course work prior to attending the course.

Your future development

  • Tutored Audits (coached live audit at your company)
  • See our Business Improvement courses

Course length

  • Five days
  • Four days - for organizations who do not require an IRCA course, this course can be delivered in 4 days

Course Dates & Booking


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