ISO 13485 Lead Auditor Training

About the Course

ISO 13485 Lead Auditor Training empowers individuals with the skills and knowledge required to lead and conduct successful audits in alignment with the international standard for medical device quality management systems. In collaboration with our sister organization, Empowering Assurance Systems (EAS), IAS provides this CQI-IRCA Certified ISO 13485 Lead Auditor Training for those keen on auditing medical device quality management systems.

What the ISO 13485 Lead Auditor Course Covers

The course combines the requirements of ISO 13485:2016 with the auditing discipline of ISO 19011, covering:

• The structure of ISO 13485:2016 and its alignment with regulatory requirements for medical devices.
• Quality management system — general requirements and documentation, including the medical device file (Clause 4).
• Management responsibility — management commitment, customer and regulatory focus, quality policy and objectives (Clause 5).
• Resource management — competence and training, infrastructure, work environment, and contamination control (Clause 6).
• Product realization — planning, customer-related processes, design and development with design controls, purchasing, production and service provision, cleanliness and sterile-device requirements, identification and traceability, and validation of processes (Clause 7).
• Risk management applied across the QMS, aligned with ISO 14971.
• Measurement, analysis and improvement — feedback and complaint handling, reporting to regulatory authorities, internal audit, control of nonconforming product, and corrective and preventive action (CAPA) (Clause 8).
• Audit principles and the full audit lifecycle: planning, conducting, gathering evidence, grading nonconformities, reporting, and follow-up.

Key Benefits

Who Should Attend

This program is tailored for professionals involved in medical device manufacturing, quality assurance, and those aspiring to become lead auditors. Whether you are from a medical device company, regulatory body, or research institution, the course will equip you with the skills needed to ensure compliance and excellence in your organization.

Training Delivery Methods

Delivered over a 5-day (40-hour) program, with the method of delivery you prefer:

Assessment & Certification

Continuous Assessment: candidates are evaluated throughout the course on attendance, active participation, completion of individual and group exercises, and professional engagement during class discussions.

IRCA Examination: at the end of the course — whether delivered in a classroom, virtual, or in-house setting — participants complete the IRCA examination, conducted online. The examination specifications are as follows:

Candidates taking the exam in languages other than English, Spanish, Japanese, Arabic, or Traditional Mandarin will complete a paper-based version.

Certification: participants achieving 70% or higher in continuous assessment, plus 50% or above in the final examination, will receive a CQI/IRCA-accredited certificate of successful course completion, recognized globally. Candidates who do not meet this threshold will be issued a certificate of attendance.

Enrolment Process

Start your professional journey by contacting us about the ISO 13485 Lead Auditor Training today.