Medical Devices Quality Management
Quality management systems standard specific to the medical devices industry. Ensures consistent design, development, production, installation, and servicing of medical devices and related services.
ISO 13485 specifies requirements for a quality management system covering the full lifecycle of medical devices, from design and development through production, installation, and post-market surveillance. It incorporates regulatory requirements applicable in major markets including the EU MDR/IVDR, FDA Quality System Regulation, and TGA requirements.
Unlike ISO 9001, ISO 13485 is not designed around continual improvement but around consistently meeting regulatory requirements and customer specifications — reflecting the strict regulatory environment of the medical devices sector.
ACI-certified auditors of this scheme demonstrate competency in evaluating QMS compliance within highly regulated medical device organisations and their supply chains.
Attend an ACI-Approved Training Provider (ATP) course for your chosen grade level. ACI-approved courses are aligned to the examination syllabus for ISO 13485.
Examinations are administered exclusively through ACI Approved Training Providers. Foundation and Internal Auditor examinations require 70% to pass; Lead Auditor requires 65%.
Submit your application through the ACI portal with your examination result, training certificate, and relevant audit experience log. Upon approval you receive your ACI Card ID and digital certificate.
Available Grades for ISO 13485
All six ACI auditor grades are available for this scheme. Each grade has defined competence, experience, and examination requirements.
Entry-level certification for those beginning their auditing career. Suitable for individuals who have completed foundation training but have limited audit experience.
For auditors who have completed Internal Auditor training and have begun accumulating audit experience under supervision or in an internal audit role.
Full auditor grade for practitioners with demonstrated audit experience. Recognised as a competent independent auditor of management systems.
Senior grade for experienced auditors capable of leading audit teams and managing full audit programmes. The most widely recognised auditor grade internationally.
Advanced grade for highly experienced auditors demonstrating sustained performance in complex audit environments and contributions to the auditing profession.
The highest ACI designation, awarded to individuals who have made an exceptional contribution to the management system auditing profession and to the ACI community.
Find an Approved Training Provider, sit the examination, and submit your application to ACI.