Quality Management System Audits and Certification for Medical Devices – TGA Guidance

Purpose of QMS Audits and Certification

TGA requires robust evidence that a manufacturer’s Quality Management System (QMS) complies with ISO 13485:2016 (or equivalent) to demonstrate Good Manufacturing Practice (GMP) and support conformity assessment for higher-risk devices (Class I sterile/measuring, IIa, IIb, III). Certification by an accredited body or direct TGA assessment verifies that the QMS effectively ensures consistent safety, quality, and performance. Source: Quality management system audits and certification guidance - TGA

Acceptable Certification Bodies

• Australian-designated Conformity Assessment Bodies (CABs): TGA-designated bodies can issue ISO 13485 certificates accepted for Australian purposes.
• MDSAP Participants: Certificates from Medical Device Single Audit Program (MDSAP) recognized auditing organizations are accepted.
• Other Accredited Bodies: Certification from bodies accredited to ISO/IEC 17021-1 by an IAF MLA signatory may be accepted, subject to TGA review.
• Direct TGA Assessment: Manufacturers can apply for TGA-conducted QMS audits instead of third-party certification.

TGA maintains a list of acceptable certification pathways and bodies.

Types of Audits

• Initial Certification Audit: Comprehensive assessment of the full QMS scope.
• Surveillance Audits: Annual or periodic audits to verify ongoing compliance (typically 1–2 per certification cycle).
• Recertification Audit: Full reassessment every 3 years.
• TGA Surveillance/For-Cause Audits: TGA may conduct its own audits regardless of third-party certification.

Audits must cover all applicable clauses of ISO 13485 and Australian-specific requirements (e.g., adverse event reporting, labelling).

Audit Process and Expectations

• Audits are conducted on-site (or remotely where justified) by qualified auditors.
• Manufacturers must provide full access to documentation, records, personnel, and facilities.
• Nonconformities are classified (major/minor) and require corrective action plans with timelines.
• Successful audits result in certification or continued certification validity.

Timelines and Ongoing Obligations

• Certification must remain current and cover the full scope of activities.
• Significant changes to QMS (e.g., scope, location, critical processes) must be notified to the certification body and TGA where required.
• Manufacturers must undergo surveillance audits on schedule and maintain records of corrective actions.
• TGA may request copies of audit reports or conduct verification audits.

Practical Considerations

• Select a certification body with relevant medical device experience and TGA acceptance.
• Prepare thoroughly for audits with mock audits and complete documentation.
• Integrate Australian regulatory requirements into QMS procedures early.
• Maintain continuous improvement and risk-based monitoring.

Detailed audit checklists, certification pathways, acceptable bodies, nonconformity management, and notification requirements are outlined in the official TGA guidance on quality management system audits and certification for medical devices. Source: Quality management system audits and certification guidance - TGA

This framework ensures ongoing QMS integrity and supports reliable supply of safe medical devices in Australia.