Medical Devices Quality Management System Certification Audits

Key requirements — selected themes

• Quality system documentation and regulatory responsibilities
• Risk-based controls across relevant product lifecycle activities
• Design and development controls where applicable
• Supplier, production and process validation controls
• Identification, traceability and product preservation
• Complaints, reporting, corrective action and effectiveness

High-level summary

A sector-specific assessment of the quality system supporting the organisation’s role in the medical device lifecycle. Audits examine the controls and records relevant to its products, processes and applicable regulatory responsibilities.

Certification provides evidence of management system conformity for the stated scope. It is not a medical device approval, marketing authorisation or substitute for a regulator’s required assessment, registration or inspection.

Third-party certification pathway

References: [S08] · [G01] · [G02] · [G03]

• Application & scope. Identify device categories, lifecycle activities, sites, outsourced processes and applicable regulatory markets.
• Review & audit planning. Confirm eligibility, impartiality, competence and applicable rules; agree scope, audit time and programme.
• Stage 1 — readiness. Review quality documentation, regulatory responsibilities, process validation and system evaluation readiness.
• Stage 2 — implementation. Evaluate applicable lifecycle controls, traceability, production records and post-production feedback processes.
• Nonconformity resolution. Review corrections and corrective actions; verify closure or accept action plans as the applicable rules require.
• Independent certification decision. A competent function independent of the audit evaluates the evidence; certification is issued only when requirements are met.
• Surveillance. Review product and regulatory changes, complaints, reportable events and continuing process control.
• Recertification. Reassess the system before certificate expiry and complete the required review and decision for a new cycle.