Internal Audit
Planned, independent evaluation of QMS conformity and effectiveness.
Definition
Internal audits per ISO 19011 evaluate whether the QMS conforms to planned arrangements, regulatory requirements, and the standard, and whether it is effectively implemented and maintained. ISO 13485 clause 8.2.4 requires an audit program planned around the status and importance of processes and previous results, with auditors who do not audit their own work. Findings must be followed by timely corrections and corrective actions, with verification. ISO 19011 provides guidance on audit principles and auditor competence. Under the QMSR, FDA can review internal audit records during inspections.What this means in practice
Auditors must be independent of the activity audited. Findings feed CAPA and management review. ISO 13485 requires a documented program covering all processes on a risk basis.Examples
- A MedTech company audits its software development process annually due to its high risk classification and frequent updates, checking adherence to IEC 62304.
- An internal auditor reviews the sterilization records for a Class III implantable device, verifying compliance with validated cycles and ISO 11135.
- During an internal audit, a manufacturer identifies that their supplier qualification process does not fully align with their updated purchasing procedures, leading to a corrective action.
- •Failing to establish a risk-based internal audit program can lead to inadequate coverage of critical processes.
- •Using personnel to audit their own work compromises auditor independence and the objectivity of audit findings.
- •Treating internal audits solely as a compliance check rather than an opportunity for continuous improvement is a common pitfall.
- •Inadequate documentation of audit plans, findings, and follow-up actions can result in non-compliance during external inspections.
- •Not linking internal audit findings to the CAPA process diminishes their effectiveness in driving corrective actions and improvements.
Frequently asked questions
Cross-references
Precedes
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsSystematic process to investigate and resolve quality issues and prevent recurrence.
Top-management evaluation of QMS performance at planned intervals.
International standard for medical device quality management systems.
More in Quality & Risk
· Same categoryAbility of a material to perform with an appropriate host response in a specific application.
Verification step confirming a corrective or preventive action actually fixed the problem.
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Process for receiving, evaluating, and responding to device complaints.
Where this term appears across MedTech Terms.
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1ISO 19011 Auditing GuidelinesTier 1 VerifiedISOiso.org
- 2MDIC Case for QualityTier 4 VerifiedMDICmdic.org
- 3FDA - Quality SystemsTier 2 VerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.