ISO 13485 Internal Audit

ISO 13485 Internal Audit [ISO 13485 Cl. 8.2.4]

ISO 13485 Internal Audit Process

Clause 8.2.4 of ISO 13485:2016 emphasizes the importance of a structured internal audit process to ensure the effectiveness and compliance of the QMS. Internal audits are a crucial component of the ISO 13485 QMS, ensuring that the system remains effective, compliant, and continuously improving. This process is integral to maintaining high standards of quality and safety in the medical device industry.

Key Requirements of Internal Audit:

Audit Planning: A documented plan for conducting internal audits. which define the Scope and frequency of audits ,Audit criteria and Personnel responsible for conducting audits.

Auditor Selection:  Auditors must be selected impartially, ensuring objectivity and impartiality should not audit their own work to maintain the integrity of the audit process.

Audit Execution: Internal audits should be systematic and objective, following the defined audit plan and criteria. This involves gathering information through interviews, document review, and observation of processes and Identifying any nonconformities.

Audit Records and Reprting: All audit findings, including identified nonconformities, positive and negative observations and observations for improvement  need to be documented in an audit report and communicated to the management and auditees.

Corrective Actions: A documented process for addressing identified nonconformities. This includes determining the root cause of the nonconformity, Implementing corrective actions to eliminate the nonconformity and prevent its recurrence recording details of corrective actions taken and verifying their effectiveness.

Follow-up: Follow-up activities must include the verification of the actions taken and the reporting of verification results and ensure that the identified issues are effectively addressed and resolved.

Internal Audit Process Flow
Frequently Asked Questions

How to control an Outsourcing vendor? How to maintain documents

updated soon


Step 1 of 3