Internal Audit Procedure | ISO 13485 | FDA QSR Compliant

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The ISO 13485 Internal Audit Procedure defines the process, methods and cycle for conducting internal audits. ​
  • ISO 13485:2016
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
SKU: SOP 8-005

Internal Audit Procedure

The Internal Audit Procedure defines the process, methods of documenting and scheduling for conducting internal audits. 

Internal Audit Procedure - Overview

​The Internal Audit Procedure applies to all areas of the company that could affect the quality of medical device products and medical device regulatory compliance.

The Internal Audit Procedure defines the process to systematically review the ISO 13485 Quality Management System to determine if it is effectively implemented and maintained. The Internal Audit Procedure ensure audits are performed throughout the audit cycle to measure conformance to:
  • Product realization practices
  • Applicable standards and regulations.
  • Company’s standard operating procedures.

Internal Audit Procedure - Compliance

The Internal Audit Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our Internal Audit Procedure contact us at [email protected]

RELATED LINKS

​Corrective and Preventive Action Procedure
Management Review Procedure
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 13485 Internal Audit Procedure
Internal Audit Procedure

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