Internal audits for SMEs

A manufacturer of medical device systems for vascular diagnostics required support in conducting an internal audit. To ensure the objectivity and impartiality of the internal audit process, EXCO was commissioned to plan and perform the internal audits independently.

ISO 13485 defines specific requirements for internal audits as a key element of a medical device Quality Management System (QMS), ensuring that the system is effectively implemented and maintained. Internal audits help identify deviations and nonconformities against ISO 13485 requirements and provide valuable insights for continuous improvement. To ensure objectivity and impartiality throughout the audit process, the manufacturer engaged EXCO to independently conduct the internal audit. This approach supports a neutral assessment of the QMS and helps verify compliance with applicable quality management requirements.

• Development of an audit plan tailored to the client's Quality Management System (QMS)
• Conducting the internal audit in accordance with EN ISO 13485:2016 + AC:2018 + A11:2021, Clause 8.2.4, including compliant documentation
• Consulting on potential corrective actions

• No internal resources were required to conduct the internal audit
• Experience gained from internal audits performed for comparable medical device companies in accordance with DIN EN ISO 13485 was applied to the client's project
• Support in preparing for certification audits

Mid-sized company in the medical technology sector