Referenzen
Audit of a logistics service provider, including the preparation of a report
Kategorie
ISO 13485
Branche
Medical technology
Unternehmen
International holding company with approximately 31,000 employees
Ansprechpartner
Tim Wedel
Ausgangssituation
A leading medical technology manufacturer commissioned an audit of an external logistics service provider after external reports of potential regulatory risks, particularly in relation to labelling processes, came to light. The logistics service provider assumes no regulatory responsibility in this context, meaning that the manufacturer remains fully responsible for compliance with regulatory requirements (e.g. ISO 13485, FDA requirements). There were organisational and documentation-related weaknesses that needed to be assessed at short notice.
Herausforderung
The challenge was to gain a comprehensive overview of the process and compliance situation whilst under significant time pressure. Varying levels of maturity in the areas of labelling, risk assessment, document control, order management and the handling of instructions for use made a complete assessment difficult. In addition, the manufacturer needed to minimise regulatory risks, as deviations in the labelling process could have a direct impact on audit and regulatory requirements.
Lösungsansatz
Conducting a comprehensive on-site gap audit over two days
Systematic collection of evidence
Assessment of processes using a standardised risk assessment
Clear identification of recommended measures to ensure compliance in the short term, including a proposal to appoint a qualified manufacturer to formally approve the process
Preparation of a structured audit report, including the prioritisation of identified non-conformities and areas for improvement
Ergebnis
A fully transparent overview of the service provider’s compliance status; identification of all relevant non-conformities in areas such as labelling, risk assessment, order management and document control; clear recommendations for action to minimise risk immediately; a significant increase in regulatory certainty for the manufacturer and enhanced readiness for audits and regulatory inspections.
Tim Wedel
Senior Consultant & Sales
