The Audit—Demonstrating Validation Capability

THE AUDIT—DEMONSTRATING VALIDATION CAPABILITY Audit Agenda 

Based on the experience of more than 50 Supplier Audits, the following agenda for a software Supplier Audit is suggested  

Introduction to the supplier s QMS and qualification strategy Detailed analysis of the quality management documents and the qualification strategy (qualification of the QMS in the sense of certification) 

Detailed analysis of development projects and maintenance activities by documented evidence showing that the defined processes of the QMS are known and adhered to 

Roundtable discussion with quality responsible persons of different groups 

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THE AUDIT—DEMONSTRATING VALIDATION CAPABILITY Audit Agenda... 

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