Internal-audit outsourcing
Your ISO 13485 internal-audit programme, run year-round by an independent team - findings cited, fixes drafted.
Services
What we run
The audit is where we start: the independent measure of a quality system's health. And it ends with the fixes drafted.
The three engagements
Mock audits
A full dress rehearsal before your certification or notified-body audit - findings you fix before anyone official sees them.
Full ISO 13485 audits
The complete audit, planned, conducted and reported end to end against every applicable requirement - with the fixes drafted.
One engine, every engagement
Every engagement runs on the same audit engine: your records read as deep as you choose - up to 100% of them - with byte-exact citations behind every finding, proportionate grading by a certified auditor, and the fixes drafted ready to adopt. The difference is scope: your mandatory yearly internal audit, the dress rehearsal before the official audit, or the complete ISO 13485 examination.
Ready when your next audit is due
Every engagement starts with one call and ends with a signed report - and the fixes to go with it.
Talk to an auditor