MedtechDelivered
Every corrective action read for an ISO 13485 audit.
Our document analysis assessed all 35,000 records in a device maker’s corrective-action list against ISO 13485, clause by clause.
An auditing consultancy for medical device manufacturers
- 35,000corrective-action records assessed, every one of them
- About 100records a manual review could reach in the time an audit allows
- 700+non-conformances traced to a single clause
The situation
An auditing consultancy came to us with a client’s corrective-action list of 35,000 records. Its review practice could reach about 100 of them in the time an audit allows, so the audit rested on a sample.
Many ISO 13485 clauses are compound: one clause holds several requirements.
What we built
We broke ISO 13485’s compound clauses into individually testable requirements.
Adaptive document analysis then ran across every record in parallel on serverless compute, mapping each one to the clauses it touched, with page references and supporting extracts for the auditors to check.
The decision that mattered
Splitting each compound clause into requirements that can be tested one at a time made every finding specific, and put a page reference and an extract behind each one, so the auditors could check the evidence for themselves.
Where it stands
The consultancy left with all 35,000 records assessed and a clause-level map with page references and supporting extracts.
One clause was identified in more than 700 non-conformances: the single largest concentration of issues in the client’s quality system, and the focus for the audit.