What auditors actually look for in supplier documentation and how to be ready before they ask.
Learn the specific clauses auditors probe, the gaps they expect to find, and the structure that closes them.
The spec drives the file. Auditors trace requirements from your purchasing controls into the supplier file, and back. Where do most teams lose the audit? On the bridge between them.
"Approved" is a status, not a file. Date of last re-evaluation, criteria applied, evidence reviewed. That's what gets read. Build a qualification record that can answer for itself.
The clause auditors flip to is change control. Notification windows, scope of changes, escalation. These are scanned line-by-line. Generic boilerplate is a major-NC magnet.
Every accept/reject criterion needs validated methodology behind it. Gage R&R, Cpk, sample-size justification. Auditors want the math, not the assurance.
Records aren't the artefact. The traceability between them is. From device master to device history, the chain has to hold under cross-examination. One broken link = one finding.
On-demand. 60 minutes. Free.
Stop reacting to findings. Months of corrective-action work sits behind a single missing re-evaluation date. The kind that takes an afternoon to prevent.
"We have it" isn't the same as "it holds up." Auditors check the change-control clause inside your QSA, the date on your last supplier re-evaluation, the validation behind every test method in your DHR. Findings live there.
Focus effort where audits are decided. Build files around the 5 Non-Negotiables and audit conversations become predictable, focused, and fact-based.
Simon is a MedTech expert and auditor with over a decade of hands-on experience in supplier audits, supplier development, and component sourcing for medical device manufacturers, across global supply chains.
As a TÜV SÜD Academy trainer he trains professionals worldwide in test method validation (TMV), applied statistics, and process validation, with a strong focus on making regulatory requirements practical, defensible, and audit-ready inside real supplier files.
In this webinar, Simon brings field experience directly to supplier documentation under ISO 13485: exactly what auditors probe, where structural gaps hide, and how to close them before they become major NCs.
Built around the auditor's actual reading order.
CEOs, founders, and QM heads at medical device manufacturers who ultimately own the audit outcome and the supplier strategy that drives it.
QA/RA leaders, regulatory specialists, and purchasing teams running supplier qualification, Quality Agreements, and audit prep on the manufacturer side.
Companies preparing to qualify, or stay qualified, as a source for MedTech manufacturers, including those facing a customer audit or pursuing their own ISO 13485 certification.
60 minutes. Free. Q&A with Simon Föger.
