Supplier documentation gaps usually surface in an audit, or during a complaint. This session shows you the 10 most common ones, and how to find out where your suppliers stand before someone else asks.
Each mistake maps to one document a capable supplier can hand you within days. You learn what each document must prove and where suppliers usually fall short.
Who owns the design, which stages applied, how supplier changes reach your file. When nobody can answer this, changes reach you late. Or never.
Subcontracted operations and skipped in-process controls that surface for the first time when something has already gone wrong.
Every conformity decision rests on a measurement method. Most suppliers never validated theirs. Visual inspection is the usual suspect.
Equipment qualified without records. Limits nobody ever challenged. A PQ run on the best day with the best operator. Serial production looks different.
Sample sizes with no link to risk, confidence or reliability. This one rarely survives a second question in an audit.
Process aids that change silently. Quality controls that exist only on paper. And a certificate with the wrong scope proving a system exists, not that your component is under control.
Most QA/RA leads assume more than they can show. Find out where your suppliers stand before your notified body does.
Every weak supplier document creates another review, another follow-up call, another delayed decision. Your QA, RA and engineering specialists end up correcting supplier documentation instead of doing the work only they can do. That is the resource drain, and it never shows up as a line item.
As legal manufacturer, responsibility for supplier evidence sits with you, ISO 13485 certificate or not. And whether you have one SQE or none, the math stays the same: dozens of critical suppliers, a handful of specialists, and every gap ends up with the people who also run releases, CAPAs and submissions.
Questionnaires, certificates and audits tell you where a supplier stands. They don't build what's missing. That's what Suppliance does: supplier development for teams without a supplier development function. Webinar attendees get a first impression of what Suppliance does for you.
Simon is an ISO 13485:2016 Lead Auditor and first- and second-party process auditor with more than 15 years in medical device QA/RA, including high-risk and Class III devices. He has completed more than 40 supplier audits across Europe and Asia, and developed a supplier with zero prior MedTech experience into a serial-production source for EU manufacturers.
He knows what lean teams can realistically demand from suppliers, and how to get it without adding headcount. As a TÜV SÜD Academy trainer he teaches test method validation, applied statistics and process validation, with one focus: turning regulatory requirements into practical evidence that stands up in real manufacturing processes.
In this webinar, Simon shows you what strong supplier evidence looks like, where it breaks down, and what to change so the same gaps stop coming back.
You lead quality or regulatory in a MedTech company. Supplier files land on your desk next to releases, CAPAs and compliance work, and there is no one to delegate them to.
No SQE, no supplier development role. Qualification, monitoring and follow-ups run on the side, and critical components and outsourced processes (moulding, metal parts, cables, packaging, sterilisation) depend on suppliers you can't watch full-time.
An external audit put a supplier-related finding on your CAPA list, or MDR surveillance is coming and your supplier evidence is not where it needs to be. You need the gaps closed at the supplier, not patched internally again.
60 minutes. Free. Q&A with Simon Föger.
