Six documents covering the full supplier controls lifecycle — qualification, audit, quality agreements, incoming inspection. Built for FDA QMSR §820.50 and ISO 13485 §7.4.
Instant download. For QA managers at regulated device manufacturers.
FDA QMSR §820.50 and ISO 13485 §7.4 require documented supplier qualification, ongoing monitoring, and quality agreements for outsourced processes. Most 483 observations in this area trace back to informal supplier management — spreadsheet ASLs, no audit program, missing quality agreements.
This toolkit gives you the complete document set: qualification procedure, audit checklist, quality agreement, ASL, performance monitoring, and incoming inspection SOP — structured for immediate use as controlled QMS documents.
Structured in the order you'd build a compliant supplier program.
Risk-based supplier classification framework per FDA QMSR §820.50 and ISO 13485 §7.4. Covers critical vs. non-critical supplier tiers, qualification criteria, approved supplier list onboarding, and re-qualification triggers. Includes section instructions and auditor guidance.
On-site and remote audit checklist for critical suppliers — 80+ checkpoints across quality system, process controls, documentation, corrective actions, and ISO 13485 §7.4 alignment. Pre-structured for both initial qualification and periodic surveillance audits.
Supplier quality agreement covering quality obligations, change notification requirements, nonconformance reporting, right-of-access provisions, and regulatory authority access clauses. FDA QMSR §820.50 and ISO 13485 §7.4 compliant.
Tiered ASL with critical/non-critical classification, qualification status tracking, re-qualification schedule, and audit history fields. Designed for direct use as a controlled QMS document. Includes ASL maintenance SOP guidance.
KPI scorecard template for ongoing supplier surveillance — on-time delivery, nonconformance rate, CAPA closure rate, and audit findings trend. Includes corrective action trigger thresholds and escalation criteria for supplier disqualification.
Receiving inspection procedure covering inspection levels, skip-lot criteria, acceptance/rejection criteria, quarantine and disposition process, and traceability to purchase order and lot records. FDA QMSR and ISO 13485 §8.3 aligned.
FDA expects risk-based supplier controls — not a flat approved vendor list. This toolkit gives you the tiered framework and criteria to defend your classification to an investigator.
The supplier audit checklist covers every ISO 13485 §7.4 requirement with actionable questions. Use for initial qualification or annual surveillance audits.
The quality agreement template covers every required clause — change notification, right of access, nonconformance reporting — without starting from a blank page.
“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
Yes. FDA QMSR §820.50 requires manufacturers to establish and maintain procedures for evaluating and selecting potential suppliers of products and services. The procedures must include requirements for supplier evaluation, re-evaluation, and qualification based on their ability to meet specified requirements.
Not necessarily every supplier — but all critical or outsourced process suppliers that can affect device quality. ISO 13485 §7.4 and FDA QMSR both require documented quality agreements with outsourced process suppliers. The risk-based classification in this toolkit helps you determine which suppliers require agreements.
There is no fixed interval in the regulations — it must be risk-based. The toolkit includes a re-qualification schedule framework based on supplier tier, audit history, nonconformance rate, and criticality. Typical practice for critical suppliers is annual re-evaluation.
No. This is a practitioner reference toolkit. Consult your regulatory counsel for formal compliance opinions.
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Six documents. Instant download. Built for FDA QMSR §820.50 and ISO 13485 §7.4.