Non-Conformity Management SOP — ISO 13485, MDSAP & FDA QMSR Compliant
€49.00
A regulatory consultant charges €150–200/hour. This SOP replaces 6–10 hours of work
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Effective control of nonconforming product and processes is a fundamental requirement of every medical device quality management system — and a mandatory documented procedure under ISO 13485:2016 (Clause 8.3), MDSAP, and FDA QMSR (21 CFR Part 820). Inadequate nonconformity management — including failure to identify, segregate, evaluate, and properly dispositions nonconforming product — is among the most frequently cited findings during third-party assessments and regulatory inspections.
This Non-Conformity Management SOP package gives your quality team a complete, audit-ready framework to identify, document, control, evaluate, and disposition nonconformities across all stages of production and service provision — fully aligned with ISO 13485:2016, MDSAP, and FDA QMSR.
What’s Included
- P-08 Non-Conformity Management Procedure — step-by-step instructions covering nonconformity identification and recording, product segregation and quarantine, disposition options (rework, repair, return, scrap, use-as-is with concession), customer and regulatory notification requirements, re-inspection after rework, and linkage to the CAPA process for systemic nonconformities
Who Is This For
Quality managers, production managers, and regulatory affairs professionals at medical device companies seeking ISO 13485 certification, preparing for MDSAP audits, or maintaining FDA QMSR compliance — particularly those building or standardizing their incoming inspection, in-process control, and final inspection processes.
Why This SOP and Not Starting from Scratch
Developing a compliant nonconformity management procedure from scratch takes 4–6 hours of a regulatory professional’s time. This package is immediately usable, written by an experienced ISO 13485 Lead Auditor and former Notified Body auditor — reflecting current notified body and regulatory expectations on what a robust nonconformity control process must demonstrate at audit.
✓ Instant download after purchase ✓ Fully editable Word format ✓ Compatible with ISO 13485:2016, MDSAP, FDA QMSR ✓ Used by quality teams across EU, US and Canada
Frequently Asked Questions
Q: Does this procedure cover both product and process nonconformities? A: Yes. The procedure covers nonconformities identified at incoming inspection, in-process stages, final inspection, and post-delivery — as well as process nonconformities identified through internal audits or monitoring activities.
Q: How does nonconformity management link to the CAPA process? A: The procedure defines the escalation criteria for linking nonconformities to the CAPA process — ensuring that systemic or recurring nonconformities trigger root cause investigation and corrective action, as required by ISO 13485 Clause 8.5.
Q: Does this cover the requirements for customer and regulatory notification? A: Yes. The procedure includes guidance on determining when customers or regulatory authorities must be notified of nonconforming product that has been released — a requirement under both ISO 13485 and FDA QMSR.
Q: In what format is the document delivered? A: The procedure is delivered in fully editable Microsoft Word (.docx) format, instantly after purchase.
€49.00
