Non-conformance Report Template - ISO 9001

Streamline your non-conformance management process with our ISO 9001:2015 Clause 10.2 Non-Conformance Report (NCR) Template. Properly documenting and addressing non-conformities is essential for maintaining product quality, regulatory compliance, and continuous improvement. This structured NCR template provides a systematic approach for logging, analyzing, and resolving non-conformances, ensuring compliance with ISO 9001:2015, ISO 13485, and FDA 21 CFR Part 820.

✔ Pre-Formatted Non-Conformance Report (NCR) Template – Covers key ISO 9001:2015 Clause 10.2 requirements.

✔ Non-Conformance Identification & Categorization – Document issues, affected products, and severity levels.

✔ Root Cause Analysis & Risk Assessment – Use structured problem-solving techniques to determine the cause.

✔ Corrective & Preventive Action (CAPA) Integration – Define containment, corrective actions, and preventive measures.

✔ Responsibility Assignment & Deadline Tracking – Assign tasks to ensure timely resolution.

✔ Effectiveness Review & Closure Approval – Ensure implemented actions successfully resolve the issue.

✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various industries and quality management needs.

This NCR template is ideal for quality managers, compliance teams, and regulatory professionals, ensuring a structured, compliant, and effective approach to non-conformance management.

Download the ISO 9001:2015 Non-Conformance Report (NCR) Template today and improve your quality control and compliance strategy!