Non-conformance procedure Template - ISO 9001

Effectively identify, document, and manage non-conformities with our ISO 9001:2015 Clause 10.2 Non-Conformance Procedure Template. A structured non-conformance management process is critical for maintaining product quality, regulatory compliance, and continuous improvement. This ready-to-use procedure template provides a systematic approach for addressing non-conformities in processes, products, or services, ensuring compliance with ISO 9001:2015, ISO 13485, and FDA 21 CFR Part 820.

✔ Pre-Formatted Non-Conformance Procedure – Covers key ISO 9001:2015 Clause 10.2 requirements.

✔ Non-Conformance Identification & Documentation – Define how to detect and report non-conformities.

✔ Investigation & Root Cause Analysis – Implement structured problem-solving methods to assess causes.

✔ Risk-Based Evaluation & Impact Assessment – Prioritize non-conformances based on severity and potential risks.

✔ Corrective & Preventive Action (CAPA) Integration – Ensure non-conformities are properly addressed and prevented.

✔ Approval & Sign-Off Workflow – Assign responsibility for resolution and verification.

✔ Audit-Ready Documentation & Record Keeping – Maintain structured records for internal audits and regulatory inspections.

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

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

Download the ISO 9001:2015 Non-Conformance Procedure Template today and enhance your quality control and compliance efforts!