FDA QMSR Nonconforming Product Control Policy, SOP & Forms

¥319,500

FDA QMSR Nonconforming Product Control Policy, SOP & Forms

FDA QMSR Nonconforming Product Control Policy, SOP & Forms

¥319,500

Nonconforming Product Control templates for FDA QMSR compliance.

Quantity

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §8.2.4
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete internal audit template set for FDA QMSR compliance. Provides structured procedures for planning, conducting, and reporting internal audits to verify QMS effectiveness and identify improvement opportunities.

Regulatory Reference: ISO 13485:2016 §8.2.4 — Internal Audit

Why You Need This

ISO 13485:2016 §8.2.4 requires a documented internal audit program covering all QMS elements. This template ensures your audit program is comprehensive, systematic, and produces full audit trails for FDA inspectors.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S901 Internal Audit SOP
📝 Form / Template MD-QMS-F901 Internal Auditor Certification List
📝 Form / Template MD-QMS-F902 Internal Auditor Certification
📝 Form / Template MD-QMS-F903 Internal Audit Plan
📝 Form / Template MD-QMS-F904 Internal Audit Report
📝 Form / Template MD-QMS-F905 Corrective Action Request
📝 Form / Template MD-QMS-F906 Corrective Action Plan
📝 Form / Template MD-QMS-F907 Corrective Action Completion Report
📝 Form / Template MD-QMS-F908 Internal Audit Completion Report
📝 Form / Template MD-QMS-K9 内部監査規程 QMSR対応 改善版
📝 Form / Template MD-QMS-S901 内部監査手順
📝 Form / Template MD-QMS-S901 内部監査手順 QMSR対応 v2

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
Internal Audit Personnel
Qualification Requirements
Auditor Independence
Auditor Certification Validity and Recertification
Ongoing Competency Development
Internal Audit Frequency
Scheduled (Routine) Internal Audits
Unscheduled (For-Cause) Internal Audits
Follow-Up (Re-) Audits
Audit Execution
Audit Planning
Risk-Based Audit Planning
Audit Numbering
Audit Checklist Preparation
Conducting the Audit
Classification of Findings
Audit Reporting
Correction and Corrective Action
Effectiveness Verification
Internal Audit Completion Report
Internal Audit File
Reporting to Management Review
Emergency Escalation
Record Retention
Integration with Supplier Audit Program
References
Supplementary Provisions

📋 MD-QMS-S901 Internal Audit SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Auditor Qualification and Certification
Audit Planning
Audit Preparation
Conducting the Audit
Audit Reporting
Correction and Corrective Action
Audit File Compilation and Completion Reporting
Reporting to Management Review
Record Retention
Forms
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §8.2.4 (Internal Audit)
  • Written for immediate use — minimal customization required
  • Structured for FDA QMSR (21 CFR Part 820) compliance
  • Microsoft Word format (.docx) — easy to edit and adapt
  • Professional quality suitable for FDA inspection review
  • Includes all required procedural elements and record templates
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