FDA QMSR Document Control Policy, SOP & Forms

¥319,500

FDA QMSR Document Control Policy, SOP & Forms

FDA QMSR Document Control Policy, SOP & Forms

¥319,500

Document Control templates for FDA QMSR compliance.

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §8.2.6
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete sampling inspection planning template set for FDA QMSR compliance. Provides statistical sampling methodology, AQL tables, and inspection planning procedures to ensure sampling plans are scientifically sound and regulatory compliant.

Regulatory Reference: ISO 13485:2016 §8.2.6 — Monitoring and Measurement / Statistical Sampling

Why You Need This

ISO 13485:2016 §8.2.6 requires statistically valid sampling procedures with documented justification. Ad-hoc sampling without statistical basis is a common FDA 483 observation.

What’s Included

Document Type Description
📋 SOP / Procedure SOP Sampling Inspection Planning
📝 Form / Template Sampling Inspection Plan Sheet MD-QMS-F2501

📋 SOP Sampling Inspection Planning — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Procedure
5.1 Sampling Plan Development
5.2 Sampling Inspection Implementation
6. Forms
7. References
8. Supplementary Provisions
Attachment 1: Sample Size Code Letters and Master Sampling Tables

Key Features

  • Fully aligned with ISO 13485:2016 §8.2.6 (Monitoring and Measurement / Statistical Sampling)
  • 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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