FDA QMSR Cleanroom Management Policy, SOP & Forms

¥319,500

FDA QMSR Cleanroom Management Policy, SOP & Forms

FDA QMSR Cleanroom Management Policy, SOP & Forms

¥319,500

Cleanroom Management templates for FDA QMSR compliance.

Quantity

SOLD OUT

✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §6.4
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete cleanroom management template set for FDA QMSR compliance. Covers cleanroom classification, environmental monitoring, gowning procedures, contamination control, and personnel behavior requirements for controlled manufacturing environments.

Regulatory Reference: ISO 13485:2016 §6.4 — Work Environment / Cleanroom

Why You Need This

ISO 13485:2016 §6.4 requires documented work environment controls. For medical devices manufactured in controlled environments, comprehensive cleanroom management documentation is essential for product quality and regulatory compliance.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure Environmental Monitoring Procedures
📝 Form / Template Air Velocity Measurement Record
📝 Form / Template Airborne Microorganism Measurement Record
📝 Form / Template Airborne Particle Measurement Record
📝 Form / Template CAPA HHE Report
📝 Form / Template Competence Training Record
📝 Form / Template Environmental Monitoring Monthly Report
📝 Form / Template IQ OQ PQ Report
📝 Form / Template Record Retention Register
📝 Form / Template Revalidation Report
📝 Form / Template Settling Microorganism Measurement Record

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Cleanroom Management
5.1 Cleanroom Management Responsibility
5.2 Cleanroom Cleanliness Classification
5.3 Environmental Monitoring Alert and Action Levels
5.4 Cleanroom Management Procedures
5.5 Daily Cleanroom Inspections
5.6 Cleanroom Cleaning
5.7 Pest Control
5.8 Environmental Monitoring
5.9 Management of Equipment and Devices in Cleanrooms
6. Personnel Working in Cleanrooms
6.1 Personnel Qualification and Management
6.2 Health and Hygiene Management
6.3 Gowning
7. Cleanroom Entry and Exit
7.1 Cleanroom Entry Restrictions
7.2 Entering the Cleanroom
7.3 Exiting the Cleanroom
8. Bringing Materials into and out of Cleanrooms
9. Prohibited Activities in Cleanrooms
10. Record Management
11. CAPA Decision Criteria
12. References
13. Supplementary Provisions

📋 Environmental Monitoring Procedures — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Roles and Responsibilities
6. Environmental Monitoring Implementation Procedures
Table 1: Airborne Particle Measurement Value Confirmation
7. Management of Environmental Monitoring Personnel
Initial Cleanroom Classification and Validation
8. Management of Measuring Instruments
9. Record Retention
10. Corrective and Preventive Actions
11. References
12. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §6.4 (Work Environment / Cleanroom)
  • 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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