Cleanroom Management templates for FDA QMSR compliance.
Preview before you buy: Download a watermarked sample PDF showing the cover, table of contents, and sample sections.
This editable Microsoft Word template set is fully aligned to FDA QMSR (21 CFR Part 820) and ISO 13485:2016 §6.4.1 Work Environment / §7.5.2 Cleanliness of Product / §820.70(c) (QMSR retained: Environmental control).
What’s Included
Policy
- 📄 Cleanroom_Management_Policy.docx
Procedure (SOP)
- 📄 Environmental_Monitoring_Procedures.docx
Forms (Records)
- 📄 Air_Velocity_Measurement_Record.docx
- 📄 Airborne_Microorganism_Measurement_Record.docx
- 📄 Airborne_Particle_Measurement_Record.docx
- 📄 Competence_Training_Record.docx
- 📄 Record_Retention_Register.docx
- 📄 Settling_Microorganism_Measurement_Record.docx
Reports
- 📄 CAPA_HHE_Report.docx
- 📄 Environmental_Monitoring_Monthly_Report.docx
- 📄 IQ_OQ_PQ_Report.docx
- 📄 Revalidation_Report.docx
Table of Contents (Policy Document)
- 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 (Restrictions / Entering / Exiting)
- 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
Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016.
📄 Preview the Document Before You Buy
Confident purchase decisions start with knowing what’s inside. Download a watermarked sample showing the cover page, table of contents, and the first sections — so you can verify scope, structure, and language fit your QMS before adding to cart.
Table of Contents — FDA QMSR Cleanroom Management Policy, SOP & Forms
- Purpose
- Scope
- Definitions
- Roles and Responsibilities
- Procedure
- References
- Supplementary Provisions
4-page sample preview
Cover · TOC · Sample sections
Watermarked PDF
The sample is provided for evaluation only. Full editable Microsoft Word files (without watermark) are delivered immediately upon purchase. © eCompliance Ltd. — All rights reserved.
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