FDA QMSR Internal Audit Policy, SOP & Forms

¥319,500

FDA QMSR Internal Audit Policy, SOP & Forms

FDA QMSR Internal Audit Policy, SOP & Forms

¥319,500

Internal Audit 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 §7.5
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A comprehensive production and service provision control template set for FDA QMSR compliance. Covers manufacturing process control, contamination management, and service provision procedures to ensure consistent, compliant product output.

Regulatory Reference: ISO 13485:2016 §7.5 — Production and Service Provision

Why You Need This

ISO 13485:2016 §7.5 requires documented production controls. This template ensures your manufacturing processes are validated, controlled, and fully documented to meet FDA and ISO requirements.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S701 SOP Control of Production and Service Provision
📋 SOP / Procedure MD-QMS-S704 Contaminated Product Management SOP
📝 Form / Template F701-01 Manufacturing Work Order
📝 Form / Template F701-02 Process Transfer Checklist
📝 Form / Template F701-03 Product Document Checklist
📝 Form / Template F701-04 Deviation Record
📝 Form / Template F701-06 Initial Production Management Plan
📝 Form / Template F701-07 Initial Production Mgmt Review Form
📝 Form / Template F701-08 Special Process Work Record
📝 Form / Template F701-11 Manufacturing Material Removal Record
📝 Form / Template F701-12 Improvement Activity Record
📝 Form / Template F701-21 Lot Release Record
📝 Form / Template MD-QMS-F704-01 Contaminated Product Management Instruction Form
📝 Form / Template MD-QMS-F704-02 Contaminated Product Evaluation Record
📝 Form / Template MD-QMS-F704-03 Unpacking and Sorting Record
📝 Form / Template MD-QMS-F704-04 Disinfectant Usage Record
📝 Form / Template MD-QMS-F704-05 Sterilization Validation Report
📝 Form / Template MD-QMS-F704-06 Sterilization Record
📝 Form / Template MD-QMS-F704-07 Sterilization Work Completion Approval Record
📝 Form / Template MD-QMS-F704-08 Bioburden Test Record
📝 Form / Template MD-QMS-K7 製造およびサービス提供の管理規程
📝 Form / Template MD-QMS-K7 製造およびサービス提供の管理規程 QMSR対応版 v2
📝 Form / Template MD-QMS-S701 製造およびサービス提供の管理手順書
📝 Form / Template MD-QMS-S701 製造およびサービス提供の管理手順書 QMSR対応 Phase3
📝 Form / Template MD-QMS-S704 汚染品管理手順書 QMSR Phase2

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
Production Control
Manufacturing Material (Process Residue) Control
Process Validation
Customer Property Control
Sterilization and Sterile Barrier System Validation
Infrastructure
Equipment Qualification
Maintenance Activities
Work Environment and Hygiene Management
Work Environment Control
Personnel Requirements
Contamination Control
Product Cleanliness
Service Provision Control
Document and Record Management
Medical Device File
QC Flow Chart
Manufacturing Work Order
Device History Record (DHR)
Lot Release Record
Manufacturing and Quality Management Assurance
Agreements with Contract Manufacturers
Market Release Control
Initial Production Management
Deviation Management
Manufacturing and Process Changes
Inspection, Measurement, and Test Equipment
Equipment Management
Calibration
Data Integrity Requirements (21 CFR Part 11)
Corrective and Preventive Action (CAPA) Initiation Criteria
Record Management Requirements (QMSR §820.35)
References
Supplementary Provisions

📋 MD-QMS-S701 SOP Control of Production and Service Provision — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
General Policy
Development of Manufacturing Control Documents
Manufacturing Material (Process Residue) Control
Process Validation
Transfer to Next Process Step
Customer Property Control
Sterilization and Sterile Barrier System Process Validation
Special Process Control
Production Monitoring and Management Review
Initial Production Management
Deviation Management
Process Change Control
Infrastructure Management
Building and Workspace Management
Equipment Qualification
Equipment Management
Equipment Maintenance
Work Environment and Hygiene Management
Work Environment Control
Personnel Hygiene
Contamination Control
Product Cleanliness Control
Production Records
Manufacturing Work Order
Device History Record (DHR)
Record Retention
Corrective and Preventive Action (CAPA) Initiation
References
Supplementary Provisions

📋 MD-QMS-S704 Contaminated Product Management SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Contaminated Product Identification, Segregation, and Control
Contaminated Product Evaluation
Unpacking, Sorting, and Sterilization Tray Loading
Disinfection and Sterilization Process Validation
Approved Disinfectant Specifications
Moist Heat (Steam Autoclave) Sterilization Validation
Ethylene Oxide (EO) Sterilization Validation
Cleaning and Housekeeping
Sterilization Operations
Moist Heat (Steam Autoclave) Sterilization
Ethylene Oxide (EO) Sterilization
Cleanroom Operations
Bioburden Management
Sterilization Personnel Management
Sterilization Equipment Management
Records Management
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.5 (Production and Service Provision)
  • 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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