FDA QMSR Complaint Handling Policy, SOP & Forms

¥319,500

FDA QMSR Complaint Handling Policy, SOP & Forms

FDA QMSR Complaint Handling Policy, SOP & Forms

¥319,500

Complaint Handling 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 §6.2
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete training management template set for FDA QMSR compliance. Systematically documents competency requirements, training plans, effectiveness evaluations, and training records for all personnel affecting product quality.

Regulatory Reference: ISO 13485:2016 §6.2 — Human Resources / Competence

Why You Need This

ISO 13485:2016 §6.2 requires documented competence and training procedures. This template ensures you can demonstrate that all personnel are adequately trained and competent for their roles.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure Training Management SOP
📝 Form / Template MD-QMS-F301 Annual Training Plan and Report
📝 Form / Template MD-QMS-F302 Training Implementation Plan and Report
📝 Form / Template MD-QMS-F303 Individual Training Record
📝 Form / Template MD-QMS-F304 Individual Competence Matrix
📝 Form / Template MD-QMS-F305 Departmental Competence Matrix
📝 Form / Template MD-QMS-F306 Training Attendee List
📝 Form / Template MD-QMS-F307 Training Instructor Qualification Form
📝 Form / Template MD-QMS-F308 Training Curriculum

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Training Objectives
6. Training Administrator
7. Training Instructors
7.1 Qualification
7.2 Competence
8. Training Content
9. Training Planning and Implementation
10. Training Records and Retention
11. References
12. Supplementary Provisions

📋 Training Management SOP — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Qualification of Training Instructors
6. Training Implementation Procedures
6.1 Creation of Competence Matrices
6.2 Creation of Training Curricula
6.3 Creation of Annual Training Plan and Report (Planning Phase)
6.4 Training Implementation
6.5 Creation of Training Records
6.6 Competence Evaluation
6.7 Creation of Annual Training Plan and Report (Reporting Phase)
6.8 Evaluation of Training Results
6.9 Record Retention
7. Forms
8. References
9. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §6.2 (Human Resources / Competence)
  • 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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