Chapter 6: QMS Documentation (质量管理体系文件)

NMPA Reference: Notice 2021-121, Attachment 5, Chapter 6
Document Code: NMPA-CH6
Responsible Party: Manufacturer (CRO may advise on compliance gaps)

Requirements Checklist

6.1 QMS Overview (综述)

• [ ] Declaration that QMS has been established per relevant regulations
• [ ] Commitment to accept QMS inspection (质量管理体系核查) at any time

6.2 Table of Contents

• [ ] All headings and sub-headings with page numbers

6.3 Manufacturing Information (生产制造信息)

6.3.1 Product Description

• [ ] Device working principle summary
• [ ] General production process overview

6.3.2 Manufacturing Information

• [ ] All manufacturing site addresses and contact information
• [ ] Contract manufacturing details: all key suppliers' names and addresses for:
  • Outsourced production
  • Critical components or raw materials (animal tissue, drugs)
  • Critical process steps
  • Sterilisation

6.4 QMS Procedures (质量管理体系程序)

High-level QMS procedures for establishing and maintaining the quality system:

• [ ] Quality Manual
• [ ] Quality Policy
• [ ] Quality Objectives
• [ ] Document and record control procedures

6.5 Management Responsibility (管理职责程序)

Procedures documenting management assurance for QMS:

• [ ] Quality policy communication
• [ ] Planning
• [ ] Responsibilities, authorities, and communication
• [ ] Management review

6.6 Resource Management (资源管理程序)

Procedures for adequate resource provision:

• [ ] Human resources (competency, training, awareness)
• [ ] Infrastructure
• [ ] Work environment

6.7 Product Realisation (产品实现程序)

High-level product realisation procedures including customer-related processes:

6.7.1 Design and Development

• [ ] Procedures covering the systematic, controlled development process from project initiation through design transfer

6.7.2 Purchasing

• [ ] Procedures for ensuring purchased products/services meet quality and technical specifications

6.7.3 Production and Service Control

• [ ] Controlled production and service procedures covering:
  • Product cleanliness and contamination control
  • Installation and service activities
  • Process validation
  • Identification and traceability

6.7.4 Monitoring and Measurement Device Control

• [ ] Procedures for controlling and maintaining calibration of monitoring and measurement equipment

6.8 Measurement, Analysis, and Improvement (测量、分析和改进程序)

• [ ] Procedures for monitoring, measuring, analysing, and improving product and QMS conformity
• [ ] Procedures for maintaining QMS effectiveness

6.9 Other QMS Procedures (其他质量体系程序信息)

• [ ] Other information important to this submission not covered above

6.10 QMS Inspection Documents (质量管理体系核查文件)

Documents to be prepared for the NMPA QMS inspection:

• [ ] Applicant basic information form (基本情况表)
• [ ] Organisational chart (组织机构图)
• [ ] Site layout plan (总平面布置图) with production area distribution
• [ ] Cleanroom certification (if applicable): environmental monitoring report from a qualified testing institution with floor plan
• [ ] Production process flow diagram with:
  • Key control points and items
  • Main raw materials and purchased components sources
  • Quality control methods at each stage
• [ ] Equipment list: main production and testing equipment
  • Incoming inspection equipment
  • In-process inspection equipment
  • Final inspection equipment
  • Environmental monitoring equipment (for cleanroom production)
• [ ] QMS self-inspection report (质量管理体系自查报告)
• [ ] Comparison with previously inspected products (if applicable): description of differences in production conditions and processes

Comparison with EU MDR

Aspect	NMPA Ch.6	EU MDR QMS
Location	Part of registration dossier (Chapter 6)	Separate assessment by Notified Body
Standard	GB/T 42061 (ISO 13485 adoption)	ISO 13485 + MDR-specific requirements
Inspection	NMPA on-site QMS inspection (核查)	NB audit (Annex IX/XI)
Design & Development	Part of Ch.6	Reviewed during NB audit
Cleanroom	Certification required for applicable products	Covered in manufacturing process validation
Self-inspection	Mandatory QMS self-inspection report	Not typically required
Submission format	Full QMS procedures in registration dossier	QMS certificate + summary in TD

Key Standards & References

• Notice 2021-121, Attachment 5, Chapter 6
• GB/T 42061-2022: Medical device quality management systems (ISO 13485:2016 adoption)
• Administrative Measures for Medical Device Production Supervision (Order No. 12, 2022)
• Good Manufacturing Practice for Medical Devices (NMPA GMP)
• Medical Device Production Quality Management Specifications (applicable regulations by device category)