This is a quality manual (template) in a form consistent with the FDA QSR.
Many medical device companies prepare quality manuals in accordance with ISO-9001 and ISO-13485.
However, in order to comply with FDA inspections, it is necessary to
QSR (Quality System Provision: 21 CFR 820),
and explain the process.
List of Forms
The following forms are included with your purchase.
・MD-QMS-M1 Quality Management Supervisory System Standards (QMS Ministerial Order 2021, QSR compliant)
・MD-QMS-M101 Quality Policy
・MD-QMS-M102 Quality Targets (Department XX)
・Diagram of interrelationships of processes.pptx
・organization chart.pptx
Table of Contents
Quality Management Supervisory System Standards (QMS Ministerial Order 2021, QSR compliant)
1. Objective.
2. Applicable Laws, Regulations and Standards
3. Scope of application
3.1 Application
3.2 Exemptions
3.3 Not applicable
3.4 Outsourcing
4. Permits, etc. for business categories held by the Company (Article 5)
5. Definition.
5.1 Definition of Terms
5.2 Terminology Contrast
6. Quality control supervision system.
6.1 Requirements for Quality Management Supervision System (QMS Ministerial Ordinance, Article 5)
6.2 Establishment of Quality Management Supervision System (QMS Ministerial Ordinance, Article 5-2)
6.3 Quality Management Supervision System Operations (QMS Ministerial Ordinance, Article 5-3)
6.4 Management and Supervision of Quality Management Supervision System (QMS Ministerial Ordinance, Article 5-4)
6.5 Outsourcing (QMS Ministerial Ordinance Article 5-5)
6.6 Use of software (QMS Ministerial Ordinance, Article 5-6)
6.7 Documentation of Quality Management Supervision System (QMS Ministerial Ordinance, Article 6)
6.8 Quality Management Supervision System Standards (this document) (QMS Ministerial Ordinance, Article 7)
6.9 Product Standard Document/DMR (QMS Ministerial Ordinance Article 7-2)
6.10 Control of Quality Control Supervisory Documents (QMS Ordinance, Article 8) [QSR §820.40].
6.10.1 Retention period for quality control supervision documents (QMS Ministerial Ordinance, Article 67)
6.11 Recordkeeping (QMS Ordinance, Article 9) [QSR §820.180, QSR §820.186].
6.11.1 Retention period for records (QMS Ministerial Ordinance, Article 68)
7. Responsibilities of Managers and Supervisors
7.1 Involvement of management and supervisory personnel (QMS Ministerial Ordinance Article 10)
7.2 Focus on product recipients (QMS Ministerial Ordinance, Article 11)
7.3 Quality Policy (QMS Article 12) [QSR §820.20(a)
7.4 Quality Objectives (QMS Ministerial Ordinance Article 13)
7.5 Development of a plan for a quality management and supervision system (QMS Ministerial Ordinance, Article 14)
7.6 Responsibilities and Authority (QMS Ordinance, Article 15) [QSR §820.20(b)(1)].
7.6.1 Organizational structure (QMS Ministerial Ordinance Article 72-2)
7.6.2 Persons legally responsible
7.7 Internal information communication (QMS Ministerial Ordinance Article 17)
7.8 Supervisor verification [QSR §820.20(c)
7.8.1 Supervisor verification (QMS Ministerial Ordinance Article 18)
7.8.2 Process Input Information for Control Supervisor Verification (QMS Ministerial Ordinance Article 19)
7.8.3 Process Output Information for Control Supervisor Verification (QMS Ministerial Ordinance Article 20)
8. Management and supervision of resources
8.1 Securing Resources (QMS Ordinance, Article 21) [QSR §820.20(b)(2)].
8.2 Human Resources [QSR §820.25].
8.2.1 Competence of Quality Workers (QMS Ministerial Ordinance, Article 22)
8.2.2 Competence, awareness and training (QMS Ministerial Ordinance Article 23)
8.3 Business Operation Basis (QMS Ministerial Ordinance Article 24)
8.4 Working Environment and Pollution Control
8.4.1 Working environment (QMS Ministerial Ordinance Article 25)
8.4.2 Contamination Control (QMS Ministerial Ordinance Article 25-2)
9. Product realization
9.1 Product realization plan (QMS Ministerial Ordinance Article 26)
9.2 Clarification of product requirements (QMS Ministerial Ordinance Article 27)
9.3 Verification of product requirements (QMS Ministerial Ordinance Article 28)
9.4 Exchange of information, etc. (QMS Ministerial Ordinance, Article 29)
9.4.1 Processing of Notifications from Sellers of Used Goods, etc. (QMS Ministerial Ordinance, Article 72-2)
9.5 Design and Development
9.5.1 Design and Development (QMS Ministerial Ordinance Article 30)
9.5.2 Information on Process Input to Design and Development (QMS Ordinance Article 31) [QSR §820.30(c)
9.5.3 Process Output Information from Design and Development (QMS Ordinance Article 32) [QSR §820.30(d)
9.5.4 Design Development Verification (QMS Ordinance Article 33) [QSR §820.30(e)
9.5.5 Verification of Design Development (QMS Ordinance Article 34) [QSR §820.30(f)
9.5.6 Design and Development Validation (QMS Ordinance Article 35) [QSR §820.30(g)
9.5.7 Design Transfer Operations (QMS Ordinance Article 35-2) [QSR §820.30(h)
9.5.8 Management of Design and Development Changes (QMS Ordinance, Article 36) [QSR §820.30(i)].
9.5.9 Recordkeeping for Design and Development (QMS Ordinance, Article 36-2) (Design History File (DHF) [QSR §820.30(j)])
9.6 Purchasing
9.6.1 Purchasing Process (QMS Ordinance Article 37) [QSR §820.50(a)
9.6.2 Purchasing Information (QMS Ministerial Ordinance Article 38)
9.6.3 Verification of purchased goods, etc. (QMS Ordinance, Article 39) [QSR §820.80(a), (b), (e)].
9.6.4 Arrangements with external contractors (QMS Ministerial Ordinance Article 72-2)
9.6.5 Management of Registered Manufacturing Plants
9.7 Manufacture and provision of services
9.7.1 Control of manufacture and provision of services (QMS Ordinance, Article 40) [QSR §820.70 (a)].
9.7.2 Product cleanliness control (QMS Ministerial Ordinance Article 41)
9.7.3 Installation Operations (QMS Ordinance, Article 42) [QSR §820.170].
9.7.4 Ancillary Service Work (QMS Ordinance, Article 43) [QSR §820.200].
9.7.5 Processing of Notifications from Repairers of Medical Devices (QMS Ordinance, Article 72-2)
9.7.6 Special requirements for the manufacturing control of sterile medical devices (QMS Ministerial Ordinance, Article 44)
9.7.7 Manufacturing and process changes [QSR §820.70 (b)
9.7.8 Validation of manufacturing processes, etc. (QMS Ministerial Ordinance Article 45) [QSR §820.75].
9.7.9 Validation of processes related to sterilization processes and sterile barrier systems (QMS Ministerial Ordinance, Article 46)
9.7.10 Identification (QMS Ordinance Article 47) [QSR §820.60] [QSR §820.86
9.7.11 Ensure traceability (QMS Ministerial Ordinance Article 48)
9.7.12 Ensuring traceability of products for implantable medical devices (QMS Ordinance, Article 49) [QSR §820.65].
9.7.13 Medical Device Labeling [QSR §820.120].
9.7.14 Goods, etc. of the product recipient (QMS Ministerial Ordinance, Article 51)
9.7.15 Shipment of products (QMS Ministerial Ordinance, Article 72, Paragraph 2)
9.7.16 Product retention (QMS Ministerial Ordinance Article 52)
9.8 Control of equipment and instruments (QMS Ordinance, Article 53) [QSR §820.72].
10. Measurement, analysis and improvement
10.1 Measurement, Analysis and Improvement (QMS Ministerial Ordinance Article 54)
10.2 Monitoring and measurement
10.2.1 Opinion of the product recipient (QMS Ministerial Ordinance, Article 55)
10.2.2 Complaint Handling (QMS Ordinance Article 55-2) [QSR §820.198].
10.2.3 Report to the Minister of Health, Labor and Welfare, etc. (QMS Ministerial Ordinance, Article 55-3)
10.2.4 Reporting to FDA [Part 803
10.2.5 Failure reports from manufacturers, etc. (QMS Ministerial Ordinance Article 69)
10.2.6 Relationship with Post-Marketing Safety Management Standards (QMS Ministerial Ordinance Article 70)
10.2.7 Control of quality information (QMS Ministerial Ordinance Article 72.2.4)
10.2.8 Occurrence of security measures (QMS Ministerial Ordinance, Article 72, Paragraph 2, Item 9)
10.2.9 Internal Audits (QMS Ordinance, Article 56) [QSR §820.22].
10.2.10 Process monitoring and measurement (QMS Ministerial Ordinance Article 57)
10.2.11 Product monitoring and measurement (QMS Ministerial Ordinance Article 58)
10.2.12 Requirements specific to implantable medical devices (QMS Ministerial Ordinance Article 59)
10.3 Control of Nonconforming Products (QMS Ordinance, Article 60) [QSR §820.90].
10.3.1 Actions to be taken for nonconforming products prior to shipment (QMS Ministerial Ordinance Article 60-2)
10.3.2 Disposal of Non-conforming Products after Shipment (QMS Ministerial Ordinance Article 60-3)
10.3.3 Re-manufacture (QMS Ministerial Ordinance, Article 60-4)
10.3.4 Recall (QMS Ministerial Ordinance Article 72.2.6)
10.4 Analysis of data (QMS Ministerial Ordinance Article 61)
10.5 Improvement (QMS Ministerial Ordinance Article 62)
10.5.1 Corrective Action (QMS Ordinance Article 63) [QSR §820.100].
10.5.2 Preventive measures (QMS Ordinance, Article 64) [QSR §820.100].
11. By-Laws…………………