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1. Quality

1.1. Quality Poliicy

1.2. Quality Manual

1.3. Qualiity Objectives

1.4. Records Related to QMS

1.5. Reports Related to QMS

1.6. External Documents

1.7. Internal Documents

1.8. Procedures

1.8.1. Procedure for Internal Audit

1.8.2. Procedure for Management Review

1.8.3. Procedure for data analysis

1.8.4. Procedure for document control

1.8.5. Procedure for Infrastructure and Work Enviroment

1.8.6. Procedure for Software validation

1.8.7. Procedure for CAPA

1.8.8. Procedure for Adverse Even Reporting

1.8.9. Procedure for Sterile Medical Devices

1.8.10. Procedure for RisK Managment

1.8.11. Non Confirming Measuring Equipment

1.8.12. Procedure for Design Control

1.8.13. Procedure for warehousing

1.9. Sandbox

1.9.1. Procedure for warehousing

1.10. Meeting

2. R&D

2.1. Project1

2.2. Project 2

2.2.1. Design Control

2.2.2. Risk management

2.2.3. Meeting

2.3. Project 3

2.3.1. Design Control | landing page DHF

2.3.1.1. Userneed

2.3.1.2. Design Inputs

2.3.1.3. DO

2.3.1.4. Test Reports Design Verification Validation

2.3.1.5. Records of Verfications

2.3.1.6. Risk managment and Usability Engineering

2.3.1.6.1. Risk managment Files

2.3.1.7. Design Drawings and other documents

2.3.2. Device Master Record

2.3.2.1. BOM

2.3.2.2. Specs

2.3.2.3. Final Design outputs with workinstructions

2.3.2.4. Plant Layout and clean room requirments

2.3.2.5. Vendor validations

2.3.3. Meeting

3. Installation and Sales

3.1. Project 1

3.2. Project 2

3.3. Procedures

4. Purchasing and Sourcing

4.1. Project 1

4.1.1. Records

4.2. Project 2

5. HR

5.1. Records

5.2. HR procedure

6. Business Development

6.1. Applications

6.2. Marketing

7. PRODUCTION AND INSTALLATION

7.1. Project1

7.1.1. Device History File

7.1.1.1. Production History