Traceability Matrix

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Date Rev. Description Prepared by Approved by
TABLE OF CONTENTS
1 Introduction 4
1.1 Document overview 4
1.2 Abbreviations and Glossary 4
1.2.1 Abbreviations 4
1.2.2 Glossary 4
1.3 References 4
1.3.1 Project References 4
1.3.2 Standard and regulatory References 4
2 Risk management during software development 5
2.1 Organization and Responsibilities 5
2.2 Objective of risk management activities 5
2.3 Tasks、Planning and Approvals 5
3 Risk management after software development 6
3.1 Organization and Responsibilities 6
3.2 Production and maintenance information 6
3.3 Annual Audit 6
4 Ranking System for Risk Analysis 7
4.1 Probability of Occurrence 7
4.2 Consequences of Hazard 7
4.3 Add your other criteria 7
4.4 Determination of risk priority number 7
4.5 Criteria for acceptability 7
5 Risk Analysis 8
5.1 End users 8
5.2 Characteristics Affecting Safety 8
5.3 Risk analysis and evaluation 10
5.4 Overall assessment of residual risks 11
5.5 Software classification 12
5.6 Software classification decomposition 12
1 Introduction

1.1 Document overview

說明此文件的目的，內容包含風險管理、風險分析及軟體安全分級

1.2 Abbreviations and Glossary

1.2.1 Abbreviations
請加上文件中有使用到的縮寫

1.2.2 Glossary
請加上文件中所使用到詞彙

1.3 References

1.3.1 Project References

# Document Identifier Document Title

[R1] 文件 ID 加上參考文件標題

1.3.2 Standard and regulatory References

# Document Identifier Document Title

[STD1] 標準 ID 加上參考的標準
增加參考的標準，可能包括 ISO14971，ISO 13485，IEC/ TR80002-1，IEC62304…等
2 Traceability

2.1 Software development traceability matrix

請填寫可追溯性矩陣，在系統需求，軟體需求，軟體系統測試以及在軟體中所實施的風險控制措施之間的可追溯性

System Software SRS REQUIREMENT

ID TEST ID TEST TITLE COMMENT
Requirement Requirement ID TITLE

1 SYS-REQ-001 SRS-REQ-001 TEST-REQ-001

2.2 Risk traceability matrix
請填寫軟體危險障礙的可追溯性，從危險情形到 SRS(控制措施)，到最後用何種測試來驗證

Software SRS REQUIREMENT

ID RISK TEST ID TEST TITLE COMMENT
Requirement ID TITLE

1 HAZA-001 SRS-REQ-001 TEST-REQ-001

2.3 Software change traceability matrix
若有進行變更程序，請填寫可追溯性矩陣，在變更請求，相關問題報告和變更要求的批准之間的可追溯性

System Software SRS REQUIREMENT

ID TEST ID TEST TITLE COMMENT
Requirement Requirement ID TITLE

1 SYS-REQ-001 SRS-REQ-001 TEST-REQ-001