IEC 62304:2006 Mapping of Requirements to Documents
IEC 62304:2006 Mapping of Requirements to Documents#
This table maps all requirements of the IEC 62304:2006 (by section) to the relevant documents (here: OpenRegulatory templates).
Note that the document names in the “Fulfilled in Document” column are based on the OpenRegulatory templates. You’ll probably have a different system for assigning document names, so feel free to rename them.
Classes |
Section |
Title |
Fulfilled in Document |
Comment |
|---|---|---|---|---|
(General) |
4.1 |
Quality management system |
Quality Management Manual |
|
4.2 |
Risk management |
SOP Integrated Software Development |
||
4.3 |
Software Safety Classification |
Risk Management Report |
||
4.4 |
Legacy Software |
(Not applicable) |
Not applicable unless you have legacy software. |
|
A, B, C |
5.1.1 |
Software development plan |
Software Development and Maintenance Plan |
|
A, B, C |
5.1.2 |
Keep software development plan update |
SOP Integrated Software Development |
|
A, B, C |
5.1.3 |
Software development plan reference to system design and development |
Software Development and Maintenance Plan |
|
C |
5.1.4 |
Software development standards, methods and tool planning |
Software Development and Maintenance Plan |
|
B, C |
5.1.5 |
Software integration and integration test planning |
Software Development and Maintenance Plan |
|
A, B, C |
5.1.6 |
Software verification planning |
Software Development and Maintenance Plan |
|
A, B, C |
5.1.7 |
Software risk management planning |
Software Development and Maintenance Plan |
|
A, B, C |
5.1.8 |
Documentation planning |
Software Development and Maintenance Plan |
|
A, B, C |
5.1.9 |
Software configuration management planning |
Software Development and Maintenance Plan |
|
B, C |
5.1.10 |
Supporting items to be controlled |
Software Development and Maintenance Plan |
|
B, C |
5.1.11 |
Software configuration item control before verification |
Software Development and Maintenance Plan |
|
B, C |
5.1.12 |
Identification and avoidance of common software defects |
Software Development and Maintenance Plan |
|
A, B, C |
5.2.1 |
Define and document software requirements from system requirements |
SOP Integrated Software Development; Software Requirements List |
|
A, B, C |
5.2.2 |
Software requirements content |
Software Requirements List |
|
B, C |
5.2.3 |
Include risk control measures in software requirements |
Software Requirements List |
|
A, B, C |
5.2.4 |
Re-evaluate medical device risk analysis |
SOP Integrated Software Development |
|
A, B, C |
5.2.5 |
Update requirements |
SOP Integrated Software Development |
|
A, B, C |
5.2.6 |
Verify software requirements |
SOP Integrated Software Development; Checklist Software Requirements |
|
B, C |
5.3.1 |
Transform software requirements into an architecture |
SOP Integrated Software Development; (Software architecture diagrams, interface documentation) |
|
B, C |
5.3.2 |
Develop an architecture for the interfaces of software items |
SOP Integrated Software Development; (Software architecture diagrams, interface documentation) |
|
B, C |
5.3.3 |
Specify functional and performance requirements of SOUP item |
SOUP list |
|
B, C |
5.3.4 |
Specify system hardware and software required by SOUP item |
SOUP list |
|
C |
5.3.5 |
Identify segregation necessary for risk control |
SOP Integrated Software Development |
|
B, C |
5.3.6 |
Verify software architecture |
SOP Integrated Software Development; Checklist Software Architecture |
|
B, C |
5.4.1 |
Subdivide software into software units |
SOP Integrated Software Development; (Software architecture diagrams) |
|
C |
5.4.2 |
Develop detailed design for each software unit |
SOP Integrated Software Development |
|
C |
5.4.3 |
Develop detailed design for interfaces |
SOP Integrated Software Development |
|
C |
5.4.4 |
Verify detailed design |
SOP Integrated Software Development |
|
A, B, C |
5.5.1 |
Implement each software unit |
SOP Integrated Software Development; (GitHub Pull Requests / GitLab Merge Requests) |
|
B, C |
5.5.2 |
Establish software unit verification process |
SOP Integrated Software Development |
|
B, C |
5.5.3 |
Software unit acceptance criteria |
SOP Integrated Software Development |
|
C |
5.5.4 |
Additional software unit acceptance criteria |
SOP Integrated Software Development |
|
B, C |
5.5.5 |
Software unit verification |
SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests) |
|
B, C |
5.6.1 |
Integrate software units |
SOP Integrated Software Development; (Merge in GitHub / GitLab) |
|
B, C |
5.6.2 |
Verify software integration |
SOP Integrated Software Development; (Merge in GitHub / GitLab) |
|
B, C |
5.6.3 |
Software integration testing |
SOP Integrated Software Development; (Merge in GitHub / GitLab, CI/CD) |
|
B, C |
5.6.4 |
Software integration testing content |
SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests) |
|
B, C |
5.6.5 |
Evaluate software integration test procedures |
SOP Integrated Software Development |
|
B, C |
5.6.6 |
Conduct regression tests |
SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests) |
|
B, C |
5.6.7 |
Integration test record contents |
SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests) |
|
B, C |
5.6.8 |
Use software problem resolution process |
SOP Software Problem Resolution |
|
A, B, C |
5.7.3 |
Retest after changes |
SOP Integrated Software Development |
|
A, B, C |
5.7.4 |
Evaluate software system testing |
SOP Integrated Software Development; Software System Test Plan |
|
A, B, C |
5.7.5 |
Software system test record contents |
SOP Integrated Software Development; Software System Test Protocol |
|
A, B, C |
5.8.1 |
Ensure software verification is complete |
SOP Integrated Software Development; Checklist Software Release |
|
A, B, C |
5.8.2 |
Document known residual anomalies |
SOP Integrated Software Development; (Release notes / changelog) |
|
B, C |
5.8.3 |
Evaluate known residual anomalies |
Risk table; (Release notes / changelog) |
|
A, B, C |
5.8.4 |
Document released versions |
SOP Integrated Software Development; (Release notes / changelog) |
|
B, C |
5.8.5 |
Document how released software was created |
SOP Integrated Software Development; (Release notes / changelog) |
|
B, C |
5.8.6 |
Ensure activities and tasks are complete |
SOP Integrated Software Development; Checklist Software Release |
|
A, B, C |
5.8.7 |
Archive software |
SOP Integrated Software Development; (Tagged commit in git) |
|
A, B, C |
5.8.8 |
Assure reliable delivery of released software |
SOP Integrated Software Development |
|
A, B, C |
6.1 |
Establish a software maintenance plan |
Software Development and Maintenance Plan |
|
A, B, C |
6.2.1.1 |
Monitor feedback |
||
A, B, C |
6.2.1.2 |
Document and evaluate feedback |
||
A, B, C |
6.2.1.3 |
Evaluate problem report’s affects on safety |
SOP Problem Resolution |
|
A, B, C |
6.2.2 |
Use software problem resolution process |
SOP Problem Resolution |
|
A, B, C |
6.2.3 |
Analyse change requests |
SOP Change Management |
|
A, B, C |
6.2.4 |
Change request approval |
SOP Change Management |
|
A, B, C |
6.2.5 |
Communicate to users and regulators |
SOP Change Management |
|
A, B, C |
6.3.1 |
Use established process to implement modification |
SOP Change Management |
|
A, B, C |
6.3.2 |
Re-release modified software system |
SOP Change Management |
|
B, C |
7.1.1 |
Identify software items that could contribute to a hazardous situation |
SOP Integrated Software Development |
|
B, C |
7.1.2 |
Identify potential causes of contribution to a hazardous situation |
SOP Integrated Software Development |
|
B, C |
7.1.3 |
Evaluate published SOUP anomaly lists |
SOP Integrated Software Development |
|
B, C |
7.1.4 |
Document potential causes |
SOP Integrated Software Development |
|
B, C |
7.2.1 |
Define risk control measures |
SOP Integrated Software Development |
|
B, C |
7.2.2 |
Risk control measures implemented in software |
SOP Integrated Software Development |
|
B, C |
7.3.1 |
Verify risk control measures |
SOP Integrated Software Development |
|
7.3.2 |
(Not used) |
|||
B, C |
7.3.3 |
Document traceability |
SOP Integrated Software Development; Software Requirements List |
|
A, B, C |
7.4.1 |
Analyse changes to medical device software with respect to safety |
SOP Change Management |
|
B, C |
7.4.2 |
Analyse impact of software changes on existing risk control measures |
SOP Change Management |
|
B, C |
7.4.3 |
Perform risk management activities based on analyses |
SOP Change Management |
|
A, B, C |
8.1.1 |
Establish means to identify configuration items |
Software Development and Maintenance Plan |
|
A, B, C |
8.1.2 |
Identify SOUP |
SOP Integrated Software Development |
|
A, B, C |
8.1.3 |
Identify system configuration documentation |
SOP Integrated Software Development |
|
A, B, C |
8.2.1 |
Approve change requests |
SOP Change Management |
|
A, B, C |
8.2.2 |
Implement changes |
SOP Change Management |
|
A, B, C |
8.2.3 |
Verify changes |
SOP Change Management |
|
A, B, C |
8.2.4 |
Provide means for traceability of change |
SOP Change Management |
|
A, B, C |
8.3 |
Configuration status accounting |
Software Development and Maintenance Plan |
|
A, B, C |
9.1 |
Prepare problem reports |
SOP Software Problem Resolution |
|
A, B, C |
9.2 |
Investigate the problem |
SOP Software Problem Resolution |
|
A, B, C |
9.3 |
Advise relevant parties |
SOP Software Problem Resolution; SOP Incident Reporting |
|
A, B, C |
9.4 |
Use change control process |
SOP Change Management |
|
A, B, C |
9.5 |
Maintain records |
SOP Software Problem Resolution |
|
A, B, C |
9.6 |
Analyse problems for trends |
SOP Software Problem Resolution |
|
A, B, C |
9.7 |
Verify software problem resolution |
SOP Software Problem Resolution |
|
A, B, C |
9.8 |
Test documentation contents |
SOP Integrated Software Development |