An essential part of the XLS checklist is the Traceability Matrix (RTM). A separate sheet in the Excel file should be dedicated to linking requirements to tests.
| Column A | Column B | |----------|----------| | Safety Class | A, B, C (based on possible harm) | | Clause Ref | IEC 62304 clause number | | Required | Yes / No / Conditional | | Verification | Not started / In progress / Done / N/A | Iec 62304 Checklist Xls
34, 18.1, "Training and competency", Training, "Provide training for personnel on software lifecycle processes and tools", "Training records, competency matrix", "Personnel trained and records stored", Not Started, HR, , , Low, An essential part of the XLS checklist is
Template: IEC 62304:2006 Mapping of Requirements to Documents "Training and competency"