Skills › Scientific Agent Skills › iso-standards-readiness › traceability-matrix-template.json
traceability-matrix-template.json
154 lines · skills/iso-standards-readiness/assets/templates/traceability-matrix-template.json at 5f2bc03
1{
2 "_notice": "DRAFT EXAMPLE ONLY. Trace links require substantive human review; this matrix cannot establish product safety, conformity, compliance, or certification.",
3 "metadata": {
4 "matrix_id": "<controlled matrix ID>",
5 "review_date": "<YYYY-MM-DD>",
6 "owner": "<traceability owner>",
7 "status": "draft",
8 "evidence": [],
9 "approval": {
10 "status": "pending",
11 "by": "",
12 "date": ""
13 },
14 "source_refs": []
15 },
16 "artifacts": [
17 {
18 "id": "INTENDED-USE-<ID>",
19 "type": "intended-use",
20 "title": "<controlled intended use>",
21 "owner": "<role>",
22 "status": "draft",
23 "evidence": [],
24 "approval": {"status": "pending", "by": "", "date": ""},
25 "source_refs": []
26 },
27 {
28 "id": "HAZARD-<ID>",
29 "type": "hazard",
30 "title": "<hazard or postmarket signal>",
31 "owner": "<role>",
32 "status": "draft",
33 "evidence": [],
34 "approval": {"status": "pending", "by": "", "date": ""},
35 "source_refs": []
36 },
37 {
38 "id": "RISK-EVAL-<ID>",
39 "type": "risk-evaluation",
40 "title": "<risk evaluation>",
41 "owner": "<role>",
42 "status": "draft",
43 "evidence": [],
44 "approval": {"status": "pending", "by": "", "date": ""},
45 "source_refs": []
46 },
47 {
48 "id": "RISK-CONTROL-<ID>",
49 "type": "risk-control",
50 "title": "<risk control>",
51 "owner": "<role>",
52 "status": "draft",
53 "evidence": [],
54 "approval": {"status": "pending", "by": "", "date": ""},
55 "source_refs": []
56 },
57 {
58 "id": "DESIGN-IN-<ID>",
59 "type": "design-input",
60 "title": "<design input>",
61 "owner": "<role>",
62 "status": "draft",
63 "evidence": [],
64 "approval": {"status": "pending", "by": "", "date": ""},
65 "source_refs": []
66 },
67 {
68 "id": "DESIGN-OUT-<ID>",
69 "type": "design-output",
70 "title": "<design output>",
71 "owner": "<role>",
72 "status": "draft",
73 "evidence": [],
74 "approval": {"status": "pending", "by": "", "date": ""},
75 "source_refs": []
76 },
77 {
78 "id": "VERIFY-<ID>",
79 "type": "verification",
80 "title": "<verification evidence>",
81 "owner": "<role>",
82 "status": "draft",
83 "evidence": [],
84 "approval": {"status": "pending", "by": "", "date": ""},
85 "source_refs": []
86 },
87 {
88 "id": "VALIDATE-<ID>",
89 "type": "validation",
90 "title": "<validation evidence>",
91 "owner": "<role>",
92 "status": "draft",
93 "evidence": [],
94 "approval": {"status": "pending", "by": "", "date": ""},
95 "source_refs": []
96 },
97 {
98 "id": "PROD-CTRL-<ID>",
99 "type": "production-control",
100 "title": "<production/process control>",
101 "owner": "<role>",
102 "status": "draft",
103 "evidence": [],
104 "approval": {"status": "pending", "by": "", "date": ""},
105 "source_refs": []
106 },
107 {
108 "id": "PMS-<ID>",
109 "type": "postmarket-signal",
110 "title": "<postmarket source or approved monitoring plan>",
111 "owner": "<role>",
112 "status": "draft",
113 "evidence": [],
114 "approval": {"status": "pending", "by": "", "date": ""},
115 "source_refs": []
116 },
117 {
118 "id": "CHANGE-<ID>",
119 "type": "change-control",
120 "title": "<change control or approved not-applicable decision>",
121 "owner": "<role>",
122 "status": "draft",
123 "evidence": [],
124 "approval": {"status": "pending", "by": "", "date": ""},
125 "source_refs": []
126 }
127 ],
128 "rows": [
129 {
130 "id": "<trace row ID>",
131 "product_id": "<product/family ID>",
132 "owner": "<traceability owner>",
133 "status": "draft",
134 "linkage_rationale": "<explain why the evidence links are adequate>",
135 "links": {
136 "intended_use": ["INTENDED-USE-<ID>"],
137 "hazard_or_signal": ["HAZARD-<ID>"],
138 "risk_evaluation": ["RISK-EVAL-<ID>"],
139 "risk_control": ["RISK-CONTROL-<ID>"],
140 "design_input": ["DESIGN-IN-<ID>"],
141 "design_output": ["DESIGN-OUT-<ID>"],
142 "verification": ["VERIFY-<ID>"],
143 "validation": ["VALIDATE-<ID>"],
144 "production_control": ["PROD-CTRL-<ID>"],
145 "postmarket_source": ["PMS-<ID>"]
146 },
147 "change_control_refs": ["CHANGE-<ID>"],
148 "open_gaps": ["<unresolved gap>"],
149 "evidence": [],
150 "approval": {"status": "pending", "by": "", "date": ""},
151 "source_refs": []
152 }
153 ]
154}