Skills › Scientific Agent Skills › iso-standards-readiness › evidence-manifest-template.json
evidence-manifest-template.json
65 lines · skills/iso-standards-readiness/assets/templates/evidence-manifest-template.json at 5f2bc03
1{
2 "_notice": "DRAFT EXAMPLE ONLY. Evidence presence is not evidence adequacy and cannot establish readiness, conformity, compliance, or certification.",
3 "metadata": {
4 "manifest_id": "<controlled manifest ID>",
5 "review_date": "<YYYY-MM-DD>",
6 "owner": "<manifest owner>",
7 "status": "draft",
8 "evidence": [],
9 "approval": {"status": "pending", "by": "", "date": ""},
10 "source_refs": []
11 },
12 "audit_context": {
13 "purpose": "internal-audit",
14 "scope": "<sites, products, processes, and dates sampled>",
15 "sampling_plan": "<risk-based sampling plan and rationale>",
16 "limitations": "<known limitations and exclusions; not a legal applicability decision>",
17 "owner": "<audit/readiness owner>",
18 "evidence": [],
19 "approval": {"status": "pending", "by": "", "date": ""},
20 "source_refs": []
21 },
22 "expected_domains": [
23 "scope-and-roles",
24 "document-and-record-control",
25 "risk-management",
26 "design-and-development",
27 "supplier-controls",
28 "production-and-service",
29 "process-and-software-validation",
30 "identification-and-traceability",
31 "complaints-and-feedback",
32 "postmarket-and-vigilance",
33 "nonconformity-and-capa",
34 "internal-audit",
35 "management-review",
36 "training-and-competence",
37 "change-control"
38 ],
39 "entries": [
40 {
41 "id": "<evidence entry ID>",
42 "domain": "document-and-record-control",
43 "title": "<controlled evidence title>",
44 "owner": "<evidence owner>",
45 "status": "draft",
46 "revision_or_date": "<revision/date>",
47 "classification": "internal",
48 "local_path": "",
49 "sha256": "",
50 "evidence": [],
51 "approval": {"status": "pending", "by": "", "date": ""},
52 "source_refs": []
53 }
54 ],
55 "open_gaps": [
56 {
57 "id": "<gap ID>",
58 "description": "<unresolved evidence or process gap>",
59 "owner": "<gap owner>",
60 "status": "open",
61 "evidence": [],
62 "approval": {"status": "pending", "by": "", "date": ""}
63 }
64 ]
65}