Skills › Scientific Agent Skills › iso-standards-readiness › qmsr-transition-template.json
qmsr-transition-template.json
181 lines · skills/iso-standards-readiness/assets/templates/qmsr-transition-template.json at 5f2bc03
1{
2 "_notice": "DRAFT EXAMPLE ONLY. QMSR has been effective and enforceable since 2026-02-02. This checklist cannot determine FDA applicability or compliance.",
3 "metadata": {
4 "checklist_id": "<controlled checklist ID>",
5 "review_date": "<YYYY-MM-DD>",
6 "owner": "<QMSR transition owner>",
7 "status": "draft",
8 "evidence": [],
9 "approval": {"status": "pending", "by": "", "date": ""},
10 "source_refs": []
11 },
12 "qmsr_basis": {
13 "as_of": "<organization source-review YYYY-MM-DD>",
14 "effective_date": "2026-02-02",
15 "current_part_820_title": "Quality Management System Regulation",
16 "inspection_compliance_program": "7382.850",
17 "owner": "<authorized RA/QA role>",
18 "evidence": [],
19 "approval": {"status": "pending", "by": "", "date": ""},
20 "source_refs": [
21 {
22 "id": "FDA-QMSR",
23 "title": "Quality Management System Regulation (QMSR)",
24 "version_or_date": "Updated 2026-02-02",
25 "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr",
26 "accessed": "2026-10-01"
27 },
28 {
29 "id": "ECFR-820",
30 "title": "21 CFR Part 820 — Quality Management System Regulation",
31 "version_or_date": "Current eCFR reviewed 2026-10-01",
32 "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820",
33 "accessed": "2026-10-01"
34 },
35 {
36 "id": "FDA-CP-7382.850",
37 "title": "Inspection of Medical Device Manufacturers Compliance Program 7382.850",
38 "version_or_date": "Effective 2026-02-02",
39 "url": "https://www.fda.gov/media/80195/download?attachment",
40 "accessed": "2026-10-01"
41 }
42 ]
43 },
44 "items": [
45 {
46 "id": "qmsr-source-basis",
47 "owner": "<role>",
48 "status": "not-started",
49 "assessment": "<record exact current sources and versions>",
50 "evidence": [],
51 "approval": {"status": "pending", "by": "", "date": ""},
52 "source_refs": [{"id": "FDA-QMSR", "title": "FDA QMSR page", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr", "accessed": "2026-10-01"}]
53 },
54 {
55 "id": "applicability-owner",
56 "owner": "<authorized role>",
57 "status": "not-started",
58 "assessment": "<identify authorized applicability decision and rationale>",
59 "evidence": [],
60 "approval": {"status": "pending", "by": "", "date": ""},
61 "source_refs": [{"id": "ECFR-820", "title": "21 CFR Part 820", "version_or_date": "current", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "accessed": "2026-10-01"}]
62 },
63 {
64 "id": "fda-supplemental-provisions",
65 "owner": "<role>",
66 "status": "not-started",
67 "assessment": "<review current FDA-specific provisions and linked regulations>",
68 "evidence": [],
69 "approval": {"status": "pending", "by": "", "date": ""},
70 "source_refs": [{"id": "ECFR-820", "title": "21 CFR Part 820", "version_or_date": "current", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "accessed": "2026-10-01"}]
71 },
72 {
73 "id": "legacy-qsr-reference-disposition",
74 "owner": "<role>",
75 "status": "not-started",
76 "assessment": "<inventory and disposition obsolete QSR/QSIT references without treating a legacy clause map as current law>",
77 "evidence": [],
78 "approval": {"status": "pending", "by": "", "date": ""},
79 "source_refs": [{"id": "FDA-QMSR-FAQ", "title": "QMSR Frequently Asked Questions", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions", "accessed": "2026-10-01"}]
80 },
81 {
82 "id": "pre-effective-date-record-review",
83 "owner": "<role>",
84 "status": "not-started",
85 "assessment": "<review evidence supporting records created before 2026-02-02>",
86 "evidence": [],
87 "approval": {"status": "pending", "by": "", "date": ""},
88 "source_refs": [{"id": "FDA-QMSR-FAQ", "title": "QMSR Frequently Asked Questions", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions", "accessed": "2026-10-01"}]
89 },
90 {
91 "id": "inspection-accessible-records",
92 "owner": "<role>",
93 "status": "not-started",
94 "assessment": "<prepare controlled access to management review, internal/supplier audit, and other QMS records>",
95 "evidence": [],
96 "approval": {"status": "pending", "by": "", "date": ""},
97 "source_refs": [{"id": "FDA-QMSR-FAQ", "title": "QMSR Frequently Asked Questions", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions", "accessed": "2026-10-01"}]
98 },
99 {
100 "id": "inspection-process-training",
101 "owner": "<role>",
102 "status": "not-started",
103 "assessment": "<approve training for current FDA inspection process>",
104 "evidence": [],
105 "approval": {"status": "pending", "by": "", "date": ""},
106 "source_refs": [{"id": "FDA-CP-7382.850", "title": "Compliance Program 7382.850", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/media/80195/download?attachment", "accessed": "2026-10-01"}]
107 },
108 {
109 "id": "qsit-retirement",
110 "owner": "<role>",
111 "status": "not-started",
112 "assessment": "<remove or archive QSIT-based current-state materials>",
113 "evidence": [],
114 "approval": {"status": "pending", "by": "", "date": ""},
115 "source_refs": [{"id": "FDA-QMSR", "title": "FDA QMSR page", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr", "accessed": "2026-10-01"}]
116 },
117 {
118 "id": "complaint-and-servicing-records",
119 "owner": "<role>",
120 "status": "not-started",
121 "assessment": "<review current Part 820 record requirements and evidence>",
122 "evidence": [],
123 "approval": {"status": "pending", "by": "", "date": ""},
124 "source_refs": [{"id": "ECFR-820", "title": "21 CFR Part 820", "version_or_date": "current", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "accessed": "2026-10-01"}]
125 },
126 {
127 "id": "labeling-and-packaging-controls",
128 "owner": "<role>",
129 "status": "not-started",
130 "assessment": "<review current FDA labeling and packaging control evidence>",
131 "evidence": [],
132 "approval": {"status": "pending", "by": "", "date": ""},
133 "source_refs": [{"id": "ECFR-820", "title": "21 CFR Part 820", "version_or_date": "current", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "accessed": "2026-10-01"}]
134 },
135 {
136 "id": "software-validation-impact",
137 "owner": "<role>",
138 "status": "not-started",
139 "assessment": "<review risk-based QMS and production software validation/change evidence>",
140 "evidence": [],
141 "approval": {"status": "pending", "by": "", "date": ""},
142 "source_refs": [{"id": "FDA-QMSR", "title": "FDA QMSR page", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr", "accessed": "2026-10-01"}]
143 },
144 {
145 "id": "supplier-and-outsourced-process-controls",
146 "owner": "<role>",
147 "status": "not-started",
148 "assessment": "<review supplier, contractor, and outsourced-process controls>",
149 "evidence": [],
150 "approval": {"status": "pending", "by": "", "date": ""},
151 "source_refs": [{"id": "FDA-CP-7382.850", "title": "Compliance Program 7382.850", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/media/80195/download?attachment", "accessed": "2026-10-01"}]
152 },
153 {
154 "id": "certificate-claims-review",
155 "owner": "<role>",
156 "status": "not-started",
157 "assessment": "<remove claims that ISO certification establishes FDA compliance or inspection exemption>",
158 "evidence": [],
159 "approval": {"status": "pending", "by": "", "date": ""},
160 "source_refs": [{"id": "FDA-QMSR-FAQ", "title": "QMSR Frequently Asked Questions", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions", "accessed": "2026-10-01"}]
161 },
162 {
163 "id": "change-control-approval",
164 "owner": "<role>",
165 "status": "not-started",
166 "assessment": "<approve linked document, training, validation, supplier, product, and postmarket changes>",
167 "evidence": [],
168 "approval": {"status": "pending", "by": "", "date": ""},
169 "source_refs": [{"id": "FDA-QMSR", "title": "FDA QMSR page", "version_or_date": "2026-02-02", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr", "accessed": "2026-10-01"}]
170 }
171 ],
172 "attestations": {
173 "iso_certificate_not_treated_as_fda_compliance": false,
174 "checklist_not_treated_as_compliance_determination": false,
175 "legacy_qsr_clause_map_not_used_as_current_requirements": false,
176 "applicability_decisions_owned_by_authorized_humans": false,
177 "owner": "<authorized role>",
178 "evidence": [],
179 "approval": {"status": "pending", "by": "", "date": ""}
180 }
181}