ISO 13485:2016 Active
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ISO 13485:2016 QMS document control overview

QMS v1.0 Active
119
Total Documents
19 categories
111
Approved
93% approval rate
8
In Draft
awaiting approval
0
Under Review
pending approval

Category Compliance

Quality ManualQuality Manual: 2/2 (100%)2/2OrganizationOrganization: 3/3 (100%)3/3DocumentationDocumentation: 30/30 (100%)30/30Design ControlsDesign Controls: 9/10 (90%)9/10Software LifecycleSoftware Lifecycle: 10/10 (100%)10/10Risk ManagementRisk Management: 6/6 (100%)6/6Production Operat…Production Operations: 5/5 (100%)5/5Security PrivacySecurity Privacy: 5/5 (100%)5/5AI ML GovernanceAI ML Governance: 6/8 (75%)6/8CAPACAPA: 3/3 (100%)3/3AuditAudit: 6/6 (100%)6/6Regulatory Submis…Regulatory Submissions: 11/11 (100%)11/11TemplatesTemplates: 12/12 (100%)12/12ValidationValidation: 3/3 (100%)3/3Management ReviewManagement Review: 0/1 (0%)0/1Human ResourcesHuman Resources: 0/1 (0%)0/1PurchasingPurchasing: 0/1 (0%)0/1Post-Market Surve…Post-Market Surveillance: 0/1 (0%)0/1Analysis of DataAnalysis of Data: 0/1 (0%)0/1

Standards Coverage

ISO 13485:2016
77
IEC 62304
10
ISO 14971:2019
6
21 CFR Part 820
21
EU MDR 2017/745
7
HIPAA
5
GDPR
5

Critical Path

QM-001

Quality Manual

Approved
REG-001

Regulatory Strategy

Approved
DOC-001

Document Control Procedure

Approved
DOC-003

QMS Master Document List

Approved
DC-001

Design Control Procedure

Approved
SW-001

Software Development Plan

Approved
RM-001

Risk Management Plan

Approved

Document Tier Distribution (ISO 13485:2016 Hierarchy)

Tier 1 — Policy
8

Quality Manual, Organization, Documentation

Tier 2 — SOP / Plan
98

Design Controls, SW Lifecycle, Risk, CAPA, Audit, Regulatory

Tier 3 — Specification
13

Templates and Validation documents

Tier 4 — Record
0

Completed records, forms, and logs

Documents Awaiting Approval (8)

AI-007AI Model CardAI ML GovernanceDraftAI-008IEC 62304 Performance Testing ReportAI ML GovernanceDraftMR-001Management Review ProcedureManagement ReviewDraftHR-001Human Resources and Training ProcedureHuman ResourcesDraftPUR-001Purchasing Control ProcedurePurchasingDraftPMS-001Post-Market Surveillance ProcedurePost-Market SurveillanceDraftAN-001Analysis of Data ProcedureAnalysis of DataDraftDC-010Requirements Traceability MatrixDesign ControlsDraft