ISO 13485:2016 Active
v1.0

Compliance Dashboard

ISO 13485:2016 QMS document control overview

QMS v1.0 Active
77
Total Documents
14 categories
18
Approved
23% approval rate
59
In Draft
awaiting approval
10
Regulatory Standards
frameworks covered

Category Compliance

Quality Manual
2 docs
100%
2/2
Organization
3 docs
100%
3/3
Documentation
3 docs
100%
3/3
Design Controls
9 docs
0%
0/9
Software Lifecycle
10 docs
0%
0/10
Risk Management
6 docs
0%
0/6
Production Operations
5 docs
0%
0/5
Security Privacy
5 docs
0%
0/5
AI ML Governance
5 docs
0%
0/5
CAPA
3 docs
0%
0/3
Audit
2 docs
0%
0/2
Regulatory Submissions
11 docs
0%
0/11
Templates
10 docs
100%
10/10
Validation
3 docs
0%
0/3

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
DOC-001

Document Control Procedure

Approved
DOC-003

QMS Master Document List

Approved
DC-001

Design Control Procedure

Draft
SW-001

Software Development Plan

Draft
RM-001

Risk Management Plan

Draft
REG-001

Regulatory Strategy

Draft

Document Tier Distribution (ISO 13485:2016 Hierarchy)

Tier 1 — Policy
8

Quality Manual, Organization, Documentation

Tier 2 — SOP / Plan
56

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 (59)

DC-001Design Control ProcedureDesign ControlsDraftDC-002Design and Development PlanningDesign ControlsDraftDC-003Design Input — Software Requirements SpecificationDesign ControlsDraftDC-004Design Output — Software Architecture SpecificationDesign ControlsDraftDC-005Design VerificationDesign ControlsDraftDC-006Design ValidationDesign ControlsDraftDC-007Design ReviewsDesign ControlsDraftDC-008Design TransferDesign ControlsDraft
View all 59 draft documents