ISO 13485 Self-Assessment
Quality Management System (Clause
4)
Quality Manual (4.2.2)
0.0
1
Document Control Procedure (4.2.4)
0.0
2
Record Control Procedure (4.2.5)
0.0
3
Control of Outsourced Processes (4.1.5)
0.0
2
Validation of QMS Software Applications (4.1.6)
0.0
1
Management Responsibility (Clause
5)
Management Review Procedure (5.6)
0.0
1
Quality Policy and Objectives (5.3, 5.4)
0.0
2
Responsibility and Authority Descriptions (5.5.1)
0.0
1
Appointment of Management Representative (5.5.2)
0.0
2
Resource Management (Clause 6)
Competence, Training, and Awareness Procedure (6.2)
0.0
1
Infrastructure and Maintenance Procedure (6.3)
0.0
2
Work Environment and Contamination Control Procedure (6.4)
0.0
3
Health, Cleanliness, and Personnel Hygiene Controls (6.4.1)
0.0
2
Product Realization (Clause 7)
Product Realization Planning Procedure (7.1)
0.0
1
Risk Management Procedure (7.1 & ISO 14971
linkage)
0.0
2
Customer Related Processes Procedure (7.2)
0.0
3
Design and Development Procedure (7.3)
0.0
3
Design and Development Planning Process (7.3.2)
0.0
3
Design Inputs Process (7.3.3)
0.0
2
Design Outputs Process (7.3.4)
0.0
4
Design Review Process (7.3.5)
0.0
3
Design Verification Process (7.3.6)
0.0
3
Design Validation Process (7.3.7)
0.0
3
Design Transfer Process (7.3.8)
0.0
3
Design Changes Process (7.3.9)
0.0
3
Design History File Process (7.3.10)
0.0
3
Purchasing Procedure (7.4)
0.0
1
Supplier Evaluation, Selection, and Re-evaluation (7.4.1)
0.0
1
Supplier Quality Agreements Process (7.4.2)
0.0
2
Verification of Purchased Product Process (7.4.3)
0.0
3
Production Control Procedure (7.5.1)
0.0
2
Manufacturing Work Instructions and Process Parameters (7.5.1)
0.0
3
Cleanliness and Contamination Control Procedure (7.5.2.2)
0.0
2
Installation Procedure (7.5.3)
0.0
2
Servicing Procedure (7.5.4)
0.0
1
Particular Requirements for Sterile Medical Devices (7.5.5, 7.5.7)
0.0
1
Validation of Production Processes Procedure (7.5.6)
0.0
1
Identification and Traceability Procedure (7.5.8,
7.5.9)
0.0
1
Customer Property Procedure (7.5.10)
0.0
2
Handling, Storage, Packaging, and Delivery Procedure (7.5.11)
0.0
2
Monitoring and Measurement Equipment Control Procedure (7.6)
0.0
2
Measurement, Analysis, and Improvement (Clause 8)
Feedback and Complaint Handling Procedure (8.2.1,
8.2.2)
0.0
1
Post-Market Surveillance / Vigilance Procedure (8.2.1)
0.0
1
Reporting to Regulatory Authorities Procedure (8.2.3, 8.3.3)
0.0
2
Internal Audit Procedure (8.2.4)
0.0
2
Monitoring and Measurement of Processes (8.2.5)
0.0
3
Monitoring and Measurement of Product (8.2.6)
0.0
1
Nonconforming Product Control Procedure (8.3)
0.0
2
Data Analysis and Trending Procedure (8.4)
0.0
1
Corrective and Preventive Action Procedure (8.5.2, 8.5.3)
0.0
2
Assess the required records for ISO 13485 certification readiness (All)
0.0
2
ISO 13485 Certification Readiness
QMS Process Implementation: 0%
* Note: This percentage is an estimate and does not reflect your ISO 13485 QMS compliance.
ISO 13485:2016 Implementation Plan
Total: 0.0 / 100.0
— Overall: 0%