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- Medical Devices QMS
- Data model
The tables behind Medical Devices QMS
Medical Devices QMS ships with 12 tables, grouped here by the feature that uses them. Every record your team works with lives in one of them, and you can add fields and tables in Proto.
- Tables
- 12
- Features
- 6
- Change it
- Add fields and tables in Proto
How the model is organised
Inspection work
Inspections carry the operational case. Inspection checks retain requirement results and evidence beneath it.
Quality response
Nonconformances link to inspections; corrective actions link to nonconformances and an owner.
Specialty evidence
Device history reviews and supplier certificates each point to an operational inspection.
Supporting quality records
Controlled documents link to training acknowledgments. Audits link to audit findings.
People and access
People connect assigned inspectors, auditors, owners and acknowledgments to Users.
Every table, by feature
- Inspections4
- Nonconformances and corrective actions5
- Device history reviews3
- Supplier certificates4
- Documents and training4
- Audits3
- Inspections
Incoming, in-process, final and service inspections
Linked to People - Inspection checks
Individual requirement checks captured during an inspection
Linked to Inspections - Nonconformances
Quality issues raised from failed inspection scope
Linked to Inspections - People
Quality staff, inspectors and approvers
Linked to Users
- Nonconformances
Quality issues raised from failed inspection scope
Linked to Inspections - Corrective actions
Corrective and preventive actions for nonconformances
Linked to Nonconformances, People - Inspections
Incoming, in-process, final and service inspections
Linked to People - Inspection checks
Individual requirement checks captured during an inspection
Linked to Inspections - People
Quality staff, inspectors and approvers
Linked to Users
- Device history reviews
Device history record review for a manufactured lot
Linked to Inspections - Inspections
Incoming, in-process, final and service inspections
Linked to People - Inspection checks
Individual requirement checks captured during an inspection
Linked to Inspections
- Supplier certificates
Supplier component certificates and expiry evidence
Linked to Inspections - Inspections
Incoming, in-process, final and service inspections
Linked to People - Inspection checks
Individual requirement checks captured during an inspection
Linked to Inspections - Nonconformances
Quality issues raised from failed inspection scope
Linked to Inspections
- Controlled documents
Version-controlled SO ps, work instructions and device master records
- Training acknowledgments
Staff acknowledgment of controlled document revisions
Linked to Controlled documents, People - People
Quality staff, inspectors and approvers
Linked to Users - Users
Users
Linked to Users
- Audits
Internal and supplier quality audits
Linked to People - Audit findings
Findings raised against audit requirements
Linked to Audits, People - People
Quality staff, inspectors and approvers
Linked to Users
Keys and references
Use the inspection number and subject reference to locate operational work. Each inspection check, nonconformance and specialty evidence record retains its reference to the case. Corrective actions use the nonconformance reference. Audit findings use the audit reference. Training acknowledgments use both the controlled document and person references.
Migration order
- Establish Users and People so assignments have valid references.
- Import controlled documents and Audits if those records are in scope for the first cycle.
- Create Inspections and their inspection checks with the correct operational subject references.
- Add device history reviews and supplier certificates to the selected inspections.
- Bring in Nonconformances and linked corrective actions after checking their inspection references.
- Add training acknowledgments and audit findings to their parent records.
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.