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Cardiovasc. tech [Design house] - Coggle Diagram
Cardiovasc. tech [Design house]
QMS Strategy
ISO 13485 Documents required
00 Document management
Procedure for doc and record control
List of documents
Type of records
01 Quality Policy
02 Quality Manual
03 Human resources
04 Risk Management
05 Design and development
06 Sterilization
07 Corrective and preventive action
2 more items...
Procedure for sterilization
1 more item...
Procedure for D&D
D&D file
Project plan and review
Change review record
Design review minutes
D&D verification and validation plans
Veriifcation and validation reports
D&D transfer record
Procedure for risk management
Risk management record
Procedure for Human resources
Training program
Training record
Record of attendance
QM
Quality Policy
Quality objectives and realization plan
Strategy employed
1. Applicable procedures as identified below from CTS will be picked up and translated to Cardiovasc.tech templates. 2. Torqview design docs, procedures will be reissued under new QMS