QMS PERFORMANCE EVALUATION
To demonstrate the suitability and effectiveness of the QMS through analyzed data, to maintain the QMS as well as evaluate where continual improvement of the QMS can be made.
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QP 5.3
1) RESPONSIBLIITY:
Chief Quality Officer:
Daniela Kozar
Responsibilities:
Collect data from all applicable procedures, analyzing them and communicating the results to the entire company through quality meetings, etc.
2) RELATED REQUIREMENTS:
ISO 13485
8.18 Measurement, Analysis and Improvement
8.2.1 Feedback
8.2.2 Complaint Handling
8.2.5 Monitoring and Measurement of Processes
8.2.6 Monitoring and Measurement of Product
AS9100
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Ensure that the QMS is performing appropriately
4) EFFECTIVENESS MEASURE:
Measurable quality objectives are established within the monthly quality meeting report, section quality objectives.
Quality objectives are verified for effectiveness on a monthly basis.
If the quality objectives are not met, management will assign activities to ensure that the quality process will perform within set guidelines, or justification will be noted on the monthly quality meeting.
Sustainability (Resource needs regarding training, equipment, software, man power): Y
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITES:
Monitor and measure manufactured product
Monitor and measure processes
EXPECTATIONS:
6) PROCESS INPUTS:
Source of Input:
SOPs
Feedback
Gemba meetings
In-process and final inspections
MRB meetings
7) PROCESS OUTPUTS:
Source of Output:
Updated procedures
Conformity to product requirements
8) RELATED DOCUMENTS:
9) TRAINING REQUIREMENTS:
Training plans have been created for the positions listed in the responsibilities section
Click on the appropriate link below to see the training plan for that position
The supervisor is responsible for ensuring their employees are completing their training plans within the specified time requirements
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
The following elements will be validated and/or verified as part of the scheduled internal auditing process.
Validation:
Quality system validated as part of the internal audit
Verification:
Compliance with all applicable requirements
Corrective actions against this process have been closed and are effective
Training Effectiveness
Status of documented information (have there been any changes or new documents issued and if documents have been changed or added have all applicable employees trained)
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