To ensure our Quality Management System takes into consideration the internal and external issues, the requirements of interested parties, and to ensure all risks and opportunities are addressed, actions implemented when needed and evaluated for effectiveness.
QP 5.1
1) RESPONSIBILITY:
2) RELATED REQUIREMENTS:
ISO 13485
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
8.5.3 Preventive Action
AS9100
6.0 Planning
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Ensure that our QMS meets the requirements of our interested parties
4) EFFECTIVENESS MEASURE:
Measurable KPI's are established within the monthly quality meeting report, section Key Performance Indicators.
KPI's are verified for effectiveness on a monthly basis.
If the KPI's are not met, management will assign activities to ensure that the quality process will perform within set guidelines.
Sustainability: ≤ 90%
Positive feedback: ≤ 90%
Number of customer complaints per month: <1
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITIES:
EXPECTATIONS:
6) PROCESS INPUT:
Source of Input:
Internal and External Issues
Interested Parties
Risks
Opportunities
7) PROCESS OUTPUT:
Source of Output:
8) RELATED DOCUMENTS:
9) TRAINING REQUIREMENTS:
Mandatory training (to be completed within the first 30 days of assignment)
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
Internal audit performed on: _______
Auditor: _________
Findings: _______
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)