Professional Documents
Culture Documents
Quality objectives
communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
Measurable
Scope
Quality Manual
Record Control
retrieval
and disposition of records.
Records shall remain legible, readily identifiable and retrievable.
provides a framework for establishing and reviewing quality objectives,
results of audits,
customer feedback,
process performance and product conformity,
status of preventive and corrective actions,
QMS Review
reporting to top management on the performance of the quality management system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout the organization.
QA Induction
Employment
Minimum qualification
Training Records
Scope: 7.2.1
Scope Review: 7.2.2
Customer Communication: 7.2.3
Inputs: 7.3.2
Outputs: 7.3.3
Review: 7.3.4
Verification: 7.3.5
Validation: 7.3.6
Change: 7.3.7
Procedures
Selection criteria
Purchasing Information: 7.4.2
Purchasing: 7.4
Vendor evaluation
DeR/NCR
a) the availability of information that describes the characteristics of the product,
Execution
Control: 7.5.1
Release
Analysis: 8.4
Continual: 8.5.1
Improvement: 8.5
Corrective: 8.5.2
Preventive: 8.5.3
improvement of the effectiveness of the quality management system and its processes,
QMS Review
TRM
QMS Audit
Site plan
Asset lists
Infrastructure
Documents
Supporting Systems
Off-site infrastructure? Subs?
Work environment controls
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or
national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
Schedule
- - Mindjet