ISO Data Analysis-Continual Improvement Procedure

The ISO Data Analysis-Continual Improvement Procedure continually improves the effectiveness of the company’s QMS, determining where improvements can be made by using the Quality Policy, quality objectives, audit results, and data analysis in conformance with ISO 9001:2015.

This procedure applies to the company’s QMS. (4 pages, 744 words)

ISO Data Analysis-Continual Improvement Responsibilities

The Quality Assurance Manager is responsible for analyzing measurement data.

Quality Management is responsible for reporting measurement data at periodic Management Reviews.

Department Managers are responsible for producing and using process monitoring and measuring data for the purpose of continually improving the company’s Quality Management System.

ISO Data Analysis-Continual Improvement Definitions

Special cause variation – Product/process variation, caused by an unusual or unexpected event.

Pareto diagrams – Histogram chart method that ranks data high to low to separate the vital few from the trivial many. Also know as the 80/20 rule.

Trend or run charts – chart method that plots process output over time.

Control charts – Output of Statistical Process Control (SPC) calculations that derive the process variability from the mean to detect special cause variation.

ISO Data Analysis-Continual Improvement Activities

• Data Collection
• Data Analysis
• Continual Improvement

ISO Data Analysis-Continual Improvement References

• ISO 9001:2015, “Quality Management Systems-Requirements”, International Organization for Standardization (ISO), Nov., 2015
• Quality Procedures
  • QP1040 CORRECTIVE ACTION
  • QP1050 PREVENTIVE ACTION
  • QP1060 MANAGEMENT REVIEWS
  • QP1070 COMPETENCE, TRAINING, & AWARENESS
  • QP1120 EXTERNAL PROVIDER EVALUATION
  • QP1180 MONITORING-MEASUREMENT
  • QP1190 CUSTOMER SATISFACTION