askartsolutions logo- TS 16949

 

Understanding The ISO/TS 16949:2002 Standard

The Continual Improvement Model

0.2 Process Approach (Continued)   

The model of a process-based quality management system shown in figure 4 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs.

Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 4 covers all the requirements of this Standard, but does not show processes at a detailed level.  

Key Explanation Points and Tips:  

Þ             Figure 4 - shows the macro level application of the PDCA model to an entire organization. The organization’s QMS (as depicted by the processes within the circle) is used to PLAN the controls over all inputs, resources, value-adding activities and outputs. We DO – implement our plan by using various resources to convert customer inputs (requirements) into outputs (product) that meet customer requirements. We CHECK - by monitoring and measuring QMS performance and through customer feedback. We ACT – by using this information to continually improve QMS effectiveness. At the micro level, this same model can be applied to each QMS process. 

Þ            Controls for your processes come from the ISO 9001 standard, customer requirements, your organization or applicable regulatory requirements.. The five clauses of ISO 9001 provide control requirements for PDCA - planning, implementation; monitoring and measurement; and for improvement of each QMS process. The applicable requirements of these five clauses must be applied to each process (inputs; outputs; resources used; transformation activities; interaction with other processes) for effective control. In clause 4.1 we will discuss this in further detail. 

 

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Preface - TS16949
◦ Introduction
◦ Major Clauses
◦ Process Approach -1
◦ Process Approach-2
◦ Plan/Do/Check/Act
◦ Cont Improve Model
◦ Compatibility
◦ TS 16949 Scope
◦ Application
◦ Normative References
◦ Terms And Definitions
◦ 4.1 General Reqmts
◦ 4.2.1 Documentation Reqmts
◦ 4.2.2 Quality Manual
◦ 4.2.3 Document Control
◦ 4.2.4 Control Of Records
◦ 5.1 Mgmt Commitment
◦ 5.2 Customer Focus
◦ 5.3 Quality Policy
◦ 5.4.1 Quality Objectives
◦ 5.4.2 QMS Planning
◦ 5.5.1 Quality Responsibility
◦ 5.5.2 Mgmtt Rep
◦ 5.5.3 Internal Communications
◦ 5.6 Mgmt Review
◦ 6.1 Resource Provision
◦ 6.2 Human Resources
◦ 6.3 Infrastructure
◦ 7.1 Planning Product Realization
◦ 7.2 Customer Processes
◦ 7.3.1 D & D Planning
◦ 7.3.2 D & D Inputs
◦ 7.3.2 D & D Outputs
◦ 7.3.4 To 7.3.6 - Review, Verification And Validation
◦ 7.3.6.2 Prototypes-PPAP-Changes
◦ 7.4.1 Supplier Mgmt
◦ 7.4.2 Purchasing Information And Supplier Performance Monitoring
◦ 7.5.1 Production Control-1
◦ 7.5.1 Production Control-2
◦ 7.5.2 Production Process Validation
◦ 7.5.3 to 7.5.5 Identification--Customer Property, etc
◦ 7.6 Monitoring And Measuring Devices
◦ 8.1 Measurement, Analysis & Improvement
◦ 8.2.1 Customer Satisfaction
◦ 8.2.2 Internal Audits
◦ 8.2.3 Monitoring Processes
◦ 8.2.4 Product Monitoring And Measurement
◦ 8.3 Control Of NC Product
◦ 8.4 Analysis Of Data
◦ 8.5.1 Continual Improvement
◦ 8.5.2 Corrective Action
◦ 8.5.3 Preventive Action
◦ TS 16949 Annex A - Control Plan