Iso 9001:2000Explanation of clause 4.1
...already purchased. ISO 9001:2000 looks on all activities as processes. The standard advocates a process approach in development and implementation of the quality management system. Process approach requires, 1. Identifying the business activities as processes, 2. Determining the proper sequence and interaction of these business processes, and 3. Effectively manage them for efficient functioning of the organization. The requirements stated in the standard are processes. These processes have to be applied interlinked to the business processes of the organization. In designing the quality management system, the business processes and the requirement processes together make up the quality management system. A typical list of business processes of an organization is given below: Developing vision and strategy Sales and marketing Design and development Purchasing Receiving materials Inspection Storage Manufacturing Process control Final Inspection Packaging Transportation and delivery. Maintenance Training Personnel Security etc. Clauses 4.1 a & b of the standard requires the organization to identify the processes (business and requirements)needed for the quality management system, and determine their application, sequence and interaction. Clause 4.2.2.c requires that a description of the interaction between the processes of the quality management system must be documented and included in the quality manual. We have already identified the companys business processes as above and all the requirements in the standard are the other processes. Our task is now to find a simple way of describing and documenting the sequence and interaction of all the processes. There can be several ways of doing this but the following method is possibly one of the easier ones. Subdivide the requirements processes of the standard and the business processes of the organization into three categories or groups. The processes dealing mainly with management functions are grouped as Management processes; those dealing mainly with operations as Operational processes and the rest which are of infrastructural or facilitating functions are grouped under Supporting processes. The processes grouped as above is shown below: Management Processes Management Processes: Operational Processes Supporting Processes ISO 9001:2000 Processes (requirements) 4.1 General requirements 5 Management responsibility 7.1 Planning of product realization 8.1 Measurement, analysis and improvement : General 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices 8.2.1 Customer satisfaction 8.2.4 Monitoring and measurement of product 8.3 Control of non conforming product 4.2 Documentation requirements 6 Resource management 8.4 Data analysis Organizational Processes Developing Vision and Strategy Sales and marketing Design and development Purchasing Receiving materials Inspection Storage Manufacturing Process control Final Inspection Packaging Transportation and delivery. Maintenance Training Security Personnel etc. The following diagram depicts the interaction between the above groups: The sequence of the processes and the interaction within the management and operating groups are shown in the diagram below. The supporting processes do not have any specific sequence in between themselves. They are however essential processes and provide support and inputs to other processes as required. MANAGEMENT PROCESSES OPERATIONAL PROCESSES SALES AND MARKETING 7.2: 8.2.1 RECEIVING & STORAGE 7.4: 7.5: 8.3 --- PRODUCTION 7.5: 8.2.4: 8.3 QA 7.6 INCOMING INSPECTION PROCESS CONTROL FINAL INSPECTION DELIVERY FACILITATING PROCESSES DOCUMENTATION REQUIREMENTS 4.2 DATA ANALYSIS 8.4 RESOURCE MANAGEMENT 6 MAINTENANCE TRAINING PERSONNEL SECURITY VISION AND STRATEGY QUALITY PLENNING 4.1:5.1:5.2:5.4:5.5: 8.5.1 PROCESS CONTROL 7.1:8.1: 8.2.3 QUALITY AUDIT 8.2.2 CUSTOMER FEEDBACK MANAGEMENT REVIEW-------- 5.6 CORRCTIVE & PREVENTIVE ACTION 8.5.2 & 8.5.3 Identify the business activities and the processes needed for development of the quality management system ISO 9001- 2000 standard advocates a process approach in development of a quality management system. Let us try to understand what exactly process approach means. A process is a set of interrelated activities which transforms inputs into outputs. Processes are planned activities carried out under controlled conditions to add value. An organization comprises of a large number of interrelated activities transforming many inputs into outputs. Each of these outputs on their own would also comprise of activities transforming inputs to outputs. Thus we can see that small processes interact to form larger processes; these larger processes again interact to from still more complex processes. Finally, all the processes interact to form a single large process which is Management. Thus management can be defined as a process comprising of many other interlinked processes; and the resulting interaction of these processes would determine the efficiency and effectiveness of organization. Process approach is the way of looking at management itself as a process, identifying its component processes, the sequence and interaction of the processes and to effectively manage them for efficient functioning of the organization. -Determine criteria and methods needed to ensure that both the operation and control of these processes are effective, Determine methods for effective operation and control of these processes Identify criteria for effective operation and control -Ensure the availability of resources and information necessary to support the operation and monitoring of these processes, Provide resources (equipment, skilled people, materials, information) required for effective operation and monitoring of these processes -Monitor, measure and analyze these processes, Monitor, measure and analyze process performances implement actions necessary to achieve planned results and continual improvement of these processes. Implement the processes, implement effective actions to ensure that planned results are achieved through the processes Take actions to continually improve the processes to achieve greater effectiveness and efficiency. The general requirements stat...