ISO 9001:2000 Objective Introduce the concept of new ISO 9001 Standard Highlight important areas and changes of the new standard Briefly introduce the system requirements of the new standard What is ISO 9001: 2000 2nd revision of Quality Management System Requirement Standard from International Organization for Standards Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994 Introduced considerable conceptual changes Applicable to all types of Organizations with possible permissible omissions of certain requirements New ISO 9001 QMS Resource management Measurement, analysis & improvements Product Realization Management Responsibility Continual Improvement cycle General requirements General requirements ISO 9001:2000 Model CUSTOMERS CUSTOMERS Quality Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8. Measurement Analysis and Improvement Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product Principles of new standard Based on eight quality management principles Leadership Process approach Involvement of people System approach to Managemen t Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus Principles of new standard Customer focus Organization depends customers Understand current & future customer needs. Meet / exceed customer expectations Leadership Leaders establish purpose & direction of the organization Should create & maintain environment to achieve organizations objectives Involvement of People People of all levels are essence of an organization Their full involvement for organizations benefit Process approach Desired results are achieved more efficiently when activities and resources are managed as process Principles of new standard System approach to Management Identifying, understanding and managing interrelated process as a system contributes to the organizations effectiveness & efficiency Continual improvements Continual improvement of the organizations overall performance should be a permanent objective of the organization Factual approach to decision making Effective decisions are based on the analysis of data and information Mutually beneficial supplier relationships An organization & its suppliers are interdependent Mutually beneficial relationship enhances the ability of both to create value Expectations of the new Standard Avoid the application of systems that are separate from the organizations business process Enable the development of a Quality system that is fully integrated into the normal operations of organizations business Enable Continual improvements of the system for enhanced customer satisfaction Enable compliance to statutory & regulatory requirements Important changes + Why it is to be doneWhat to do, When, Whom & How to do Involvement of people Continual improvements should be achieved Maintain the system requirements Improvements + Statutory & regulatory requirements Requirements specified by customer / organization Product requirements Value adding processes20 quality elementsApproach Customer satisfactionProductsMain focus New VersionPrevious versionCriteria Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs Ensure continual improvements Identify the processes Do it for all value adding processes Establish measurin g criteria Identify the Interactions to other processes Identify the Inputs & outputs Process approach Continual improvements of Process PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK Understandings & meeting requirements PLAN E.g. - Purchasing Process Performance Measurements Delivery status On-time, On spec, NCP etc Supplier evaluation Outputs Receipt of Material on right condition Right Quality Right Quantity Right Time Purchasing Procedure Interactions to Storage Inspection and Testing Manufacturing Finance Inputs Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements Provision of resources Human resources Infrastructures Work environment 6 Resource Management General requirements Documentation Requirements Planning Customer related processes Design & development Purchasing Production & service provision Management Commitment Customer focus Quality policy Planning Responsibility, authority & communication Management Reviews 5 Management Responsibility 8 Measurement Analysis & improvement System Requirements / Structure of the Standard 4 Quality Management System 7 Product Realization General Monitoring & measurement Control of NCP Analysis of data Improvements 4 - Quality management system 4.1 General requirements Identification of processes required Criteria and methods to ensure Operation & control Availability