QUALITY MANAGEMENT SYSTEM ISO 9001:2000 QUALITY MANAGEMENT SYSTEM 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Objectives Introduce the Concept of ISO 9001:2000 Standard Highlight the Important Areas and Changes of the New Standard Briefly introduce the system requirements of the Standard 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Introduced considerable conceptual changes What is ISO 9001: 2000 2nd revision of Quality Management System Requirement Standard from International Organization for Standards Replacement of the previous ISO 9001 / 9002 and 9003: 1994 version of the Standards Introduced considerable conceptual changes Applicable to all types of Organizations with possible permissible omissions of certain requirements 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Continual Improvements cycle New ISO 9001:2000 QMS Management Responsibility General Requirements Resource Management Measurement, Analysis & Improvements Product Realization Continual Improvements cycle 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

CUSTOMER’S CUSTOMER ISO 9001:2000 – Process Model 5.Management Continual Improvement of the Quality Management System ISO 9001:2000 Quality Management System 5.Management Responsibility 8. Measurement Analysis and Improvements CUSTOMER CUSTOMER’S 6. Resource Management Satisfaction 7. Product Realization Requirements Product Consumption 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

8 Principles of the New Standard Customer focus Leadership Mutual beneficial supplier relationship Involvement of people Based on eight quality management principles. Factual approach to decision making Process approach System approach to Management Continual improvement 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Process Approach Process Definition: Set of interrelated or interacting activities which transforms Inputs into Outputs Identify the Processes Identify the Inputs & Outputs Identify the Interactions to other Processes Establish Measuring Criteria Ensure Continual Improvements Do it for all “Value Adding Processes” 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Process Approach – Continual Improvements of All Processes Understanding & Meeting the Requirements PLAN 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 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

E.g. - Purchasing Process Procedure Inputs Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements Outputs Receipt of Materials on right conditions Right Quality, Right Quantity Right Time. Interactions to Storage Inspection and Testing Manufacturing Finance Performance Measurements Delivery status – On-time, On spec, NCP etc Supplier evaluation 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

System Requirements / Structure of the Standard 4 Quality Management System Requirements 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & Improvements Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority & Communication Management Reviews General Requirements Documentation Requirements Provision of Resources Human Resources Infrastructure Work Environment Planning Customer Related Processes Design & Development Purchasing Production & Service Provision General Monitoring & Measurements Control of NCP’s Analysis of Data Improvements 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Criteria for Measurements Satisfaction Surveys for customers and other interested parties Feedback on products Customer & market requirements Financial Measurements Prevention cost Non conforming / failure cost Lifecycle cost System Performance Self Assessment Internal Audits Effectiveness & Efficiency of Processes Opportunities for Improvements Use of Data / Information Effective & Efficient Use of Resources Adequacy, Accuracy and Performance of Measurements Relationships with customers/ suppliers/ other interested parties 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Criteria for Measurements Process Capability / Process validation Reaction time Cycle time / throughput (Capacity) Utilization of new technology Waste reduction Cost reduction Processes Products Inspection and testing of incoming, in process and final products Product verification Product validation 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

Challenges in Implementing the Standard Management Support Encouragement ISO 9001 Other employee Support Communication 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved

(c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved Thank you for your time. 22/11/2018 (c) 2004, IMS-INTEGRATED MANAGEMENT SERVICES. All Rights Reserved