International Quality Standard ISO 9000 2000 Overview and

International Quality Standard ISO 9000: 2000 Overview and Orientation ASQ Section 509 - ISO 9000 Users Group ISO 9000 Overview Version 1. 1 11. 05. 2001 1

This Presentation … ü Provides an overview of the ISO 9000: 2000 standard ü Is intended to instill a concept of the standard to users having little or minimal understanding of ISO standards ü Is sponsored by the ISO 9000 Users Group, ASQ 509 ISO 9000 Overview Version 1. 1 11. 05. 2001 2

Why Become Certified to International Quality Standards? ü Global Recognition - Product standards allow consumers to purchase items from different manufacturers and know those items will perform predictably ü Forces a customer focus throughout the organization - Improved operational effectiveness; “Walking the talk” builds teamwork; continual process improvement efforts strengthens business posture ü Competition - Qualify to compete in international markets ü World-wide Benchmarks for Improvement – Consistent methodology for managing quality systems based on the widest base of industry best practices ISO 9000 Overview Version 1. 1 11. 05. 2001 3

ISO 9000: 2000 Standards Structure 9000 Fundamentals and Vocabulary (Concepts and Definitions) 9001 Quality Measurement System - Requirements 9004 Guidelines for Performance Improvements (Total Quality Management) 10012 Measurement Control 19011 Quality Management System/Environmental Management System (QMS/EMS) Auditing ISO 9000 Overview Version 1. 1 11. 05. 2001 4

ISO 9000: 2000 Core Elements ISO 9000: 2000 aims to enhance customer satisfaction by focusing on the following: • Quality management system – Put structure in what you do • Management responsibility – Put someone in charge • Resource management – Provide the resources to achieve goals • Product realization – Design and perform to requirements • Measurement, analysis and improvement – Know where you are and get better ISO 9000 Overview Version 1. 1 11. 05. 2001 5

ISO 9000: 2000 Implementation Continual Improvement of the Quality Management System CUSTOMER Management Responsibility Resource Management Product Realization Requirements Measurement, Analysis, Improvement Satisfaction Product Legend: Value adding activities Information flow ISO 9000: 2000 - a process based approach ISO 9000 Overview Version 1. 1 11. 05. 2001 6

ISO 9000: 2000 Quality Management Principles 1. 2. 3. 4. 5. 6. 7. 8. Customer-focused Organization Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships ISO 9000 Overview Version 1. 1 11. 05. 2001 7

ISO 9000: 2000 Quality Management Principles 1. Customer Focus Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations 2. Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives ISO 9000 Overview Version 1. 1 11. 05. 2001 8

ISO 9000: 2000 Quality Management Principles (Cont’d) 3. Involvement of People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit 4. Process Approach A desired result is achieved more efficiently when activities and related resources are managed as a process 5. Systematic Approach to Management Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness in achieving its objectives ISO 9000 Overview Version 1. 1 11. 05. 2001 9

ISO 9000: 2000 Quality Management Principles (Cont’d) 6. Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective of the organization 7. Factual Approach to Decision Making Effective decisions are based on the analysis of data and information 8. Mutually Beneficial Supplier Relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value ISO 9000 Overview Version 1. 1 11. 05. 2001 10

ISO 9000 Uses a Third Party Registration Process An objective body does a neutral and unbiased assessment Registrar Accreditation Board (accredits the auditors) accredit certify Registrar Registration & Certification assessment hire Auditors (certified) Your Company accredit train Course Providers assess certification Customers ISO 9000 Overview Version 1. 1 11. 05. 2001 11

The Typical Sequence for ISO 9000 Registration & Certification Management commitment to go for registration Ø Form a steering committee Ø Write your QA Manual Ø Write process procedures Ø Conduct internal process reviews Ø Refine your processes Ø Conduct internal system audits Ø Undergo a “mock” pre-assessment audit Ø Refine your processes Ø Registration auditor performs assessment Receive registration ISO 9000 Overview Version 1. 1 11. 05. 2001 12

Information Sources - Getting Started • Web sites – http: //standardsgroup. asq. org – http: //www. bsi. org. uk/iso-tc 176 -sc 2 – http: //www. asq 509. org • US Standards Group on QEDS – Patricia Kopp <sginfo@asq. org> • Purchase the documents – 800 -248 -1946 – http: //qualitypress. asq. org – http: //e-standards. asq. org ISO 9000 Overview Version 1. 1 11. 05. 2001 13