© 2002 Systex Services1 ISO 9000:2000 OUTLINE Quality Management System

© 2002 Systex Services2 MIL Std US Military & NATO Standards AQAP National Standards BS 5750 Background CANADA FRANCE GERMANY SPAIN JAPAN USA UK + others International Standards Organisation (ISO) Committee ISO 9000: 1987 International Standard ISO 9000: 1994 ISO 9000: 2000

© 2002 Systex Services3 What is ISO 9000? [1] ISO 9000 is an internationally recognised quality management system developed by ISO (International Organisation for Standardisation) UNIVERSALLY RECOGNISED - SOUND QUALITY SYSTEM

© 2002 Systex Services4 What Is ISO 9000? [2] ISO 9000 Series ISO 9000 : 2000 QUALITY MANAGEMENT SYSTEMS - Fundamentals and vocabulary - supersedes ISO 8402 and ISO :1994 ISO 9000 : 2000 QUALITY MANAGEMENT SYSTEMS - Fundamentals and vocabulary - supersedes ISO 8402 and ISO :1994 ISO 9001: 2000 QUALITY MANAGEMENT SYSTEMS - Requirements - supersedes ISO 9001/2/3:1994 ISO 9001: 2000 QUALITY MANAGEMENT SYSTEMS - Requirements - supersedes ISO 9001/2/3:1994 ISO 19011: 2002 Guidelines on auditing quality and environmental management systems - supersedes ISO 19011:1994 ISO 19011: 2002 Guidelines on auditing quality and environmental management systems - supersedes ISO 19011:1994 ISO 9004 : 2000 QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement - supersedes ISO ISO 9004 : 2000 QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement - supersedes ISO

© 2002 Systex Services5 What Is ISO 9000? [3] Standard based on 8 quality management principles –customer focus –leadership –involvement of people –process approach –system approach to management –continual improvement –factual approach to decision making –mutually beneficial supplier relationships

© 2002 Systex Services6 Process approach model CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Customer Requirements Satisfaction Product realisation Product realisation Input Product Output Measurement analysis improvement Measurement analysis improvement Resource management Resource management Management responsibility Management responsibility

© 2002 Systex Services7 ISO 9001 Requirements 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realisation 8. Measurement, analysis and improvement

© 2002 Systex Services8 4. Quality management system General requirements –identify QMS processes –sequence & interaction of processes –criteria & measures for effective operation –information to support processes –measure, monitor, analyse, action & improvement General documentation requirements –procedures –other documents

© 2002 Systex Services9 5. Management responsibility Management commitment Customer focus Quality policy Planning –quality objectives –quality planning permissible exclusions resources continual improvement Administration –responsibility & authority –management representative –internal communication –quality manual –control of documents –control of quality records Management review –inputs (results) –outputs (actions / resources)

© 2002 Systex Services10 6. Resource management Provision of resources –relating to QMS –customer satisfaction Human resources –competency –training –effectiveness of training –contribution to quality objectives –staff records Facilities –workspace & facilities –equipment, h/ware, s/ware Work environment –human & physical factors

© 2002 Systex Services11 7. Product realisation Planning of realisation processes Customer related processes Design & development –planning –inputs –outputs –review –verification –validation –changes Purchasing –control –information –verification Production & service operations –control –identification & traceability –customer property –preservation –measuring & monitoring

© 2002 Systex Services12 8. Measurement, analysis & improvement Planning Measurement & monitoring –customer satisfaction –internal audit –processes –product –control of noncomformity –analysis of data Continued --->

© 2002 Systex Services13 8. Measurement, analysis & improvement (continued) Improvement –planning for continual improvement –corrective action identifying non- conform. causes solutions action results review –preventive action potential non- conformance preventive actions results of actions review

© 2002 Systex Services14 Certification Milestones 2. Prepare quality manual, policy, processes, planning 3. Prepare procedures, work instructions & records 10. Certification 9. External assessment ISO 9000 Certificate ISO 9000 Certificate Proced -ures Proced -ures Work Instructs Work Instructs Quality Records Quality Records 1. Brief management team4. Implement procedures5. Train internal auditors6. Conduct internal audits 7. Conduct management review 8. Preliminary assessment Quality Policy Quality Policy Quality Manual Quality Manual QMS Processes Quality Plan Quality Plan

© 2002 Systex Services15 Who requires ISO 9000? Credible suppliers Major customers Government agencies Retailers NO LONGER A FEATURE - INCREASINGLY AN EXPECTATION

© 2002 Systex Services16 What Are The Benefits? Sound quality system Single systems audit Eligibility for tenders Evidence of compliance Recognition of standard achieved Opportunity to improve existing processes A process for continual improvement ADDED VALUE, MARKET ACCESS & PRIDE

© 2002 Systex Services17 How long will it take? It has been done in less than 6 months… It has taken longer than 18 months… It can normally be done COMFORTABLY within 12 months SET YOUR OWN SCHEDULE - AND HOLD IT!

© 2002 Systex Services18 Responsibilities Management representative - for overall project & process control Prime & support - to develop & implement each ISO 9000 section

© 2002 Systex Services19 Schedule - short term LUNCH DOCUMENT PREPARATION REVIEW & ACTION PLANNING LUNCH PRESENTATIONS, QUESTIONS & ASSIGNMENTS PLANT TOUR CONSULTING DAY 1DAY 2DAY 3DAY 4 TOURTEAMSOLO GROUP QUALITY MANAGEMENT SYSTEMS 5. MANAGEMENT RESPONSIBILITY 7.1 REALISATION PROCESS 7.2 CUSTOMER RELATED PROCESSES 7.3 DESIGN AND OR DEVELOPMENT 7.4 PURCHASING 7.5 PRODUCTION & SERVICE OPERATIONS 7.6 CONTROL OF MEASURING & MONITORING DEVICES 8.2 MEASURING & MONITORING 8.3 CONTROL OF NONCONFORMITY 8.4 ANALYSIS OF DATA 8.5 IMPROVEMENT

© 2002 Systex Services20 ISO 9001 Outline Questions Prepared for Electranet Partners by : Ray Spencer - Systex Services Tel: Fax: