afhofmann: ISO 9001:2000 Practical Guidance to Implementation III International Congress for Micro/Small Industry – Mexico City May 22, 2001 KPMG Quality Registrars Inc.
Presentation Objectives • Contents of ISO 9001:2000 • Commitment Required by Organization • Keys to successful implementation • Questions
ISO 9001:2000 Content of ISO 9001:2000 - Overview
Documented Quality System Audit / Check Corrective Action Measurement and Review A Quality System: Formalizes the processes within the organization which are so important to meet the business objectives that they need a systematic approach. Say what you do! Do what you say! Document what you’ve done! Measure the difference! Act on it!
C U S T O M E R Requirements Business Process Flow Quality Management System Continual Improvement Continuous ImprovementCycle C U S T O M E R Satisfaction Management Responsibility Measurement, Analysis, Improvement Resource Management Input Product and/or Service Realization Output A P C D Quality Management System
Structure of ISO 9001 Based on a “Business Process Model” rather than the artificial 20 element structure in 9001:1994. 20 Elements have become 5 Major Clauses: • 4.0 Quality Management System (general requirements, documentation requirements, quality manual, control of documents and records) • 5.0 Management Responsibility (policy, objectives, planning, customer focus, QMS, management review) • 6.0 Resource Management (human resources, facilities, work environment) • 7.0 Product and/or Service Realization (contract, design, purchasing, production, calibration) • 8.0 Measurement, Analysis and Improvement (monitoring, audit, control of NC, continual improvement, customer satisfaction)
Summary of New Requirements Items now explicit in ISO 9001:2000 that your QMS must address: • Measurement of customer satisfaction and/or dissatisfaction • Customer communication • Continual improvement • Facilities and work environment • Internal communication • Departmental and functional objectives • Employee awareness • Training – competency, effectiveness
ISO 9001:2000 Implementation Commitment
Implementation Commitment • Full support by Top Management • Implementation is planned, consistently communicated and appropriate training provided • Regular review of progress - audit • Successes are identified and celebrated • Maximum use is made of existing methods
Implementation Commitment • Establishment of organizational direction through policy • Setting of objectives and targets • Definition of metrics • Provision of resources and removal of road blocks • Assessment of customer risk • Consistent reinforcement of positives
Implementation Commitment • Establishment of direction through policy - Strategic framework for the organization - Commitment to customer and stakeholders - Framework for measurement and improvement
Implementation Commitment • Setting of Objectives and Targets - Linked to customer needs - Measurable and Meaningful - Risk Based
Implementation Commitment • Metrics - Monitoring direct measurables - Monitoring of audits of processes - Monitoring of customer indicators - Action when different from plan
Implementation Commitment • Resources - Adjustment where metrics indicate - Recognition and removal of road blocks to improvement - Measurement of Improvement - Review of Strategy for continued “fit”
Implementation Commitment • Assessment of Customer Risk - Identification of key needs, past and future - Review of delivery systems and personnel - Optimization of resources to consistently deliver against needs
ISO 9001:2000 Keys to Success
Keys to Success • Map your processes • Maximum use of existing systems • Assign ownership of process steps • Identify sub-processes and controls/procedures • Obtain management direction for policy, goals, targets and metrics • Training, Training, Training… • React to measures
Keys to Success • A time line for activities – usually six to 18 months • A focus point, someone responsible to encourage each stakeholder • Regular status meetings with Senior Management • Regular communication on progress to everyone • An external resource to assist with interpretations
Keys to Success • Have Fun!
Keys to Success Quotation: You do not have to do this; Survival is not compulsory ! Dr. W. Edwards Deming
Questions ?
