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ISO 9001:2000 Management System Overview

ISO 9001:2000 Management System Overview. Business Management System ISO 9001Management System Manufacturer and Customer Benefits Eight Quality Management Principles System and Process Approach to Improvement Customer Oriented Process Development Clauses and Elements of ISO 9001:2000

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ISO 9001:2000 Management System Overview

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  1. ISO 9001:2000 Management System Overview

  2. Business Management System ISO 9001Management System Manufacturer and Customer Benefits Eight Quality Management Principles System and Process Approach to Improvement Customer Oriented Process Development Clauses and Elements of ISO 9001:2000 4.0 Quality Management System 5.0 Management Responsibility 6.0 Resource Management 7.0 Product Realization 8.0 Measurement, Analysis and Improvement Terms and Definitions ISO 9001:2000 Overview

  3. ISO9001:2000 System Structure Overview Documentation Hierarchy • Level 1: • Quality Manual • Policy • Scope • Associated Docs • Level 2: • Procedures • Policies in Practice • Responsibilities • Corrective Action • Level 3: • Work Instructions • Product Specifications • Method Sheets • Control Forms • Level 4: • Quality Records • Audit & Test Results • Meeting Minutes ISO Department/Element Owners: Responsible for developing, implementing, and ensuring compliance Documented Business System: Documentation that supports business operations and the ISO9001Standard Forms Roles Procedures Review & Improvement: Responsible for evaluating the effectiveness of business against documented system Registrar Audits: Third Party audits will be conducted to assure understanding, compliance and effectiveness of QMS for registration

  4. Organizational Ownership and Accountability Senior Management Steering Committee 5.4 Quality Planning Management Representative 5.6 Management Review Internal Audit Team 8.2 Internal Audits System Ownership System Ownership Sales & Marketing 7.2 Customer-related processes Material Control 7.2 Purchasing processes Manufacturing 7.1 Product Realization processes Quality Assurance 8.4 Analysis of Data processes Inspection & Test 8.3 Identification and Traceability processes Shipping 7.5 Preservation of Product processes

  5. What What are the necessary facilities, equipment, materials, services? Facilities: Equipment: Materials: Output What does the customer get? Service : Warranty: Specs: Input What does the customer want? Customer Requirements: Critical Success Factors: Customer Specs: How How are processes realized? Support Processes: Sequence & Interaction: Procedures, Methods & Instructions: Who Who applies the resources? Process Owner: Personnel: Training: Core Process Measure How is the analysis of process effectiveness accomplished? Performance Goals: Measurement & Metric Selection: Use of Data: Actions Based on Data: Organizational Core Process Analysis and Development

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