1. ISO 9001:2000 Management System Overview

2. ISO 9001:2000 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
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

3. Product Specifications
ISO9001:2000 System Structure Overview
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
Documentation Hierarchy
Department/Element Owners:
Responsible for developing, implementing, and ensuring compliance
Documented Business System:
Documentation that supports business
operations and the ISO9001Standard
Procedures
Roles
ISO
Forms
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 Management Representative
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. Organizational Core Process Analysis and Development
What
What are the necessary facilities, equipment, materials, services?
Facilities:
Equipment:
Materials:
Who
Who applies the resources?
Process Owner:
Personnel:
Training:
Input
What does the customer want?
Customer Requirements:
Critical Success Factors:
Customer Specs:
Output
What does the customer get?
Service :
Warranty:
Specs:
Core Process
How
How are processes realized?
Support Processes:
Sequence & Interaction:
Procedures, Methods & Instructions:
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