Transcript No Slide Title

International Quality Standard
ISO 9000:2000
Overview and Orientation
ASQ Section 509 - ISO 9000 Users Group
ISO9000Overview Version 1.1
11.05.2001
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This Presentation …
 Provides an overview of the ISO 9000:2000 standard
 Is intended to instill a concept of the standard to users
having little or minimal understanding of ISO standards
 Is sponsored by the ISO 9000 Users Group, ASQ 509
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Why Become Certified to International
Quality Standards?
 Global Recognition - Product standards allow consumers to purchase
items from different manufacturers and know those items will
perform predictably
 Forces a customer focus throughout the organization - Improved
operational effectiveness; “Walking the talk” builds teamwork;
continual process improvement efforts strengthens business posture
 Competition - Qualify to compete in international markets
 World-wide Benchmarks for Improvement – Consistent methodology
for managing quality systems based on the widest base of industry
best practices
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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
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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
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ISO 9000:2000 Implementation
Continual Improvement of the
Quality Management System
CUSTOMER
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
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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
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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
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ISO 9000:2000 Quality Management Principles (Cont’d)
3. Involvement of People
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
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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
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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
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The Typical Sequence for ISO 9000 Registration
& Certification
Management commitment to go for registration
 Form a steering committee
 Write your QA Manual
 Write process procedures
 Conduct internal process reviews
 Refine your processes
 Conduct internal system audits
 Undergo a “mock” pre-assessment audit
 Refine your processes
 Registration auditor performs assessment
Receive registration
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Information Sources - Getting Started
• Web sites
– http://standardsgroup.asq.org
– http://www.bsi.org.uk/iso-tc176-sc2
– http://www.asq509.org
• US Standards Group on QEDS
– Patricia Kopp <[email protected]>
• Purchase the documents
– 800-248-1946
– http://qualitypress.asq.org
– http://e-standards.asq.org
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