2. International Organization for Standardization
◦ Worldwide federation of national standards bodies
from 130 countries
◦ Over 11,000 standards
◦ Over 97 categories
2
3. ISO 9000 can benefit many
industries, such as:
Banking
Health Care
Manufacturing, etc.
ISO 9000 is generic, so it can be applied
virtually anywhere!
Remember, ISO 9000 is just one part of an
entire system needed to create value for
customers
3
4. ISO is not an acronym
ISO is a name used for the International
Organization for Standardization
The ISO was formed in 1947 in
Geneva, Switzerland
4
5. ISO 9000 is a European Standard
The organization has two stated
objectives:
1. To promote development of
standardization to facilitate international
exchange of goods and services.
2. To promote cooperation in
intellectual, scientific, technological, and
economic activity.
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6. The “Plan-Do-Check-Act” cycle, also known
as the “Deming Cycle”
A dynamic cycle that is deployed
to organization’s processes
Associated with the
planning, implementation, control and continual
improvement
6
7. Note in Clause 0.2
Plan: establish the objectives and processes
necessary to deliver results in accordance
with customer requirements and the
organization's policies;
Do: implement the processes;
Check: monitor and measure processes and
product against policies, objectives and
requirements for the product and report the
results;
Act: take actions to continually improve process
performance;
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16. ISO 9000 is composed of 5 different, but
related parts:
ISO 9000, 9001, 9002, 9003 and 9004
ISO 9000 and 9004 are guidelines,
ISO 9001, 9002, and 9003 are the
categories in which a company may apply
for certification
16
17. ISO 9000: “Quality Management and Quality
Assurance Standards – Guidelines for
Selection and Use”
Written in order to determine which category
your organization should apply for
17
18. ISO 9001: “Quality Systems – Model for
Quality Assurance in
Design/Development, Production, Installatio
n, and Servicing”
This is the category for companies which
are involved in manufacturing or the
creation and delivery of a service.
18
19. ISO 9002: “Quality Systems – Model for
Quality Assurance in Production and
Installation”
Companies who perform many
functions, with the exception of design and
development, may apply to this category
19
20. ISO 9003: “Quality Systems – Model for
Quality Assurance in Final Inspection and
Test”
This category is useful for outside of the
manufacturing sector, such as in distributors
ISO 9003 is being used less and may be
dropped in the future
20
21. ISO 9004: “Quality Management and Quality
System Elements – Guidelines”
Used in order to help interpret the categories
included in ISO 9000 certification
21
22. 21 elements organized into five major
sections:
1. System Requirements
2. Management Responsibility
3. Resource Management
4. Product Realization
5. Measurement, Analysis, and
Improvement
22
23. 1. System Requirements
◦ Establish a quality management system
◦ Document the quality management
system
23
25. 3. Resource Management
◦ Provision of Resources
◦ Human Resources
◦ Facilities
◦ Work Environment
25
26. 4. Product and/or Service Realization
◦ Planning of Realization Processes
◦ Customer-Related Processes
◦ Design and/or Development
◦ Purchasing
◦ Production and Service Operations
◦ Control of Measuring and
Monitoring Devices
26
27. 5. Measurement, Analysis, and
Improvement
◦ Planning
◦ Measurement and Monitoring
◦ Control of Nonconformity
◦ Analysis of Data
◦ Improvement
27
28. Implementing ISO 9000 in an organization
can be very beneficial
The goal of this implementation is to achieve
customer satisfaction at its highest level
28
29. Manual
(philosophy, policy, objectives, approach)
Procedures
Work instructions
(department, product, process)
Records (proof and objective evidence)
Ad-hoc, temporary documents
29
30. 1.The company first implements the control and
documentation procedures outlined in the series.
2. Internal Audit
3. It then involves a thorough audit by an
independent certification organization (i.e., a
Registrar) that is licensed to register quality
systems by an accreditation body (e.g., Registrar
Accreditation Board in U.S.)
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31. 4. Upon compliance, it receives a registration
certificate and its name is included in a
published directory of registered suppliers.
5. The systems will be continually verified by the
registrar in periodic surveillance and full audits
are conducted every few years.
31
32. Through Dec. 2002, at least 561,747 ISO
9000 certifications have been issued in
159 countries and economies. In North
America, 53,806 certifications were
issued. In Europe, 292,970 certifications
were issued – The ISO Survey
Some beginning to question its
usefulness
32
33. Documentation of quality
management system
Reduction of variation
Help develop and expand business
Reduction or elimination of customer
audit
Increased profitability/reduced costs
33
34. Improved communication, both internal
and external
Greater awareness of quality by employees
Provision of training to all employees
An internationally recognised QMS
Increased opportunities in specific markets
Increased customer satisfaction
34
35. Costs - application & maintenance
Time - maintenance
Executive commitment
Selection of registration
35
36. How to select ISO model ?
Has significant product/service design
activities
Manufactures products or services according to
approved design or customer specifications.
(This may be the case of companies without
significant new product/design activities.)
Has a product/service where the quality of this
product/service is solely dependent on final inspection
and testing.
(This may be the case of distributors of certain products.)
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