ISO 9000
 Produced by: Matthew Carino

Operations and information systems management
student at The Pennsylvania State University
ISO 9000
European standards
influencing a worldwide
quality focus.
ISO 9000 Background and
Introduction
 Background

The ISO 9000 Standard was designed by
delegates from the United States and members
from 14 European countries.

Purpose of Standard = To increase conformance
and productivity by reducing nonconformance at
all stages.
Background and Introduction Cont.
 The standard covers all aspects of
business and production.
 From small businesses to large
corporations.
 Covering tangible and intangible products
and services.
Why get certified?
 Over 90 countries have incorporated ISO
9000 into their common day business web.
 Companies and organizations expect and
acknowledge that suppliers or producers
that are ISO 9000 compliant will
consistently provide quality products or
services.
Internal and External Benefits
Entities that have obtained their Certification
have shown reductions in waste and increase in
productivity and reliability, as well as increase in
product demand and return buyers.
 By producing high quality products/services it
stimulates international growth and feelings of
well being and satisfaction in the consumer
markets.

Should you be certified?
Is it worth it?
Can we survive in this ever
changing and evolving business
world without being certified?
What do others say?
 "Without an increase in our sales volume,
ISO 9000 compliance has easily saved our
company $200,000 a year by increased
efficiencies alone."

- Jim Sharpe, President, Extrusion Technology, Inc., Randolph, MA
Increasing rate of compliancy
and standardization.
The rate of entities becoming ISO 9000 compliant
has risen dramatically in the last 10 years or so.
 The number of U.S. based companies that have
been certified has risen from around 1,000 in
1993 to well over 20,000 in the late 90’s
 Other countries have followed this same trend.
Making ISO 9000 a big focus in many economies.

The Ideology of ISO 9000
 ISO 9000 is mainly concerned with quality
management
 It focuses on quality services and products.
 The standards of compliancy are set forth
by researchers who determine quality
based on market research.
Beginning the process
 Once an entity has decided that becoming
ISO 9000 compliant will benefit themselves
they must go through a standard process.
Pre-requisites of Becoming ISO
9000 Compliant
 ISO 9000 distinguishes from Quality
system requirements, and product/service
quality requirements.
 It also recognizes 4 types of products:




Hardware
Software
Materials
Services
What does quality rely on? What
Questions should be asked?
*Are we able to constantly and routinely update
products/services to meet the changing
environment?
*Is the product/service a desirable one for the
marketplace?
*Is the product/service you produce reliable and
constant?
*Will you be able to provide customer service
throughout the duration of the product’s/service’s
life cycle?
All work is a Process!
 This process consists of Inputs and
outputs, and the transformation processes
involved in making a final product that
appeals to customers.
An organization as a network!

Within each organization, players must link and
manage processes efficiently with a relay of
accurate pertinent information from source to
source.
Quality definition and
management
 Quality is based on how well all the
processes are defined and managed.
 What is the weak link if any?
 Are the processes of high quality? And can
they be implemented in a system that
utilizes the strength of each process?
Pre-requisites of Becoming ISO
9000 Compliant
 What should be asked to determine if your
process is of high quality?
Pre-requisites of Becoming ISO
9000 Compliant
 Have procedures been developed for the
control of the processes at hand?
 Are these procedures well documented
and well defined?
 Are these procedures being put to full use?
 Can these processes lead to the final
output you wish to deliver to the supplier?
Action Planning Checklists
 Once an entity decides to seek registration,
they may use action planning checklists.
– Action Planning Checklists= Guidelines and areas
that ISO 9000 inspectors focus on during their
inspection.
Evaluation of quality systems
Who evaluate these processes and systems?
 Executive managers:

– Within one’s own business/corporation.
– If an internal source can pick out faults or weaknesses, they
will most likely be seen by outsiders.
Evaluation of quality systems
 The second body of review are Quality
auditors.
Quality Auditors
Internal:
First party: Your employees
External:
Second Party: Your customers
Third Party: Independent bodies
Documentations of quality
systems
 Quality aspect processes should be well
reviewed and documented in writing.
– This allows for easy reflect and review of past
procedures in looking to advance new ones.
– Also an easy way to document failure and causes,
which are used for reference.
Audits
 An audit is an inspection of the documents
and records that make up your quality
system.
 An audit may be done in advance of the
actual ISO 9000 audit.
– These are usually done by consultants, and
together with management, they try to iron out all
non conforming aspects.
Final Step
 The registration audit is the final step in
gaining ISO 9000 compliancy.
– After the inspection, the number and severity of
unconformities are reviewed and scrutinized, If the
overall scope of business operations and goal of
focus is not skewed then a certificate of
compliancy will most likely be granted.
ISO FAMILY
ISO 9000-1
ISO 9000-2
ISO 9000-3
ISO 9000-4
General guidance tool to determine
which publications to focus on.
Helps organizations implement ISO
9001,9002,or 9003
Deals with Software businesses and
the use of ISO 9001 to help set up new
quality systems.
Focuses of Dependability*
*Dependability includes, but not limited to reliability, maintainability, and availability.
Expansions:
 ISO 9000 is only a guide to the beginning of
quality assurance.
 Many companies and organizations that
are ISO 9000 compliant try to stay up to
date on new ISO standards.
– That may mean implicating different ISO sectors in
order to prevail in a fast growing and competitive
market.
– These sectors are explained in detail
at:http://www.isoeasy.org/selusee.pdf
Challenges
 In the fast changing business world it is not
only important to satisfy customers, but to
improve all aspects of a changing business
environment to improve and exceed
expectations.
Summary
 Becoming ISO 9000 compliant does not
guarantee success, but allows for a good
basis for future accomplishments.
 Once one becomes certified, it is their
responsibility to remain a high quality
producer/ service provider.
Exercise
 Form into groups and discuss what you
think is the ideal company that would
benefit from becoming ISO 9000 compliant.
 Also list factors why companies would not
try for their certificate.
Bibliography




“ISO easy” internet. http://www.iso easy.org
“Testimonials from ISO 9000 network clients” internet.
http://www.isonet.com/clientco.htm
“Frequently asked questions about ISO 9000” internet.
http://www.isoeasy.org/faq10.htm
“Quality and Environmental Management Systems Consultants in Continuous
Improvement” . Internet. http://www.isonet.com/informat.htm