ISO 9001:2000
José
Ockerman
Marco A.
EIN 5322 ENGINEERING MANAGEMENT
Soto
FALL 2007
What is ISO?
International Organization for Standardization (Organisation
internationale de normalisation)
Founded
on February 23, 1947, it promulgates world-wide industrial and
commercial standards
Headquartered
in Geneva, Switzerland
Two
official languages: English and French
ISO
is based on the Greek word ἴσος (isos), which means equal
Recognized
by the world with 157 member nations out of 195 in the
world, ensures adherence to operating standards
Works
in partnership with other technical organizations to coordinate
standards. They are:
IEC-
International Electronics Commission -IEEE- (1906)
ITU- International Telecommunications Union –UN- (1865)
ANSI- American National Standards Institute (1918)
ASTM – American Society for Testing and Materials (1898)
EIN 5322 ENGINEERING MANAGEMENT
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ISO Member countries
Members
Correspondent members
Subscriber members
other places with an ISO 3166-1 code who aren't members of ISO
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History of ISO 9001
Pre ISO 9000:During WWII, due to British high-tech industry having many
manufacturing problems and accidents the government sets new standard
and calls it BS 5750
BS
5750 required factories to document manufacturing procedures, and prove
by record-keeping that the procedures were being followed
ISO
9000:1987 had the same structure as BS 5750, with three 'models' for
quality management systems:
ISO 9001:1987 Model for quality assurance in design, development,
production, installation, and servicing

9002:1987
Model for quality assurance in production, installation, and
servicing
ISO
ISO
9003:1987 Model for quality assurance in final inspection and test
9000:1994 emphasized quality assurance via preventative actions
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History of ISO 9001
ISO 9001:2000 combines the three standards 9001, 9002, and
9003 into one, now called 9001. Requirements are:
Radical
change in thinking by placing the concept of
process management front and center
Demands involvement by upper executives to integrate
quality into the business system and avoid delegation to
junior executives and staff

Inclusion
of process performance metrics
Expectations
of continual process improvement and
tracking customer satisfaction
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ISO 9001:2000 Certification:
ISO
doesn’t certify organizations
Countries
have accreditation bodies to authorize certification bodies
which in turn audit organizations applying for ISO 9001 certification
Commonly
referred to as ISO 9000:2000 certification, the actual
standard to which an organization's quality management can be
certified is ISO 9001:2000
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ISO 9001:2000 Standard
1.
Scope
2.
Normative reference
3.
Terms and definitions
4.
Quality management system
5.
Management responsibility
6.
Resource management
7.
Product realization
8.
Measurement, analysis and improvement
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ISO 14001:2004 Standard
Standard for Environmental Management,
Contains six main clauses:
4.1 General requirements
4.2 Environmental policy
4.3 Planning
4.4 Implementation and operation
4.5 Checking and corrective action
4.6 Management review
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Current state of a
Non-ISO Business
No
consistent quality policy (QMS)
Inconsistent
procedures and processes
Inconsistent
focus on quality
Inconsistent
documentation of processes and procedures
Lack
of management support for continuous improvement
Lack
of a monitoring and measurement program
Deficient
of nonexistent corrective action documentation
Poor
focus on customer feedback and concerns
Inability to compete for contracts with ISO certified businesses
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Why should I get certified?
Your
customers are demanding it!
You
want to compete for other business
You
want to improve productivity
You
want to establish processes and standards for your
company to follow
You
want to brand your products with ISO
You
want to improve quality
You
want to establish continuous improvement
You
want to sustain your current performance
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IAAR Survey
IAAR (Independent Association of Accredited
Registrars) conducted a survey and found the following
reasons for getting QMS Certification:
29%
Customer Mandate
17% Competitive pressure or advantage
16% Continuous improvement based on customer
requirements
14% Improve Quality
10% Implementation of best practices
9% Corporate mandate
1% Reduce costs and legal mandate
http://www.qualitydigest.com/may07/articles/02_article.shtml
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IAAR Survey
The
IAAR Survey also found that Quality Certification came with
external benefits
Improved
perceived quality 57%
Improved customer satisfaction 55%
Competitive advantage 38%
Reduced customer audits 31%
Increased market share 11%
Quicker time to market 4%
Internal
benefits include:
Greater
quality awareness and better documentation 73%
Increased efficiency 37%
Positive cultural change 33%
Improved financial performance 12%
Improved employee morale 9%
http://www.qualitydigest.com/may07/articles/02_article.shtml
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What do you have to do?












Dedicate resources and personnel to ISO
Develop a quality oriented management team
Create a quality team with a quality manager
Train them on ISO and Auditing to the standard
Hire an outside registrar
Develop a QMS
Document processes and procedures
Do a gap analysis audits and pre assessments
Have the registrar pre audit you
Then schedule the actual audit for certification
Make continuous improvement your mantra
Dedicate your activities to your customers needs
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What does it cost?
Depends
on the complexity of your business (service,
manufacturing or retail)
Depends
on the size of your business
Depends
on the standard you are pursuing
On
average it can cost from a high of $4,500 to a low of
$1,000 per employee*
Average
initial registration costs average from $1,500 to
$2,500 per employee*
Source http://www.ciras.iastate.edu/publications/management/iso.asp
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Real world cost examples
Medium
sized companies such as Continental Circuits
Corp., is spending close to $100,000 ($40,000 in
software and $60,000 labor costs associated with
implementation and pre-assessments*
“The
cost of the whole ISO 14001 certification
process, beginning with gap analysis and culminating
with Certification, could run from $40,000 to more than
$100,000, estimates Edward Pinero, director of
environmental services at Miller-Rettew Associates.**
*Source http://www.qualitydigest.com/jul/iso14k1.html
**Source http://www.qualitydigest.com/oct/iso14000.html
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ISO 9001 2000 Certified
Quality
Management System
Documented
Root
policies and procedures
cause analysis
Continuous
improvement
Management
support and responsibility
Regular
reporting and maintenance
Control
of facility requirements
Focus
on the customer
Fielding
of customer complaints and requirements
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ISO 9001 2000 Certified
Regular
calibration of tools and equipment
Tracking
of performance
Periodic
auditing and measurement of the overall organizations
adherence to their own stated procedures
Certification
Trained
by an outside governing body
quality specialists providing guidance and internal
auditing
Management
commitment to quality
Documentation
EIN 5322 ENGINEERING MANAGEMENT
of performance and auditing
FALL 2007
ROI
Consistent
procedures
Commitment
to a quality policy
Management
support
Quality
infrastructure and consistent focus on Quality
performance
Continuous
Branding
performance
of certification
Additional
revenue
Product
improvement
Competitive advantages
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Measured ROA
Certification in the chemical industry
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Measured ROA
Certification in the machinery and
computer industry
EIN 5322 ENGINEERING MANAGEMENT
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Measured ROA
Certification in the electronic equipment
and components industry
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Conclusion
ISO
9001:2000
ISO 14001
Why, what, how much and benefit
ROA
Depending on the industry, ISO certification brings many
advantages both perceived and tangible, but ultimately with
empirical data it provides sustained and improved return on
assets. Unfortunately, the data also indicates that that return
may be small when compared over several years of post
certification growth, but if you compare it to non-certified
companies it proves to be a worthwhile investment.
EIN 5322 ENGINEERING MANAGEMENT
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QUESTIONS?
???
EIN 5322 ENGINEERING MANAGEMENT
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Bibliography
http://www.iso.org/iso/iso_catalogue/the_iso_portfolio.htm
http://www.iso.org/iso/standards_development/processes_and_procedures/stages_description.htm
http://en.wikipedia.org/wiki/International_Organization_for_Standardization
http://en.wikipedia.org/wiki/Image:ISO_French_logo.svg
http://www.qualitydigest.com/may99/html/body_iso9000.html
http://www.qualitydigest.com/may07/articles/02_article.shtml
http://www.ciras.iastate.edu/publications/management/iso.asp
http://www.qualitydigest.com/jul/iso14k1.html
http://www.qualitydigest.com/oct/iso14000.html
http://www.aworldofquality.com/content/Downloads/Financial%20Benefits%20of%20ISO%209000
%20Certification.pdf
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ISO 9001:2000 - Florida International University