1. José Ockerman Marco A. Soto
ISO 9001:2000
José Ockerman
Marco A. Soto
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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)
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ISO Member countries
Members
Correspondent members
Subscriber members
other places with an ISO 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 9003:1987 Model for quality assurance in final inspection and test
ISO 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 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
Scope
Normative reference
Terms and definitions
Quality management system
Management responsibility
Resource management
Product realization
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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9. 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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10. 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
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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%
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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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14. 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
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15. 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 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
**Source
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ISO Certified
Quality Management System
Documented policies and procedures
Root 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 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 by an outside governing body
Trained quality specialists providing guidance and internal auditing
Management commitment to quality
Documentation of performance and auditing
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ROI
Consistent procedures
Commitment to a quality policy
Management support
Quality infrastructure and consistent focus on Quality performance
Continuous performance
Branding of certification
Additional revenue
Product improvement
Competitive advantages
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19. Measured ROA Certification in the chemical industry
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20. Measured ROA Certification in the machinery and computer industry
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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.
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QUESTIONS?
???
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Bibliography
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