fall 2007ein 5322 engineering management iso 9001:2000 josé ockerman marco a. soto

FALL 2007EIN 5322 ENGINEERING

MANAGEMENT

ISO 9001:2000ISO 9001:2000

José OckermanJosé Ockerman

Marco A. SotoMarco A. Soto


MANAGEMENT

What is ISO?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 Recognized by the world with 157 member nations out of 195 in the world, ensures adherence to operating 195 in the world, ensures adherence to operating standardsstandards

Works in partnership with other technical organizations to Works in partnership with other technical organizations to coordinate standards. They are:coordinate standards. They are:

IEC- International Electronics Commission -IEEE- (1906)IEC- International Electronics Commission -IEEE- (1906)ITU- International Telecommunications Union –UN- (1865)ITU- International Telecommunications Union –UN- (1865)ANSI- American National Standards Institute (1918)ANSI- American National Standards Institute (1918)ASTM – American Society for Testing and Materials (1898)ASTM – American Society for Testing and Materials (1898)


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ISO Member countriesISO 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 9001History of ISO 9001Pre ISO 9000Pre 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 9002:1987 Model for quality assurance in production, Model for quality assurance in production, installation, and servicing 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 9001History 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 Radical change in thinking by placing the concept of process management front and concept of process management front and centercenter

Demands involvement by Demands involvement by upper executivesupper executives to to integrate quality into the business system and integrate quality into the business system and avoid delegation to junior executives and staffavoid delegation to junior executives and staff

Inclusion of process performance metricsInclusion of process performance metrics

Expectations of continual Expectations of continual process process improvementimprovement and tracking customer and tracking customer satisfactionsatisfaction


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ISO 9001:2000 ISO 9001:2000 Certification: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 ISO 9001:2000 StandardStandard

1.1. ScopeScope

2.2. Normative referenceNormative reference

3.3. Terms and definitionsTerms and definitions

4.4. Quality Quality management system system

5.5. Management responsibilityManagement responsibility

6.6. Resource managementResource management

7.7. Product realizationProduct realization

8.8. Measurement, analysis and Measurement, analysis and improvementimprovement


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ISO 14001:2004 ISO 14001:2004 StandardStandard

Standard for Environmental Management,Contains six main clauses:

4.1 General requirements4.2 Environmental policy4.3 Planning4.4 Implementation and operation4.5 Checking and corrective action4.6 Management review


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Current state of a Current state of a Non-ISO BusinessNon-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 concernsInability to compete for contracts with ISO certified businesses


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Why should I get Why should I get certified?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 SurveyIAAR Survey

IAAR (Independent Association of Accredited Registrars) conducted a survey and found the following reasons for getting QMS Certification:

29% Customer Mandate17% Competitive pressure or advantage16% Continuous improvement based on customer requirements14% Improve Quality10% Implementation of best practices9% Corporate mandate1% Reduce costs and legal mandate

http://www.qualitydigest.com/may07/articles/02_article.shtml


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IAAR SurveyIAAR SurveyThe 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 What do you have to do?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?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 examplesReal world cost examplesMedium 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 CertifiedISO 9001 2000 CertifiedQuality 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 customerFocus on the customer

Fielding of customer complaints and requirementsFielding of customer complaints and requirements


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ISO 9001 2000 CertifiedISO 9001 2000 CertifiedRegular calibration of tools and equipmentRegular calibration of tools and equipment

Tracking of performanceTracking of performance

Periodic auditing and measurement of the overall Periodic auditing and measurement of the overall organizations adherence to their own stated organizations adherence to their own stated proceduresprocedures

Certification by an outside governing bodyCertification by an outside governing body

Trained quality specialists providing guidance and Trained quality specialists providing guidance and internal auditinginternal auditing

Management commitment to qualityManagement commitment to quality

Documentation of performance and auditingDocumentation of performance and auditing


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ROIROIConsistent procedures

Commitment to a quality policy

Management support

Quality infrastructure and consistent focus on Quality performance

Continuous performance

Branding of certification

Additional revenue

Product improvementCompetitive advantages


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Measured ROAMeasured ROACertification in the chemical Certification in the chemical

industryindustry


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Measured ROAMeasured ROACertification in the machinery Certification in the machinery

and computer industryand computer industry


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Measured ROAMeasured ROACertification in the electronic Certification in the electronic equipment and components equipment and components

industryindustry


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ConclusionConclusion

ISO 9001:2000ISO 9001:2000ISO 14001ISO 14001Why, what, how much and benefitWhy, what, how much and benefitROAROADepending on the industry, ISO certification Depending on the industry, ISO certification brings many advantages both perceived and brings many advantages both perceived and tangible, but ultimately with empirical data it tangible, but ultimately with empirical data it provides sustained and improved return on provides sustained and improved return on assets. Unfortunately, the data also indicates assets. Unfortunately, the data also indicates that that return may be small when compared that that return may be small when compared over several years of post certification growth, over several years of post certification growth, but if you compare it to non-certified companies but if you compare it to non-certified companies it proves to be a worthwhile investment.it proves to be a worthwhile investment.


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QUESTIONS?QUESTIONS?

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BibliographyBibliography

http://www.iso.org/iso/iso_catalogue/the_iso_portfolio.htmhttp://www.iso.org/iso/iso_catalogue/the_iso_portfolio.htm

http://www.iso.org/iso/standards_development/processes_and_procedures/stages_descrihttp://www.iso.org/iso/standards_development/processes_and_procedures/stages_description.htmption.htm

http://en.wikipedia.org/wiki/International_Organization_for_Standardizationhttp://en.wikipedia.org/wiki/International_Organization_for_Standardization

http://en.wikipedia.org/wiki/Image:ISO_French_logo.svghttp://en.wikipedia.org/wiki/Image:ISO_French_logo.svg

http://www.qualitydigest.com/may99/html/body_iso9000.htmlhttp://www.qualitydigest.com/may99/html/body_iso9000.html

http://www.qualitydigest.com/may07/articles/02_article.shtmlhttp://www.qualitydigest.com/may07/articles/02_article.shtml

http://www.ciras.iastate.edu/publications/management/iso.asphttp://www.ciras.iastate.edu/publications/management/iso.asp

http://www.qualitydigest.com/jul/iso14k1.htmlhttp://www.qualitydigest.com/jul/iso14k1.html

http://www.qualitydigest.com/oct/iso14000.htmlhttp://www.qualitydigest.com/oct/iso14000.html

http://www.aworldofquality.com/content/Downloads/Financial%20Benefits%20of%20ISOhttp://www.aworldofquality.com/content/Downloads/Financial%20Benefits%20of%20ISO%209000%20Certification.pdf %209000%20Certification.pdf

fall 2007ein 5322 engineering management iso 9001:2000 josé ockerman marco a. soto

Documents

pre iso

test iso

members of iso slide

french iso

quality management systems

concept of process management

emphasized quality assurance

commercial standards