ISO 9000ISO 9000

Produced by: Matthew CarinoProduced by: Matthew Carino Operations and information systems Operations and information systems

management student at The Pennsylvania management student at The Pennsylvania State UniversityState University

European standards European standards influencing a influencing a worldwide quality worldwide quality focus.focus.

ISO 9000ISO 9000

ISO 9000 Background and ISO 9000 Background and IntroductionIntroduction

BackgroundBackground The ISO 9000 Standard was The ISO 9000 Standard was

designed by delegates from the designed by delegates from the United States and members from United States and members from

14 European countries14 European countries.. Purpose of Standard = To increase Purpose of Standard = To increase

conformance and productivity by conformance and productivity by

reducing nonconformance at all stagesreducing nonconformance at all stages..

Background and Introduction Background and Introduction ContCont..

The standard covers all aspects of The standard covers all aspects of business and production.business and production.

From small businesses to large From small businesses to large corporations. corporations.

Covering tangible and intangible Covering tangible and intangible products and services.products and services.

Why get certified?Why get certified?

Over 90 countries have Over 90 countries have incorporated ISO 9000 into their incorporated ISO 9000 into their common day business web.common day business web.

Companies and organizations Companies and organizations expect and acknowledge that expect and acknowledge that suppliers or producers that are ISO suppliers or producers that are ISO 9000 compliant will consistently 9000 compliant will consistently provide quality products or services.provide quality products or services.

Internal and External Internal and External BenefitsBenefits

Entities that have obtained their Entities that have obtained their Certification have shown reductions in Certification have shown reductions in waste and increase in productivity and waste and increase in productivity and reliability, as well as increase in product reliability, as well as increase in product demand and return buyers.demand and return buyers.

By producing high quality By producing high quality products/services it stimulates products/services it stimulates international growth and feelings of well international growth and feelings of well being and satisfaction in the consumer being and satisfaction in the consumer markets.markets.

Should you be certified? Should you be certified?

Is it worth it?Is it worth it?Can we survive in this ever Can we survive in this ever

changing and evolving changing and evolving business world without business world without being certified?being certified?

What do others say?What do others say?

"Without an increase in our sales "Without an increase in our sales volume, ISO 9000 compliance has volume, ISO 9000 compliance has easily saved our company easily saved our company $200,000 a year by increased $200,000 a year by increased efficiencies alone." efficiencies alone."

- Jim Sharpe, President, Extrusion Technology, Inc., Randolph, - Jim Sharpe, President, Extrusion Technology, Inc., Randolph, MAMA

Increasing rate of Increasing rate of compliancy and compliancy and standardization.standardization.

The rate of entities becoming ISO 9000 The rate of entities becoming ISO 9000 compliant has risen dramatically in the last compliant has risen dramatically in the last 10 years or so.10 years or so.

The number of U.S. based companies that The number of U.S. based companies that have been certified has risen from around have been certified has risen from around 1,000 in 1993 to well over 20,000 in the 1,000 in 1993 to well over 20,000 in the late 90’slate 90’s

Other countries have followed this same Other countries have followed this same trend. Making ISO 9000 a big focus in trend. Making ISO 9000 a big focus in many economies.many economies.

The Ideology of ISO 9000The Ideology of ISO 9000

ISO 9000 is mainly concerned with ISO 9000 is mainly concerned with quality managementquality management

It focuses on quality services and It focuses on quality services and products.products.

The standards of compliancy are The standards of compliancy are set forth by researchers who set forth by researchers who determine quality based on market determine quality based on market research.research.

Beginning the processBeginning the process

Once an entity has decided that Once an entity has decided that becoming ISO 9000 compliant will becoming ISO 9000 compliant will benefit themselves they must go benefit themselves they must go through a standard process.through a standard process.

Pre-requisites of Becoming Pre-requisites of Becoming ISO 9000 CompliantISO 9000 Compliant

ISO 9000 distinguishes from Quality ISO 9000 distinguishes from Quality system requirements, and system requirements, and product/service quality requirements.product/service quality requirements.

It also recognizes 4 types of products:It also recognizes 4 types of products: HardwareHardware SoftwareSoftware MaterialsMaterials ServicesServices

What does quality rely on? What does quality rely on? What Questions should be What Questions should be asked?asked?

*Are we able to constantly and routinely *Are we able to constantly and routinely update update products/services to meet products/services to meet the changing the changing environment? environment?

*Is the product/service a desirable one *Is the product/service a desirable one for the for the marketplace? marketplace?

*Is the product/service you produce *Is the product/service you produce reliable and reliable and constant? constant?

*Will you be able to provide customer *Will you be able to provide customer service service throughout the duration of throughout the duration of the product’s/service’s the product’s/service’s life cycle? life cycle?

All work is a Process!All work is a Process!

This process consists of Inputs and This process consists of Inputs and outputs, and the transformation outputs, and the transformation processes involved in making a processes involved in making a final product that appeals to final product that appeals to customers.customers.

An organization as a An organization as a network!network!

Within each organization, players must Within each organization, players must link and manage processes efficiently link and manage processes efficiently with a relay of accurate pertinent with a relay of accurate pertinent information from source to source.information from source to source.

Quality definition and Quality definition and management management

Quality is based on how well all the Quality is based on how well all the processes are defined and processes are defined and managed. managed.

What is the weak link if any?What is the weak link if any? Are the processes of high quality? Are the processes of high quality?

And can they be implemented in a And can they be implemented in a system that utilizes the strength of system that utilizes the strength of each process?each process?

Pre-requisites of Becoming Pre-requisites of Becoming ISO 9000 CompliantISO 9000 Compliant

What should be asked to What should be asked to determine if your process is of high determine if your process is of high quality?quality?

Pre-requisites of Becoming Pre-requisites of Becoming ISO 9000 CompliantISO 9000 Compliant

Have procedures been developed for Have procedures been developed for the control of the processes at hand?the control of the processes at hand?

Are these procedures well documented Are these procedures well documented and well defined?and well defined?

Are these procedures being put to full Are these procedures being put to full use?use?

Can these processes lead to the final Can these processes lead to the final output you wish to deliver to the output you wish to deliver to the supplier?supplier?

Action Planning ChecklistsAction Planning Checklists

Once an entity decides to seek Once an entity decides to seek registration, they may use action registration, they may use action planning checklists.planning checklists.

– Action Planning Checklists= Guidelines Action Planning Checklists= Guidelines and areas that ISO 9000 inspectors focus and areas that ISO 9000 inspectors focus on during their inspection.on during their inspection.

Evaluation of quality Evaluation of quality systemssystems

Who evaluate these processes and Who evaluate these processes and systems?systems?

Executive managers:Executive managers:– Within one’s own business/corporation.Within one’s own business/corporation.– If an internal source can pick out faults or If an internal source can pick out faults or

weaknesses, they will most likely be seen by weaknesses, they will most likely be seen by outsiders.outsiders.

Evaluation of quality Evaluation of quality systemssystems

The second body of review are Quality The second body of review are Quality auditors.auditors.

Quality AuditorsQuality Auditors

Internal:Internal: External:External:First party: Your employeesFirst party: Your employees Second Party: Your Second Party: Your

customerscustomersThird Party: Third Party:

Independent bodiesIndependent bodies

Documentations of quality Documentations of quality systemssystems

Quality aspect processes should be Quality aspect processes should be well reviewed and documented in well reviewed and documented in writing.writing.

– This allows for easy reflect and review of This allows for easy reflect and review of past procedures in looking to advance past procedures in looking to advance new ones.new ones.

– Also an easy way to document failure and Also an easy way to document failure and causes, which are used for reference.causes, which are used for reference.

AuditsAudits

An audit is an inspection of the An audit is an inspection of the documents and records that make documents and records that make up your quality system.up your quality system.

An audit may be done in advance An audit may be done in advance of the actual ISO 9000 audit. of the actual ISO 9000 audit.

– These are usually done by consultants, These are usually done by consultants, and together with management, they try and together with management, they try to iron out all non conforming aspects.to iron out all non conforming aspects.

Final StepFinal Step

The registration audit is the final The registration audit is the final step in gaining ISO 9000 step in gaining ISO 9000 compliancy.compliancy.

– After the inspection, the number and After the inspection, the number and severity of unconformities are reviewed severity of unconformities are reviewed and scrutinized, If the overall scope of and scrutinized, If the overall scope of business operations and goal of focus is business operations and goal of focus is not skewed then a certificate of not skewed then a certificate of compliancy will most likely be granted.compliancy will most likely be granted.

ISO FAMILYISO FAMILY

ISO 9000-ISO 9000-11

General guidance tool to General guidance tool to determine which publications determine which publications to focus on.to focus on.

ISO 9000-ISO 9000-22

Helps organizations Helps organizations implement ISO 9001,9002,or implement ISO 9001,9002,or 90039003

ISO 9000-ISO 9000-33

Deals with Software Deals with Software businesses and the use of ISO businesses and the use of ISO 9001 to help set up new 9001 to help set up new quality systems.quality systems.

ISO 9000-ISO 9000-44

Focuses of Dependability*Focuses of Dependability*

*Dependability includes, but not limited to reliability, maintainability, and availability.

Expansions:Expansions:

ISO 9000 is only a guide to the ISO 9000 is only a guide to the beginning of quality assurance. beginning of quality assurance.

Many companies and organizations Many companies and organizations that are ISO 9000 compliant try to that are ISO 9000 compliant try to stay up to date on new ISO stay up to date on new ISO standards. standards.

– That may mean implicating different ISO That may mean implicating different ISO sectors in order to prevail in a fast growing sectors in order to prevail in a fast growing and competitive market.and competitive market.

– These sectors are explained in detail These sectors are explained in detail at:http://www.isoeasy.org/selusee.pdfat:http://www.isoeasy.org/selusee.pdf

ChallengesChallenges

In the fast changing business world In the fast changing business world it is not only important to satisfy it is not only important to satisfy customers, but to improve all customers, but to improve all aspects of a changing business aspects of a changing business environment to improve and environment to improve and exceed expectations. exceed expectations.

SummarySummary

Becoming ISO 9000 compliant Becoming ISO 9000 compliant does not guarantee success, but does not guarantee success, but allows for a good basis for future allows for a good basis for future accomplishments.accomplishments.

Once one becomes certified, it is Once one becomes certified, it is their responsibility to remain a their responsibility to remain a high quality producer/ service high quality producer/ service provider. provider.

ExerciseExercise

Form into groups and discuss what Form into groups and discuss what you think is the ideal company that you think is the ideal company that would benefit from becoming ISO would benefit from becoming ISO 9000 compliant.9000 compliant.

Also list factors why companies Also list factors why companies would not try for their certificate.would not try for their certificate.

BibliographyBibliography

““ISO easy” internet. http://www.iso easy.orgISO easy” internet. http://www.iso easy.org ““Testimonials from ISO 9000 network clients” internet. Testimonials from ISO 9000 network clients” internet.

http://www.isonet.com/clientco.htmhttp://www.isonet.com/clientco.htm ““Frequently asked questions about ISO 9000” internet. Frequently asked questions about ISO 9000” internet.

http://www.isoeasy.org/faq10.htmhttp://www.isoeasy.org/faq10.htm ““Quality and Environmental Management Systems Consultants Quality and Environmental Management Systems Consultants

in Continuous Improvement” . Internet. in Continuous Improvement” . Internet. http://www.isonet.com/informat.htmhttp://www.isonet.com/informat.htm