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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
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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: External: First party: Your employees 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 *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