ISO 9000 Produced by: Matthew Carino Operations and information systems management student at The Pennsylvania State University

European standards influencing a worldwide quality focus. ISO 9000 European standards influencing a worldwide quality focus. ISO is the international quality standards organization.

ISO 9000 Background and Introduction 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. ISO 9000 was completed and introduced in 1987 by the international organization of standards in Geneva, Switzerland.

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. Anyone may apply for the certificate it is open to all business forms.

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. Awards for excellent quality are given in each country.

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. Benefits will vary depending on types of products or services. Some may argue that ISO 9000 had a huge impact on our current booming economy.

Should you be certified? Is it worth it? Can we survive in this ever changing and evolving business world without being certified? Do the potential financial gains outweigh loses and stress.

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 Waste reduction and efficiency are very common advantages in becoming compliant.

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 numbers of companies that are becoming ISO 9000 Compliant will peak in the next several years, and the rate of new applicants will start decreasing due to the fact that companies that are competing, or want to compete have been certified or are very close to being certified.

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. These researchers are professionals in all fields such as economics, business trends, consumer need and wants etc…

Beginning the process Once an entity has decided that becoming ISO 9000 compliant will benefit themselves they must go through a standard process. Although most aspects of the process are not formal, they are just as important, if not more.

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 Ideas and intangibles are also important facets.

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? These questions need to be answered logically, and are the basis for a company to promote and obtain success..

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. Must realize A to B only works if the path is clear.

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. This also deals heavily with information systems. And the tabulation of data in an important manor that can be understood and worked with.

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? Even if all processes work well if they do not link together it causes a bottle neck in production.

Pre-requisites of Becoming ISO 9000 Compliant What should be asked to determine if your process is of high quality? Think about this before viewing the next slide.

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? As you can see efficiency and control are the 2 main ideas in distinguishing quality and in turn profit.

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. Preparation is the key to obtaining compliancy.

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. It is the executive managers responsibility to have a good grasp of all the companies dealings and processes.

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 The best feedback and responses will come from your employees and customers. They know more about your products and/or processes than any independent body will.

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. People may be hired to write up a quality log of activities, or may be done internally, some CEO’s feel it is their responsibility to write up the journal.

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. The auditors will look at the documentation and compare it to what is actually occurring. Consistency is very important.

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. The certificate is usually valid up to 3 years. However, follow up surveillance may be required by the agency to make sure of continued compliance.

ISO FAMILY ISO 9000-1 General guidance tool to determine which publications to focus on. ISO 9000-2 Helps organizations implement ISO 9001,9002,or 9003 ISO 9000-3 Deals with Software businesses and the use of ISO 9001 to help set up new quality systems. ISO 9000-4 Focuses of Dependability* These are the basic 9000 areas as you will see there are many subtopics in 9001, 9002 etc… *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 The most successful companies will try to advance and be quality benchmarkers in their field of expertise.

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. The ISO system is an excellent tool to help identify the challenges that must be focused on in order to be the successful business entity that one strives for.

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. This means keeping with new updated quality measures.

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. An ideal company is one that has many different responsibilities and want to be competitive in the market. Companies that might not want to be compliant would be novelty item producers, or small companies that would be financially burdened by the push for compliancy.

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