In like the US Registrar Accreditation Board.


In order to stay competitive, businesses have to be the best at what theydo. Companys must be efficient and presise in all aspects of the job. (Metcalfe1).ISO 9000 is made up of managements responsibility, the producersinvolved in the Quality Management System, the contract review, the designcontrol, document and data control, purchasing, process control, inspection andtesting, control of non-conforming product, corrective action, handling, storage,packaging and delivery, internal quality audits, training, servicing and statisticaltechniques (Prasanna 1). Quality control and quality assurance is veryimportant there are certain requirements that take time and money to be met butin the end there are benefits. Types of specifications are very significant and thedocumentation of those is even more. Manufacturers and purchasers havemajor responsibility in the process of being successful.

The quality of a productis so important, especially to the customer.A companys quality managementsystem must become the documented proof of a firms commitment to qualitymanagement. A plan put together with quality procedures and work instructionsis provided to help companies design their own quality management system. After completing the quality procedures, companies are audited and thendetermined if they should be certified for ISO 9000 or not (Parsanna 2).ISO: International Organization of StandardsFounded in 1947 in Geneva Switzerland, ISO developed internationalstandards and helped exchange goods and services worldwide.

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It is made up ofover 90 countries including the US, which is called the American NationalStandards Institute. The name ISO came from the Greek word, isos, meaningequal (Henkoff 2). ISO was created by business men (Henkoff 2). Thesebusiness men knew what businesses needed to become more competitive andhow they could get higher customer satisfaction, so ISO was developed. ISO isnot government regulated, but is ran by organizations like the US RegistrarAccreditation Board.

Such organizations authorize registrars which issue ISOcertificates (Barrier 2). In Europe some organizations are government regulated. The American National Standards Institute runs the ISO in the US andauthorizes the US Registrar Accreditation Board (Barrier 2). ISOs job is to setstandards for companies all over the world so that their products come outefficiently and to the best quality. This helps the customers who receive theexports know exactly what they are getting and are satisfied with the product. Setting these standards is done by ISO members at assembly meetings. Proposals are developed by the ISO Council, which is like the board of directorsin a business. These meetings are held three times a year and the membershipis rotated to allow more representatives in (iso online).

Standards aredeveloped by technical committees. 30,000 experts participate to givecomments, feedback and to vote in meetings which are held15 times a dayelectronically.The experts are chosen by an ISO member of that country (isoThe ISO 9000 series was published in 1987 (iso online). It is astandardization system that was developed by ISO.

It is obtained by 130countries, but its main office is in Geneva, Switzerland where the system iscoordinated and the finished standards are published (iso online). These ISOstandard are rules and guidelines that ensure the product that a manufacturingbusiness produces is safe, reliable and efficient (iso online). These standardsmakes sure that businesses are living up to their promises. An ISO 9000certificate is given to a business when it maintains the quality managementrequirements determined by ISO (Henkoff 1). ISO 9000 helps a business to getcertified by telling it what requirements it should meet and how it will meet them. It provides a framework for a company.

It sets standards worldwide and helpexport goods to other countries. However, the company must have good strongleaders for it to thrive. The success of ISO 9000 on a business largely dependson the businesss organization. Planning, training, setting and achieving goalsare all key to improvement or success of a business (Henkoff 5). ISO 9000makes sure a company is doing what it says it is doing and helps them do it. However, that doesnt mean it is running the company and telling it what to do(USAToday 1). The business is still an independent business it is just gettingadvice on how to manufacture things and earning a certificate that is appealingto customers. However, that also doesnt mean that ISO 9000 promises thequality of a companys product will be great; Richard Buerow, director ofcorporate quality at Motorola states: With ISO 900 you can still have terribleprocesses and products.

You can certify a manufacturer that makes life jacketsfrom concrete, as long as those jackets are made according to the documentedprocedures and the company provides the next of kin with instructions on how tocomplain about defects. Thats absurd (Henkoff 3). Its steps and procedureswill help a manufacturers product become better produced. ISO 9000 is divided into three equally ranked quality systems which abusiness can chooses by what quality system will cover their business processISO 9001 is for a business whose processes range from design anddevelopment, to production, installation and servicing. ISO 9002 is for a business that does not carry out design and development butanything else that is under ISO 9001.ISO 9003 is for a business whose process does not include design control,process control, purchasing or servicing, but uses inspection and testing toensure that final products and services meet specified requirements.Element 4.1: Management ResponsibilityThe responsibility of executive level management in regard to qualitypolicy, goals, commitment and implementation of the company quality systemHere management must have a Quality Policy and have it understoodthroughout the business.

It is then managements responsibility to gatherresources and have trained employees to do the work. The Quality System isthen monitored by management representatives who report back to managementA Quality System must be used to ensure the product conforms tospecifications. The system will be described in documentation of sufficient detailto include structure, processes, and procedures that ensure product qualityThis system must be fully documented to fit ISO 9000 standards in aquality manual.

This manual should contain a table of contents and history ofthe company (Stimson 168). This manual should also include customersspecifications and requirements (Stimson 165). The system should go with thebusinesss mission and policy and show how its requirements should be met. Written plans should be shown on how to fulfill customers standards. A documented system for review and amendment of the contract, toensure customer performer agreement of expectations (Stimson 317).

Review of the contract will ensure the requirements are stated anddocumented and will be met. Any amendments should be made to parts of theA system is required to control, verify, and validate the designs ofproducts and processes to ensure adherence to specifications (Stimson 215).There are three key types of cycles: requirements, specifications,prototypes, acceptable design in the process of Design Control (Stimson 217). Verification , validation and participation by external and internal customers areElement 4.

5: Document and Data ControlControl of the distribution of all documents and data related to quality, isrequired to associate procedures describing the control mechanisms (StimsonAll documents and data should be controlled and authorized with changesand removals occurring in a controlled manner (iso online).A purchasing system must ensure the purchased product conforms tospecifications that subcontractors maintain quality criteria (Stimson 127).Information on purchasing must be complete and accurate and vendersElement 4.7: Control of Customer-Supplied ProductA process control of any product that is provided by the customer isrequired for use in the company supply systems (Stimson 249).During receipt inspection delivery, condition, quantity and fitness of theproduct should be checked and evaluated (Stimson 256).Element 4.8: Product Identification and TraceabilityDemanded by specifications or suitability, a system to identify and tracepurchase products during all stages of production.

Traceability will includeidentification of product within batch or lot (Stimson 259).Inventory and production process is essential with use of identification. Policies will identify those parts in receipt to delivery (Stimson 263).The planning and implementation of production, installation, and serviceprocesses affect quantity.

Furthermore, it requires that these processes beoperated under controlled conditions (Stimson 265).The process control system is made up of flexibility and customeroverview. Changes set baseline of quality (Stimson 2). Process controldepends on how the company chooses to define it, what materials to purchaseElement 4.10: Inspection and TestingInspection and testing activities are conducted in order to verifyadherence to specifications.

Appropriate records will be maintained of theresults of these activities (Stimson 279). Inspection and testing process has policies procedures, documentationincluding status and employees methodologies (Stimson 289).Element 4.

11: Control of Inspection, Measuring, and Test EquipmentThe control, calibration and maintenance of equipment, hardware andsoftware that is used for inspection, measuring and testing of productconformance to specifications is required (Stimson 227).Measurements made, equipment to be used are taken down and keptrecord of as quality records. Methods are set for trained personnel (iso online).Element 4.12: Inspection and Test StatusThe status of a product is identified relative to conformance, to inspectionand test criteria.

The identification process defined inappropriate procedures,will be maintained throughout the production and post production process toensure that only an acceptable product is delivered (Stimson 291).The test will determine if the product passes or fails inspection.Element 4.13: Control of Nonconforming ProductA system that will control product that fails to meet specifications,preclude unintended use, and define product disposition (Stimson 296).Element 4.14: Corrective and Preventive ActionSystems are needed to correct and prevent non conformances. Corrective or preventive actions will be appropriate to the risks (Stimson 37).

Formal process should be formed to correct or prevent the problem.Element 4.15: Handling, Storage, Packing, Preservation, and DeliveryA documented system to control post productive activities fromacceptance by testing through delivery of product (Stimson 305).This goes straight to the final customer and must concentrate oncustomer satisfaction.

The key is delivery (Stimson 313).Element 4.16: Control of Quality RecordsDocumented procedures are required for the identification anddisposition of quality records. Quality records are required to demonstrateconformance to the specifications and effectiveness of the quality systemElement 4.17: Internal Quality AuditsA program of regular and periodic internal quality audits are required todetermining the effectiveness of the quality system (Stimson 202).IQA(internal quality audit) represents the customer self evaluation andimprovement. Audits will be based on documentations affecting quality(StimsonA training program is required to identify training needs, resources,schedule and records for all persons whose work affects quality. Personnel willbe assigned tasks that are appropriate to their level of training and experienceManagement needs to be specific in what training an employee needs fora certain position, then they must provide the training and assign tasks.

Allemployee training should be kept on record (Stimson 152).The performance of service activities are specified in the contract. Procedures will verify that the service meets specifications (Stimson 326).Equipment and personnel must be controlled and products proceduresand methods should be carried out correctly (iso online).Element 4.20: Statistical TechniquesThe company is required to identify statistical techniques needed toverify adherence to product specifications and system capability (Stimson 235).Characteristics must be identified and then type of metrics is selected.

Chart results of data collection and methods, which must be based onprocedures and techniques (Stimson 239). To become registered a business must prove that it has goodmanagement qualities and organizational skills. Businesses usually book for aregistrar six months ahead and the audit can take up to twenty four monthsdepending on the size of the business (Henkoff 2). A smaller business will takelonger because their are fewer people to help during the registration and audit(Metcalfe 1). However, educating and training employees would take less timedue to the small number of employees to educate (Barrier 5). A good qualitymanagement will make the certification process easier. The business mustfollow the ISO 9000 steps and document everything.

They will be then auditedby an outside business person. The company must prove that it can handle itsown inspections, updating engineering drawings, maintaining the machinery andequipment, training workers and dealing with customer complaints (Henkoff 3). They dont have to prove that production is faster and customers are satisfied. The audit is mainly based on the documentation (Barrier 4) of the data taken andquizzing managers and factory workers (Henkoff 3). The auditor will then verifyif the company is up to what it promises to do and is moving towards its goals.

they then issue a certificate if the company passes (USAToday 1). The auditorwill return every six months to make sure everything is still up to its standardsand if not the company will lose its ISO 9000 certificate (Metcalfe 1). It is best ifa company performs internal audits to assure that everything is up to regulation. The Certificate must also be renewed annually (Barrier 6) after an audit goesAn ISO certification requires business owners to make large capitalinvestments (Metcalfe 3) and has cost up to $200,000 (Henkoff 2). The cost ofcertification has run into a problem with small businesses and has put up abarrier between them and a competitive edge. However, small business are nowable to negotiate prices now that ISO 9000 is more popular (Barrier 2). Andeven more good news, the IRS is allowing companies to deduct the cost of ISO9000 certification (Bloomberg 1).

States are also awarding grants tomanufacturing companies to help pay for certification. $400,000 was given to sixLong Island manufacturers by the states economic development agency, forexample (Martorana 1). So, cost will probably go down in the future once ISO9000 gets more popular and whatever it does cost it will be tax deductible. Thiswill give more businesses to get the chance to become ISO 9000 certified andform a more competitive business arena.Customers have such a broad list of choices that today the competitivefield almost forces a company to be ISO 9000 certified. The certification helpsbusinesss compete, plan, audit and award (Henkoff 2) which means companieswho dont have it should get it.

It is only implying that with out it their operatingsystem is incoherent by the workers and their quality system is poor. Foreignconsumers now demand ISO 9000 because they will know what they are goingto get when purchasing with that company (Metcalfe 2). ISO 9000 certification isvery important to the manufacturer because it saves money by reducing need foroutside quality audits and incoming products inspections (Barrier 1). Being ISO9000 certified is very important to the customer, because he/she knows that thebusiness has quality management procedures and knows what quality is in theproduct because it has the same standard through out the world. This opensnew global doors to companies which they would never get without ISO 9000. Now, ISO 9000 is more recognized than when it first came out, but only by somecustomers and only some companies have it. Two thirds of executives atmidsize manufacturing dont know what ISO 9000 is, they think it is a legalrequirement for doing business (Henkoff 2).

The businesss who do have itusually get chosen by the customers. During the year 2000 it will be impossibleto compete with out it because it will be a very recognized and a very popularISO has produced and developed standard systems for screw threads tocredit and telephone cards to the this way up sign on boxes to the ISBNnumber in every book (iso online). Thousands of companies all over the worldare ISO 9000 certified. Here are some real life businesses that are certified andstories on how they have used ISO 9000 as a competitive weapon.Caterpillar Engines in Mosville, Illinois had customer complaints abouttheir engines not performing properly. ISO 9000 gave the manufacturers asystematic way to order a design change, make sure they used only the latestdocuments and made engines more efficiently. Their production time went downand their customer satisfaction went up (Henkoff 3).The Rockwell Internationals Allen-Bradley plant in Twinsburg, Ohio makecircuit boards and other electronics.

Their problem was that they were extremelyunorganized. Tons of documentation and memos were posted up on a memoboard, most workers didnt get them until months later. Their managementquality was poor, so they got ISO 9000 certified. After getting certified withinone year their productivity improved 21%, time dropped 18% and productExcalibur USA became ISO 9000 certified and more than $10 million wassaved in operating expenses in a year. They gained 30% more business. Production increased, costs went down and customer satisfaction went upESPITI, a European software industry wanted to become morecompetitive so they got ISO 9000 certified.

Being certified was essential to thembecause they knew it ensured quality and productivity and it is very good forUganda textile companies in Africa were getting hit by the worst cheapimports of fabric and their sales were bad. Once ISO 9000 certified they hadnew standards and fabric imported to them was good. It will lower productioncost and improve sales. Uganda is so satisfied with the improvement that fiftymore companies will have certification by the end of the year (Africa 1).In Batam, Indonesia twelve companies were ISO 9000 certified. Thecompanies were chosen because they wanted to have a competitive edge in ahuge global market demand and wanted to attain a good quality working systemCloister Spring Water Company in Lancaster, PA expanded by openingup three new plants.

However, they were afraid that water would be bottled anddelivered differently at each plant. ISO 9000 certification solved that problemand in three years sales soared 250% more than they expected (USAToday 1).ISO 9000 is a competitive weapon all over the world and is becomingmore and more popular. In the October 1998 issue of Quality Progress, asurvey of 1240 US companies showed that of the certified companies (iso90% – thought it is a value-added quality system87% – thought that it was necessary to remain competitive78% – thought that it definitely improved quality within a company73% – thought it will save money in the long run99% – said that it cannot be implemented without management commitment.Over 20,000 companies in the US are certified today. This shows thatbusinesses believe in a strong quality system, management quality,improvement, profit and competitiveness. All these business essential make upBibliography:BibliogrphyStimson, William A.

Beyond ISO 9000: How to Sustain Quality in a DynamicWorld. New York: Amacom, 1998.Barrier, Micheal, Amy Zuckerman. Quality Standards the World Agrees on: Small Businesses Can Meet ISO 9000 Standard.

Nations Business01 May 1994: 71-73.Martorana, Jamie. Newsbreak: 6 LI Manufacturers Granted Funds.

Newsday29 November 1999: 1.Raman, Prasanna. An Insight into ISO 9000 for Small Businesses. NewStraits Times 24 February 1998.Metcalfe, Coll. Ventura County Business; The Business Beat: Firms Find ISO9000 Certification Means Business. Los Angeles Times02 March 1999: B1.

Henkoff, Ronald. Managing: The Hot New Seal of Quality. Fortune 28 June 1993: 116.

Surveyor Indonesia to Grant 12 ISO 9000/14000 Certificates. Asia Pulse 03 February 1998.ISO 9000 Helps Firms Achieve Consistency. USA Today 27 May 1998: 02B.Software Industry: ISO 9000 Key to Improving Europes SoftwarePerformance. European Report 01 May 1996.

ISO Raises Manufacturers Hopes. Africa News Service 05 January 2000.IRS Lets Manufacturers Deduct Quality Certification Expenses. BloombergL.P. 06 January 2000.ISO 9000.

Computer Desktop Encyclopedia 01 January 1998.International Organization for Standardization Homepage. 27 February 2000.

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