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ISO 9000: Quality Control and Quality Assurance

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    In order to stay competitive, businesses have to be the best at what they

    do. Company’s must be efficient and presise in all aspects of the job. (Metcalfe

    1). ISO 9000 is made up of management’s responsibility, the producers

    involved in the Quality Management System, the contract review, the design

    control, document and data control, purchasing, process control, inspection and

    testing, control of non-conforming product, corrective action, handling, storage,

    packaging and delivery, internal quality audits, training, servicing and statistical

    techniques (Prasanna 1). Quality control and quality assurance is very

    important there are certain requirements that take time and money to be met but

    in the end there are benefits. Types of specifications are very significant and the

    documentation of those is even more. Manufacturers and purchasers have

    major responsibility in the process of being successful. The quality of a product

    is so important, especially to the customer. A company’s quality management

    system must become the documented proof of a firm’s commitment to quality

    management. A plan put together with quality procedures and work instructions

    is provided to help companies design their own quality management system.

    After completing the quality procedures, companies are audited and then

    determined if they should be certified for ISO 9000 or not (Parsanna 2).

    ISO: International Organization of Standards

    Founded in 1947 in Geneva Switzerland, ISO developed international

    standards and helped exchange goods and services worldwide. It is made up of

    over 90 countries including the US, which is called the American National

    Standards Institute. The name ISO came from the Greek word, “isos,” meaning

    equal (Henkoff 2). ISO was created by business men (Henkoff 2). These

    business men knew what businesses needed to become more competitive and

    how they could get higher customer satisfaction, so ISO was developed. ISO is

    not government regulated, but is ran by organizations like the US Registrar

    Accreditation Board. Such organizations authorize registrars which issue ISO

    certificates (Barrier 2). In Europe some organizations are government regulated.

    The American National Standards Institute runs the ISO in the US and

    authorizes the US Registrar Accreditation Board (Barrier 2). ISO’s job is to set

    standards for companies all over the world so that their products come out

    efficiently and to the best quality. This helps the customers who receive the

    exports 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 directors

    in a business. These meetings are held three times a year and the membership

    is rotated to allow more representatives in (iso online). Standards are

    developed by technical committees. 30,000 experts participate to give

    comments, feedback and to vote in meetings which are held15 times a day

    electronically. The experts are chosen by an ISO member of that country (iso

    The ISO 9000 series was published in 1987 (iso online). It is a

    standardization system that was developed by ISO. It is obtained by 130

    countries, but it’s main office is in Geneva, Switzerland where the system is

    coordinated and the finished standards are published (iso online). These ISO

    standard are rules and guidelines that ensure the product that a manufacturing

    business produces is safe, reliable and efficient (iso online). These standards

    makes sure that businesses are living up to their promises. An ISO 9000

    certificate is given to a business when it maintains the quality management

    requirements determined by ISO (Henkoff 1). ISO 9000 helps a business to get

    certified 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 help

    export goods to other countries. However, the company must have good strong

    leaders for it to thrive. The success of ISO 9000 on a business largely depends

    on the business’s organization. Planning, training, setting and achieving goals

    are all key to improvement or success of a business (Henkoff 5). ISO 9000

    makes sure a company is doing what it says it is doing and helps them do it.

    However, that doesn’t mean it is running the company and telling it what to do

    (USAToday 1). The business is still an independent business it is just getting

    advice on how to manufacture things and earning a certificate that is appealing

    to customers. However, that also doesn’t mean that ISO 9000 promises the

    quality of a company’s product will be great; Richard Buerow, director of

    corporate quality at Motorola states: “With ISO 900 you can still have terrible

    processes and products. You can certify a manufacturer that makes life jackets

    from concrete, as long as those jackets are made according to the documented

    procedures and the company provides the next of kin with instructions on how to

    complain about defects. That’s absurd (Henkoff 3).” Its steps and procedures

    will help a manufacturer’s product become better produced.

    ISO 9000 is divided into three equally ranked quality systems which a

    business can chooses by what quality system will cover their business process

    ISO 9001 is for a business whose processes range from design and

    development, to production, installation and servicing.

    ISO 9002 is for a business that does not carry out design and development but

    anything 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 to

    ensure that final products and services meet specified requirements.

    Element 4.1: Management Responsibility

    “The responsibility of executive level management in regard to quality

    policy, goals, commitment and implementation of the company quality system

    Here management must have a Quality Policy and have it understood

    throughout the business. It is then management’s responsibility to gather

    resources and have trained employees to do the work. The Quality System is

    then monitored by management representatives who report back to management

    “A Quality System must be used to ensure the product conforms to

    specifications. The system will be described in documentation of sufficient detail

    to include structure, processes, and procedures that ensure product quality

    This system must be fully documented to fit ISO 9000 standards in a

    quality manual. This manual should contain a table of contents and history of

    the company (Stimson 168). This manual should also include customer’s

    specifications and requirements (Stimson 165). The system should go with the

    business’s mission and policy and show how its requirements should be met.

    Written plans should be shown on how to fulfill customer’s standards.

    “A documented system for review and amendment of the contract, to

    ensure customer performer agreement of expectations (Stimson 317).”

    Review of the contract will ensure the requirements are stated and

    documented and will be met. Any amendments should be made to parts of the

    “A system is required to control, verify, and validate the designs of

    products 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 are

    Element 4.5: Document and Data Control

    “Control of the distribution of all documents and data related to quality, is

    required to associate procedures describing the control mechanisms (Stimson

    All documents and data should be controlled and authorized with changes

    and removals occurring in a controlled manner (iso online).

    “A purchasing system must ensure the purchased product conforms to

    specifications that subcontractors maintain quality criteria (Stimson 127).”

    Information on purchasing must be complete and accurate and venders

    Element 4.7: Control of Customer-Supplied Product

    “A process control of any product that is provided by the customer is

    required for use in the company supply systems (Stimson 249).”

    During receipt inspection delivery, condition, quantity and fitness of the

    product should be checked and evaluated (Stimson 256).

    Element 4.8: Product Identification and Traceability

    “Demanded by specifications or suitability, a system to identify and trace

    purchase products during all stages of production. Traceability will include

    identification 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 service

    processes affect quantity. Furthermore, it requires that these processes be

    operated under controlled conditions (Stimson 265).”

    The process control system is made up of flexibility and customer

    overview. Changes set baseline of quality (Stimson 2). Process control

    depends on how the company chooses to define it, what materials to purchase

    Element 4.10: Inspection and Testing

    “Inspection and testing activities are conducted in order to verify

    adherence to specifications. Appropriate records will be maintained of the

    results of these activities (Stimson 279).”

    Inspection and testing process has policies procedures, documentation

    including status and employees methodologies (Stimson 289).

    Element 4.11: Control of Inspection, Measuring, and Test Equipment

    “The control, calibration and maintenance of equipment, hardware and

    software that is used for inspection, measuring and testing of product

    conformance to specifications is required (Stimson 227).”

    Measurements made, equipment to be used are taken down and kept

    record of as quality records. Methods are set for trained personnel (iso online).

    Element 4.12: Inspection and Test Status

    “The status of a product is identified relative to conformance, to inspection

    and test criteria. The identification process defined inappropriate procedures,

    will be maintained throughout the production and post production process to

    ensure 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 Product

    “A 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 Action

    “Systems are needed to correct and prevent non conformance’s.

    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 Delivery

    “A documented system to control post productive activities from

    acceptance by testing through delivery of product (Stimson 305).”

    This goes straight to the final customer and must concentrate on

    customer satisfaction. The key is delivery (Stimson 313).

    Element 4.16: Control of Quality Records

    “Documented procedures are required for the identification and

    disposition of quality records. Quality records are required to demonstrate

    conformance to the specifications and effectiveness of the quality system

    Element 4.17: Internal Quality Audits

    “A program of regular and periodic internal quality audits are required to

    determining the effectiveness of the quality system (Stimson 202).”

    IQA(internal quality audit) represents the customer self evaluation and

    improvement. Audits will be based on documentations affecting quality(Stimson

    “A training program is required to identify training needs, resources,

    schedule and records for all persons whose work affects quality. Personnel will

    be assigned tasks that are appropriate to their level of training and experience

    Management needs to be specific in what training an employee needs for

    a certain position, then they must provide the training and assign tasks. All

    employee 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 product’s procedures

    and methods should be carried out correctly (iso online).

    Element 4.20: Statistical Techniques

    “The company is required to identify statistical techniques needed to

    verify 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 on

    procedures and techniques (Stimson 239).

    To become registered a business must prove that it has good

    management qualities and organizational skills. Businesses usually book for a

    registrar six months ahead and the audit can take up to twenty four months

    depending on the size of the business (Henkoff 2). A smaller business will take

    longer because their are fewer people to help during the registration and audit

    (Metcalfe 1). However, educating and training employees would take less time

    due to the small number of employees to educate (Barrier 5). A good quality

    management will make the certification process easier. The business must

    follow the ISO 9000 steps and document everything. They will be then audited

    by an outside business person. The company must prove that it can handle its

    own inspections, updating engineering drawings, maintaining the machinery and

    equipment, training workers and dealing with customer complaints (Henkoff 3).

    They don’t 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 and

    quizzing managers and factory workers (Henkoff 3). The auditor will then verify

    if 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 auditor

    will return every six months to make sure everything is still up to its standards

    and if not the company will lose its ISO 9000 certificate (Metcalfe 1). It is best if

    a company performs internal audits to assure that everything is up to regulation.

    The Certificate must also be renewed annually (Barrier 6) after an audit goes

    An ISO certification requires business owners to make large capital

    investments (Metcalfe 3) and has cost up to $200,000 (Henkoff 2). The cost of

    certification has run into a problem with small businesses and has put up a

    barrier between them and a competitive edge. However, small business are now

    able to negotiate prices now that ISO 9000 is more popular (Barrier 2). And

    even more good news, the IRS is allowing companies to deduct the cost of ISO

    9000 certification (Bloomberg 1). States are also awarding grants to

    manufacturing companies to help pay for certification. $400,000 was given to six

    Long Island manufacturers by the state’s economic development agency, for

    example (Martorana 1). So, cost will probably go down in the future once ISO

    9000 gets more popular and whatever it does cost it will be tax deductible. This

    will give more businesses to get the chance to become ISO 9000 certified and

    form a more competitive business arena.

    Customer’s have such a broad list of choices that today the competitive

    field almost forces a company to be ISO 9000 certified. The certification helps

    business’s compete, plan, audit and award (Henkoff 2) which means companies

    who don’t have it should get it. It is only implying that with out it their operating

    system is incoherent by the workers and their quality system is poor. Foreign

    consumers now demand ISO 9000 because they will know what they are going

    to get when purchasing with that company (Metcalfe 2). ISO 9000 certification is

    very important to the manufacturer because it saves money by reducing need for

    outside quality audits and incoming products inspections (Barrier 1). Being ISO

    9000 certified is very important to the customer, because he/she knows that the

    business has quality management procedures and knows what quality is in the

    product because it has the same standard through out the world. This opens

    new 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 some

    customers and only some companies have it. Two thirds of executives at

    midsize manufacturing don’t know what ISO 9000 is, they think it is a legal

    requirement for doing business (Henkoff 2). The business’s who do have it

    usually get chosen by the customers. During the year 2000 it will be impossible

    to compete with out it because it will be a very recognized and a very popular

    ISO has produced and developed standard systems for screw threads to

    credit and telephone cards to the “this way up” sign on boxes to the ISBN

    number in every book (iso online). Thousands of companies all over the world

    are ISO 9000 certified. Here are some real life businesses that are certified and

    stories on how they have used ISO 9000 as a competitive weapon.

    Caterpillar Engines in Mosville, Illinois had customer complaints about

    their engines not performing properly. ISO 9000 gave the manufacturers a

    systematic way to order a design change, make sure they used only the latest

    documents and made engines more efficiently. Their production time went down

    and their customer satisfaction went up (Henkoff 3).

    The Rockwell International’s Allen-Bradley plant in Twinsburg, Ohio make

    circuit boards and other electronics. Their problem was that they were extremely

    unorganized. Tons of documentation and memos were posted up on a memo

    board, most workers didn’t get them until months later. Their management

    quality was poor, so they got ISO 9000 certified. After getting certified within

    one year their productivity improved 21%, time dropped 18% and product

    Excalibur USA became ISO 9000 certified and more than $10 million was

    saved in operating expenses in a year. They gained 30% more business.

    Production increased, costs went down and customer satisfaction went up

    ESPITI, a European software industry wanted to become more

    competitive so they got ISO 9000 certified. Being certified was essential to them

    because they knew it ensured quality and productivity and it is very good for

    Uganda textile companies in Africa were getting hit by the worst cheap

    imports of fabric and their sales were bad. Once ISO 9000 certified they had

    new standards and fabric imported to them was good. It will lower production

    cost and improve sales. Uganda is so satisfied with the improvement that fifty

    more companies will have certification by the end of the year (Africa 1).

    In Batam, Indonesia twelve companies were ISO 9000 certified. The

    companies were chosen because they wanted to have a competitive edge in a

    huge global market demand and wanted to attain a good quality working system

    Cloister Spring Water Company in Lancaster, PA expanded by opening

    up three new plants. However, they were afraid that water would be bottled and

    delivered differently at each plant. ISO 9000 certification solved that problem

    and in three years sales soared 250% more than they expected (USAToday 1).

    ISO 9000 is a competitive weapon all over the world and is becoming

    more and more popular. In the October 1998 issue of “Quality Progress”, a

    survey of 1240 US companies showed that of the certified companies (iso

    90% – thought it is a value-added quality system

    87% – thought that it was necessary to remain competitive

    78% – thought that it definitely improved quality within a company

    73% – thought it will save money in the long run

    99% – said that it cannot be implemented without management commitment.

    Over 20,000 companies in the US are certified today. This shows that

    businesses believe in a strong quality system, management quality,

    improvement, profit and competitiveness. All these business essential make up


    Stimson, William A. Beyond ISO 9000: How to Sustain Quality in a Dynamic
    World. New York: Amacom, 1998.

    Barrier, Micheal, Amy Zuckerman. “Quality Standards the World Agrees on:
    Small Businesses Can Meet ISO 9000 Standard.” Nation’s Business
    01 May 1994: 71-73.

    Martorana, Jamie. “Newsbreak: 6 LI Manufacturers Granted Funds.” Newsday
    29 November 1999: 1.

    Raman, Prasanna. “An Insight into ISO 9000 for Small Businesses.” New
    Straits Times 24 February 1998.

    Metcalfe, Coll. “Ventura County Business; The Business Beat: Firms Find ISO
    9000 Certification Means Business.” Los Angeles Times
    02 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 Europe’s Software
    Performance.” European Report 01 May 1996.

    “ISO Raises Manufacturers’ Hopes.” Africa News Service 05 January 2000.

    “IRS Lets Manufacturers Deduct Quality Certification Expenses.” Bloomberg
    L.P. 06 January 2000.

    “ISO 9000.” Computer Desktop Encyclopedia 01 January 1998.

    International Organization for Standardization Homepage. 27 February 2000.

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