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ISO 9000

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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

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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.

Cite this ISO 9000

ISO 9000. (2018, Jun 15). Retrieved from https://graduateway.com/iso-9000/

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