International Organisation of Standardisation - Basics

What is ISO?

The International Organization for Standardization is the specialized international

agency for standardization comprising the national standards bodies of 91 countries.
The purpose of ISO is to promote the development of standardization and related
world activities to facilitate to international exchange of goods and services and to
develop cooperation in intellectual, scientific, technological and economic activity.
The results of ISO technical work are published as International standards.

ISO 9000 SERIES

It is a series of standards on Quality Management System. This was brought in for

the purpose of establishing a customer oriented quality discipline in marketing,
design engineering, procurement, production, and inspection, testing related service
functions.

The following constitute ISO 9000 series.

 ISO 9001-- Quality systems-Model for quality Assurance in

design/development, production, installation and servicing.
 ISO 9002—Quality Systems-Model for Quality Assurance in production
installation and servicing.
 ISO 9003—Quality systems—Model for Quality Assurance in final inspection
and test.
 ISO 9004—Quality Management and Quality system elements- Guidelines.

Why an organization should go for ISO 9000 certification.

 The basic objective of every organization is to attain excellence in economic

performance.
 The most important factor for good economic performance is quality of
products/services
 Quality is the basic customer decision factor. Whether a buyer is a housewife,
industrial organization, government department or defense program,
departmental store or importer, everyone wants to buy only best quality
product.
 A buyer looks for an organization, which has established consistency in quality
of products or services.
 Consistently producing good quality product or service is very important for
customer confidence and higher positioning of buyer perceptions. Such an
effort needs a set of rules or context of trading at international levels,
rationalising and standardization of national guidelines are the needed efforts

Every conscious company, which wants to survive and grow, must realize in a
practical manner should improve one’s business in the world standards are to be
met.

How can one establish the Quality Management System and get the certification?
This involves a structured approach, consisting of :
  Preparation: create awareness amongst all the employees about the need
for ISO 9000 certification and then necessary training should be given.
 Implementation: An action plan should be worked out after reviewing the
organizations business policies. Next step is the documentation, which
involves preparation of quality manual, procedures, work-instruction, quality
plans and quality records.
 Certification: Contact the accredited certification body and fulfill the
requirements of the chosen standards.

Advantages of ISO 9000 Quality Systems:

 Reduction in quality costs.

 Improvement in work culture and quality of products and services.
 Involvement and commitments of management and employees.
 Regular audit and management reviews establish good communications.
 Increased market share and customer confidence.
 To deal with only one certification agency.
 Benefits the members of organization and society.
 Improved presence in national and international markets.

What Every Employee Needs to Know About ISO 9000

Thousands of organisations strive to gain ISO 9000 certification quality system

standard. It can improve the way an organization is managed as well as the quality
of processes, products and services. There are twenty ISO 9000 Standards. Each
standard describes how an area of a company should be documented; the kinds of
written policies, procedures and work instructions that should be available to let
employees know exactly how to do a good job. Also what types of records need to be
kept to show the results of doing the job? This system can lead to better product and
service quality since detailed documentation (and good training on how to use the
documents), provides a more reliable, consistent method of teaching employees how
to do quality work.

The ISO 9000 standard was adopted by the European Economic Community about
ten years ago but since has spread to almost 100 countries throughout the world. It
is the biggest force in quality assurance today and many customers require this
certification since they believe it leads to good business practices, better
documentation for traceability, and lower internal costs. For the most part,
employees will continue to do their jobs in the same manner as they had in
the past. The effectiveness of the ISO 9000 system relies on increased awareness in
specific areas of each person’s work routines. The following are some of the main
areas every employee needs to be familiar with the company’s Quality Policy
statement, the 4 levels of ISO 9000 documentation, what authorizes an employee to
do their job and what qualifies them for it.

The 4 Levels of Documentation

ISO 9000 requires 4 levels of documents in every area of the company that effects
product, or service quality. All documents must be current and have correct data
including titles, numbers, dates, revision letters and authorizing signatures.

Policies Explain WHY things are done the way they are. Managers
need to be familiar with them.

Procedures explain WHO does WHAT. This AUTHORISES to do your

job so get to know them.

Work Instructions Explain HOW the job must be done.

Records to document the result of the job done.

Training and Qualification

ISO 9000 requires everyone who affects product or service quality to be trained.
Training QUALIFIES you to do your job. Every person has a TRAINING RECORD.
Training must include the following

Basic Things to Know About Your Job:

Where all the paperwork and material comes from before it is routed

What to do with incorrect paperwork, or wrong material.

How to identify, report or segregate defective material.

The following paragraphs are based on many years of experience accumulated by the
ACA consulting staff working with dozens of companies nationwide. Experience
comes from both large and small companies and covers all types of manufacturing
industries, process industries, service companies, local and state agencies, hospitals
and universities.

As we provide training to these organisations as well as consulting services, we have

learned from people on the shop floor, the administrative support groups, and all
levels of management that, although every company has a unique personality and
unique competitive advantages, there are common, core fundamental that must be
embraced by every employee to ensure the company’s journey to World-Class
standing in the marketplace. The ACA consultants specialize in providing these core
fundamentals and are pleased to present the following example as a service to the
global community via the Internet.

The following paragraphs cover 9 important ISO 9000 issues. These paragraphs are
not intended to cover the 20 standards, but will familiarize you with the most
important general issues.
QUALITY POLICY

Every ISO 9000 certified company has an established quality policy. You should know
and understand it. It incorporates the company’s mission statement and may list
specific actions for achieving the mission. You should all be able to state the quality
policy in your own words and you should be familiar with the actions that allow a
company to achieve the policy.

Procedures and Work Instructions

From a production point of view, you will be doing a few things differently under the
new quality system. You will notice that your work processes are now documented in
written procedures and written work instructions. Your responsibilities are now
defined in the procedures manual that has been developed by the company. Make
sure you understand and follow these procedures and make sure they are accurate.
From now on, if you want to change the way you do things in your work, you will
have to make the appropriate changes in the procedures manual also.

DOCUMENT CONTROL

Under this new quality system, all documents relating to your job will be controlled
documents. That means they will be reviewed and approved before issue, and
distributed under a formal system of control. You will no longer assume that
procedures and work instructions are correct or complete before you use them.
Before using any of these documents, you should look at the header information that
identifies the document name, document number, revision date, and authorization
signature. These must be verified as correct. And finally you will ensure that you
have the correct revision of the document either through the “CONTROL COPY”
stamp or through reference to the Master Document Index.

CALIBRATION

All instrumentation used to measure critical characteristics of the product must be

calibrated. A calibrated instrument is identified by a calibration sticker listing its date
of calibration, and the date when that calibration expires. Do not use an instrument
to measure any critical product characteristics unless you have assured yourself that
the instrument is calibrated. Of course, you have to know which measurements are
critical product characteristics.

INTERNAL QUALITY AUDITS:

The ISO 9000 quality system requires an internal audit programme. From time to
time, employees from different departments will come to your department and audit
the effectiveness of the ISO 9000 system. This is done to ensure that department
personnel have received good training, and are complying with the approved
procedures and work instructions. When there are problems in a department, it will
be audited more often; less problems mean it will be audited less often. Different
employees will perform the audits to ensure different viewpoints. The internal
auditors have a special training for this job. There are no surprise audits; they will be
scheduled in advance. There are three types of things an auditor may find
  An OBSERVATION (may be a problem, keep an eye on it but corrective action
required.
 A MINOR NON-CONFORMANCE (a small problem that needs corrective action)
 A MAJOR NON-CONFORMANCE (a large problem that needs corrective action)

There is nothing negative about these audits. They are merely a means of identifying
improvements required in the system; they are not set up to identify poor operator
performance and names of employees are not recorded, only situations are recorded.
Audit reports lead to corrective action that improves company performance. Audit
reports also lead to training that may be required to help employees understand how
to comply with the procedures and work instructions.

Training

You may be receiving more training than you had in the past, and it will be recorded
on a training record. These records will be an assurance that you get full credit for
any training you have completed during the course of your work. When an auditor
asks how you do a job you should answer that you’ve have been trained to do that
job. It may have been formal classroom training, or on-the-job training, or you may
have been trained at another company or school before you came to work at your
present company. In all cases, your training record list all the various types of
training you have had and you should be aware of who has your training record and
whether they are keeping it up to date.

Corrective Action

There is an emphasis on corrective action in the new quality system. Whenever one
finds a significant problem in the process it is not only corrected but a Corrective
Action Request is filled out to document it. These forms will go to the quality systems
group where they will be reviewed and analysed for further preventive actions.
Everyone should consider a problem in the system to be an opportunity to correct
the problem and improve the system.

NONCONFORMING PRODUCT

We should always know when our process or product is within specifications and
when it is not. Additionally when the process or product is out of specification it is
our responsibility to make every effort to isolate or re-direct the nonconforming
product for later processing, and initiate corrective action to bring the process back
into specifications. We should additionally recognise the difference between the
product or process being out of a defined control range and when it is out of
specification.

Quality Records

Throughout the process, there will be records to fill out and file. All required entries
on a record form must be completed. If an entry cannot be made because a part of
the process was broken or inoperable, then a small note to that effect should be
made in the entry block. All record entries must be legible. Data or information that
cannot be understood is as bad as putting no data on the form. Care must also be
taken to keep it clean, and not ruined by water, grease or dirt. All records are filed
when one finishes with them. The fling system is organized to facilitate record
retrieval when necessary.