2010

Implementation & Impact of Quality

Standards among Small Industry

Vaibhav Borkar. Tanuj Jindal

Indo-German Training Centre,
Bangalore
4/23/2010
 TABLE OF CONTENT

No Contains Page no

1 About ISO 2

 ISO's origins

 ISO's name

2 The ISO brand 3

 Democratic
 Voluntary

3 Information 4

 How ISO decides to develop a standard

 Who develops ISO standards
 How ISO standards are developed
 Why standards matter
 Why standards matter
 What standards do
 How the ISO system is financed

4 ISO 9000 7
 Element of ISO 9000
 Steps in ISO 9000 registration
 Steps in ISO 9000 registration
 Quality documentation

5 Advantages of ISO 9000 10

6 Benefits of ISO 12

7 Conclusion 13

8 Bibliography 14

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 1. About ISO
ISO (International Organization for Standardization) is the world's largest developer and
publisher of International Standards.

ISO is a network of the national standards institutes of 159 countries, one member per
country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private
sectors. On the one hand, many of its member institutes are part of the governmental
structure of their countries, or are mandated by their government. On the other hand, other
members have their roots uniquely in the private sector, having been set up by national
partnerships of industry associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both the
requirements of business and the broader needs of society

ISO's origins
In 1946, delegates from 25 countries met in London and decided to create a new
international organization, of which the object would be "to facilitate the international
coordination and unification of industrial standards". The new organization, ISO, officially
began operations on 23 February 1947, in Geneva, Switzerland.

ISO's name
Because "International Organization for Standardization" would have different acronyms in
different languages ("IOS" in English, "OIN" in French for Organisation internationale de
normalisation), its founders decided to give it also a short, all-purpose name. They chose
"ISO", derived from the Greek isos, meaning "equal". Whatever the country, whatever the
language, the short form of the organization's name is always ISO.

What "international standardization" means

When the large majority of products or services in a particular business or industry sector
conform to International Standards, a state of industry-wide standardization exists. The
economic stakeholders concerned agree on specifications and criteria to be applied
consistently in the classification of materials, in the manufacture and supply of products, in
testing and analysis, in terminology and in the provision of services. In this way,
International Standards provide a reference framework, or a common technological
language, between suppliers and their customers. This facilitates trade and the transfer of
technology.

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 2. The ISO brand

 Democratic

Every full member of ISO has the right to take part in the development of any standard
which it judges to be important to its country's economy. No matter what the size or
strength of that economy, each participating member in ISO has one vote. Each country is
on an equal footing to influence the direction of ISO's work at the strategic level, as well as
the technical content of its individual standards.

 Voluntary

ISO standards are voluntary. As a non-governmental organization, ISO has no legal

authority to enforce the implementation of its standards. ISO does not regulate or legislate.
However, countries may decide to adopt ISO standards - mainly those concerned with
health, safety or the environment - as regulations or refer to them in legislation, for which
they provide the technical basis. In addition, although ISO standards are voluntary, they may
become a market requirement, as has happened in the case of ISO 9001 quality
management systems, or of dimensions of freight containers and bank cards.

ISO itself does not regulate or legislate.

 Market-driven

ISO only develops standards for which there is a market requirement. The work is mainly
carried out by experts from the industrial, technical and business sectors which have asked
for the standards, and which subsequently put them to use.

 Consensus

ISO standards are based on international consensus among the experts in the field.
Consensus, like technology, evolves and ISO takes account both of evolving technology and
of evolving interests by requiring a periodic review of its standards at least every five years
to decide whether they should be maintained, updated or withdrawn. In this way, ISO
standards retain their position as the state of the art.

 Globally relevant

ISO standards are technical agreements which provide the framework for compatible
technology worldwide. They are designed to be globally relevant - useful everywhere in the
world.

ISO standards are useful everywhere in the world.

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3.Information

How ISO decides to develop a standard

ISO launches the development of new standards in response to the sectors that express a
clearly established need for them. An industry or business sector communicates its
requirement for a standard to one of ISO's national members. The latter then proposes the
new work item to ISO as a whole. If accepted, the work item is assigned to an existing
technical committee. Proposals may also be made to set up technical committees to cover
new scopes of activity.

At the end of 2006, there were 3 041 technical bodies in the ISO system, including 193 ISO
technical committees.

The focus of the technical committees is specialized and specific. In addition, ISO has three
general policy development committees that provide strategic guidance for the standards'
development work on cross-sector aspects. These committees ensure that the specific
technical work is aligned with broader market and stakeholder group

Who develops ISO standards

ISO standards are developed by technical committees comprising experts from the
industrial, technical and business sectors which have asked for the standards, and which
subsequently put them to use. These experts may be joined by representatives of
government agencies, testing laboratories, consumer associations, non-governmental
organizations and academic circles.

The experts participate as national delegations, chosen by the ISO national member
institute for the country concerned. These delegations are required to represent not just the
views of the organizations in which their participating experts work, but of other
stakeholders too.

According to ISO rules, the member institute is expected to take account of the views of the
range of parties interested in the standard under development. This enables them to
present a consolidated, national consensus position to the technical committee.

How ISO standards are developed

The national delegations of experts of a technical committee meet to discuss, debate and
argue until they reach consensus on a draft agreement. This is circulated as a Draft
International Standard (DIS) to ISO's membership as a whole for comment and balloting.

Many members have public review procedures for making draft standards known and
available to interested parties and to the general public. The ISO members then take
account of any feedback they receive in formulating their position on the draft standard.
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 If the voting is in favour, the document, with eventual modifications, is circulated to the ISO
members as a Final Draft International Standard (FDIS). If that vote is positive, the
document is then published as an International Standard.

Every working day of the year, an average of eight ISO meetings is taking place somewhere
in the world. In between meetings, the experts continue the standards' development work
by correspondence. Increasingly, their contacts are made by electronic means, some ISO
technical bodies have already gone over entirely to working electronically, which speeds up
the development of standards, and cuts travel costs.

Why standards matter

Standards make an enormous and positive contribution to most aspects of our lives.

Standards ensure desirable characteristics of products and services such as quality,

environmental friendliness, safety, reliability, efficiency and interchangeability - and at an
economical cost.

When products and services meet our expectations, we tend to take this for granted and be
unaware of the role of standards. However, when standards are absent, we soon notice. We
soon care when products turn out to be of poor quality, do not fit, are incompatible with
equipment that we already have, are unreliable or dangerous.

When products, systems, machinery, and devices work well and safely, it is often because
they meet standards. And the organization responsible for many thousands of the
standards which benefit the world is ISO.

When standards are absent, we soon notice.

What standards do

 make the development, manufacturing and supply of products and services more efficient,
safer and cleaner
 facilitate trade between countries and make it fairer
 provide governments with a technical base for health, safety and environmental
legislation, and conformity assessment
 share technological advances and good management practice
 disseminate innovation
 safeguard consumers, and users in general, of products and services
 make life simpler by providing solutions to common problems

How the ISO system is financed

ISO's national members pay subscriptions that meet the operational cost of ISO's Central
Secretariat. The subscription paid by each member is in proportion to the country's Gross
National Income and trade figures. Another source of revenue is the sale of standards.

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However, the operations of ISO Central Secretariat represent only about one fifth of the
cost of the system's operation. The main costs are borne by the member bodies that
manage the specific standards development projects and the business organizations that
provide experts to participate in the technical work. These organizations are, in effect,
subsidizing the technical work by paying the travel costs of the experts and allowing them
time to work on their ISO assignments.

Standards benefit

ISO standards provide technological, economic and societal benefits.

For businesses, the widespread adoption of International Standards means that suppliers
can develop and offer products and services meeting specifications that have wide
international acceptance in their sectors. Therefore, businesses using International
Standards can compete on many more markets around the world.

For customers, the worldwide compatibility of technology which is achieved when products
and services are based on International Standards gives them a broad choice of offers. They
also benefit from the effects of competition among suppliers.

For governments, International Standards provide the technological and scientific bases
underpinning health, safety and environmental legislation.

For trade officials, International Standards create "a level playing field" for all competitors
on those markets. The existence of divergent national or regional standards can create
technical barriers to trade. International Standards are the technical means by which
political trade agreements can be put into practice.

For developing countries, International Standards that represent an international consensus

on the state of the art are an important source of technological know-how. By defining the
characteristics that products and services will be expected to meet on export markets,
International Standards give developing countries a basis for making the right decisions
when investing their scarce resources and thus avoid squandering them.

For consumers, conformity of products and services to International Standards provides

assurance about their quality, safety and reliability.

For everyone, International Standards contribute to the quality of life in general by ensuring
that the transport, machinery and tools we use are safe.

For the planet we inhabit, International Standards on air, water and soil quality, on
emissions of gases and radiation and environmental aspects of products can contribute to
efforts to preserve the environment.

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 4. ISO 9000

In 1987, the international Standard Organization (ISO) published its first standard on
‘Quality system’ ISO 9001, ISO 9002 and ISO 9002. At the same, time the European version
of quality standard EN 2900i, EN 29002. Moreover, EN 29003 were published and British
standard BS 5750(part 1, 2, 3) were updated and aligned with their equivalent foreign
counterpart.

All three standards are identical. They were essentially manufacturing standard are soon
came to be applied to services as well as possible misinterpretations of products, but the
1994 standard has resolved some of those difficulties by redefining the products.

The structure of the ISO 9000 standard : The family of ISO 9000 standards has been
developed by ISO and it is made up of four core standards:

a) ISO 9000:2000 – Fundamentals and Vocabulary

b) ISO 9001:2000 – Quality Management Systems – Requirements

c) ISO 9004:2000 – Quality Management Systems – Guidelines for performance

improvements

d) ISO 9011: 2002 – Guidelines for quality and/or environmental management systems
auditing

The ISO 9000 series of Standard consist of two broad categories of standards and
supplementary guidance standards

Core standard: are standard in meant for internal use by organization and provides
guidance in designing and implementing a quality system so that they can meet their market
needs and achieve overall success.

Supplementary standards:

Element of ISO 9000

1. Management Responsibility. Management sets the company quality policy and implements
it by providing resources, personnel and training.
2. Quality System. A Quality System comprised of a Quality Manual and supporting procedures
is created and maintained.
3. Contract Review. Contracts reflect the customers' needs and expectations. Products and
services provided must comply with those requirements.
4. Design Control. Engineering drawings and design changes are carefully documented to
ensure that changes have been fully coordinated and approved internally, and when
appropriate, by the customer.

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5. Document Control. The creation and modification of documents supporting the Quality
System is strictly controlled by ISO 9001 procedures.
6. Purchasing. Purchasing procedures describe supplier requirements and the system for
ensuring compliance to these standards.
7. Handling of Purchaser Supplied Product. Procedures detail methods of handling and
safekeeping of product supplied by the customer.
8. Product Identification and Traceability. Methods of tracking date and lot codes of product
and raw materials from start to finish guarantee traceability.
9. Process Control. Work instructions, quality plans and workmanship standards verify that
each job is being done correctly.
10. Inspection and Testing. Inspection and testing at receiving, in-process and final inspection
areas ensures quality. Test and inspection records are preserved as part of the quality
system.
11. Inspection, Measuring and Test Equipment. Instruments and measuring tools are calibrated
regularly and records maintained.
12. Inspection and Test Status. Only inspected materials may be used or processed further.
Inspected product is always identified.
13. Control of Nonconforming Product. Materials or products that fail to meet specifications
are rejected and separated from normal production. Only the proper authorities may decide
if rejected material will be used as is, reworked or returned to the supplier.
14. Corrective Action. The corrective action system focuses on identifying the root cause of
quality concerns and any corrective action required.
15. Handling, Storage, Packaging and Delivery. Procedures outline practices that protect
products from damage during manufacturing and shipping.
16. Quality Records. Quality records provide an audit trail for internal and external auditors.
17. Internal Quality Audits. Specially trained teams verify that the Quality System is working by
evaluating the same 20 elements required by the external auditors, on an on-going basis.
18. Training. Training records are maintained for every employee showing their levels of
expertise.
19. Servicing. Where servicing is specified in the contract, procedures are established to verify
that servicing meets the indicated requirements.
20. Statistical Techniques. Control charts, graphs and other methods of analysis determine how
well a process is working and facilitate continuous improvement.

Steps in ISO 9000 registration

1. select the appropriate standard from ISO 90001, 9002, 9003 using guidelines in 9000
2. prepare quality manual to cover all element of selected model
3. Develop proper procedure and shop floor instruction which may be necessary for the
implementation of the quality system.
4. conduct self audit to check compliance of selected model
5. select the register and apply for certification and registration

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 Quality documentation

First tier: quality manual

Manual may be organized according to ISO standard it is general in nature and moderate in
length which summarizes the whole quality system in one document. it is written in policy
level and acts as an overview in quality system. It defines the policies, objectives,
organization structures and general quality practices of the company.

Second tier: procedure

Each procedure consists of the objective of the objective and description of the activity. the
procedure describes what is to be done and by whom. And how, when, why and where the
activity is to be carried out. At the procedure level step by step instruction for performing
activities are not included.

Third tier: instruction

It consists of step by step instruction that must be followed in order to get the particular job
done. These direct the worker in a single activity and subordinate document to procedure.
Such instruction may be needed for specific tasks processes, operation, Tests and inspection
etc.

Forth tier: forms and records

It includes files, specification, code of practices, checklists, technical and legal document and
other form to recode data. All documentation of record which demonstrates compliance of
quality system requirement comes under this tier.

Quality assurance models of ISO 9000

1. ISO 9001 model for quality assurance in design, development, production, installation and
servicing. When conformance to specified requirement is to be assured by supplier during
the various stages. It consist of 20 elements
2. ISO 9002 model for quality and assurance in production, installation and servicing. It is used
when conformance to specified requirement is to be assured by supplier during the
production and installation it consist of 18 elements.
3. ISO 9003 model for quality assurance in final inspection and test. . It is used when
conformance to specified requirement is to be assured by supplier solely at final inspection
and test it consist of 12 elements.

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5. Advantages of ISO 9000
1. Increased Efficiency

Companies that go through the ISO 9001:2000 Quality Management Standards certification
process have given a lot of thought to their processes and how to maximize quality and
efficiency. Once certified for QMS, the processes are established and guidelines in place for
anyone to follow easily, making training, transitions, and trouble-shooting easier.

2. Increased Revenue

Studies have shown that ISO QMS certified companies experience increased productivity
and improved financial performance, compared to uncertified companies.

3. Employee Morale

Defined roles and responsibilities, accountability of management, established training

systems and a clear picture of how their roles affect quality and the overall success of the
company, all contribute to more satisfied and motivated staff.

4. International Recognition

The International Organization for Standardization (ISO) is recognized worldwide as the

authority on quality management.

5. Factual Approach to Decision Making

The ISO 9001:2000 QMS standard sets out clear instructions for audits and process reviews
that facilitate information gathering and decision making based on the data.

6. Supplier Relationships

Mutually beneficial supplier relationships are one of the key attractions to ISO certification.
Following the processes for documentation and testing ensure quality raw materials go into
your production system. The process also requires thorough evaluation of new suppliers
before a change is made and/or consistency with respect to how and where orders are
placed.

7. Documentation

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The ISO QMS standard requires documentation of all processes and any changes, errors and
discrepancies. This ensures consistency throughout production and accountability of all
staff. This also guarantees traceable records are available in case of non-compliant products
or raw materials.

8. Consistency

One of the foundations of ISO; All processes from research and development, to production,
to shipping, are defined, outlined and documented, minimizing room for error. Even the
process of making changes to a process is documented, ensuring that changes are well
planned and implemented in the best possible way to maximize efficiency.
Recommendations in the biotech industry to use XML authoring or similar software
formatting for data collection, reports, and product labelling, minimizes the risk of obsolete
documents/labels being mistakenly used.

9. Customer Satifaction

Client confidence is gained because of the universal acceptance of the ISO standards.
Customer satisfaction is ensured because of the benefits of ISO 9001:2000 QMS to company
efficiency, consistency and dedication to quality service.

10. Improvement Processes

The ISO 9001:2000 QMS outlines audit processes, management review and improvement
processes based on collected data. Improvements are carefully planned and implemented
based on facts, using a system of documentation and analysis, to ensure the best decisions
are made for your company.

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 6. Benefits of ISO 9000
ISO 9000 should be much more than a certificate hanging on the wall of your business. It
should be a comprehensive living system that provides measurable bottom line
improvements to the health of your company by assisting you to:

 Increase access to international markets

 Maintain consistently dependable processes
 Guarantee less wasted time, materials, and efforts
 Some documented case histories of ISO 9000 benefits include:
 A wholesale distributor
 10% percent sales increase directly attributable to ISO
 2% reduction in costs yielding $300K per year

Manufacturing assembly shop

 Return on investment achieved in less than two years

Service and repair shop

 Savings of $250K in the first year following registration

Hardware manufacturer

 18% reduction in customer returns

 25% increase in production backlog

Process control systems and instrumentation manufacturer

 Inventory reduction of 50%

 Product cost reduction of 5%
 Decrease in lost work days of 80%
 Increase in on-time deliveries of 12%
 Reduction in credit memos of 70%
 Increase in market share of 15%

Keypad manufacturer

 2% increase in overall margin

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 7. Conclusion:
Continual improvement is a process of increasing the effectiveness of your organization to
fulfill to quality policy and your quality objectives that you have established which are
updated periodically. Many organizations expand their management systems by extending
the ISO 9001 structure to include the requirements of other management systems
standards. Organizations are recognizing that an effective Quality Management System
leads to reduced costs and greater operating margins.

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8. Bibliography:
 Impact of ISO 9000 certi cation on quality management practices: A

comparative study by Hesan A. Quazi, Chang Wing Hong & Chan Tuck

Meng

 ISO 9001: 2000

 http://www.iso.org/iso/iso_catalogue/management_standards/iso_900

0_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_a

nd_continual_improvement.htm

 http://www.isocenter.com/9000/benefits.html

 http://www.google.com/

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