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  • 8/9/2019 Implementation & Impact of Quality Standards among Small Industry

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    2010

    Vaibhav Borkar. Tanuj Jindal

    Indo-German Training Centre,

    Bangalore

    4/23/2010

    Implementation & Impact of Quality

    Standards among Small Industry

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    Indo-German Training Centre, Bangalore | No 1

    TABLE OF CONTENT

    No Contains Page no

    1 About ISO

    ISO's origins ISO's name

    2

    2 The ISO brand

    Democratic Voluntary

    3

    3 Information

    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

    4 ISO 9000

    Element of ISO 9000 Steps in ISO 9000 registration Steps in ISO 9000 registration Quality documentation

    7

    5 Advantages of ISO 9000 10

    6 Benefits of ISO 12

    7 Conclusion 13

    8 Bibliography 14

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    Indo-German Training Centre, Bangalore | About ISO 2

    1. About ISOISO (International Organization for Standardization) is the world's largest developer and

    publisher ofInternational Standards.

    ISO is a network of the national standards institutes of 159 countries, one member percountry, 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 indifferent 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

    DemocraticEvery 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 legalauthority 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-drivenISO 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.

    ConsensusISO 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 relevantISO 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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 4

    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.

    http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees.htmhttp://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees.htmhttp://www.iso.org/iso/standards_development/processes_and_procedures/stakeholders.htmhttp://www.iso.org/iso/standards_development/processes_and_procedures/stakeholders.htmhttp://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees.htm
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    Indo-German Training Centre, Bangalore | 2. The ISO brand 5

    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 somewherein 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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 6

    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 themtime 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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 7

    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 Britishstandard 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 andsupplementary 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 implementsit by providing resources, personnel and training.

    2. Quality System. A Quality System comprised of a Quality Manual and supporting proceduresis created and maintained.

    3. Contract Review. Contracts reflect the customers' needs and expectations. Products andservices provided must comply with those requirements.

    4. Design Control. Engineering drawings and design changes are carefully documented toensure that changes have been fully coordinated and approved internally, and whenappropriate, by the customer.

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    Indo-German Training Centre, Bangalore | 2. The ISO brand 8

    5. Document Control. The creation and modification of documents supporting the QualitySystem is strictly controlled by ISO 9001 procedures.

    6. Purchasing. Purchasing procedures describe supplier requirements and the system forensuring compliance to these standards.

    7. Handling of Purchaser Supplied Product. Procedures detail methods of handling andsafekeeping of product supplied by the customer.

    8. Product Identification and Traceability. Methods of tracking date and lot codes of productand raw materials from start to finish guarantee traceability.

    9. Process Control. Work instructions, quality plans and workmanship standards verify thateach job is being done correctly.

    10.Inspection and Testing. Inspection and testing at receiving, in-process and final inspectionareas 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 calibratedregularly 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 specificationsare 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 ofquality concerns and any corrective action required.

    15.Handling, Storage, Packaging and Delivery. Procedures outline practices that protectproducts 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 ofexpertise.

    19.Servicing. Where servicing is specified in the contract, procedures are established to verifythat servicing meets the indicated requirements.

    20.Statistical Techniques. Control charts, graphs and other methods of analysis determine howwell 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 90002. prepare quality manual to cover all element of selected model3. 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 model5. select the register and apply for certification and registration

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    Indo-German Training Centre, Bangalore | 2. The ISO brand 9

    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 theactivity 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 andservicing. 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 usedwhen 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 whenconformance to specified requirement is to be assured by supplier solely at final inspection

    and test it consist of 12 elements.

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    Indo-German Training Centre, Bangalore | 2. The ISO brand 10

    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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 11

    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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 12

    6.Benefits of ISO 9000ISO 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 yearsService and repair shop

    Savings of $250K in the first year following registrationHardware 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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 13

    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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    Indo-German Training Centre, Bangalore | 2. The ISO brand 14

    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: 2000http://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.htmlhttp://www.google.com/

    http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.isocenter.com/9000/benefits.htmlhttp://www.isocenter.com/9000/benefits.htmlhttp://www.google.com/http://www.google.com/http://www.google.com/http://www.isocenter.com/9000/benefits.htmlhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htmhttp://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use/maintaining_the_benefits_and_continual_improvement.htm