What are standards?

ISO series

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 140 countries, one from each country. ISO is a non-governmental voluntary standards organization with worldwide membership. Its charter is the development & promulgation of voluntary international standards. ISO is essentially an organization of organization s, in that no individuals, companies, or countries are typically direct members. Each national membership is generally held by the recognized standards body or agency from the member country. With some countries the national standards body holding ISO membership is a recognized function or quasi function of the government, with other countries, the membership is held by an accepted non-governmental body that represents the country.

ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity.ISO's work results in international agreements which are published as International Standards.

ISO's name 

Many people will have noticed a seeming lack of correspondence between the official title when used in full, International Organization for Standardization, and the short form, ISO. Shouldn't the acronym be "IOS"? Yes, if it were an acronym – which it is not.

In fact, "ISO" is a word, derived from the Greek isos, meaning "equal", which is the root of the prefix "iso-" that occurs in a host of terms, such as "isometric" (of equal measure or dimensions) and "isonomy" (equality of laws, or of people before the law).

From "equal" to "standard", the line of thinking that led to the choice of "ISO" as the name of the organization is easy to follow. In addition, the name ISO is used around the world to denote the organization, thus avoiding the plethora of acronyms resulting from the translation of "International Organization for Standardization" into the different national languages of members, e.g. IOS in English, OIN in French (from Organization internationale de normalization). Whatever the country, the short form of the Organization's name is always ISO.

        ISO is based in Geneva, Switzerland. Although it has a limited staff the primary standards development activities are performed by volunteers from the member countries. The volunteers are usually technical & standards specialists. ISO’s basic mission is the development of international standards on subjects selected & approved for development by the member countries. ISO is not involved in the actual application of the resultant standards to any business or national activity. It is the basic source for international consensus voluntary standards Leadership within the ISO tends to be based on the member country’s background in the standards field. Leadership is based on long-time extensive experience in the development of quality system standards

ISO Principal officers

The day-to-day standards development activities are accomplished by individual standards specialists in various fields. These people work on a voluntary basis and have been approved for the activity by the standards bodies of their respective nations. They serve on selected ISO technical committees. ISO has over 200 technical committees that address a variety of subjects. The only technical committee directly involved in the development of quality system standards is ISO 176. Its formal title is quality management and quality assurance. The ISO technical committee on quality management and quality assurance maintains liaison with a number of other organizations, both within and outside of the ISO. This ensures that the quality standards that are being developed or used by each body do not have conflicting requirements, and that there is no omission of any valuable information.

        ISO is not involved in the actual appliciation of the resultant standards to any business or national activity. It is the basic source for international consenss voluntary standards. Usually the ISO developed   standards are applied by their user organizations. Acceptance of the ISO series as the national quality system standard by a country’s standards body does not change the fact that the standards are voluntary in nature. The ISO thrust is always directed towards accomplishing the systematic development of universally accepted voluntary standards those having common interpretation within the international user community. The nature, extent, timing & methods of appliciation are not within the ISO charter.

 In 1987, the International Organization for Standardization (ISO) published the first international standards for quality management systems (QMSs) — the ISO 9000 series. Since then, ISO 9000 has become one of the organizations most influential and widely recognized products. Today, nearly half a million sites and organizations around the world have registered an ISO 9000 QMS.

Like all ISO standards, the ISO 9000 series is periodically reviewed and revised

What are ISO 9000 standards?

The ISO (International Organisation for Standardization) in recognizing the need for the harmonization of various quality standards used worldwide had issued the ISO 9000 series of standards in 1987. This 9000 series embodies comprehensive quality management concepts and guidance, together with models for external assurance requirements. The ISO 9000 series was revised 1994 and 2000 (current version).

            ISO 9000 is the name of a family of international standards which defines a Quality Assurance System. It is a non-prescriptive standard that does not specify how a firm's Quality Assurance processes must occur, but mandates that a company define appropriate quality standards, document its processes and prove that it consistently adheres to both.

          The intent of these standards is simple; they require that a basic quality system be in place to assure customers that suppliers have the capabilities and systems to provide quality products and services. ISO 9000 provides a foundation for continuous improvement. Documenting the quality system clarifies how the company really works, enables critical process measurements, and facilitates process improvement and increased customer satisfaction.

ISO 9000 family structure (as per the 1994 guidelines)

ISO 9000               the first in the series, it provides definitions of all the terms used in the ISO series

ISO 9000-1:1994  quality management and quality assurance standards –guidelines for selection and use.

ISO 9001:1994     quality systems—model for quality assurance in design, development, production, installation and servicing.

ISO 9002:1994     quality systems--- model for quality assurance in final inspection and test.

ISO 9004-1:1994  quality management and quality system elements---part 1: guideline              

ISO 9000 family structure (as per the 2000 guidelines)

 The latest revision effort culminated on December 15, 2000, with the publication of new editions of the three key standards in the series:

ISO 9000 - Quality management systems - Fundamentals and vocabulary. It describes fundamentals of the quality management system and defines the terminology used.

ISO 9001 - Quality management systems - Requirements. It specifies quality requirements for external quality assurance and aims to enhance customer satisfaction. The Organisation implements the Quality System in response to immediate demands by customers, that is to assure the external parties. Such situations include a contract with the customer, obtaining the customer's (second party) approval or third party (independent certification authority) approval. This 'customer motivated' approach is the main driving force in many countries and sectors of the industry.

ISO 9004 - Quality management systems - Guidelines for performance and improvement. It provides guidance that consider both the effectiveness and efficiency of the quality management system and is intended for internal use by the Company (internal assurance). The Company's own management initiates the effort to improve its own operations or in anticipation of emerging marketplace needs and trends. This 'management motivated' approach will normally be more comprehensive and fruitful than the models used for external assurance purposes. Unfortunately, very few companies recognize this. Normally, certification under this type of standard is not possible, as the system developed is for a Company's internal assurance.

ISO 90011 - Guidelines on quality and/or environmental management systems auditing. It provides guidance on auditing quality and environmental management systems.

Basically speaking the three key standards include: -

• ISO 9000:2000, Quality Management Systems -- Fundamentals and Vocabulary 
• ISO 9001:2000, Quality Management Systems -- Requirements
• ISO 9004:2000, Quality Management Systems -- Guidelines for Performance Improvements

Users who want to register a new or existing QMS will have until December 2003 to bring the system in line with the new standards.

Key Improvements:
While the previous version of the ISO 9000 standards has been widely accepted and applied, some users have reported problems related to complexity and effectiveness. Many of the changes in the new versions respond to these concerns.

• In previous versions of ISO 9000, there were three standards that described the requirements for registering a QMS. Organizations had to decide which standard to register to based on the operations covered by their QMS. In the new version, these are integrated into a single standard, ISO 9001, Quality Management Systems -- Requirements. To make it easier for organizations to use a QMS to improve productivity and performance, ISO 9004, Quality Management Systems -- Guidelines for Performance Improvements has also been extensively revised.
• In recognition of the wide variety of organizations using the standards, the new version of ISO 9001 provides detailed guidance on which activities can be excluded from the scope of a QMS. These requirements take into account factors such as the nature of the organization’s product and services, customer requirements or applicable regulatory requirements.
• The concept of "continual improvement" is highlighted in the new version. Evaluating improvement, based on measurable criteria, is now an element in assessing the effectiveness of a QMS.
• The structure of the standards is now process-oriented, so requirements and guidelines appear in a more logical sequence.
• Organizations must now monitor customer satisfaction as part of the process of assessing their performance.
• The revised standards place greater emphasis on the role of senior management in developing, implementing and maintaining a QMS.
• The new series is intended to be more business-oriented and "user-friendly" than previous versions.

The main new requirements include:

• Continual improvement
• Increased emphasis on the role of top management.
• Consideration of statutory and regulatory requirements.
• Establishment of measurable objectives at relevant functions and levels.
• Monitoring of information on customer satisfaction as a measure of system performance.
• Increased attention to resource availability.
• Determination of training effectiveness.
• Measurements extended to system, processes, and product.
• Analysis of collected data on the performance of the quality management system

Quality management principles
The revised standards are based on eight quality management principles that can be used by top management as a framework to guide their organization towards improved performance.

1. Customer Focus: Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and should strive to exceed customer expectations.
2. Leadership: Leaders establish unity of purpose and the direction of the organization. They should create and maintain an internal environment in which people can become fully involved in achieving the organization’s objectives.
3. Involvement of People: People at all levels are the essence of an organization, and their full involvement enables their abilities to be used for the organization's benefit.
4. Process Approach: A desired result is achieved more efficiently when activities and related resources are managed as a process.
5. Systems Approach to Management: Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.
6. Continual Improvement: Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
7. Factual Approach to Decision-making: Effective decisions are based on the analysis of data and information.
8. Mutually Beneficial Supplier Relationship: An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Should My Company Implement the ISO 9000 Standard?

Benefits accrue in two main arenas: productivity gains and competitive advantage.

A company's compliance with ISO 9001 ensures optimal Quality Assurance, which leads to lower costs, greater customer satisfaction and higher profits.

ISO 9000 registration certifies to customers that consistent quality standards are met and superior products and services result. More and more countries and companies require their suppliers to become registered. Because of this, companies which achieved ISO 9000 registration early find that demand for their products and services has increased both domestically and internationally. Dun and Bradstreet now collects and reports ISO 9000 registration status.

At present, ISO 9000 has been adopted as a national standard in nearly 100 countries. Products or services purchased from an ISO 9000 registered company guarantee that consistent quality standards have been met. ISO 9001 is the most comprehensive of the standards, because it covers product or service design and development, manufacturing, installation and customer service

How should my organization deal with the transition to the year 2000 standards?

Consultation on 'transition' arrangements between ISO TC 176, ISO CASCO, and the International Accreditation Forum (IAF) in September 1999 resulted in the following agreements:

• Accredited certificates to ISO 9001: 2000 shall not be granted until its publication as an International Standard.
• Certification/registration body assessments to the latest draft of the revised standard may begin prior to publication of ISO 9001: 2000 as an International Standard.
• Certificates issued to the 1994 editions of ISO 9001, ISO 9002, or ISO 9003 shall have a maximum validity of three years from the date of publication of ISO 9001: 2000.
• ISO 9001: 2000 will require auditors and other relevant certification body personnel to demonstrate new competencies.
• Certification bodies will need to take particular care in defining the scope of certificates issued to ISO 9001: 2000 and the permissible exclusions to the requirements of the standard.

The elements that make up ISO 9000 certification include:

An effective quality system.
Valid measurements and properly calibrated test equipment.
Appropriate statistical techniques.
A method for identifying and tracing products, including adequate record keeping.
An adequate process for handling, storing, packaging and delivering products.
Adequate processes for inspecting and testing as well as for dealing with   nonconforming items.
An internal audit system, including concrete evidence of compliance.
Adequate training and experience among employees.

         There are three distinct processes which occur during the implementation activities. The first process relates to the creation or existence of a quality system documentation that covers all elements of the selected ISO 9000 standard. The second process is assuring the company quality system, as documented and directed by the newly written or revised documentation, is adequate for meeting the ISO quality standard. The third process is accomplishing quality system implementation and assuring that full and effective complience has been achieved by management and the workforce.

The first and second processes are matters of assuring the company’s documented quality system, as created, is capable of addressing all requirements in each system element of the selected ISO quality standard. This latter phase involves the company’s actual performance or compliance to its documented ISO 9000 based quality system. This activity is termed as demonstrating compliance. The three steps to achieving ISO 9000 compliance are

         establishing existence of a documentated system

achieving adequacy by developing a quality system capable of meeting the   standard.

demonstrating compliance that the company does, in fact meet the documented   system.

What are the benefits of the revised standards?

There are a number of major benefits with the revised quality management systems standards. Among them are:

• Applicability to all product categories, in all sectors and to all sizes of organizations
• Simple to use, clear in language, readily translatable, and easily understandable
• Significant reduction in the amount of required documentation.
• Connection of quality management systems to organizational processes
• Provision of a natural move towards improved organizational performance
• Greater orientation toward continual improvement and customer satisfaction
• Compatibility with other management systems such as ISO 14000
• Provision of a consistent basis to address the needs and interests of organizations in specific sectors (e.g. medical devices, telecommunications, automotive, etc)
• The concept of the consistent pair - ISO 9001 covering the requirements and ISO 9004 for going beyond the requirements in order to further improve the performance of the organization.
• Consideration of the needs of and benefits to all interested parties.

With ISO registration:

• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share.

Customers and users will benefit by receiving the products that are:

• Conforming to the requirements
• Dependable and reliable
• Available when needed
• Maintainable

People in the organization will benefit by:

• Better working conditions
• Increased job satisfaction
• Improved health and safety
• Improved morale
• Improved stability of employment

Owners and investors will benefit by:

• Increased return on investment
• Improved operational results
• Increased market share
• Increased profits

Suppliers and partners will benefit by:

• Stability
• Growth
• Partnership and mutual understanding

Society will benefit by:

• Fulfillment of legal and regulatory requirements
• Improved health and safety
• Reduced environmental impact
• Increased security

ISO 14000 : Environmental Management System

History of Development

The ISO 14000 series emerged primarily as a result of the Uruguay round of the GATT negotiations and the Rio Summit on the Environment held in 1992. While GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio Summit generated a commitment to protection of the environment across the world. The environmental field has seen a steady growth of national and regional After the rapid acceptance of ISO 9000, and the increase of environmental standards around the world, ISO assessed the need for international environmental management standards. They formed the Strategic Advisory Group on the Environment (SAGE) in 1991, to consider whether such standards could serve to:

• Promote a common approach to environmental management similar to quality management;
• Enhance organizations' ability to attain and measure improvements in environmental performance

In 1992, SAGE's recommendations created a new committee, TC 207, for international environmental management standards. The committee, and its sub-committees include representatives from industry, standards organizations, government and environmental organizations from many countries. The new series of ISO14000 standards are designed to cover:

• environmental management systems
• environmental auditing
• environmental performance evaluation
• environmental labeling
• life-cycle assessment
• environmental aspects in product standards

ISO 14001 is an emerging standard entitled 'Environmental Management Systems - Specification'. Although it has no formal relationship to the ISO 9000 family of documents, it is structured much like the ISO 9001 standard. A central element of the ISO14001 standard is the Environmental Policy defined by an organization's top management. A system is then defined that ensures that the environmental policy is carried out by the organization. This involves planning, implementation and operations, checking and corrective action, and management review.

IS/ISO 14001 : 1996 "Environmental Management Systems - Specification with Guidance for Use"

IS/ISO 14001:1996 should be implemented to demonstrate the organization's capability for compliance/conformity to the legislative and regulatory requirements, protection of the environment, prevention of pollution and for continual improvement in environmental performance. The standard encourages the organization to periodically review and evaluate its Environmental Management Systems (EMS) in order to identify opportunities for improvement and their implementation. It is a system-based standard that gives the organization a blue-print for managing its environmental impacts/issues.

EMS provides a structured process for the achievement of continual improvement, the rate and extent of which will be determined by the organization in the light of socio-economic and other circumstances.

Integration of environmental matters with the overall management system can contribute to the effective implementation of the Environmental Management System

Member countries

Many countries have endorsed the ISO standards and issued them as their local standards or standards with a dual numbering system. The contents of these local or dual numbering standards are identical in every respect with the ISO standards. For example ISO 9001 is named as:

USA - ANSI/ASQC Q9001
Australia - AS/NZS ISO 9001
UK - BS EN ISO 9001
Canada - CAN/CSA-ISO 9001
Germany - DIN ISO 9001
India - IS/IS0 9001
Japan - JIS Z 9901
Malaysia - MS-ISO 9001
France - NF-EN 29001
South Africa - SABS ISO 9001
Thailand - TISI ISO 9001
Philippines - PNS ISO 9001

ISO 9000 registration is now required in the European community for 35 product categories. New required categories are added continually. Japan has also adopted ISO 9000 registration requirements for companies wishing to market their products or services in Japan. The United States Department of Defense, which has always enforced quality standards from its suppliers is switching to ISO 9000 as well.

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS), the National Standards Body of India has been providing service to the Indian industry for more than four decades by way of formulation of national standards and operation of product certification scheme. With the advent of ISO 9000 Series of Standards and liberalization of economy, BIS has also introduced the Quality Systems Certification Scheme according to IS/ISO 9000 Series of Standards.

In the wake of increasing public awareness about the environment which has become an important factor in the decision making process of the organizations. BIS has now launched Environmental Management Systems (EMS) Certification as per IS/ISO 14000 Series of Standards. These standards are adoption of and identical to the internationally accepted ISO 14000 Series of Standards on Environmental Management Systems.

Case study

ISO 9001 registration: the TELCO story

TELCO designs and develops much of the commercial and passenger vehicles, CNC machines, and other engineering products it produces and markets to 11 countries worldwide. TELCO’s workforce nears 35000 and its turnover exceeds Rs. 3000 crores.

    Through  collaborations with world class producers of vehicles, TELCO has steadily acquired and absorbed state-of-the-art production and QA know-how. Its employees use well proven systems and methods, some superior even to ISO 9000. consequently, when the company decided to use quality as its strategic thrust, it faced relatively low resistance within. Employees generally welcomed the decision with many coming forward to be involved. Before the start, however, TELCO engaged its top management, forming “quality councils” manned by top and divisional management.

     TELCO’s internal transformation strategy can serve solidly as guidelines to others seeking ISO 9000. these are:

• Jamshedpur declared quality (which it termed “total quality “) as the key thrust among the objectives of the organization, subsidiary to nothing else.
• The resident director activated this thrust by personally appointing a total quality facilitator in each division.
• Mass quality training covered all 21000 employees.
• Experts from companies successfully practicing “total quality” were invited to share their expertise and experiences first hand with TELCO personnel.
• Management reinforced employee participation and involved at all levels building on TELCO’s already existing suggestion scheme and quality circle-like(sga) activities.
• Collaborative inter-divisional workshops promoted communication among divisions and functions.
• Perhaps rare in India, TELCO organized inter-divisional and inter-departmental “customer-supplier” workshops-to drive home the internal customer concept.

TELCO put well-structured systems in place by first requiring all operating as well as service divisions to develop and document their own quality management systems, procedures, and practices. It also formally set up cross functional teams for resolving major critical issues and problems identified through customer complaints, and those related to the reduction of wastages.

Steps taken by TELCO JAMSHEDPUR towards ISO 9000 registration

Aside from upgrading procedures and practices, TELCO affected organizational values( quality over quotas), work culture, and the enviroment ( e.g., in vendor and in customer relationships). Vigorous spade work ( the needed orientation and exposure) did much to cut the time to registration. The journey had seven phases. They were –

Phase 1: Planning

• Corporate decision to go for ISO 9000 registeration.
• Corporate steering committee set up to manage the effort
• Selection of certification agency
• ISO 9000 consultant appointed
• Corporate quality policy formulated and published
• Divisions identified for certification
• Quality stewards for various divisions appointed

Phase 2: Awareness building/mass education

• ISO 9000 awareness programmes conducted for all employees
• Experience sharing through interaction with ISO 9000-certified companies organized
• The quality policy communicated to all the employees
• ISO 9000 requirements disseminated through booklets

Phase 3: Training

• ISO 9000 courses conducted for all employees
• Lead assessor course conducted for 45 officiers
• Internal audit course conducted for 180 officiers
• Auditee course conducted for selected personnel
• Programme for union officials held
• Senior executives attended ISO 9000 programme

Phase 4: Documentation

• Preparation of quality manual
• Writing of procedures
• Preparation of work instructions, process sheets, quality plans, check sheets; various formats designed
• Procedures interlinked and checked for their adequacy

Phase 5: Implementation

• Procedures, work instructions and process sheets installed
• Appropriate control of documents exercised
• Special process qualification carried out
• Calibration of gauges and process equipment completed
• Record keeping started

Phase 6: Internal audit

• Comprehensive internal audit for all the divisions planned
• Audit conducted by Lead assessors and internal auditors
• Audit findings analysed in detail
• Quality councils discussed findings and planned corrective actions
• Follow up audit conducted to ensure closing of all non-conformities

Phase 7: Assessment by the certification agency

• Pre-assessment audit conducted
• Final assessment for certification carried out

Jamshedpur’s excavator division received ISO 9001 in August 1993, along with the foundry and forge divisions registering ISO 9002.