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Regulatory Requirements: Quality Management:
Bureau of Indian Standards (BIS) and ISO 9000
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Bureau of Indian Standards Act,1986 is the governing Act in India for the preparation and enforcement of standards. The Act extends to whole of India. Under the Act, the Central Government has set up, Bureau of Indian Standards(BIS) renamed for Indian Standards Institution(ISI) as the National Standards Body of India for promoting and nurturing the standardization movement in the country. Under the Provisions of BIS Act 1986 and rules and regulations framed therein, Bureau of Indian Standards is operating various Management Systems Certification Schemes under which licences are granted to various industry and service organizations:-
  • Quality Management Systems Certification Scheme - IS/ISO 9001 (QMS)

  • Environmental Management Systems Certification Scheme - IS/ISO 14001(EMS)

  • Occupational Health and Safety Management Systems - IS 18001 (OHSMS)

  • Hazard Analysis Critical Control Point - IS 15000 (HACCP) certification

Bureau of Indian Standards(BIS) is a founder member of ISO (International Organization for Standardization). ISO is a worldwide federation of national standards bodies that aims to provide a single set of standards that people world over would recognise and respect. The objective of ISO is to promote the development of standardization and related activities in the world with a view to facilitating international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO's work programme ranges from standards for traditional activities, such as agriculture and construction, through mechanical engineering, to medical devices, to the newest information technology developments, such as the digital coding of audio-visual signals for multimedia applications.

ISO has published a wide range of international standards. The ISO 9000 series is among ISO's most widely known standards ever. It refers to a set of quality management standards. It represents an international consensus on good management practices with the aim of ensuring that the organization can time and time again deliver the product or services that meet the client's quality requirements. It provides a framework for quality management throughout the processes of producing and delivering products and services for the customer. It has become an international reference for quality requirements in business to business dealings. More than half a million organizations in more 149 countries are implementing these standards. The series enables an organisation to set up a quality management system and supply products and services that aim to achieve customer satisfaction. It provides a set of standardized requirements for a quality management system, regardless of what an organization does, its size, or whether it is in the private, or public sector.

Quality management under the ISO 9000 family means that an organization needs to fulfil:-

  • The customer's quality requirements, and

  • Applicable regulatory requirements, while aiming to

  • Enhance customer satisfaction, and

  • Achieve continual improvement of its performance in pursuit of these objectives.

The family of ISO 9000 standards is made up of four core standards:-

  • 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

  • ISO 19011: 2002 :– Guidelines for quality and/or environmental management systems auditing

Bureau of Indian Standards(BIS) has adopted these ISO 9000 standards and has numbered them as IS/ISO 9000:2000; IS/ISO 9001:2000; IS/ISO 9004:2000; and IS/ISO 19011:2002. These standards published by BIS are exact replica of ISO 9000 standards.

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