Conformity Assessment: Conformity Assessment Used in India
In addition to various private sector testing, inspection and certification activities carried out in the Indian market, the Bureau of Indian Standards (BIS) operates a Product Certification Scheme,
which is governed by the Bureau of Indian Standards Act of 2016. In general, the BIS certification is voluntary in nature, although the Government of India has
placed certain products under mandatory certification due to public health and safety considerations.
BIS act and other Rules and Regulations that govern BIS.
The presence of a Standard Mark (Popularly known as ISI Mark) on a product indicates conformity to the relevant Indian Standard.
Before granting license to any manufacturer, BIS ascertains the availability of required infrastructure and capability of the manufacturer to produce and test the product
conforming to the relevant Indian Standard on a continuous basis. Samples are drawn from the production line as well as from the market and tested in independent
laboratories to ensure their conformance to the relevant Indian Standard (IS).
Procedures for Foreign Manufacturers
The BIS Act of 2016 frames the Foreign Manufacturers Certification Scheme (FMCS). Foreign manufacturers—manufacturers based outside of India—may obtain a license to use the Standard Mark of conformity with appropriate Indian Standards. Interested manufacturers must submit an application form and application fees, and in most cases are required to set up a branch office in India. Foreign companies may not need to open an Indian location if their home country has signed a Memorandum of Understanding (MoU) with BIS, or if they have nominated an authorized representative located in India to be responsible for compliance with the BIS Act.
Product Certification
BIS’ Product Certification Scheme is designed to provide a third-party guarantee of the quality, safety, and reliability of products.
It is essentially a voluntary system, although the Government of India has placed certain products under mandatory certification due to public health and safety considerations.
In all other cases, the manufacturer is permitted to self-certify the products, under a licence, after determining conformity to the relevant IS.
System Certification
In addition to Product Certification, BIS operates a Management System Certification for various systems. This scheme originally began with the scheme certifying Quality Management Systems (QMS), but has since expanded. BIS now offers certification for the following systems and their respective international and/or Indian standard(s):
- Quality Management System (IS/ISO 9001)
- Environmental Management System (IS/ISO 14001)
- Food Safety Management System (IS/ISO 22000)
- Energy Management System (IS/ISO 50001)
- Occupational Health & Safety Management System (IS 180001 & IS/ISO 45001)
- Service Quality Management System (IS 15700)
- Hazard Analysis and Critical Control Points (HACCP) (IS 15000)
- Medical Device Management System (IS/ISO 13485)
- Social Accountability at Workplace (IS/ISO 16001)
- Road Traffic Safety Management System Certification Scheme (IS/ISO 39001)
- Adventure Tourism Safety Management System (IS/ISO 21101:2014)
- Ready Mixed Concrete Certification Scheme (ISO 9001 & IS 4926)
- Integrated Milk Certification for Packaged Pasteurized Milk (IS 13688 & ISO 22000)
- Educational Organization Management System (EOMS) (ISO 21001)
- Anti-Bribery Management System (IS/ISO 37001)
- Medical Devices –¬ Quality Management System requirements and Essential Principles of Safety & Performance for Medical Devices (IS 23485)
- Information Security Management System (IS/ISO 27001:2013)
- Food Safety Audits (Food Safety and Standards Authority of India (FSSAI) Recognized)
QUALITY MANAGEMENT SYSTEM (QMS) CERTIFICATION
BIS operates a scheme certifying Quality Management Systems (QMS) as per the IS/ISO 9001:2000 standard. The goal of the scheme is ensure consistency of quality in products and services, and increase consumer satisfaction and productivity.
BIS is accredited by the Dutch Council for Accreditation (Raad voor Accreditatie) in the following 23 areas:
- Textile and textile products
- Chemicals, chemical products and fibers
- Rubber and plastic products
- Non-metallic mineral products
- Concrete, cement, lime, plaster, etc
- Basic metals and fabricated metal products
- Machinery and equipment
- Electrical and optical equipment
- Other transport equipment
- Wholesale and retail trade; repair of motor vehicles, motorcycles and personal and
- Household goods
- Food Products, beverages and Tobacco
- Leather and Leather Products
- Wood and Wood Products
- Pulp, Paper and Paper Products
- Printing Companies
- Manufacturing not elsewhere Classified
- Transport, Storage and Communication
- Other Services
- Hotel & Restaurants
- Electricity Supply
- Pharmaceuticals
- Manufacture of Coke Ore and Refined Petroleum Products
- Financial Intermediation; Real Estate; Renting (Limited to NACE 65)
ENVIRONMENTAL MANAGEMENT SYSTEM (EMS) CERTIFICATION
The International Organization for
Standardization (ISO) has published the ISO 14000 series of standards with a
view to providing organizations worldwide with a structure for managing
environmental impacts of their activities, products and services and to have a
uniform international Environmental Management System (EMS) for use as an environmental
management tool for achieving sustainable development. ISO 14000 is an evolving series of generic
standards which include a broad range of environmental disciplines. ISO 14000 addresses six distinct but related
subjects like Environmental Management Systems (EMS), Environmental Auditing
(EA), Environmental Performance Evaluation (EPE), Environmental Labelling (EL),
Life Cycle Assessment (LCA) and Environmental Aspects in Product Standards
(EAPS). Together, these standards
provide the necessary guidance for implementing an effective environmental
management system.
BIS launched its EMS Certification Scheme in response to increasing environmental awareness and its effect on
business.
Hallmarking of Gold Jewelry
Gold plays a significant role in both the economy and culture of India. The annual consumption of gold is estimated at over 500 tons, with about 80% of that amount representing gold jewelry. As an industry,
over 2 million workers are employed in gold jewelry fabrication. Due to gold’s cultural and economic significance, India places a high priority on protecting the quality and purity of its gold. Hallmarking is the
accurate determination and official recording of the proportionate content of precious metal in gold. Hallmarks are thus official marks used in many countries as a guarantee of purity or fineness of gold jewelry.
The BIS Precious Metals Sectional Committee is responsible for formulating
Indian Standards on gold and gold alloys, and BIS operates the Hallmarking Scheme in line with international criteria for hallmarking.
Hazard Analysis Critical Control Point (HACCP)
Hazard Analysis and Critical Control Point (HACCP) is a process control system
designed to identify and prevent microbial and other hazards in food
production. It includes steps designed
to prevent problems before they occur and to correct deviations as soon as they
are detected. HACCP enables the
producers, processors, distributors, exporters, etc, of food products to
utilize technical resources efficiently and in a cost effective manner in assuring
food safety.
BIS offers two Certification schemes to the food industry:
- HACCP Stand-alone Certification against IS 15000:1998
- HACCP based Quality System Certification provides for two Certification through one audit
Certification of Quality System against IS/ISO 9000 and Certification of HACCP
against IS 15000:1998
Certification for Foreign Manufacturers
The BIS Act of 2016 frames the Foreign Manufacturers Certification Scheme (FMCS). Foreign manufacturers may obtain a license to use the Standard Mark of conformity with appropriate Indian Standards. Interested manufacturers must submit an application form and application fees, and in most cases are required to set up a branch office in India. Foreign companies may not need to open an Indian location if their home country has signed a Memorandum of Understanding (MoU) with BIS, or if they have nominated an authorized representative located in India to be responsible for compliance with the BIS Act.
Key Organizations
