BIS (Conformity Assessment) Regulations, 2018

[YAGAY andSUN]

The BIS (Conformity Assessment) Regulations, 2018 are part of the Bureau of Indian Standards (BIS) framework designed to ensure that products meet established quality standards and specifications before they are manufactured, sold, or imported into India. These regulations are essential for maintaining consumer safety and ensuring that products in the Indian market meet the required quality standards.

Here is an overview of the BIS (Conformity Assessment) Regulations, 2018:

Introduction to BIS (Conformity Assessment) Regulations, 2018

The Bureau of Indian Standards (BIS) is the national standards body of India, established under the Bureau of Indian Standards Act, 1986. BIS is responsible for setting standards and ensuring the conformity of products to these standards, which covers a wide range of consumer products, including industrial products, food items, electrical appliances, and more.

The BIS (Conformity Assessment) Regulations, 2018 were introduced to establish a structured and standardized procedure for ensuring that products comply with the applicable Indian standards before they are imported, sold, or used in India. These regulations are a part of the broader BIS Conformity Assessment Scheme.

Key Features of the BIS (Conformity Assessment) Regulations, 2018

1. Scope and Applicability
   • These regulations apply to products that are regulated under BIS standards, which include both domestic and imported goods.
   • Conformity assessment is required for products that are intended for consumer use and those which may impact health, safety, or the environment.
2. Conformity Assessment Process The regulations outline the procedures for conformity assessment which include the following key steps:
   • Certification Scheme: Products that comply with the relevant Indian standards are issued a BIS certification mark (ISI mark). This certification applies to a variety of products, ranging from food items to electrical appliances.
   • Product Testing: The manufacturer must ensure that their products are tested either in-house or by accredited laboratories to verify that they meet the standards set by BIS.
   • Factory Inspection: For certain products, regular inspections of the manufacturing facilities are conducted by BIS to ensure continued compliance with standards.
   • Third-Party Certification: In some cases, third-party certification may be required, particularly for products that are imported into India, to ensure that they meet the prescribed quality standards.
3. Conformity Marks
   • The ISI mark is one of the most recognized conformity marks in India and signifies that the product has been tested and complies with the relevant BIS standards.
   • Other conformity marks may also be issued depending on the product category and applicable standard.
4. Procedures for Obtaining BIS Certification The process for obtaining BIS certification includes the following:
   • Application: The manufacturer or importer submits an application to BIS to get their product certified.
   • Testing: The product undergoes testing in an approved laboratory, either within India or internationally.
   • Inspection: BIS inspects the manufacturer’s facilities to ensure that the product is being consistently produced in accordance with the prescribed standards.
   • Issuance of Certificate: Once the product passes the testing and factory inspections, BIS issues a certificate of conformity, and the product is granted the relevant mark.
5. Types of Conformity Assessment Schemes
   • Product Certification: BIS certifies that the product meets the standards and specifications defined by Indian regulations.
   • Quality Control Orders: For specific products, there are Quality Control Orders (QCOs), which mandate that all goods manufactured and imported into India must meet the prescribed standards.
   • Compulsory Registration Scheme (CRS): Certain products, such as electrical appliances, must undergo registration under the Compulsory Registration Scheme to ensure that they meet mandatory standards before being sold in the Indian market.
6. Conformity Assessment for Imports
   • Imported Goods: Imported products that are subject to BIS standards must undergo testing and certification before they can be sold or used in India. The process for importing goods typically involves submitting the product for testing in an authorized BIS laboratory.
   • Importers must also register with BIS, ensuring that they adhere to the relevant standards set for their products.
   • Certification Requirement: In cases of non-compliance, products will not be allowed for sale in the Indian market and could be subject to seizure or penalties.
7. Renewal and Continuity of Certification
   • The certification provided by BIS is typically valid for a certain period and needs to be renewed. Manufacturers must continue to meet BIS standards, undergo regular inspections, and submit periodic reports to maintain their certification.

Governance and Authorities Involved

The key governing authority responsible for administering these regulations is BIS (Bureau of Indian Standards), which is under the Ministry of Consumer Affairs, Food & Public Distribution, Government of India.

Other involved authorities:

• Ministry of Commerce and Industry: For matters related to trade and imports.
• Directorate General of Foreign Trade (DGFT): For regulations related to imports and the certification of imported goods under the Compulsory Registration Scheme.
• Customs Department: For ensuring that non-compliant goods are prevented from entering the Indian market.

Steps to Comply with BIS (Conformity Assessment) Regulations, 2018

1. Check the Relevant BIS Standard: Identify the BIS standard applicable to your product (whether domestic or imported).
2. Submit Application to BIS: Manufacturers or importers must apply for certification through the official BIS portal or relevant BIS office.
3. Product Testing: The product will be tested by accredited BIS laboratories.
4. Factory Inspection (if applicable): BIS may inspect the manufacturer’s facilities to ensure compliance.
5. Issuance of Certification: Once the product meets the necessary standards, BIS issues a conformity certificate, allowing the product to be sold in the market with the appropriate BIS mark.
6. Regular Monitoring and Renewal: Maintain ongoing compliance with BIS standards, which may involve periodic inspections, reporting, and renewals of certifications.

Conclusion

The BIS (Conformity Assessment) Regulations, 2018 are a crucial aspect of India's regulatory framework aimed at ensuring the quality and safety of products available in the market, including both domestically produced and imported goods. By adhering to these regulations, manufacturers and importers can ensure that their products meet the high standards expected in India, thereby protecting consumer interests and enhancing the reliability of goods circulating in the market.

To comply with the regulations, it is important for businesses to understand the relevant standards, follow the certification process, and work with BIS for testing, factory inspection, and obtaining the necessary conformity marks. Regular monitoring and renewal of certifications are necessary for continued compliance.

The Bureau of Indian Standards (BIS), as India’s national standards body, is responsible for maintaining the quality, safety, and reliability of products and services in India. Through the BIS (Conformity Assessment) Regulations, 2018, BIS formalized ten distinct conformity assessment schemes, each aimed at facilitating compliance with Indian Standards (IS) across various sectors. These schemes not only protect consumer interests but also support India’s regulatory framework and export market competitiveness.
In this article, we shall dive into an in-depth analysis of each scheme, its legal scope, and significant updates.
Conformity Assessment by BIS
In a wider sense, different schemes of BIS are as follows:

• Domestic Manufacturer Certification Scheme;
• Foreign Manufacturer Certification Scheme;
• Compulsory Registration Scheme;
• BIS Hallmarking Scheme; and
• Eco Mark Scheme.

However, the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, along with its subsequent amendments, lay down ten different kinds of conformity assessment schemes that align with specific types of goods and articles.
Schedule I of the said regulations provides a layout of different types of conformity assessment schemes and their respective types of goods and articles, whereas Schedule II lays down each conformity assessment scheme in detail.
An application for grant of licence to use or apply a Standard Mark shall be made to the Bureau in the form and manner specified in the applicable Scheme in Schedule-II. It further specifies the processes involved in grant of licence, conditions of licence, provisions pertaining to validity, renewal, and cancellation of licence, etc.
Let’s go over each scheme through a birds-eye view.
Ten different Conformity Assessment Schemes
Scheme I
Conformity assessment scheme for grant of licence to use or apply Standard Mark on goods and articles as per Indian Standard.
Applicable Standard Mark:

It is the product certification scheme which covers maximum number of daily use as well as industrial products. At present. 174 Quality Control Orders (QCOs) have been issued under Scheme I of BIS, covering 688+ products.
Examples include copper products, hinges, stainless steel utensils, chemicals, textile products, pneumatic tyres, etc.
Scheme II
Conformity assessment scheme for grant of licence to use or apply Standard Mark through registration based on self-declaration of conformity for goods and articles as per Indian Standard.
Applicable Standard Mark:

It is the Registration Scheme of BIS. At present, 6 QCOs have been issued under this scheme covering 73+ products.
Examples include Electronics & IT goods such as laptops, electronic video games, along with cotton bales, solar photovoltaics, etc.
Scheme III
Conformity assessment scheme for grant of licence to use Standard Mark or certificate of
conformity for management system as per Indian Standard.
Applicable Standard Mark:

Scheme IV
Conformity assessment scheme for Grant of certificate of conformity for goods and articles as per any standard.
Scheme V
Conformity assessment scheme for grant of certificate of conformity for a batch or lot of goods and articles as per any standard.
Scheme VI
Conformity assessment scheme for grant of certificate of conformity for services as per any standard.
Scheme VII
Conformity assessment scheme for grant of certificate of conformity for type approval of goods and articles.
Scheme VIII
Conformity assessment scheme for grant of licence or certificate of conformity for process as per Standard(s).
This scheme was introduced under Bureau of Indian Standards (Conformity Assessment) Amendment Regulations, 2020 vide a notification by BIS dated 21 February 2020.
Scheme IX
Conformity Assessment Scheme for grant of licence to use or apply Standard Mark for goods and articles conforming to Indian Standard combined with conformity of management system to Indian Standard and conformity of process requirements, as specified.
This scheme was introduced under Bureau of Indian Standards (Conformity Assessment) (Sixth Amendment) Regulations, 2021 vide a notification by BIS dated 8 December 2021.
Scheme X
Conformity assessment scheme for grant of licence to use or apply Standard Mark for goods and articles as per the specified requirements.

This scheme was introduced under Bureau of Indian Standards (Conformity Assessment) Amendment Regulations, 2022 vide a notification by BIS dated 16 March 2022.
At present, 2 QCOs have been issued under this Scheme by the Ministry of Heavy Industries for various kinds of electrical equipment and machinery.
LKS Comments
The ten conformity assessment schemes under the BIS Conformity Assessment Regulations form the foundation of India’s quality and standards regulatory landscape. By systematically categorizing certification schemes based on product types and sectors, BIS not only facilitates compliance but also promotes a culture of quality assurance in Indian industries.
For manufacturers and businesses, understanding the specific requirements and legal mandates of each scheme is essential for both regulatory compliance and market credibility.