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- The BIS Conformity Assessment Regulations 2018 specify compliance with Indian Standards through various BIS sanctioned schemes.
- The schemes covered include ISI Mark, CRS, FMCS, Eco Mark, and Hallmarking schemes that guarantee safety and quality of products.
- BIS certification allows for legal access to any market, particularly concerning electronics, medical devices, and infrastructure materials.
- Everyone in the supply chain including manufacturers, wholesalers, traders and importers must be compliant or risk penalty, confiscation of products, and damage to reputation.
- By hiring a qualified BIS Certification consultant, you can ensure you have an easier BIS audit, testing, and approval process, under the 2018 framework.
Introduction
In May 2023, a Pune-based electronics startup was set to launch its new LED floodlights just before the monsoon infrastructure rush. Their Chinese manufacturer shipped the batch—but customs held it back. Why? The products lacked a valid BIS license under the CRS Scheme.
Despite investing in design, testing, and branding, they had overlooked a critical regulation—the BIS Conformity Assessment Regulations 2018. A small documentation error nearly caused losses over ₹35 lakh. Fortunately, Diligence Certifications intervened, facilitated emergency testing, and obtained a BIS registration within 3 weeks—just in time.
This incident is not isolated. Many Indian and foreign businesses are unaware of how these BIS Conformity Schemes apply to them until it’s too late.
What Are the BIS Conformity Assessment Regulations 2018?
Under the BIS Act 2016, the BIS Conformity Assessment Regulations, 2018 provide the legal framework within which products and services can be assessed, certified and regulated in India to ensure quality, reliability and safety.
The regulations exist to ensure that all products produced domestically or imported in India satisfy the requirements of Indian Standards (IS). They allow BIS to function in a structured, regulated and transparent way thus preventing, as much as possible, the circulation of inferior or unsafe products into the market.
The framework under the BIS regulations makes it clear that no manufacturer or importers can sell certain classes of goods/persons in India before obtaining certification from BIS. It brings together unifying quality assurance for all parties—domestic producers, foreign manufacturers, and importers, and even retailers.
Why Were These Regulations Introduced?
India’s expanding consumer base and increasing industrialisation with the need for a tighter quality regime. Until 2018, product compliance mechanisms existed in a fragmented manner. The use of sub-standard products and materials particularly in the steel, electronics and automobile sectors have led to serious accidents and recalls.
To combat these evident challenges, the BIS took the first step in redesigning its certification regime as part of the 2016 Act, and subsequently issued the BIS Conformity Assessment Regulations 2018. The new regulations brought standardisation, risk-based and digitisation to the certification regime providing a platform of transparency and efficiency. It enables us to align Indian certification practice with international benchmarks while respecting local needs and capabilities.
For example, in 2018 the BIS by categorising products based on their risk level, was able to develop faster simplified certification pathways for low-risk products and more detailed and comprehensive assessment procedures for products categorised in the high-risk factor. The new structure also allows for better surveillance, penalisation and recall.
All BIS Conformity Assessment Schemes under 2018 Framework
The Bureau of Indian Standards (BIS) has established various BIS Conformity Assessment Schemes according to the 2018 regulations. These were established according to the risk profile of the product, where the manufacturer is based, and where the product may be used.
The purpose of these is to support conformity, which gives confidence to consumers, industry actors, and regulators. Each scheme has its own purpose – when buying services/providing a demonstration of product quality in India, to facilitating a better experience for overseas goods entering the Indian marketplace.
Let’s look at some of the main schemes:
1.Product Certification Scheme (ISI Mark Scheme/ Scheme-I)
This is the most comprehensive and general certification scheme under BIS. This scheme allows both Indian and overseas manufacturers to certify their products meet the specific criteria under the applicable Indian Standards.
For manufacturers, there is no mileage gained from taking an easy path to compliance – the performance of their product lies in the assessment in two specific areas. First, manufacturers must provide a comprehensive application and the required technical documentation, show regulatory compliance with products to enter the marketplace, and then export compliance (if required).
Secondly, there is an onsite compliance audit to a Manufacturing Standard in your ISI application (as applicable), and on-site at your factories there can be a wide variety of product testing all conducted in BIS recognized labs. After positive verification by BIS and any of the thousands of ISI only to name thousands, after receiving a licence from BIS, marketers can apply the ISI mark on their products.
2. Compulsory Registration Scheme (CRS / Scheme-II)
CRS Scheme is aimed at electronics and IT items such as mobile devices, power banks, LED lights, vintage speakers etc. These items are mainly imported in an area where technology changes quickly, requiring testing and certification to be flexible and speedy.
A manufacturer applying for CRS must get the products evaluated by BIS recognized labs and they can self-declare the products as meeting the relevant Indian Standard requirement and register the product with BIS.
The CRS scheme does not impose factory inspections like the ISI mark scheme so obtaining certification is less time consuming and resource consuming. The registered product is issued a unique R-number and must bear a CRS label to indicate compliance status.
3. Foreign Manufacturer Certification Scheme (FMCS)
FMCS is used for foreign manufacturers who are looking to sell their products in India. Because these manufacturers do not operate in India, there are some additional safeguards in the certification process.
Foreign manufacturers must appoint an Authorized Indian Representative (AIR), this role acts as a contact point for BIS. The certification process includes a documentation review, product testing at any BIS recognized labs, and a thorough audit of the foreign factory premises by BIS officials.
Depending on the product category, the certified goods may display either the ISI mark or the CRS mark, just as manufactured goods in India. In summary, FMCS assures that foreign products entering India are equivalent to domestic products in terms of safety and quality.
4. BIS Hallmarking Scheme
This scheme promotes precious metal articles, such as gold and silver jewellery. Because of its historical and economic importance, the purity and standardisation of gold and silver became a priority in India.
Jewellers wishing to participate in the scheme must register with BIS to confirm their compliance with a standard. They must also have the testing of their jewellery done at BIS-approved Assaying and Hallmarking Centres (AHCs) located in India. The AHCs assess purity and the quality of the article should conform to the defined standard (e.g., IS 15820:2009).
After the jewellery has successfully passed testing, it will be stamped with the BIS Hallmark – a mark which provides consumers with some confidence that the jewellery has been tested for purity. The BIS Hallmark contains the following information: the BIS logo, the purity in carat, identification mark of the jeweller and the hallmark centre.
5. Eco Mark Scheme
The Eco Mark Scheme is a voluntary certification launched to encourage environmentally responsible consumerism. Products certified through the Eco Mark Scheme meet not only quality requirements, but also certain environmental requirements such as reduced toxicity, reduced wastes and recyclability.
The Eco Mark application process is very similar to the ISI Mark Scheme application process. The manufacturer must ensure that the product meets both the Indian Standard and the specific environmental requirements that have been set out by BIS.
Once the environmental testing is complete and the manufacturers are confident, the product is marked with the ISI mark as well as the Eco Mark logo, which represents sustainable product consumption. The Eco Mark Scheme would be particularly relevant for industries such as packaging, cleaning products, cosmetics and processed foods.
6. Other Specialized Schemes
a) Certificate of Conformity (Scheme IV) – This scheme is for certifying batches or lots of goods as opposed to continuous production. Examples of sectors and products covered include bicycle components, reflective devices, and some electrical hardware. The intent of the scheme is that ‘for each consignment or shipment of evaluated products, the applicant will verify compliance before the product enters the market.
b) Scheme X Certification – A recently established scheme specifically for low-voltage switchgear and control gear. This scheme was created to renew and simplify previous certification processes, traditionally made known under the ISI Mark Scheme. Moving forward, it is anticipated that processes that were included in the ISI Mark Scheme are expanded to draw efficiencies and reduce certification timelines.
c) Service and Management System Certification – In additional to certifying products, the BIS has also certified services and management systems. Services include, telecom operation, quality management for service organisations, food service hygiene and other intangible offerings. These schemes will substantiate the compliance of available services with respect to both consumer expectations and regulatory provisions.
These additional schemes are evidence of the BIS’s stewardship to response to new industry needs and reflect internationally accepted practices.
Certification Process (Step-by-Step)
Identify Applicable Scheme
- Identify the relevant BIS scheme (ISI, CRS, FMCS, etc.) for the product, according to its nature in the market and whether it is listed in the appropriate QCO.
Testing the Product in BIS recognized labs
- The product must be tested in an BIS recognized labs according to the relevant Indian Standard. These test results are basically the basis for certification.
Prepare Documents
- You will need to compile documentation such as factory details, product specifications, manufacturing flow chart, test reports, trademark registration, and identification proof.
Submit Application Online
- Submit the application through the BIS portal along with all documents and payment of the relevant government fee.
Factory Audit (for ISI/FMCS)
- BIS officials will visit the factory to see the manufacturing and quality assurance systems in place, as well as material traceability.
Grant of License or Registration
- If the application and audit (if applicable) are approved, the BIS will issue license or registration as applicable.
Requirement to Mark
- The use of relevant BIS marks (ISI, CRS, Hallmark) are now mandatory on the products, packaging and user manual.
Surveillance & Renewal
- Surveillance will occur through regular audits and surprise inspections. The license must be renewed before expiration through application through the BIS portal.
BIS Certificate Cost
The BIS certificate cost varies greatly depending on the product type, the scheme it falls under, whether the applicant is a domestic or foreign manufacturer, etc. In general, the total BIS certificate cost consists of 4 major costs:
Government Fees: This consists of application fees, processing fees and marking fees as per BIS norms.
Testing Charges: Products must be tested at BIS recognised labs . The testing charge will depend on the product type and complexity.
Audit & Inspection Costs: The ISI Scheme and FMCS Scheme require inspections to be done at the factory. Therefore, fees associated with travel, accommodation and inspection costs must be included for an overseas audit.
Consultancy Fees: Many people decide to hire a BIS certification consultant to help manage the process and to reduce the chances of getting a ‘no’ at the end of the process. The costs of a consultant vary from product to product, based on what services the consultant offers.
The total BIS certificate cost will depend on the items above, and although costs in each of the categories and schemes may be fixed, the BIS certificate cost is a necessary investment in ensuring legal compliance and trust from clients.
Sanctions for Non-Compliance
The BIS Conformity Assessment Regulations 2018 allow authorities to take serious action for violations as follows:
- Fines of up to ₹2,00,000 per product sold without certification.
- A daily fine of ₹5,000 for continued non-compliance.
- Seizure of goods at customs, warehouses, or markets.
- Legal prosecution for repeated or wilful violations.
- Blacklisting of the manufacturer or importer.
These sanctions are provided for in Section 29 of the BIS Act, 2016. It is important for businesses to comply in order to manage these legal and financially challenging consequences pro-actively.
How BIS Consultants Add Value
Using a conscientious BIS consultant can make the certification process much simpler:
- Scheme Selection: Finding the correct scheme to avoid doing procedures incorrectly.
- Documentation Support: Helping ensure that the test reports, technical files and declarations are compiled correctly.
- Laboratory Coordination: Working with BIS recognised labs to ensure testing is coordinated and streamlined.
- Auditing Preparation: Guidance on organisation, quality control and BIS expectations.
- Post License Services: Assistance with renewals, surveillance audits and using the mark correctly.
With companies like Diligence Certifications, businesses are able to avoid unnecessary red tape and eliminate common mistakes.
Conclusion
The BIS Conformity Assessment Regulations 2018 have changed the quality assurance landscape in India. The BIS programme provides a structured certification scheme, enforced standards, legal backing, and it assures customers that all products are safe and fit for purpose.
Manufacturers and importers need to consider these regulations seriously—not only to ensure compliance, but to build long-term trust in their brand. Whether it be a kitchen appliance, telecoms device or gold ornament—if it is regulated product, it needs to be certified by the BIS.
To access expert knowledge on standards, audits, administrative processes, testing arrangements, and trademark license, connect with Diligence Certifications, your BIS Certification Consultant.
Make sure your brand stands for trust. Make sure it’s BIS compliant.
Frequently Asked Questions
What is BIS Conformity Assessment Regulations, 2018?
It lays down certification schemes (ISI, CRS, FMCS, Hallmarking) to comply with Indian Standards and to ensure product quality.
Is BIS certification mandatory for all products?
No, it is only mandatory for products that fall under Quality Control Orders (QCOs), such as electronics, steel and gold.
What can happen if a company sells a product without BIS certification?
The potential penalties include fines up to ₹2 lakh, continued fines, seizures of product and/or imprisonment for those responsible.
What is the difference between ISI Mark and CRS?
The ISI certification scheme means audits and laboratory testing is conducted if they are industrial/household goods; whereas, indicating CRS means the product is electronic and that only laboratory tests are conducted.
How long is the certification process for BIS?
ISI/FMCS: 4-6 weeks; CRS: 2-3 weeks if all documentation/tests available to use.
Can a foreign manufacturer or supplier apply for certification?
Yes, foreign manufacturers can apply for BIS certification but they will go through FMCS only, and must appoint an Authorized Indian Representative. All testing will still be conducted in India.
Does BIS require license renewal?
Yes, the license must be renewed periodically every 1-2 years along with compliance report reports, company documentation, and periodic audting where appropriate.
What does a BIS consultant do?
They help determine which scheme works best for the company and facilitate the necessary documentation they will be required to submit, as well as assist to expedite approval.
Is BIS certification recognized internationally?
It was mainly designed to recognize Indian Standards, but once certified, it could help the business gain confidence in India requiring businesses knowing they have complied with Indian Standards for the location of India.
How much does BIS certification cost?
It depends on which scheme is used and the product itself; ISI tends to be the most expensive due to audits which will not be utilized in other schemes, while other schemes are less at order to expedite product testing.
