Big Relief for Manufacturers BIS Relaxes In-House Lab Requirement For Product Certification

The Bureau of Indian Standards (BIS) has introduced an important regulatory update that removes the mandatory requirement for manufacturers to maintain an in-house laboratory under the BIS Product Certification Scheme. This is a significant step forward in simplifying compliance and reflects a more practical and business-friendly approach to quality regulation in India.

Earlier, manufacturers were required to set up and maintain a fully equipped in-house testing laboratory as part of the BIS certification process. This meant investing in infrastructure, purchasing advanced testing equipment, and employing trained technical staff to carry out product testing in line with Indian Standards. While this ensured strong quality control, it also created a considerable financial and operational burden—especially for MSMEs and smaller manufacturers.

With the latest notification, BIS has now provided manufacturers with the following options for product testing:-

This reform is intended to promote the "Make in India" initiative by reducing the cost of compliance and lowering entry barriers for new businesses. However, it is important to note that manufacturers must still ensure that their products meet all the prescribed quality and safety standards as per the relevant Indian Standard (IS). The responsibility for product quality remains with the manufacturer because With the latest notification (16 December 2025),BIS has made the in-house lab optional and introduced multiple alternatives options for product testing and regular monitoring, market surveillance, and factory inspections will continue to be applicable.

Accepted External Labs Include:

• Utilizing shared laboratory facilities
• Engaging BIS-recognized or accredited external laboratories for routine testing

This flexibility ensures that manufacturers can maintain compliance without heavy infrastructure investment.

Impact on Manufacturers

This regulatory change is expected to bring several positive outcomes for the manufacturing sector:-

• Lower Costs: Businesses can avoid significant capital investment in laboratories and equipment.
• Simplified Compliance: Certification procedures become more straightforward and flexible.
• Support for MSMEs and Startups: Smaller manufacturers can now enter the market more easily without heavy infrastructure requirements.
• Better Focus on Core Activities: Companies can concentrate more on production, innovation, and product development instead of regulatory setup.

Overall, this move supports the government's vision of improving the ease of doing business in India and fostering a more dynamic industrial environment.

Quality Assurance Responsibility (QAP)

Step - 1 : A new update has been made for the Quality Assurance Plan (QAP). Now, BIS testing schemes are not compulsory—they are only for guidance. This means manufacturers have more flexibility. However, they still need to create and follow a QAP that includes regular testing and checks during production to make sure the product meets all requirements of the Indian Standard (IS).

Step - 2 :Manufacturers must create their own QAP and clearly mention:

• What will be treated as a control unit (like lot or batch)
• How often testing will be done and how many samples will be tested
• Where testing will be done (in-house, shared lab, or external approved lab)

This QAP should be shared with the BIS Branch Office for information. Manufacturers must follow this plan and keep proper test records.

Step - 3 : Even though manufacturers have more flexibility now, they are fully responsible for product quality. They must always make sure their products meet the required Indian Standards.

What Remains Unchanged?

Despite this relaxation, regulatory oversight continues to remain strong:

• Factory inspections will continue to verify compliance
• Market surveillance remains active to monitor product quality in real conditions
• Penalties for non-compliance still apply and can be strictly enforced

Conclusion

The recent BIS update has relaxed the rule that companies must have their own in-house laboratory. This shows that India is moving towards a more practical and business-friendly system. Now, manufacturers can choose flexible testing options like shared Authorized labs or approved external laboratories.

This helps reduce costs while still maintaining good quality standards. This change makes the certification process easier and helps small businesses (MSMEs) and new companies enter the market more easily. At the same time, inspections, market checks, and strict responsibility for product quality will continue. So, even with more flexibility, companies are still fully responsible for maintaining quality.

Lower Costs: Businesses can avoid significant capital investment in laboratories and equipment.

Simplified Compliance: Certification procedures become more straightforward and flexible.

Support for MSMEs and Startups: Smaller manufacturers can now enter the market more easily without heavy infrastructure requirements.

Better Focus on Core Activities: Companies can concentrate more on production, innovation, and product development instead of regulatory setup.

FAQs

1. What is the latest BIS update about?

The Bureau of Indian Standards (BIS) has removed the mandatory requirement for manufacturers to maintain an in-house laboratory under the Product Certification Scheme. This makes compliance easier and more flexible.

2. Is having an in-house laboratory still required?

No, it is no longer compulsory. Manufacturers can choose whether or not to maintain an in-house lab.

3. Does this mean quality standards are relaxed?

No, quality standards are not relaxed. Products must still fully comply with the applicable Indian Standards (IS).

4. Who is responsible for product quality now?

The manufacturer is fully responsible for ensuring that their products meet all required standards at all times.

5. What is the Quality Assurance Plan (QAP)?

A QAP is a plan created by the manufacturer that defines how product quality will be maintained through regular testing and production checks.

6. Is following BIS testing schemes still mandatory?

No, BIS testing schemes are now recommendatory (guidelines). However, manufacturers must still create and follow their own QAP.