Prerequisite of BIS FMCS

FMCS stands for Foreign Manufacturers Certification Scheme. FMCS-certified manufacturing companies provide licenses to such foreign manufacturers who conform to the standards of BIS. BIS (Bureau of Indian Standards) ensures standardization, marking, and quality of products. 

FMCS ensures that the products that are available in the Indian Market for consumption are of high quality, thus securing public health. 

International Manufacturers who are willing to begin or expand their trade In India would require to acquire all the documents that they are required to submit to the BIS FMCS authority during the time of Registration. Here at our site, you will be informed about all the requirements that you will be needing in detail during your Registration. 

Table Of Content

Requirements of BIS FMCS

• Location of factory premise: Any Manufacturer who wishes to obtain FMCS must ensure that their manufacturing unit is located outside India. Any foreign manufacturer whose manufacturing activities, in other words, the whole manufacturing process is performed at a factory located abroad. 
• Product Compliance: Foreign or International Manufacturers must ensure that their products are compliant with the Bureau of Indian Standards. They must look after the quality of the product so that it is not a threat to public health, animals, the environment, and national security. As stated in BIS Standards, the applicant must consider the safety, reliability, and efficiency of the product. 
• Available Machinery and Testing Facilities: The applicant must ensure that their manufacturing unit comprises all the equipment that is used for the manufacturing activities as well as the equipment that is used for conducting an audit of the factory premise. The manufacturer must have an established In-House Laboratory present at the site to assess the product samples regularly along with at the time of an audit. It helps in maintaining the quality standards of the manufacturer. 
• Scheme of Inspection and Testing: The company must accept the established scheme of Inspection and Testing. The SIT ensures the manufacturing company matches the standards of BIS by testing the products regularly. Similarly, it should accept the Inspection and Annual Marking Fee. The annual Marking Fee refers to the payment of the utilization of Standard Mark to the BIS. 
• Terms and Conditions: The manufacturer is mandated to accept the terms and conditions of the BIS, ensuring compliance with the BIS standards as well as the cooperation for paying the required fees to progress the processing. 
• Separate Application Form: The manufacturer is required to submit a separate application form for each product or factory location that a manufacturing company is obtaining FMCS certification for. 
• Nominee for the foreign company: The manufacturing unit must appoint a nominee to represent itself in front of the BIS FMCS authorities within India. The nominee is called Authorized Indian Representative. As the name suggests, the representative must be an Indian Resident containing the entire knowledge of FMCS rules and regulations as well as of the manufacturing company. AIR takes care of the communications with BIS related to the product, arrangements of inspection at the on-site premises, sample testing within India, submission of all the needed documents, etc. 
• Quality Control Personnel: The manufacturer requires a competent person to assist with the quality control procedures at the location. He/ She makes sure to keep a check on the quality standards of the company.

Documents for FMCS Registration : 

• Factory Registration Documents: The manufacturer has to submit the registration certificate of the factory premises. 
• Business License and ISO certification: This demonstrates that the business or factory has an ISO certification and is registered with the necessary authorities. When issued in a language other than English, all certifications must be mandatorily translated into English.
• Nomination of AIR: The manufacturer must submit the details of the appointed AIR. A signed letter from the organization is submitted assigning the authority to the Indian agent for representing itself on behalf of them.
• Flow Chart of Manufacturing Process: A detailed description of the procedure of manufacturing activities performed at the site maintaining the quality standards of the company.
•  Test Reports: The manufacturing unit must contain the results of the sample testing of the product. The sample testing is performed at the In-House Laboratory established for assessing the sample’s efficiency. Also, the manufacturer must contain the reports of BIS’ independent labs after the inspection is conducted. 
• Schematic Drawing of Item:  The manufacturer must contain the sketches of the applicable product or its components for better decision-making of BIS authorities. 
• Raw Material List: The manufacturer must consist of a meticulous list of the raw materials used for the manufacturing of the product.
• Raw Material Certificate: The manufacturer must assemble all the certifications of raw materials used in the process that assures BIS authority of product quality parameters.
• Testing Equipment: This includes all the machinery or facilities that are used to determine the company’s compliance with BIS FMCS standards. It includes in-house laboratories established for the above-mentioned purpose.
• Layout of location: This includes the whereabouts of the factory as well as the structure plan of the location for the use of BIS FMCS authority. 

Conclusion

The BIS FMCS requirements are designed to ensure that products manufactured outside of India meet the same high standards as products manufactured in India. The requirements cover a wide range of areas, including the manufacturing unit location, product conformity, manufacturing machinery and testing facilities, product testing equipment and quality control personnel, Scheme of Inspection & Testing (SIT), terms and conditions of the Licence, and the documents that must be submitted with the application.

The BIS FMCS requirements are a set of standards that help to ensure the quality of products manufactured outside of India. This can help to improve the reputation of the manufacturer and their products, and it can also open up new markets for their products.