The present pandemic has highlighted the significance of face masks. Wearing a face mask has become a requirement, whether you are leaving the house to pick up a package at the door or go shopping for everyday supplies. We may simply infer from the existing circumstances that these masks will continue to be used for a while. With covid-19 evolving under different circumstances & introducing different variants, the government has made it for manufacturers or importers to obtain a BIS ISI Certification for Mask. BIS ISI Certification for masks is necessary to gain the trust of your customers. So before you start marketing your masks, make sure they have undergone quality testing and have got BIS ISI Certification for Mask.
BIS Act
BIS has the authority to carry out commodity, facility, programme, and procedure compliance in accordance with the BIS Act of 2016[1], Rules, and Regulations that are laid out therein. BIS provides licences to use the standard mark or conformity certifications under the product certification scheme (PCS) – I, as outlined in the BIS (Conformity Assessment) Regulations, 2018. The 2018 BIS (Compliance Evaluation) Regulations outline the conformity assessment systems, which are based on IS/ISO/IEC 17067:2013 criteria.
What Is BIS Certification Issued For?
BIS Certification allows the certificate holder to provide third-party assurance of product quality, safety, and dependability to clients and is mostly necessary for the import of items. Although the certification was optional, the Government of India has made it compulsory for a handful of products. The ISI mark, which indicates that the product complies with the Indian standards specified by the Bureau of Indian Standards, may be used on items by a licensee who has the BIS ISI certification. After executing a safety test on the product in accordance with the established Indian Standard and receiving the necessary documentation, the Bureau of Indian Standards issues this certificate.
Various Types of Schemes under BIS Certification
The Bureau of Indian Standards (BIS) has three separate certification schemes, which are as follows:
- Indian Standards Institute (ISI)
- Foreign Manufacturers Certification Scheme (FMCS)
- Compulsory Certification Scheme (CRS)
Let’s understand each one of them in detail.
- Indian Standards Institute, also called ISI, is the certificate scheme under BIS (Bureau of Indian Standards), which confirms that a product withstands the BIS standards, which ensures safety.
- Foreign Manufacturers Certification Scheme, also known as FMCS, as per the BIS Act, 2016 and BIS (Conformity Assessment) Regulations, 2018, BIS has the power to provide a license to the Foreign Manufacturer who wants to sell their products in the Indian market.
- CRS or the Compulsory Registration Scheme under the Scheme II of Schedule II of BIS (Conformity Assessment) Regulations of 2018.
Though all these certification schemes are not applicable to masks, only ISI & FMCS are two certification schemes application on the same. Thus, to build credibility & trustworthiness, you need to obtain ISI & FMCS BIS certification for masks.
If you are wondering, out of ISI & FMCS, which one you are required to obtain, then please pay attention to the following:
ISI certification is applicable to Indian manufacturers, be it manufacturing food products, drinking water, cattle feed, and many more.
FMCS certification is only applicable to foreign manufacturers who want to sell their goods in the Indian market, be it food products, drinking water, cattle feed, and many more.
Who Can Apply For BIS ISI Certification For Mask?
- According to the scheme, Manufacturers of the products are notified whether they are located in India or outside India.
- The separate registration number for the goods being produced at various locations.
- The separate registration number for each brand that is manufactured at the same location.
List of Documents for BIS ISI Certification for Mask
Following is the list of all the documents that are needed for BIS ISI certification for Mask:
- PCB Layout
- Schematic Diagram
- Acknowledgement proof of online file submission;
- A copy of identity proofs, including the business license and other government documents;
- Application signed by the company’s CEO or a letter of authority from the CEO;
- Brand name registration certificate, or a copy of the trade mark application (if requested) or a letter of authorisation from the brand owner;
- Affidavit and undertaking for the approved Indian representative, along with proof of identity of the individual signing an affidavit if the manufacturer is located outside the country;
- Undertaking for test report;
- Original test report(s) from the specified laboratory, not being older than one month
- Form VI and VII.
List of Mandatory Documents for FMCS ISI Mark Certificate
The following are the mandatory documents that the applicant must have before starting the project:
- Registration documents of your factory/company
- Flow chart of your manufacturing process
- Details regarding manufacturing capabilities in-house and also outsourcing agreement of manufacturing operation, if applicable.
- Adequate facilities for testing
- Quality Control Parameters and their records
- Accept Scheme of Testing & Inspection and Annual Marking fee, laboratory product testing report and other information as per BIS norms and so on. The list of documents is quite tedious and can be obtained from BIS.
Process of BIS ISI Certification for Mask for Indian Manufacturer
The steps involved in the BIS ISI Certification for Mask process are as follows:
- Select the relevant product Code
- Fill out the BIS ISI mark registration form with all the required documents
- BIS authorised auditor to visit the manufacturing unit
- BIS agent will collect a sample and send it to BIS-authorised laboratories
- After receiving the results from the lab, the BIS authority will grant the licence
Procedure to Be Followed For Foreign Manufacturers Certification Scheme
The foreign manufacturer is required to set up a branch office in India; also, the applicant has to appoint an agent in India:
- Submit the application form to BIS in the prescribed format along with the required fee and the documents
- A preliminary inspection will take place at the applicant’s manufacturing and testing units.
- Additionally, samples will be taken for testing at independent labs.
- If the BIS is satisfied, they will issue the BIS Certificate, following which the applicant shall pay an annual minimum marking fee and annual license fee.
- BIS ISI certification will be valid for a period of one year.
Conclusion
Since the BIS Act of 2016 took effect on October 12, 2017, the BIS has served as India’s National Standards Body. Although acquiring a BIS licence is optional, BIS has made obtaining the certificate mandatory for particular products in order to safeguard buyers from fake and counterfeit goods. To get the BIS ISI mark certification on masks, a number of conditions must be met in accordance with the applicable standard.
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