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Introduction

BIS certification for Shoe Covers ensures that these protective products meet Indian quality and safety standards as outlined in the Indian standard IS 17349: 2020. Following the Medical Textiles (Quality Control) Order, 2023, issued by the Ministry of Textiles, it is mandatory for manufacturers to obtain BIS certification before selling Shoe Covers in the Indian market. This certification allows manufacturers to use the ISI Mark on their products, indicating compliance with the required standards. Ensuring quality and safety through BIS certification is crucial for maintaining high hygiene standards in industries like healthcare, where shoe covers play an essential role in infection control.

Why is BIS Certification for Shoe Covers Necessary? 

BIS certification is necessary for Shoe Covers to ensure they meet the prescribed quality, safety, and performance standards under IS 17349: 2020. Poor-quality shoe covers can result in contamination, which is particularly dangerous in medical and cleanroom environments. The Medical Textiles (Quality Control) Order, 2023 mandates BIS certification to ensure that only products adhering to regulated standards are sold in the Indian market. Non-compliance can result in penalties under the Bureau of Indian Standards Act, 2016, making certification vital for market access and product reliability.

BIS QCO for Shoe Covers

Overview of Indian Standard IS 17349: 2020 

IS 17349: 2020 specifies the requirements and testing methods for Shoe Covers used in medical, industrial, and other sensitive environments. This standard outlines essential characteristics like material strength, impermeability, resistance to tearing, and proper fit. Compliance with IS 17349: 2020 ensures that Shoe Covers provide effective protection against contamination and meet durability and safety standards. Manufacturers must adhere to this standard to obtain BIS certification, which is mandatory as per the Medical Textiles (Quality Control) Order, 2023, for selling shoe covers in the Indian market.

Process for BIS Certification

The BIS certification process for shoe covers involves multiple steps, designed to thoroughly evaluate a product's compliance with the required standards. Here is a general overview of the certification process:

1. Application Submission: Manufacturers must submit an application form along with required documentation to BIS.

2. Documentation Review: BIS reviews the submitted documents to ensure completeness and correctness.

3. Factory Inspection: BIS officials conduct an on-site inspection of the manufacturing facility to assess the production process and quality control measures.

4. Sample Testing: Product samples are taken and tested in BIS-approved laboratories to verify compliance with Indian standards.

5. Certification Grant: Upon successful completion of the inspection and testing, BIS grants certification, allowing the manufacturer to use the BIS mark on their products.

Documents Required for BIS Certification

To apply for BIS certification, manufacturers need to submit the following documents:

●      Application form

●      Manufacturing process details

●      Quality control plan

●      Test reports from BIS-approved laboratories

●      Factory layout and equipment details

●      Proof of business registration

●      Product specifications and technical details

●      Declaration of conformity to Indian standards

Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.

BIS Documents For Domenstic and Foreign Manufacturer Check

To Know The Process in Detail, Please Visit:

Conclusion
In conclusion, BIS certification for Shoe Covers ensures adherence to Indian standards for quality, safety, and performance, particularly as mandated by IS 17349: 2020. The certification process, required under the Medical Textiles (Quality Control) Order, 2023, guarantees that only compliant products are sold in the Indian market, ensuring reliability and hygiene.

Navigating the BIS certification process can be challenging, especially for small and medium-sized enterprises. EVTL India is a leading consultancy firm dedicated to assisting manufacturers in obtaining BIS certification (ISI Mark) efficiently. With expertise in managing BIS portal submissions, documentation, and regulatory fees, EVTL India ensures a smooth and successful certification process. By choosing EVTL India, manufacturers can enhance their product's marketability both in India and internationally, securing a competitive edge. Additionally, EVTL India provides ongoing support post-certification, helping manufacturers maintain compliance with BIS standards and renew their licenses as needed.