BIS Certification of PPE Coveralls
For Manufacturers of Personal Protective Equipment (PPE) coverall manufacturing, Bureau of Indian Standards (BIS) is mandatory. With the rise of infectious diseases like COVID-19, competitiveness and complexity of the PPE industry have increased. Whether you’re a manufacturer of coveralls, safety gloves, face masks or eye protectors, etc, PPE kits require maintaining quality via testing and meeting certification requirements. Best PPE Manufacturers in India use Global Omega QMS for the BIS Certification of PPE Coveralls as per IS 17423:2020. We provide professional guidance to PPE coverall manufacturers for hassle-free and genuine BIS certification services.
Why Do You Require BIS Certification for PPE Coveralls?
Bureau of Indian Standards (BIS) Certification, also known as ISI (BIS Act 1986) was introduced to regulate and confer a statutory status of ISI for promotion of mandatory quality, reliability and safety of certain products considered necessary in terms of Health, Environment, Safety, Consumer Security, etc. PPE Kits is among those products which are under compulsory certification and maintenance of standards by the Government of India. They are considered essential by healthcare professionals who are treating COVID-19 patients. Thus, getting BIS certification ensures the avoidance of inferior quality PPE gowns.
Important Information for PPE Kit Manufacturers Seeking BIS Certification 2020
Without BIS Certification, you cannot manufacture or sell PPE coveralls or PPE kits. Therefore, getting a certification has been made mandatory as specified by the Ministry of Health and Family and Textile Ministry for coveralls. Bureau of Indian Standards (BIS) as per Medical Device Rules 2017 are need to be followed. It should complement Make in India campaign to support economy hit by COVID-19. The Drugs Controller General of India (DCGI) has asked all the PPE manufacturers to voluntarily register on portal. As per a source, Sanjiv Rehlan, chairman, Preventive Wear Manufacturer Association of India (PWMAI) asks manufacture to follow QMS system like ICMED/ISO 13485 to ensure that the output is qualitative and meets customer satisfaction.
Getting ISI Market – BIS Certification of PPE Coveralls Benefits
Getting an ISI certification of BIS ensures quality which builds the trust of buyers and your associates! People invest in products that promise to deliver reliability. Products developed and manufactured under the Bureau of Indian Standards (BIS) get ISI Mark. The Government of India (GOV) has promoted and encourages customers to go for products that have BIS certification and ISI Mark. Nowadays, it has become the best standards for measuring the quality of a product. The advantages of getting BIS certification services are as follows:
- BIS builds customer trust as it ensures better safety and quality.
- Manufacturing is done under compliance with Indian Standard Quality.
- Easily Expand Business as you are Eligible to Sell pan India.
- Better Customer Satisfaction
- Government of India prioritizes those with ISI mark products for purchase through tender.
Best PPE Coveralls BIS License Consultants in India – Omega QMS
We are the prominent BIS certification consultants in India
- Fast and Reliable ISI or BIS certification documentation to reduce the period of owning an ISI marketing license from BIS for PPE Coverall/Gowns.
- We have a team of professional personnel who will ensure that the complete production procedure and process is under compliance with BIS standards IS 17423:2020.
- Any deviation or discrepancies are provided to the manufacturer along with training at all levels.
Frequently Asked Questions
What is IS 17423:2020 and why is it important for PPE coveralls?
IS 17423:2020 is the Indian Standard specification for personal protective equipment (PPE) coveralls, specifically designed to protect healthcare workers and frontline personnel from infectious agents and biological hazards.
This standard specifies the requirements for:
- Material performance: Barrier properties, tensile strength, and tear resistance of coverall fabrics
- Design features: Construction requirements including seams, closures, and coverage areas
- Protective characteristics: Resistance to liquid penetration, blood-borne pathogens, and viral contamination
- Safety and comfort: Breathability, flexibility, and wearability standards
Adherence to IS 17423:2020 ensures that PPE coveralls provide adequate protection against infectious diseases like COVID-19 while maintaining quality, safety, and reliability standards mandated by the Bureau of Indian Standards (BIS).
Is BIS certification mandatory for PPE coveralls in India?
Yes, BIS certification is mandatory for PPE coveralls in India. The Government of India, through the Ministry of Health and Family Welfare and the Ministry of Textiles, has made BIS certification compulsory for the manufacture and sale of PPE coveralls.
This mandatory certification requirement ensures that:
- Only quality-tested PPE coveralls conforming to IS 17423:2020 are available in the Indian market
- Healthcare workers and frontline personnel receive adequate protection against infectious diseases
- Inferior quality or substandard PPE products that could endanger lives are prevented from entering the market
- Manufacturers comply with Medical Device Rules 2017 as specified by the Drugs Controller General of India (DCGI)
Without BIS certification and the ISI mark, you cannot legally manufacture or sell PPE coveralls in India. Non-compliance can result in legal penalties and market restrictions.
What are the key benefits of obtaining BIS certification for PPE coveralls?
Obtaining BIS certification and the ISI mark for PPE coveralls provides multiple strategic and commercial advantages:
Market Access and Legal Compliance:
- Legal authorization to manufacture and sell PPE coveralls across India
- Pan-India market access with eligibility to participate in government tenders and procurement programs
- Priority in government purchases: Government agencies prioritize ISI-marked products for procurement
Business and Brand Advantages:
- Enhanced customer trust and confidence: BIS certification signals commitment to safety, quality, and reliability
- Competitive differentiation: ISI mark distinguishes your products from uncertified or inferior alternatives
- Higher customer satisfaction and loyalty due to proven quality standards
- Market reputation and brand credibility backed by a nationally recognized quality seal
Operational Excellence:
- Manufacturing excellence: Ensures production processes comply with Indian Standard Quality requirements
- Quality assurance: Systematic quality management through BIS-mandated testing and inspections
In summary, BIS certification is not just a legal requirement — it is a strategic business asset that drives trust, market access, and long-term growth.
What is the general BIS certification process for PPE coveralls?
The BIS certification process for PPE coveralls follows a structured, step-by-step approach to ensure compliance with IS 17423:2020. Here is the general process:
1. Application and Documentation:
- Submit an application to BIS under the relevant certification scheme
- Provide required documents including technical specifications, manufacturing process details, company registration, quality management system documentation, and test reports
2. Product Testing:
- Product samples are tested at BIS-recognized laboratories to verify compliance with IS 17423:2020 requirements
- Testing covers material performance, barrier properties, liquid penetration resistance, tensile strength, and other critical parameters
3. Factory Inspection:
- BIS officials conduct an inspection of your manufacturing facility to assess production capabilities, quality control systems, and compliance with BIS standards
- Any deviations or non-conformities identified during inspection must be corrected before approval
4. Grant of License:
- Once testing and inspection requirements are successfully met, BIS grants a certification license authorizing the use of the ISI mark on your PPE coveralls
- You can now legally manufacture, market, and sell BIS-certified PPE coveralls in India
5. Ongoing Compliance and Surveillance:
- Periodic surveillance audits and sample testing to ensure continued compliance with BIS standards
- Maintain quality management systems and production processes as per approved standards
Omega QMS provides end-to-end support throughout the BIS certification process, including documentation assistance, testing coordination, factory readiness, and compliance training to ensure a fast, hassle-free certification experience.
