BIS Certification of Face Shield

OMEGA QMS Expert Certification Services

As per the Government of India, BIS Certification of Face Shield is mandatory to own for a Personal Protective Equipment (PPE) Manufacturers. According to the latest official memorandum by the Department of Pharmaceuticals, the procurements agencies need to follow Indian Standards (BIS) standards along with USFDA/CE certification for making face shields. Trust Omega, leading consultants for getting Face Shield BIS certification as per IS 5983. Experts will assist you in ensuring that all the standards/parameters are being diligently followed while producing the equipment. The best manufacturing companies use BIS standards to provide quality, durable and reliable products to protect against vulnerable diseases and hazards. Remember, only manufacturers with complete in-house testing facilities are granted licenses.

Testing and Inspection Scheme for BIS Certification of Face Shields

Laboratory: Well-equipped laboratory should be maintained. Skilled staff is hired to carry of frequent tests as per BIS methods.
Test Records: The records by maintained as acceptable by BIS. They can ask for a copy of any record or chart any point of time, so it is important you have it in an orderly manner.
Quality Control Methods: Statistical Quality Control (SQC) methods should be followed while production of face shields. Quality Management System should be introduced in accordance with IS/ISO 9000.
Marking: All the products should mention in clear visible and durable ink the following:
- (a) Identification of the Manufacturer: Name, Trade Mark
- (b) Batch No. or Serial No
- (c) BIS License No. (CM/L-----------------------)
- (d) Sub-assemblies and components with the considerable bearing on safety should be marked
- (e) Date of Manufacture

There are mandatory schemes and specifications for face shield manufacturers to follow. Omega is here to provide single-window solutions to BIS certification requirements and procurement.

Complete Umbrella Solution for BIS Certifications

Getting a direct certification can be a tough task and even a single mistake can make your efforts futile. Omega has a team of professional experts and equipment required to ensure that your manufacturing unit complies with BIS standards efficiently and follow the specification effectively. We have detailed information about the BIS requirements for face shield as updated in 2020 latest notification.

Our experts will help you analyze each process and mark deviation as per BIS needs.
Help you provide quick approval.
All necessary methods to test your product are available in our advanced lab.

Frequently Asked Questions

Is BIS certification mandatory for face shield manufacturers in India?

Yes, BIS certification of face shields is mandatory for Personal Protective Equipment (PPE) manufacturers in India. As per the Government of India, according to the latest official memorandum by the Department of Pharmaceuticals, procurement agencies need to follow Indian Standards (BIS) standards along with USFDA/CE certification for making face shields.

Only manufacturers with complete in-house testing facilities are granted licenses to produce certified face shields.

Which Indian Standard applies to face shield certification?

Face shield BIS certification is governed by IS 5983 standard. Manufacturers must ensure that all the standards and parameters specified in IS 5983 are being diligently followed while producing the equipment to ensure quality, durability, and reliable protection against vulnerable diseases and hazards.

What marking requirements must be followed on certified face shields?

All face shield products must mention the following in clear, visible, and durable ink:

Identification of the Manufacturer: Name and Trade Mark
Batch No. or Serial No.
BIS License No. (CM/L-----------------------)
Date of Manufacture
Sub-assemblies and components with considerable bearing on safety should be marked

These marking requirements ensure traceability and compliance with BIS standards.

What laboratory and testing requirements are needed for BIS certification of face shields?

Manufacturers must maintain a well-equipped laboratory with skilled staff hired to carry out frequent tests as per BIS methods. Key requirements include:

Laboratory facilities: Complete in-house testing facilities are mandatory for license grant.
Test records: Records must be maintained as acceptable by BIS. They can ask for a copy of any record or chart at any point of time, so orderly maintenance is essential.
Quality control methods: Statistical Quality Control (SQC) methods should be followed while producing face shields.
Quality Management System: Should be introduced in accordance with IS/ISO 9000.

How can Omega QMS help with face shield BIS certification?

Omega QMS provides a complete umbrella solution for BIS certifications. Our team of professional experts helps ensure that your manufacturing unit complies with BIS standards efficiently and follows specifications effectively. We have detailed information about the BIS requirements for face shields as updated in 2020 latest notification.

Our services include:

Process analysis: Our experts will help you analyze each process and mark deviation as per BIS needs.
Quick approval: Help you provide quick approval.
Advanced lab testing: All necessary methods to test your product are available in our advanced lab.

Since getting a direct certification can be a tough task and even a single mistake can make your efforts futile, Omega provides single-window solutions to BIS certification requirements and procurement.