Quality Control

At Pioneer hygiene Products, Quality control is at par with global standards and covers manufacturing Hygienic films, Poly compound & Masterbathces, Medical Devices in a single premises. We have sourced refined laboratory equipment’s from the world’s leading manufacturers to outfit our units with an independent quality control department.

Different quality checks are taken into consideration for each step of processing. Our laboratory follows ISO 9001:2015 Quality Management guidelines for performing and ensuring best quality of raw materials, materials that are packed, in storage, in process and end products. We have skilled employed who have undergone rigorous training procedure to handle the quality control infrastructure.

To make sure that quality is maintained for the entire batch of products produced, we follow strict in-process monitoring practices. We identified the solutions that are innovative for maintaining the quality and the same is implemented for efficient quality assurance procedure.

TUV Nord

2

ISO 9001 : 2015

Pioneer Hygiene Products Certified for meeting the requirements of ISO 9001:2015 for Manufacture and Supply of Breathable and Non-Breathable Plastic Films & Non-Woven Laminated Fabrics

1

ISO 14001: 2015
Pioneer Hygiene Products Certified for meeting the requirements of ISO 14001:2015 for Manufacture of Breathable and Non-Breathable Plastic Films & Non-Woven Laminated Fabrics

3

BS OHSAS 18001 : 2007
Pioneer Hygiene Products Certified for meeting the requirements of BS OHSAS 18001:2007 for Manufacture of Breathable and Non-Breathable Plastic Films & Non-Woven Laminated Fabrics

FDA

Pioneer Hygiene Products (A unit of Vikram Nuvotech India Pvt. Ltd) is registered with the U.S Food & Drug Administration for FY 2020 pursuant to Title 21,807 et seq. of the United States Code of Federal Regulations.

1

Device Classification Name: Suit, Surgical
Product Code: FXO

Regulation Number: 878.4040

2

Device Classification Name: Non-Surgical Isolation Gown
Product Code: OEA

Regulation Number: 878.4040

3

Device Classification Name: Drape, Surgical, Exempt
Product Code: PUI

Regulation Number: 878.4370

4

Device Classification Name: Emergency Response Safety Kit
Product Code: OKI

Regulation Number: 878.4040

5

Device Classification Drape, Surgical
Product Code: KKX

Regulation Number: 878.4370

PHP’s Quality Management System shall be based on the logical approach to process and systems committing consistent quality of products and services in compliance with customer requirements, specifications and international manufacturing standards. We are in advanced stages of audits for the following proposed certifications.

ISO 13485:2016

ISO 13485:2016

CE

CE

GMP

GMP