Quality at Harsoria Healthcare

Harsoria prides itself on rigorous Quality Control with Triple-Testing, i.e. testing at the Incoming, In-Process and Finished Goods Stages. Our team of dedicated and diligent QC and QA professionals conduct various visual, dimensional, functional and microbiological tests to ensure compliance with product standards such as ISO 10555-1 and -5 for IV Catheters, ISO 80369-7 for Luers and Stop Cocks and ISO 11070 for Hemodialysis Catheters and Vessel Dilators. The Physical Testing Laboratory operates 24-hours to ensure samples are drawn for functional tests such as flow rates, leakage and penetration force from each production shift. Qualified micro-biologists conduct Sterility Testing on all finished production lots as per US Pharmacopoeia, in addition to other micro-biological evaluation for product and environment bio-burden. Furthermore, all production processes and equipment are Validated on a periodic basis to ensure highly reliable and repeatable manufacturing.

Our dedicated and in-house QA and Regulatory team ensures that we continue to meet and exceed the stringent requirements of international standards. This enables us to register our products in multiple countries worldwide and satisfy documentary requirements of customers as well as regulators. Today, Harsoria holds ISO 13485:2016 as well as MDSAP Certification from TUV Sud, along with CE Certification from DNV Product Assurance, Norway, in addition to USFDA Registration and 510(k) Approvals.

Harsoria strives to provide the highest-quality medical devices by inculcating:

  • Empathy with end users and a deep concern for their well being in every single Harsoria employee.
  • Discipline and an uncompromising adherence to strict tolerances at every stage of quality control.
  • Standardization in all products through an automated and tightly controlled environment.

Quality Objectives

  • To produce quality products with built-in safety to meet well defined need, use and purpose of customers.
  • To comply with statutory and regulatory requirements.
  • Judicious and efficient utilization of resources. Conservatiom of water and energy.
  • Promoting innovations and development of new products/processes.
  • Monitoring and enhancing process capability by adopting Statistical Quality Control, Total Quality Management and total Productive Maintenance and similar Quality Management Tools.
  • Adherence to CE guidelines and provisions.
  • To achieve Continual Improvement in Customer Satisfaction in terms of Product Quality, Availability and Services.
  • To improve competence and skill of each employee by identifying the current and future requirements and bridging the gap by providing training and multi-skilling.
  • To control and contain the level of rejection/scrap.
  • To develop a team of motivated, dedicated and devoted workforce that encourages professional excellence.

Quality Certification