Quality
Assurance
"Quality is never an accident; it is always the result of high intention, sincere effort, intelligent decision and skillfull execution; it represents the wise choice of many alternatives."
The DR. A.R. Medical Devices’ facility is an integrated manufacturing facility, producing finished products, in-house ETO sterilization as well as all quality inspections & testing. All facilities are maintained in strict compliance with international quality standards. All products are moulded in Class 10 and assembled in a controlled environment in a Class 8 clean room. Finished products follow a regimen of physical, biological and chemical tests before they are allowed to be dispatched to the consumer.
The ongoing analysis of data gathered through customer feedback & internal processes, followed by required corrective and/or preventive action, ensures for continuous improvement in our product and further enhances for deeper customer satisfaction.
The quality assurance process begins with constant surveillance of raw materials and its suppliers, intensive in-process control of all manufactured components and sub-assemblies to the final inspection and testing of the finished products.
Quality
Management System
The Quality Management System (QMS) is developed as per ISO 13485: 2016 to provide assurance that all systems are designed and implemented as per the national & international standard norms.
The QMS is based on the following strong pillars:
- Quality Policy
- Quality Risk Management
- Robust Technology
- Quality By Design
- Facility Designing as per international standards
- Standard Operating Procedures:-
- Compliance to Standard Operating Procedures
- Internal Audit System
- Role & Responsibility of Quality Assurance function
- Independent QA
- Well-equipped QC Laboratory
- Quality-control systems
- Well-equipped Microbiology Laboratory
