Since last few decades Medical science has improved to many times. This has been possible only due to the medical devices ranging from Simple bandages, through life maintaining implantable devices, Diagnostic reagents and Kits, equipment to screen to the most important sophisticated diagnostic imaging and minimal invasive surgery equipment.
Organizations in the medical devices industry need to take intensive care of the quality of the product they are manufacturing, the safety and security of the materials they are using to manufacture the devices, the environmental impact that can arise during the manufacture of these devices, the health and safety of the staff and employees as the manufacturing can involve the usage of highly hazardous chemicals and reagents.
SIS portfolio of schemes related to Medical Device manufacturers and service providers are as below:
Quality Management System for Medical Devices- ISO 13485
The ISO 13485 is a quality system which has been exclusively designed for the organizations who are involved in the manufacturing of Medical devices. It intends to promote the harmonization in the medical device industry and set a basis for quality system and quality products worldwide. Read More
Quality Management System – ISO 9001
The ISo 9001 Certification aims in providing the customer satisfactions, reaching the needs and expectations of the interested parties and providing a global standard that spells out the quality, trust and readiness. It is also called as QMS- Quality management system and is applicable to all the types of industries.Read More
Environment Management System
During the manufacturing , there are various operations involved where the action can lead to significant impact on the environment. During this requirement, lot of natural resources are misused or not used wisely and lot of such activity which lead to impact on the environment takes place. ISO 14001- EMS- Environmental management system is Dedicated to Management the optimum use of These natural resources so that the activities involved give a minimum impact on the environment. Read More
Occupational Health Safety Management System
To make sure that there is always a check on the safety practices that are being maintained during the work at site. OHSAS 18001 Certification Standard helps you to understand and follow a safety driven management system which takes care of all possible hazards which can occur during the course time which helps the organization to develop such a product which is ultimately safe and secure. OHSAS 18001/ISO 45001 Certification establishes a recognized management system and demonstrates the organization’s commitment to provide a safe working environment to protect the employees Other concerns.Read More
To gain the confidence of the customers and self confidence that the product which are being used during the manufacture of the product are safe and secure. The product which has been manufactures comprises of various steps of manufacturing and various different parts, the safety and security of the product during the manufacture is determined by testing the product and maintain the documentations as per the relevant directives.