Advantage of implementing ISO 13485 Certification in Medical devices Manufacturing
What is ISO 13485 Certification?
ISO 13485 Certification is the International ISO standard addresses QMS- MD (Quality Management System for Medical Devices). ISO 13485 Certification is suitable for the distributors, manufacturers and suppliers of medical devices. It is required for the companies who are into the export of medical devices to other nation to adopt ISO 13485 Certification. The primary objective of the standard is to maintain harmony between the legal-requirements and the management-system, the one which is being followed to manufacture or trade the medical-devices.
Advantage of implementing ISO 13485:
Organizations seek ISO 13485 Certification to enjoy various financial-operational and other advantages. Here is a details of some main benefits of achieve ISO 13485 Certification-
1. Ability to captur- large and new markets: Getting ISO 13485 will support the organization to cater new-market and open-doors for worldwide markets. Large organization ensure that sub-contractors have certified them-selves with ISO 13485 Certification or not. Means organization prioritize the contractors who have certified themselves with ISO 13485.
2. Show your tendency on delivering best quality devices: The administrative structure of ISO 13485 is to inculcate medical device quality management system in organization. ISO 13485 Support to exhibit tendency on practicing and proffering-quality.
3. Consolidate the business knowledge
4. Builds credibility of the company: ISO 13485 Certification suport to satiate the require of the customers which will provide your organization confidence.
5. Increase in the productivity and profitability of your organization: The engagement of employees shall grow which will output in increased profitability and productivity.
Applicability of ISO 13485 Certification?
The industry oriented ISO 13485 is apt for all the big and small organizations dealing with medical devices. All the below given organizations are viable for the ISO standard-
- Suppliers of medical devices
- Manufacturers of medical-devices
- Manufacturers of surgical-medical equipment
- Companies designing the medical devices
Requirements of getting ISO 13485 Standard
1. Quality management System: Quality Manual, Control of Documents, all the essentials of QMS
2. Management responsibility: It is the responsibility of the superiors to structure the framework to ensure consumer loyalty and growth.
3. Resource management: ISO 13485 are covers all the assets of the organization
4. Product realization: arranging product require audit and controlling the gear used to screen and measure the product or management.
5. Analysis, Measurement and Improvement – This last section is responsible to complete the need expected to ensure whether your QMS is implemented in right direction or not.
FAQ :-
Q. What is cost of ISO 13485 Certification?
Q. How can i get ISO 13485 Certification for medicle device manufacturer?
Q. What is process of ISO 9001 Certification?
Q. What is QMS?
Q. What are benefits of ISO 13485 Certification?
Related blog : -
