Benefits of ISO 13485 in Medical devices manufacturing
About ISO 13485 Certification?
ISO 13485 is a stand-alone QMS Certification. ISO 13485 is the International ISO standard addresses Quality Management System for Medical Devices. ISO 13485 is suitable for the manufacturers , distributors and suppliers of medical devices. It is required for the organization who are into the export of medical-devices to other nation to adopt ISO 13485. The primary objective of the standard is to maintain harmony between the management-system and legal-requirements . The one which is being followed to manufacture or trade the medical devices.
Applicability of ISO 13485 Certification?
The industry oriented standard ISO 13485 Certification is best of all type and size of organization . All the below given organizations are viable for the standard-
- organization designing the medical devices
- Manufacturers of surgical medical equipment
- Suppliers of medical devices
Benefits of ISO 13485 :
Organizations seek ISO 13485 to enjoy several financial-operational and other benefits. Here is a information of some main advantage of getting ISO 13485 Certification-
1. Ability to capture- large and new markets: obtain ISO 13485 will help the organization to cater new market and open doors for international markets. Large organization confirm 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 standard.
2. Show your propensity on delivering better quality Medical devices: The administrative structure of ISO 13485 is to inculcate medical-device quality management system (QMS) in organization. ISO 13485 certification to exhibit tendency on practicing and proffering-quality.
3. Builds reputation of the organization: The standard support to satiate the require of the customers/client which will give your organization confidence.
4. increase in the productivity and profitability of your organization: The engagement of employees/client shall boost which will result in increased profitability and productivity.
Requirements of obtaining ISO 13485 Standard
1. Quality management System (QMS): Quality Manual, , and Control of Records, all the essentials of QMS.
2. Management responsibility: It is the responsibility of the superiors to structure the framework to guarantee consumer/client loyalty and improvement.
3. Control of Documents This are covers all the assets of the organization
4. Product realization: arranging product requirement audit and controlling the gear used to screen and measure the product or management.
5. Measurement, Improvement and Analysis– This last section is responsible to fulfil the requirements expected to ensure whether your QMS is implemented in right direction or not.
About SIS Certifications : -
SIS Certifications is best ISO Cortication body. We offer ISO 13485 Certification in USA (Florida, Miami, Chicago, Boston, Austin, Washington) , UAE/Dubai, Kuwait, Saudi Arabia, KSA, Uzbekistan, Shri Lanka, Morocco, Denmark, Italy, Bangladesh, Afghanistan and any other countries. ISO 13485 Certification is beneficial for all organizations, regardless of size and sector. In the case of Medical Devices manufacturing .
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