What is ISO 13485 Certification?
ISO 13485 Certification is the worldwide standard addresses QMS- MD (Quality Management System for Medical Devices). This standard is applicable for the manufacturers, distributors and suppliers of medical devices. It is obligatory for the companies who are into the export of medical devices to other countries to adopt ISO 13485. 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.
Benefits of implementing ISO 13485 Standard
Companies seek ISO 13485 Standard to enjoy various financial operational and other benefits. Here is a list of some major advantage of accomplishing ISO 13485 Certification-
1. Ability to capture large and new markets: Accomplishing ISO 13485 Standard will help the associations to cater new market and open doors for international markets. Large companies ensure that sub-contractors have certified themselves with ISO 13485 or not. Means companies prioritize the contractors who have certified themselves with ISO 13485 Standard.
2. Exhibition your tendency on delivering quality devices: The administrative structure of ISO 13485 Certification in Indonesia is to inculcate quality management system in organization. This helps to exhibit tendency on practicing and proffering quality.
3. Consolidate the business knowledge
4. Builds credibility of the company: The standard helps to satiate the needs of the customers which will give your company confidence.
5. Boost in the productivity and profitability of your organization: The engagement of employees shall increase which will result in increased productivity and profitability.
Applicability of ISO 13485 Certification?
The industry oriented standard ISO 13485 is apt for all the small and big organizations dealing with medical devices. All the below given organizations are viable for the standard-
- Manufacturers of medical devices
- Suppliers of medical devices
- Companies designing the medical devices
- Manufacturers of surgical medical equipment
Requirements of obtaining ISO 13485 Standard
1. Quality management System: Quality Manual, Control of Documents, 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 loyalty and improvement.
3. Resource management: This are covers all the assets of the company
4. Product realization: arranging product necessities audit and controlling the gear used to screen and measure the product or management.
5. Measurement, Analysis and Improvement — This last section is responsible to fulfil the requirements expected to ensure whether your QMS is implemented in right direction or not.
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