ISO 13485 Certification Process

  • September 27, 2018
  • Registrationwala
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If you are in a medical industry that provides medical devices, you need to make sure that the quality management system of these devices is trusted. Making such QMS trustworthy is the job of the ISO 13485 standard. Through the ISO 13485 Certification process, you can certify that your medical devices are up to international standards. Throughout the course of this blog, looking into this process is going to be our focus. 

Process of ISO 13485 Certification:

ISO-13485 certification in India is something that you need if you want to manage the quality of your medical devices. However, the process associated with this certification is quite generic and it consists of the following steps:

  1. Getting the ISO 13485 standard and train: if you want the certification, you need to be confident enough that you are up to the international standards. Therefore, you need to get the standard first and train the employees according the standard.
  2. Application: Now, once you are confident enough, you need to apply for the certification through an online or offline application. For that, you would need an ISO expert to assist you. With the application, you will need to the submit the quality management system’s 
  3. Auditing: the application and the policy document will then be audited by an auditor of the ISO body. They are going to examine several aspects of the quality management system.
  4. Certification: if the auditing yields the positive result, you are going to get this certification. 

Once you have the ISO 13485 certification, you have access to:

  1. Better quality of medical devices
  2. Better budgeting for your company
  3. Better employees
  4. More trust from the customers
  5. More economical benefits. 

Now, that you know that ISO 13485 can do for you, are you willing to certify yourself? If so, you should get in touch with Registrationwala and get the right ISO experts to get this certification. 

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