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ISO 13485:2016
Medical devcie Quality Management System Building Training

ISO 13485 is a QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Some countries had the law that require the medical devices company need to apply QMS standard. This standard will help the company:

  • Knowing their roles based on the present laws.

  • Knowing the requirement of laws that apply for company.

  • Combine the requirement of present laws with their QMS standard.

ISO 13485:2016 Implementation

Building a Quality management system - Medical device and applying 13485:2016 certification specifically for your business, Won-Med will make the implementation process of your business as simple as possible.

This standard is open to all organizations, whether your organization is: a small business, a global corporation, a nonprofit organization, a charity, a training organization, or a government organization,...

As long as your organization carries out the production and business of medical equipment, medical services in general (for example: medical masks, medical protective equipment, disinfectant solutions, sterilization equipment for medical products, endoscopes, infusions, ...)

Are you ready to apply ISO 13485:2016?

The structure of ISO 13485 is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System.

The ISO 13485 standard does not have a high-level Annex SL structure that's found in the other ISO 9001:2015 standards. However, it requires risk-based approaches for quality and safety protection just like the requirement that is mentioned over a dozen times in the ISO 9001:2015 standards

수술 장비 임대 서비스

After finishing all your documentation and implementing it, your organization also needs to perform these steps to ensure a successful certification:

  • Internal audit – The internal audit is in place for you to check the effect of your QMS processes.

  • Management review – A formal review by your management to evaluate the relevant the effect of facts about the management system processes in order to make appropriate decisions and assign resources.

  • Corrective actions – After finished the internal audit and management review, you need to find and correct the root cause of any identified problems and document how they were resolved.

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