What is ISO 13485?
ISO 13485:2016 is the standard of the Quality Management System (QMS). This is used for the design and manufacture of Medical Devices. Certification requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program (MDSAP Audit).
ISO 13485 = ISO 9001 + Additional Medical Device Required
The Documentation and safety requirements are much greater in ISO 13485:2016. Hence, ISO 9001:2015 only focuses on customer satisfaction and continuous improvement. These standards are mandatory in some countries.
What is a Medical Device?
The ISO 13485 is developed to ensure the safety and quality of medical devices which are not negotiable in the medical devices industry. A medical device is an instrument, or machine which is intended to use for the diagnosis, and treatment of diseases.
Why ISO 13485 is important?
ISO 13485 is important for designer’s manufacturers and even distributors of medical devices. Medical Device Manufacturing considers patient safety which greatly depends on the quality and consistency of medical products. This will ensure the effectiveness, control, and maintenance of your Quality Management System is critical.
Key Benefits of ISO 13485
The company has significant savings in cost and time. Moreover, the improvements that and Quality Management System brings out makes the difference.
There are benefits of ISO 13485:
1. Improve company credibility: Those who are certified with ISO 13485 show clients and customers that they take quality very seriously and have a system to make sure it works properly.
2. Improve customer satisfaction: ISO 13485 is a set of quality management principles. This ensures customer satisfaction by assessing customer needs and fulfilling their expectations. The customer knows what exactly they want, so they don’t entertain a supplier that isn’t certified or fulfilling the basic requirements.
3. Improve your Processes: When approached by using outlined ISO 13485 processes, the chances to discover opportunities for improvement is much easier. You will easily identify and reduce the waste within the process, reduces errors, and avoid rework. This will lead to improving efficiency and cost-saving.
4. Improve Decision making: The principle of ISO 13485 outline the use of evidence-based decision making with the facts and data. These help decisions to be better aligned with strategic goals for the company.
5. Create a culture for continual improvement: Making the foundation of ISO 13485 is the actual concept of continual improvement. When it is adopted as culture in any organization, the management and staff will always be on the ways to improve on how things can be done.
6. Better employee engagement: The more employees get engaged and understand their roles by delivering quality products and services, this will leads to an increase in their efficiency and productivity.
URS Certification 