Medical services are the basic requirement which one needs one or other time in his life. There are a number of medical practitioners, hospitals etc present in our society. Standardization of medical devices is very important from the safety point of view. As medical is the Nobel profession and is directly associated with one’s health and well being, devices used need to have gone all through all the quality check. To give a solution to this, ISO 13485 which gives the guidelines for the standardization of medical; devices was published in 1996 for the first time. ISO 13485 gives you the guidelines for compressive quality management in order to design the medical devices.
It might come in your mind that if ISO 9001 is already present which check the standardization and quality check then what was the need of ISO 13485? There are some differences between ISO 9001 and ISO 13485. ISO 9001 gives emphasis on that the organization needs to demonstrate continual improvement where as ISO 13485 emphasizes that the quality system has been implemented or not.
ISO 13485 checks that the organizations have the ability to produce standard medical devices. It is used in the designing, production and installation of medical devices in the Organization. ISO is reviewed after every 5 years and hence, ISO 13485 was reviewed in 2016. It emphasizes more on risk management involved in the medical devices and practices involved. It also includes technology and expectations which can meet the requirements of the customers. ISO 13485 is important for you if you are looking to work internationally as well as locally.