This may also interest you. Enter the first cyborg-type robot What if cyborgs were real? Partly robot, partly man, functioning as one. No, we are not talking science fiction anymore. The first one is here and his name is HAL. Latest ISO survey reveals sharp rise in use of standards for food safety and information security. The ISO Survey sheds light on roles of management system standards in globalization. After some information added in the introductory section that mainly tailors the text to the medical device industry, the first inclusions are in the terms and definitions.
There are 14 new terms used by the medical device industry. The differences between manufacturers, importers, distributors, and terms such as clinical evaluation and post-market surveillance are specifically explained. If your organization is at all involved in the medical device industry, ISO is the QMS standard you should look at for additional requirements above and beyond ISO Free white paper that provides guidelines for each clause of the ISO standard.
Download now. You may unsubscribe at any time. For more information, please see our privacy notice. For full functionality of this site it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. ISO is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Like other ISO management system standards, certification to ISO is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. Quality management systems. Life cycle Previously Withdrawn. Full report circulated: decision for new DIS ballot.
Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat. International Standard under systematic review. This may also interest you. New ISO standards for medical devices Taking the headache out of regulations while improving product safety and performance. Reducing the risks of medical devices: international guidance just updated Virtually no medical procedure is without risk, but there are many ways to minimize it.
The International Standard to ….
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