The iso 13485 2016 checklist covers everything from the identification of risks and vulnerabilities to the management of processes and procedures. It also includes a section on corrective action plans, which will help you track and measure your progress in implementing QMS enhancements. If you're looking to improve your QMS, then it's important to make sure that you have all the necessary pieces in place. The iso 13485 2016 checklist can be a useful tool in this process.
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Medical devices are critical to the safety of patients, users, and others. These products are regulated by the medical device regulation (MD) in order to ensure their safety, effectiveness, quality, and security. The iso 13485 2016 checklist is used to help identify gaps in your Quality Management System (QMS). By using the iso 13485 checklist, you will be able to assess your system's compliance with the MD requirements. This will help to ensure that your medical devices are safe and effective for use by patients and others.
If you're a company that manufactures or offers medical devices, you'll want to make sure that your products are certified as being of high quality. This is especially important if you want to sell your products in important markets such as the United States and Europe. Iso 13485 2016 certification is the standard used to certify the quality of medical devices. If your products don't meet this standard, it's likely that they will be refused access to these markets.
The iso 13485 2016 checklist can be structured and customized in such a way that all areas can be processed step by step without omitting important aspects. For this purpose, Lumiform's provided iso 13585 checklist contains the basic audit questions for all standard requirements of the current Iso 13485:2016 and supports companies in meeting individual requirements.
Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.