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The first thing one needs when working with quality management, as with numerous other areas within and outside the medical device industry, is their own copy of the standard. ISO 13485:2016 is the Medical devices – Quality management systems standard and it can be bought and downloaded as a PDF from various online sources.
However, there is one more source that offers considerably lower prices on this standard, as well as many other standards. It is the Estonian Centre for Standardization and there, you can get this standard for the price of 25€. That is a lot of times less than any of the previous sources.
This website boasts another great feature, which is renting a document for 24 hours. Basically, you pay 2€ and own a standard or any other document for a day, which is a convenient way of quickly browsing and seeing if the document matches what you need, without spending large sums of money.
The American National Standards Institute (ANSI) has an online view-only system where you can access ISO 13485 for free.
On page 2 on the website, you will find the ISO 13485:2016 standard. To open and view the file, you will need either Adobe Reader or FileOpen browser plugins. Note that not all Adobe Reader versions are compatible with the document protection.
If you want to know more about ISO 13485 and quality management for medical devices, take a look at our online Quality Management for Medical Devices and ISO13485 course. This comprehensive course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management systems.
Our online courses are frequently taken by competent authorities, notified bodies and medical device manufacturers and distributors. Or if you’re looking for a tailored training to align with your company’s specific needs – contact us for inhouse training options.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
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