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.
- ISO CHF 158
- British Standards Institution £289
- ANSI $200
- Swedish Standards Institute 1770 SEK
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.
Where to find ISO 13485 for free
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.
