HI, everyone, I am new in this forum. I am handling the ISO 13485 compliance for a medical device company. Our company is small but we sell 2000+ products to customers. I am thinking of a cloud-based ISO 13485 compliance software to manage the quality and get the certificate for 13485. Is there any solution suitable for small business?
Hi pplcat, welcome to the forum!
Define in advance what your requirements are. For example, perhaps you want:
- Automatic timestamped revision history
- Customizable access permission
- Export/backup of data to generic/portable formats (PDF, CSV,...)
- Need to be able to track specific data (e.g. related to your quality objectives or performance indicators)
- ...
Also, depending on your needs, don't discount what free resources are available before rushing out and purchasing a software package.
Google Drive, for example, is a very powerful tool, as it maintains automatic revision history, and the access controls can be customized.
I'd say that a lot of what you pay for is "look-and-feel". If it's not important that your records be nicely formatted, with company header, etc., then simpler solutions are game. Simple spreadsheets and templated word-docs will often suffice in a lot of cases. As long as the required data is there, and everything is legible.
Finally, you probably want something that has a lot of flexibility (potential customization). The problem with a lot of pre-packaged ISO software is that they define in advance your business needs, instead of the other way around. You need to be able to tailor the software to
YOUR requirements. In this respect, we've had good experiences with wiki systems, as they make linking documents/records/references a breeze. Takes some time to setup (as far as I know there are no out-of-the-box ISO 13485 wikis), but worth it once established.
Best of luck!
MM.