When implementing and maintain ISO standards such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history.
Good organization is essential for guaranteed successful business. There are few reasons for choosing an eQMS over the paper-based system:
- Saves money – paper-based QMS requires more staff to manage all the documentation which affects time and money; it also requires printing a lot of papers.
- Saves time – it takes less time to train staff to use an electronic system of QMS then paper-based because they can get all the necessary assistance on the network, and all is on one place, easy to find, it’s just ‘one click away’
- More document control – by the paper-based system, it’s easy to mix up all that paperwork, which moves back and forward, while eQMS sorts out all that for you.
- Less risk – during an audit, it’s very likely to get confused while searching the requested document, or which version is approved, which one is not. All those possible ‘interruptions’ can lead to non-conformity and on the end losing a certificate.
To the majority, the first few questions that arise in their heads when thinking of the implementation of eQMS, is probably how much it will cost transition from one to another system, how much time and effort it will take.
But, going “digital’ can actually become a requirement.
EQMS is the bigger capability of being analyzed and changed quickly. It may seem that a paper-based QMS is cheap to maintain. However, there is a huge amount of hidden costs due to the enormous amount of time the organization spends to ensure the ongoing management of such a system. With an eQMS, you cut down costs in the long run.