What is ISO 13485 – QMS ?

A Quality Management System is “A formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management.” A QMS is comprised of the core set of business policies, procedures, forms, and work instructions, along with their sequence, interactions, and resources required to conduct business within a medical device company. Quality records are documentation that demonstrate the QMS is being executed and followed.

If you choose to outsource any process(es) that impacts requirements of the standard (for example, contract manufacturing), it is your responsibility to monitor and ensure controls over the outsourced processes. This includes defining roles and responsibilities in documented quality agreements with any outsourcing resources.

In the event you use an eQMS software tool, software validation procedures must be defined and the system must be validated before use. It is worth noting that validating most eQMS tools available to you will be time consuming and frustrating. Why? Most eQMS tools are general purpose and not specifically aligned to ISO 13485:2016 and medical device QMS requirements.

This means the first step you have to do to even use these types of tools is to customize and configure to align with ISO 13485. And this easily takes several months. Then, once configured, you have to define protocols and execute testing in order to validate the tool–again taking weeks and months to complete.

At Exsolutiongroup it is our goal to alleviate those efforts and streamline your processes through our multi-tenant, cloud-based SaaS platform. According to a LNS Research ‘State of the Market’ piece on Software Validation in the Life Sciences industry, they assert,

Cloud-based technologies create new opportunities to streamline validation [and] industry leading vendors are providing pre-validated platforms, pre-validated functions, and pre-validated pre-configurations.