When should you start a QMS?

Heading –When should you start a QMS? “When do I need a Quality Management System (QMS)?” is the most common question that we get from new clients who are just entering into the medical device field. The answer depends on your target market and your exit plan.

QMS is quality management system as the name suggests this is an essential for any simplest medical device too. There are two aspects of QMS. One initial is to build system wherein you will document system mostly as per ISO standard 13485. System build means, write down the procedure for each section of ISO stating that what, how, when and where you are going to do. At this stage you are only developing strategy or system but actually not doing anything in action.

In second stage you will actually carry out action and create evidence of action through records of your system. This is an explanation for QMS one has to do.

This is just basic need. Then comes regulatory requirements which are different for different countries. These are must requirement, and you have no choice for follow of not.

In theory, a medical device is supposed to be developed using design control as described in ISO 13485 and 21 CFR 820. In the US once clearance or approval is granted for a device it can be legally placed on the market and the FDA may inspect the manufacturing facility to ensure the required quality system is in place. During an inspection auditor look for evidence that the QMS is being obeyed to and this most often comes in the form of records, or more specifically manufacturing records.

Every company is exclusive and wishes will differ counting on a variety of issues, early within the design phase of the merchandise life cycle. Having the processes and procedures in place helps to verify that the device is designed in accordance with the various regulations and provides for the simplest chance of success during a regulatory submission. Actual certification of the system could also be postponed until the design transfer introduces order to line up manufacturing activities and produce some initial records for inspection. This will help to scale back costs by avoiding follow-up inspections. At the top of the day, the more mature a system is, the easier an auditor feels about issuing certification. This results in less time spent debating the readiness of the system.

The decision when to develop an in-house QMS will depend on business strategy. Does one want to be the manufacturer of the device or just sell the technology? supported all of the above, if you're getting to sell the technology, the FDA is your most suitable option because you'll get the 510(K) without the registrar’s audit and certification of your QMS. If you're targeting Canada or EU, you'll get to found out a QMS before you'll get the HCMD license or CE Mark. Also, if you're getting to market the device within the US, you'll get to have a QMS in situ before the primary sale of the device.

IZiel works with clients to make the QMS simple yet effective and flexible to allow changes in order to keep up with the changing regulatory requirements.