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 the medical device field. The answer depends on your target market and your exit plan.
QMS is a quality
management system as the name suggests this is essential for any simplest
medical device too. There are two aspects of QMS. One initial is to build a system
wherein you will document the system mostly as per ISO standard 13485. System build
means, writing down the procedure for each section of ISO stating what, how,
when and where you are going to do. At this stage, you are only developing a strategy
or system but not doing anything in action.
In the second stage, you will carry out the action and create
evidence of action through records of your system. This is an explanation ofwhat
QMS one must do.
This is just a basic need. Then comes regulatory requirements
which are different for different countries. These are must requirements, and you
have no choice to follow or 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,the auditor looks
for evidence that the QMS is being obeyed and this most often comes in the form
of records, or more specifically manufacturing records.
IZiel works with clients
to make the QMS simple yet effective and flexible to allow changes to keep up
with the changing regulatory requirements.
Comments
Post a Comment