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 of what 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 covers all the product-specific requirements for all components, manufacturing processes, verification & validation along with corrective and preventative actions (CAPA) for assessing customer satisfaction, product non-conformance, assessing and improving quality policies and procedures, carrying out and assessing the results of internal audits, and implementing systems for continuous improvement.

 

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

 

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