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How to set up a Quality Management System for a SME in medical field

How to set up a Quality Management System for a SME in medical field

It’s time of the year again where perhaps this question of setting up a Quality Management System has come up to your mind. Whether it is due to a new business direction or complying to upcoming regulations, it’s always good to start early. Let’s go through the 5 steps to do this quickly.

  1. Understand what is required for the Quality Management System. A Quality Management System is a set of guidelines and operating procedures to ensure that the company meets its objectives to provide quality and efficient product and services. It can means having a masterfile to provide an overview of the company’s activities and a set of working SOPs/ Work Instructions (WIs) that are already in place.
  2. Identify the objectives of the Quality Management System. Identify the key processes in your company’s activities that can impact on your product or services. Identify the key personnels as well as their roles and responsibilities in the Quality Management System.
  3. Do a simple gap analysis exercise to improve upon what is missing and add on missing documentation.
  4. Execute the Quality Management System for one to two months.
  5. 5. Perform a internal audit to assess efficacy as well as area of improve or engage a third party internal auditor to provide feedback on the system.


Voila. If you are keen to learn more, please contact us !

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