Quality Management System

Quality Management System

Whether you have a start-up company or doing business for many years fast-changing regulations require your QMS system to improve or set up from scratch.

  • Our QMS projects start with an analysis of your existing system. Then we share a QMS improvement or an establishment plan according to your strategies and targets.
  • In the next phase, we determine our suggestions in accordance with EN ISO 13485:2016, medical device regulations (MDD 93/42, MDR, FDA, 21 CFR Part 320) and good manufacturing practices.
  • After getting your consent for the final version of QMS, implementation starts for improvement or establishing a new system.
  • As the final step, our consultants give a full day training about how to maintain your new QMS up to date.


Our expert consultants are ready to assist you to overcome the challenges you may encounter during the establishment or implementation of your quality management system. 

If you intend to manage your Quality Management system documentation electronically, we have a very good recommendation for you. Please contact us for E-QMS service.

Running a medical device company requires you to set up a Quality Management System as the first step.

As we did in many projects that we have accomplished, our team prepares a draft quality management system after analyzing your company’s role distribution and procedures. Then we present you a draft document that is appropriate to your workflow in order to get your opinion. 

Project finalizes when you give your consent to the final version and we give a full day on-site training to your personnel to manage and maintain the new QMS.

There are many reasons that urge you to update your QMS such as changing standards, moving a new plant, introducing a new product or a method of production, changing the entire organization structure etc. 

When you have problems with your existing quality management system, AdviQual is ready to adapt your current QMS to the most up-to-date standards and changes in your business.

Quality Management System