The importance of the Quality Management System in the healthcare industry.

Healthcare companies wishing to apply for new licences or expand into new GxP areas must first ensure that they have a robust Quality Management System (QMS) appropriate for the type of operations prior to changing activities or initiating the licence application process.  ​

The QMS consists of all of the manuals, policies and procedures required to ensure that regulated processes are carried out in a controlled manner and ensure that the company manufactures high quality, safe and effective products.
​ 
Consistency
The main benefit of designing an effective and comprehensive QMS is that it provides consistency. So that every time a process is completed, it is carried out in the same way and to the same high standards.  This will mean that employees can access the Standard Operating Procedures (SOPs) and get detailed instructions on how to carry out each task without any deviation from the expected highest standards of research, investigation, reporting and documentation.  

Compliance

---

 
​An effective QMS will also ensure compliance with the relevant competent authority, notified body or broader corporate standards relating to Good Manufacturing Practice (GMP), ISO13485, or other regulatory standards to be applied.  A good QMS will be written in conjunction with the associated GxP regulations and will utilise industry best practices.  ​

Continuous Improvement
​A well designed QMS will also include feedback mechanisms to assure continuous improvement. Where deviations occur CAPAs should be implemented to ensure that the identified root causes of issues encountered are eliminated or mitigated as much as possible.  Similarly, effective management review will ensure that the system and processes are regularly reviewed and any identified trends are actioned appropriately.
​  
Improve efficiency, cost and customer satisfaction
Finally, a well-designed quality management system will also complement other business processes and will lead to streamlined and efficient practices.  When developing procedures that meet the regulatory and licensing requirements companies often utilise business excellent best practices to drive efficiency, cost improvement and customer satisfaction.   
  
Orion Consulting has decades of experience in implementing compliant quality management systems that are correctly suited for the GxP type or phase of your products development lifecycle.  So whether it is an initial GCP QMS to allow your products to enter clinical development, or a QMS for a Marketing Authorisation Holder (MAH) and commercial distribution via a WDA, we can assist.  
​To discuss your needs further contact us at info@orionconsulting.ie.