The ISO 13485 audit is an essential qualification for medical device manufacturers, showing HRA Pharma’s commitment to the highest quality standard.
David Wright, CEO of HRA Pharma, says, “This is an enormous achievement for HRA Pharma and exemplifies success involving many parts of the HRA organisation.”
Consumer healthcare company HRA Pharma recently passed the ISO 13485 audit of their Quality Management System (QMS). This audit was conducted by the Notified Body DQS-MED and ensures that medical device manufacturers establish and maintain an adequate and effective quality system.
ISO 13485 is an internationally recognised quality standard, specific to the medical device industry and highlights HRA Pharma’s commitment to the highest level of medical device quality controls. HRA Pharma are number one in emergency contraception, scar and blister care in Europe and have a superior product portfolio which includes ellaOne®, NorLevo®, and Compeed®.
The entire process was led by an internal HRA core team and involved individuals across the company. Although the objective of the ISO 13485 certification was fulfilled at the end of two days, preparatory work throughout the whole year guaranteed that the audit would be passed with flying colours.
Paul Carter, Chief Scientific Officer, says, “Passing the audit was a fantastic achievement and demonstrates that HRA Pharma are truly committed in supplying customers with the best quality products. A lot of work was put in throughout the year across the whole HRA company to define our processes and ensure that we were working in the way the ISO Norm requires.”
David Wright, CEO of HRA Pharma, says, “HRA Pharma is fast growing and we are aiming to more than double in size by 2022. Passing this audit was hugely important for our future goals and I’m positive we will maintain the high standards we have set.”