Quality Systems

Understanding ISO 13485 and 21CFR 820

They're called Quality Management Systems for a reason.  Quality systems are all about management - providing the rigour and discipline to drive product quality to meet your customers’ needs and providing the information that is the life blood of management effectiveness.  A well executed system drives excellence, bringing your business processes under control and giving you the information you need to drive continuous improvement. Your employees and partners will understand their role in the Quality System and the value they add to it through compliance.

Marketing worldwide?  Then you will need to meet requirements in multiple markets.  Let us show you how you can build one Quality System that is compliant to both ISO 13485 and the US FDA 21CFR 820 "Quality System Regulations".  We can also advise on more specialist GxP requirements, including ISO 17025 GLP and specialist quality systems for clinical laboratories and for R&D facilities or design houses.

Contact us and we will be pleased to show how an effective and well designed quality system can add value to your business. 

While we're talking we can explain to you the benefits of Q-Pulse quality management software.

We have implemented and operate our own quality system pursuant to AS ISO 9001:2008.  Please view our certificate here.