Primerdesign is regularly audited by the British Standards Institute to ensure that high quality standards are being met in all areas of the business. This includes our design and manufacturing process, our quality control systems, our customer care, administration and management systems.
Quality is fundamental to Primerdesign's success and reputation. We take great pride in ensuring that all of the products that our customers receive are meticulously quality controlled to ensure that they get fantastic real-time PCR data for their project.
Primerdesign has achieved ISO 13485:2003 and EN ISO 13485:2012 accreditation in addition to our ISO 9001:2008 accreditation.
Expanding our Quality Management System to include requirements for the medical devices industry demonstrates our ability to systematically provide medical devices and services that consistently meet customer and regulatory requirements.
For example ISO 13485 promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale. A number of countries have incorporated ISO 13485 into their regulatory systems, PrimerDesign ships products to over 100 countries worldwide and compliance with ISO 13485 can be used in support of these regulatory requirements for those customers.
The benefit of having dual certification is being able to focus on business aspects that are good for all businesses from academia right the way through to industry. The emphasis of ISO 9001 is on customer satisfaction and continuous process improvement, whilst the emphasis of ISO 13485 is on meeting regulatory as well as customer requirements, risk management and maintain effective processes. We have created a management system that can be seen as a platform on which we can build compliance to various regulatory and customer requirements.
We still provide the same service for our customers. By achieving this accreditation we have again demonstrated that we are thoroughly committed to quality and we still strive to continually improve and put our customers at the heart of all we do. In everything we do we hope to be able to demonstrate our core values of Professionalism, Expertise, Friendliness and Dedication.
If anyone would like a copy of our BSI certificates then we are happy to provide this. Similarly if anyone would like to know more about our quality system then we are happy to help. Simply contact our MRQA Quality Manager on firstname.lastname@example.org