By Robert Goodney, Quality Manager
Our accreditations undergo regular audits to uphold EMS’ unfaltering high-quality standards across our manufacturing processes.
On the 29th and 30th of November 2021, global certification body NQA conducted two days of re-certification of the existing ISO 9001:2015 at EMS. The audit didn’t identify any nonconformities or opportunities for improvement, resulting in a new certificate being issued.
And on the 8th and 9th of December 2021, NQA conducted their first surveillance audit of our Business Management System to ISO 13485:2016 at EMS. Both previous minor conformities were closed, and the audit was passed with flying colours.
These successful audits confirm and underline EMS’ core focus on quality and our proven processes in place — a standard we’d be unable to achieve without the dedication of the EMS team.
ISO 9001:2015
The ISO 9001:2015 certificate is an internationally-recognised quality management system (QMS) that clearly defines a set of business processes to demonstrate a company’s commitment to providing products and services that meet the highest standards.
This historic certification has undergone regular revision and is recognised as the world’s best-known QMS thanks to its credibility, universality and record of success.
While we’re delighted to have this QMS in place for EMS’ own peace of mind, our primary focus has been and will always be our customers. We depend on our customers and are dedicated to providing a world-class service that meets requirements and exceeds expectations.
Implementing the ISO 9001:2015 means we’re able to deliver absolute consistency in our manufacturing services even if there are reshuffles in staff or changes to individual elements on the manufacturing floor. In essence, we’re not reliant on the separate abilities of our team members but have processes in place to ensure our service is consistent and our failure levels low.
Another key prong of the ISO 9001:2015 is that it demonstrates EMS’ competency to new customers and new markets, acting as a marker of trust and reliability to bring in new business.
ISO 13485:2016
EMS formally received its ISO 13485:2016 certificate from esteemed regulatory body NQA in May 2021.
As a standalone QMS standard, the ISO 13485:2016 is based on the ISO 9001 and is designed for regulatory compliance for the manufacture of medical devices.
Few pieces of equipment require the level of quality of medical devices. Their accuracy is pivotal to the safety of professionals using the devices and, of course, their patients. Therefore, the ISO 13485:2016 needs to be comprehensive and focus on the importance of the design, development, production, storage, distribution, installation, servicing and final decommissioning of a medical device.
At EMS, we manufacture components such as printed circuit boards (PCBs) for medical-grade equipment. We want to ensure the parts we provide don’t falter in their accuracy and are 100% compliant with industry standards. The ISO 13485:2016 means our customers can trust the quality of our services and can rest assured that we have the proper processes in place for achieving this quality.
To learn more about our quality assurance and the processes we have in place, you can read our 2022 Quality Policy. If you’d like to work with EMS, please don’t hesitate to email us at sales@emsolutions.co.uk or give us a call at +44 (0)1635 588 870.
