We’re thrilled to say we’ve been awarded our ISO 13485:2016 certificate.
This certification pertains to medical devices, which ISO (the International Organization for Standardization) defines as ‘a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.’
For EMS, ISO 13485:2016 means that the assemblies we produce for medical devices and related services consistently meet customer and regulatory requirements.
Our steps to success
During our strategic business planning review at the beginning of 2020, the subject of additional certifications was raised in support of our business growth plans. At this stage, there was no pressure from customers to undertake the certification process. However, we received a request shortly after from a health sector customer to consider ISO 13485:2016.
The outbreak of COVID-19 and the consequent social distancing restrictions meant we faced some initial delays to the certification process at the start of 2020. However, despite these curveballs, EMS has now completed the certification process — which went smoothly, all things considered.
The process worked in three stages. Stage one saw the selection of the accreditation body. Stage two saw auditors from NQA review our documentation to ensure it met the requirements of ISO 13485:2016. The third stage involved inspecting our day-to-day manufacturing activities, records and company practices to certify their compliance.
Our Quality Manager, Robert Goodney, chose NQA as EMS’ accreditation body based on the company’s breadth of experience in the relevant standards, as well as the training, support, and resources available online. We’ll be audited once annually to both ISO 9001:2015 and ISO 13485:2016 until the re-certification in three years’ time. These consistent reviews mean we ensure our processes continue to meet the high standards set out by ISO.
Building on our quality foundations
EMS has had its ISO 9001:2015 standard in place for over 10 years. This certification is one of the world’s best-known standards and is seen as the entry-level for quality management.
ISO 13485:2016 supplements an already mature process system, adding another level of quality regulation to our medical devices processes. All requirements across both standards have been reviewed for compliance, and we’ve adapted our Business Management System to ensure this compliance continues.
In the medical industry, ensuring accuracy and safety across electronic medical equipment is vital. As such, it’s no surprise that the ISO 13485:2016 certification places more emphasis on traceability, records and risk management. For medical devices manufacturers, ISO 13485:2016 is, of course, advisable to guarantee quality in such an important field.
What does the accreditation mean for EMS?
At EMS, we’re an integral manufacturer and supplier of PCB assemblies used in various medical devices. As such, we felt it essential to obtain the accreditation to strengthen our position in the medical devices sector, support access to new business, further improve our process and product quality, protect our long-term future and bolster our standing as the supplier of choice.
Jonathan Plummer explains that “certification to ISO 13845:2016 was a key strategic aim for EMS in 2020. Given the events of the past year, the quality department — headed by Robert Goodney — and the wider business have done very well to achieve the certification.
ISO 13485:2016 supports EMS’ current medical customers as well as new customer opportunities. Beyond medical, the methodology of the certification supports existing and new customers in all industries and builds on EMS’ commitment to high standards of quality.”
While ISO 13485:2016 isn’t mandatory, we recognise the benefits of demonstrating our consistency and commitment when meeting standard requirements as well as opening opportunities for new business in this sector.
The accreditation provides evidence of our even more rigorous quality standards, offering greater assurance to our clients of the controls and parameters in place. In fact, we’ve already received positive feedback from our clients on hearing of the certification:
“Congratulations once again to the EMS team on attaining the ISO13485 certification. We recognise the hard work that goes into achieving this and the confidence it inspires in the procedures that underpin the production processes.”
Additionally, the ISO 13485:2016 inspires confidence in our staff that we’re meeting industry standards and are fully committed to quality.
Our accreditation journey and continuous improvement to our services are both contributing to the future of the medical industry. If you’d like assistance with an upcoming electronics manufacturing project, please get in touch — we’d be delighted to help.