Reading time ( words)
Electronic Manufacturing Solutions (EMS) is now certified to ISO 13485:2016 standard, which means that the assemblies the company produces for medical devices and related services consistently meet customer and regulatory requirements.
During EMS’ strategic business planning review at the beginning of 2020, the subject of additional certifications was raised in support of its business growth plans. At this stage, there was no pressure from customers to undertake the certification process. However, the company 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 EMS faced some initial delays to the certification process at the start of 2020. Despite these curveballs, EMS has now completed the certification process—which went smoothly, all things considered.
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. EMS will 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 EMS ensures its processes continue to meet the high standards set out by ISO.
ISO 13485:2016 supplements an already mature process system, adding another level of quality regulation to EMS’ medical devices processes. All requirements across both standards have been reviewed for compliance, and the company adapted its 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 advisable to guarantee quality in such an important field.
“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,” says Jonathan Plummer, managing director of EMS. “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.”
The accreditation underscores EMS’ even more rigorous quality standards, offering greater assurance to clients of the controls and parameters in place.