Global Sourcing Spotlight: Tariffs—The New Reality
Knocking Down the Bone Pile: Gold Mitigation for Class 2 Electronics
Punching Out: Your Financial Preparation for a Sale
EMS Receives ISO 13485:2016 Accreditation
March 25, 2021 | EMSEstimated reading time: 1 minute
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.
Share on:
Suggested Items
K & F Electronics Invests in Workforce Training with IPC-A-610
05/15/2025 | K & F ElectronicsIn a strategic move to prioritize employee development and uphold quality standards, K & F Electronics, a third-generation, family-owned printed circuit board (PCB) manufacturer based in Fraser, Michigan, used a recent period of reduced production to certify its employees in IPC-A-610, the industry standard for the acceptability of electronic assemblies.
Canadian Circuits Inc. Unveils Rapid Prototype PCB Assembly Service to Accelerate Innovation
05/14/2025 | Canadian Circuits, Inc.Canadian Circuits Inc. (CCI), a leading provider of high-quality, made-in-Canada, Printed Circuit Board (PCB) solutions, is proud to announce the launch of its Prototype PCB Assembly (PCBA) service. This new offering enhances CCI’s commitment to empowering engineers and OEMs by accelerating the journey from concept to product launch with precision and efficiency in electronics manufacturing.
Breaking Down Barriers: The Connectivity of Machines in SMT Production Lines
05/14/2025 | Bill Cardoso, Creative ElectronAs the world increasingly moves toward erecting trade barriers, we find ourselves in a paradox. Across the globe, the rise in tariffs and protectionist policies is creating a more fragmented global economy, with nations seeking to insulate themselves from external economic pressures. However, within the confines of the SMT production line, the trend is moving in precisely the opposite direction—toward greater connectivity, integration, and collaboration. Rather than isolating one machine from another, SMT production lines are increasingly interconnected, with data being shared across various stages of the process to improve quality, efficiency, and defect detection.
Merlin Circuit Technology Earns NADCAP 2nd Year Merit
05/13/2025 | Merlin Circuit TechnologyMerlin Circuit Technology Ltd, a leading manufacturer of advanced printed circuit boards (PCBs) for mission-critical applications, has announced the successful completion of its latest NADCAP audit, achieving prestigious 2nd Year Merit Status.
Fresh PCB Concepts: The Power of a Lunch & Learn for PCB Professionals
05/15/2025 | Team NCAB -- Column: Fresh PCB ConceptsIn the electronics industry, innovation isn’t simply a competitive edge, it’s a survival strategy. For those working in printed circuit board (PCB) design, engineering, procurement, and quality control, staying informed and connected is key to creating high-performance, cost-effective, and manufacturable products. Enter the Lunch & Learn—a simple yet highly effective format for professional development offering technical insights in short, informal sessions (served with lunch).