Company News

The benefits of dual quality certification

13th August, 2020

Medical Electronics now accounts for over half of Simtek EMS Limited’s turnover and the company has invested heavily in the training of key personnel in workmanship standards now demanded within this sector, such as IPC-A-610 and IPC-7711.

The company gained certification to the ISO 13485 medical equipment manufacturing quality standard in 2015, further enhancing the ISO 9001 certificate held for over 13 years. There is, therefore, more than 5 years experience working with a variety of customers within this complex quality framework

What is ISO 13485 certification?

Most global medical device market regulators require manufacturers to implement a quality management system (QMS) as part of their product registration effort. In most countries, ISO 13485 certification is the preferred or required method of meeting QMS requirements for medical devices.

What is ISO 13485?

This international standard is based upon the ISO 9001 standard with specific requirements to meet regulatory needs. This standard, applicable on a voluntary base, was designed in particular for medical device manufactur­ers; ISO 13485 addresses most or all of the quality system requirements in markets including Europe, Australia, Japan and Canada.

The US Food and Drug Administration does not formally recognize ISO 13485 certification, but US Good Manu­facturing Practice requirements overlap with the standard in many areas. ISO 13485 is also the basis for quality system regulations in other markets such as South Korea and Brazil.

The ISO 13485 standard, officially named EN ISO 13485:2016, can be used by organisations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements.

Though replicating the format of ISO 9001, ISO 13485 switches the focus from customer satisfaction and contin­ual improvement to standardisation of regulatory requirements for medical device manufacturers. ISO 13485 can be achieved by either upgrading from ISO 9001 or as a standalone certification.