Ensure compliance with EN ISO 13485:2016

The company FMI is a specialist for complex silicone parts in Chicago and has immediately taken the necessary measures: The company already carried out a gap analysis in January 2017 and plans to have its compliance with EN ISO 13485 audited in April 2018. In order to meet the increasing quality requirements, the company has, for example, optimized its risk management for product realization as well as its CAPA program.

"For OEMs, it is not always easy to ensure that parts supplied comply with ISO standards," explains Leo Gele-ra, Quality Manager at FMI. "Optimally, suppliers' quality management systems are efficient enough to identify risks and prevent defects." For the medical device manufacturer, the effectiveness of internal processes can be seen in factors such as certification to ISO standards, risk management for product realization, the use of a Corrective and Preventive Actions (CAPA) program, and the importance of quality in the company's culture.

Certification according to revised standards essential
With both EN ISO 9001, which defines the minimum requirements for QM systems, and EN ISO 13485 recently revised, it is now a priority for OEMs to ensure that suppliers meet the deadlines for certification to these revised standards. "The essential goal of the new standards is to improve risk management among suppliers to the medical industry," Gelera said. "One of the ways this is being done is by placing a stronger focus on the need for control throughout the supply process chain." To successfully complete the certification process within the deadline, the supplier can hire an external consultant or rely on internal human resources. If the latter approach is chosen, the notified body responsible for certification should be contacted. This body advises on the optimal procedure and provides the checklists that are also used for the subsequent evaluation. In addition, the quality manager responsible for the project should attend a training course on the requirements of the new standards and become certified as a lead auditor. Once this has been done, the next step is to carry out a gap analysis. This involves comparing the requirements of the new guidelines with the current processes at the supplier and deriving steps for adaptation.

Pressing deadline
"Companies should not dawdle in the process. The control bodies provide exactly the time between the publication of the standard and the expiry of the dead-line that is necessary for successful certification," emphasises Gelera. FMI, for example, conducted a gap analysis back in January 2017 and identified areas where changes needed to be made. "The essential elements of ISO 13485:2016, in my opinion, are the training and CAPA programs, in addition to the more detailed supplier control," says the quality manager. "We are making great progress in these areas, for example, we have redefined our training program and added a particularly robust review. This helps us ensure that our training programs are effective for our employees." FMI has already agreed with the certifying body on an evaluation date in April 2018. Even if not all companies in the supplier industry work so quickly, in September 2017 at least the gap analysis should have been carried out and a detailed plan for the upgrade should have been worked out.

"There can be serious consequences for an OEM to purchase components from a company whose quality management system is not certified to ISO 13485:2016," Gelera said. "This certification is an essential prerequisite for placing a medical device on the market in the European Union.

"The aim of the new standards is to improve risk management at suppliers."

market. Accordingly, it is one of the standard requirements for suppliers at many OEMs." If the deadline is not met, the medical device manufacturer must refrain from using these components in its production until the delay has been made up. Since OEMs usually have only one supplier for a given component, there is a risk that existing orders cannot be fulfilled. If the medical device manufacturer has the impression that its supplier is not far enough along in the certification process at the current time, the OEM should at least request its action plan and schedule for the adjustments in order to obtain a more precise overview and to be able to take measures in good time.