Festo started supplying products for gas and liquid handling in medical applications and was confronted with the ISO 13485 standard. A decision was made in favor of certification, which in retrospect was the best way to go.
Today, certified quality management is indispensable for suppliers in industry automation. And thus it goes without saying that Festo complies with ISO 9001, which is approved and adequate in most of the industry sectors with which Festo does business. However, ISO 13485 focuses much more attention on product safety and reliability. Since Festo also aspires to deliver top quality in terms of safety and reliability, we decided to additionally obtain certification in accordance with ISO 13485.
ISO 13485 was initially implemented at Festo in 2015. And thus in particular processes related to product development and clarification of customer requirements had to be examined carefully. It was decided that the production location where medical device components had already been manufactured would adapt its quality management procedures to comply with the new standard first.
The processes have been assessed by the notified bodies with positive results for headquarters and the production facility. Annual audits show improvement in the application of the standard in all departments. This is above all due to improved qualification of employees working in these business segments. Employees have to be trained internally and externally in order to fulfill the requirements which are now mandatory. Ongoing, frequent qualification of employees is an important and useful recommendation in ISO 13485.
For medical device customers, this means that they can now rely on a well-known, approved standard when selecting us as a supplier. Internally, Festo has the flexibility to decide which standard will be used. ISO 9001 is always specified, ISO 13485 is optional. If the customer stipulates a requirement or if there’s any other necessity, e.g. if the respective component has been identified as a critical part, Festo can apply ISO 13485 as well.
For medical device OEMs, it’s beneficial to work with suppliers who produce in accordance with ISO 13485. Medical device manufacturers must comply with ISO 13485, which means that they have to ensure that their suppliers can fulfill the specified quality standards. This can be done by means of audits, but these are time-consuming and expensive for both the customer and the supplier. Compliance with ISO 13485 makes it possible to reduce the number of audits. Additionally, complying with the same standard is advantageous for both parties and makes it easier to generate the right documents for mutual assurance of the requirements, which can be shared and integrated into the other party’s documentation.
Furthermore, Festo is a company with high ethical standards and the employees embrace and support this mindset, which promotes implementation and ongoing improvement of processes related to ISO 13485. With three years of experience, recertification in accordance with the new ISO13485:2016 is scheduled for this year.
Looking back at the progress which has resulted from certification, it’s apparent that the projects have benefitted from compliance with this standard. In particular the importance of risk management leads to a closer look at the customer’s application and the intended use of the Festo component within his equipment. Close cooperation and good communication between the equipment manufacturer and the supplier simplify processes and clarify responsibility on both sides. The implemented Medical Risk Management Process is in compliance with ISO 14971 and has been integrated into the customer’s product development process. It connects Festo’s world, which has emerged from industry automation, with the world of medical technology and is therefore an important element for success in this field of business. Certified quality management provides our partners and customers with added value for products developed for the medical segment.
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Festo AG & Co. KG