Assel renews ISO 13485 certification through 2029
Polish EMS provider Assel has successfully completed a recertification audit of its quality management system for medical devices. The company has obtained a renewed ISO 13485 certification, confirming that its production processes meet the requirements of the medical sector through 2029.
The recertification audit, carried out in April, covered the quality management system used in the production of electronics for medical applications. Following its completion, Assel received an updated ISO 13485 certificate, widely regarded as one of the key standards for manufacturers operating in the medical device market.
“Extending our ISO 13485 certification through 2029 is an important element of our development strategy in the most demanding market segments. It confirms the maturity of our quality management systems and our consistent approach to projects involving medical device assembly. Later this year, we also plan to certify an additional quality management system, further strengthening our capabilities and readiness to meet evolving customer requirements,” a member of the management board of Assel told Evertiq.
For the company, the recertification goes beyond a formal requirement. It confirms that the facility meets standards related to quality, safety and process repeatability. As noted in a statement shared with the editorial team, it represents “a confirmation of the maturity of operational processes.”
The company specialises in a high-mix, low-volume model, supporting projects characterised by high variability and relatively low production volumes.
