Rebound Electronics, a leading independent distributor of electronic components, has strengthened its commitment to its medical customers by gaining ISO 13485 accreditation, which is a quality management system standard specifically for the medical devices industry.
ISO 13485 is an international standard, incorporating some aspects of ISO 9001 but with additional industry-specific medical device requirements. This standard places an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective management processes. Part of the requirements demand that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle. The assessment report highlighted many positive areas about internal management systems and staff at Rebound, in particular that the company’s management system was deemed to be mature and effective, and that Rebound itself was demonstrated to be highly effective with a competent and effective workforce.
Commenting on the accreditation Sheila Lord, Quality Manager at Rebound Electronics said, “Once again Rebound has been able to demonstrate to an external assessor that we have the correct processes in place to maintain the effectiveness of our management systems. This accreditation will mean that customers and prospects in the medical market can have confidence in Rebound, and demonstrates our commitment to their industry”.
The benefits of gaining ISO 13485 certification include increased efficiency through improved processes which can lead to cost savings and an improved ability to respond to customer requirements, and additional effective risk management and quality assurance.