Complying with ISO 13485:2016 & #039;s New Expectations for Supplier Management

One of the main changes to ISO 13485:2016 “Medical devices -- Quality management systems – Requirements for regulatory purposes” pertaining to suppliers is the “increased emphasis on use of a risk-based approach to supplier management,” Ron Schmitz, president of Grand Avenue Software, told MD+DI. “Medical device companies are increasingly required to not only analyze supplier-related risks during supplier qualification, but also to monitor their suppliers’ performance and feed the monitoring results back to a requalification process.”   Grand Avenue Software will be exhibiting at Booth #1612 at MD&M West 2018 in Anaheim February 6-8, 2018.   Schmitz highlighted some of the changes that were introduced within Section 7.4 Purchasing of the 2016 standard. “Per this section, suppliers are selected according to criteria that are based on performance and ability to deliver, as well as on the overall effect of the purchased product or service on the quality of the medical device. A new area of emphasis is that these criteria must be in proportion to the risks associated with the medical device.”   Companies across the medical product supply chain now need to work towards compliance, Schmitz said. “For all involved, that will include a review of current practices versus the requirements, followed by new practices and possibly new tools to close any gaps.”   To help companies comply, Grand Avenue Software has added a new Supplier Management module to...
Source: MDDI - Category: Medical Devices Authors: Tags: MD & M West (Anaheim) Regulatory and Compliance Source Type: news