50821 DOCUMENT NO. QA-040 REV BB 10301 WILLOWS ROAD NE, REDMOND, WA 98052 SHEET Unless otherwise indicated, printed copies are. 4.1.5: When the organization outsources a process that affects product conformity: ▻ Monitor and control the process. ▻ Retain responsibility for conformity to ISO, customer and applicable regulatory requirements. ▻ Controls shall be proportionate to the risk involved and the ability of.

Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.).

Morceau De Concours Pdf Reader. With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. Backwards Bob Monster Truck on this page. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems. How to Implement ISO 13485 Updates • 1.