ISO 13485:2016 is the internationally agreed upon standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. This standard will be fully implemented by 2019. New rules and revisions to existing requirements apply throughout the QMS, especially for those organizations managing vast networks of suppliers and vendors. Key areas/processes impacted are document control/management, change management, supply chain, and product lifecycle. Additionally, device usability and post-market surveillance requirements will all be affected.
Learn more from the resources below:
- Understanding the Medical Device Single Audit Program (MDSAP) audit process
- MDSAP Audit Model (FDA): An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine.
- ISO 13485:2016 & MDSAP: How to Prepare Your QMS Now
- 13485 Academy is offering a free matrix (PDF) download of demonstrating the relationships between ISO 13485:2003 and ISO 13485:2016. Specifically, the matrix addresses what changes organizations should be prepared for, how to identify which parts of the standards are similar and how to transition to the new version with as little stress as possible.
Looking for more support and guidance with respect to MDSAP inspection readiness? Contact MWA today.