|ISO 9001:2015 can help medical device |
companies anticipate forthcoming
ISO 13485 changes.
by David R. Butcher
Marketing Communications, MasterControl
This fall, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated quality management system (QMS) standard that now follows a new, higher-level structure and includes a number of other key changes that regulated companies have three years to meet.
We’ve already delved into how the changes directly affect a wide range of manufacturing organizations — including adoption of the Annex SL high-level structure framework and increased leadership requirements — and what these regulated organizations can do to ease the transition. However, the revisions also have implications for other standards, including ISO 13485, which is often harmonized with ISO 9001.
For medical device companies, the publication of ISO 9001:2015 offers something of a preview of forthcoming revisions to ISO 13485, which outlines QMS requirements for medical devices.