It is said that “necessity is the mother of invention.” It is an idiom that has been adopted from the more specific insight of Greek philosopher Plato. In Republic, Plato writes, “A need or problem encourages creative efforts to meet the need or solve the problem.”
In September, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated high-level system (HLS) quality management system standard that includes some fundamental changes in how organizations are expected to operate to remain in conformance.
Quality management professionals focused their eyes on the big update to ISO 9001 in September, and changes in the standard will require top leadership to do the same moving into the new year and beyond.
RISK IS GIVEN A FRONT-AND-CENTER PRESENCE IN SECTION 6 OF THE STANDARD.
October 2, 2015
Years in the making, the ISO 9001:2015 revision has been published. Prior to the release date, auditors, inspectors, quality managers, and many others studied the initial drafts in an attempt to understand the changes.
On Demand In this webinar, you’ll learn how Arena helps medical device companies with FDA compliance and audits, and how Product-centric QMS solutions enable medical device companies to achieve and maintain regulatory compliance and reduce project/compliance cost.