A robust document control management process lies at the heart of a quality management system (QMS); almost every aspect of auditing and compliance verification is determined through the scrutiny of documented evidence. As the saying goes: “If it’s not documented, it didn’t happen.”
It shouldn’t come as a surprise, but even after all these years the ISO9001 quality management system (QMS) requirements still come under attack and mostly from those in the quality profession. I recently read another super critical appraisal of ISO9001 from someone who commented they were on the “front lines.” I’m not sure what front lines they’ve been on, but it’s obviously not the same ones I’ve been on.
The company will implement Q-Pulse in two stages, with document control, supplier management and asset care within the labs being of most importance for its Quality team. The second stage will involve the software being rolled out across the entire production team.
The management systems auditing community has recently engaged in a lot of talk about how to audit a quality management system (QMS) when there are minimal requirements for documentation in the ISO 9001:2015 standard.
The long-awaited revision to ISO 9001 has arrived. The standard will be familiar to those in the quality industry: more than 1.1 million companies are certified to the standard as of 2014, and more than 33,000 certifications in the U.S. Whether you’re in the process of implementing the revision, just planning for it, or curious to see what’s new, here’s a look at the ISO 9001 revision.
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.
Now On Demand! In this webinar, we will look into the concept of risk-based thinking, what it means and how you can apply risk to your Quality Management System. We will specifically look at some of the core tenets of Risk Management, discuss how the standard looks at risk, and look into some of the details around automating risk.