AssurX Blog
Straight talk for regulated industries.
Aligning Incident Management with ISO 45001 Requirements
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021 according to the ISO Survey. This occupational health and safety standard is especially prevalent in [...]
EHS Incident Management and Root Cause Analysis
Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their emp [...]
Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Qual [...]
SOP in QMS
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today. Consider, for example, an electron [...]
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of pa [...]
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life sciences quality management, with implications for operations, product design, risk management, and more. It’s also critical to ISO [...]
