ISO 9001: 2015 (Part 3): Risk-based Thinking Goes from Implicit to Explicit

August 25, 2015

In the conclusion of this ISO 9001:2015 series, Walt Murray and Peter Knauer focus on the risk-based thinking that pervades the newest version of this ISO standard. Risk management should pervade every aspect of an organization’s quality management system (QMS) and Walt and Peter walk viewers through the different phases of risk management and what they entail.

Risk analysis, risk evaluation, risk control and post-production information should all play a role in your QMS under ISO 9001. Properly performing risk management requires some kind of risk assessment tool, but the standard doesn’t specify which tool should be used. Regardless, risk management should start with a planning stage at the management level.

Risk is mentioned in every section of the standard, which is a considerable change from the past. While Walt and Peter acknowledge that there are a lot of changes in this version, they emphasize that the way forward is with incremental changes and that the time to start planning for this is now.

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