1. Understanding the risks and opportunities approach
Risk is the "effect of uncertainty" and "An effect is a deviation, positive or negative, from an expectation" (ISO 9000:2015 § 3.7.9).
ISO 9001:2015 does not require a risk management method or process (Annex A4), but ISO 31000 provides definitions and principles that are useful for the process.
ISO 9001 requires us to determine the relevant external and internal issues (§ 4), and then to define objectives for our QMS, consistent with these issues. A challenge is what can be gained or lost by undertaking something...
The result is subject to hazards, influences and disturbances, which generate uncertainty, or in the case of repetitive activities, dispersion. Uncertainty is the consequence of ignorance and/or lack of control over factors that make a result...
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Understanding the risks and opportunities approach
Identify key objectives
ToolReference standards
ISO 9000:2015 – Quality management systems – Essential principles and vocabulary
ISO 9001:2015 – Quality management systems – Requirements
ISO 31000:2009 – Risk management — Principles and guidelines
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