ABSTRACT

After decades during which “quality” has been thought of as preventing “non-quality”, the new edition of the ISO 9001:2015 standard brings a new concept, defined as “risk-based thinking”. Risk is defined as the effect of uncertainty in relation to the expected results. When talking about risk, the 2015 edition of the ISO 9001 standard defines it in relation to uncertainty within the organization which is required to plan and implement actions to deal with risks and opportunities”. Is it recognized that “risk-based thinking” is a requirement to “reduce prescriptive requirements” and replace them with performance-based requirements. It is required that management at the highest level drives the planning activities for avoiding or mitigating the negative effects of risks, which means having a proactive and beneficial attitude for the organization.

A Critical Approach of Thinking Risk-Based in the New Issue of ISO 9001:2015 Standard