ABSTRACT
In clause 6.1, the ISO 9001:2015 Standard presents a new concept: risk-based thinking. Risk-based thinking directs people to look for opportunities, address risks, and come up with actions either to develop those opportunities or to mitigate or eliminate those risks. Risk-based thinking is actually a development and broadening of the wellknown “preventive action” concept. Organizations should migrate from preventive action to risk-based thinking. Let us start by reviewing the ISO 9001 requirements:
6.1.1
• The organization shall determine which risks and opportunities may affect its ability to achieve the intended results.
