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Following are the intend of Risk based thinking in ISO 9001:2015:
- To provide confidence in the organization’s ability to consistently provide customers with conforming goods and services.
- To improve customer confidence and satisfaction.
- To assure consistency of quality of goods and services.
- To establish a proactive culture of prevention and improvement.
Successful companies intuitively take a risk based approach. Risk is often thought of only in the negative sense. Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk. ISO 9001:2015 requires companies to address risk and opportunities as they relate to QMS processes (Clause 4.4.1), planning (Clause 6.1), and product risks (Clause 5.1.2). The effectiveness of risk management and opportunities for analysis must be evaluated (Clause 9.1.3). Also, the effectiveness of the actions associated with objectives or planning must be included in the management review (Clause 9.3.2).
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