The seventh and eighth way of improving quality, mentioned in ISO 9001:2015 standard is positive and negative risk based thinking.
Negative Risk Based Thinking
When an organization plans for the quality management system, it has to consider external and internal issues as well as all customer, statutory and regulatory requirements. The organization shall also determine the opportunities and risks that can prevent or reduce the undesired effects.
This keeps the focus on the investigation of the root cause followed by preventive and corrective actions.
Positive Risk Based Thinking
The organization shall, while planning for the QMS, consider the issues referred to in 4.1 (i.e. internal and external issues) and the requirements referred to in 4.2 (i.e. customer, statutory and regulatory requirements) and determine the risks and opportunities that need to be addressed to achieve improvement.
This is mentioned in Clause No. 6.1.1 d of the ISO 9001:2015 standard. This is the first time that an ISO standard has addressed the positive side of risk by viewing opportunity, which can lead to adoption of new practices, launching new products, opening new markets, etc to address the needs of the organization as well as its customers.
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