Defining risk and opportunities

When you consider desired or expected results and due to uncertainty, you realize that you might not meet those results you are considering the influence of risks. Positive risks, also known as opportunities, help you meet or surpass desired results. Negative risks, risks, hinder your ability to meet those desired results.

ISO 9001:2015 does not require documenting risks and opportunities. So, organizations are free to decide if they document and how to document. I recommend organizations develop a register for risks and opportunities. That register can be global or per product/service, or per process, or per department.

For example, in the purchasing department you can identify risks such as:

• Selecting a bad supplier
• Receiving ordered material too late
• Receiving ordered material with quality problems

For example, in the purchasing department you can identify opportunities such as:

• Selecting a supplier with know-how that helps us develop innovative products
• Selecting a supplier that allows us to manufacture small amounts with fast response.

The following material will provide you more information:

• Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
• How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
• How to identify risk significance in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
• How to identify risk controls in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/21/how-to-identify-risk-controls-in-iso-90012015/
• Methodology for ISO 9001 Risk Analysis - https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
• ISO 9001:2015 Risk Management Toolkit - https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
• Please check this free webinar on-demand - Free webinar – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
• Enroll for the free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/