--- title: ISO9001:2015–How to apply Risk-based Thinking to Quality Processes XII description: This is the final part on how you might apply Risk Assessment techniques to meet the possible RBT requirements of the forthcoming ISO9001:2015 standard. --- [DMS Insights from Cognidox ](https://www.cognidox.com/blog) # [ISO9001:2015–How to apply Risk-based Thinking to Quality Processes XII](https://www.cognidox.com/blog/2015/07/iso-90012015-how-to-apply-risk-based-thinking-to-quality-processes-part-xii) Written by [Paul Walsh](https://www.cognidox.com/blog/author/paul-walsh) | 23 Jul, 2015 *There are twelve posts in this series. To read Part XI, please click [here](https://www.cognidox.com/blog/2015/06/iso-90012015-how-to-apply-risk-based-thinking-to-quality-processes-part-xi).* This is the final part in our series on how you might apply Risk Assessment techniques to meet the possible Risk Based Thinking (RBT) requirements of the forthcoming ISO9001:2015 standard. Events are moving along for the new version: the last formal draft of ISO/FDIS 9001 has just been issued, and final publication is scheduled on September 23rd 2015. To close out the series we take another look at the 6 step process we're recommending and provide links to templates for documenting the outputs that we hope you will find useful. Click on the document icon to download the PDF. ### 1. Establish the context This step determines the issues and requirements that can impact on the planning of the quality management system; including: (a) the main objectives and outcomes that are uncertain / subject to risk; and (b) the needs and expectations of the organization’s customers and other relevant interested parties; the products and services it provides; the complexity of processes it employs and their interactions; the competence of persons within or working on behalf of the organization; and its size and organizational structure. An example statement of context template was introduced in Part X of the series and is available [here](https://www.cognidox.com/the-value-of-a-document-management-system-for-sustainable-product-download-ebook). ### 2. Risk identification This step involves selecting a suitable process for risk identification and for each quality process, identifying and numbering the risks. This process records the risks in a Risk and Opportunities Register (R&O Register) that would form an integral part of the Quality Management System. We offer two supporting templates - a Risk Description Brainstorming Sheet and a Risks & Opportunities Register. Risk Description Brainstorming Sheet: Risks & Opportunities Register: ### 3. Qualitative risk analysis & risk evaluation This step considers (for each risk) the effectiveness of the existing controls using a suitable effectiveness scale; the consequences (impact) for each risk; the likelihood of these consequences occurring; and the potential exposure were the controls in place to fail. ### 4. Semi-Quantitative risk assessment for systems and processes A semi-quantitative measure of risk is an estimate derived using a scoring approach. Risk indices are used to rate a series of risks using similar criteria so that they can be more easily compared. An example Semi-Quantitative Risk Assessment Calculator Template was introduced in Part XI of the series and is available [here](https://www.cognidox.com/the-value-of-a-document-management-system-for-sustainable-product-download-ebook). ### 5. Risk-treatment This step considers options for either avoiding or seeking the risk; changing the likelihood; changing the consequences; sharing the risk; or explicitly accepting the risk without further treatment. We offer two supporting templates - a Risk Treatment Plan Template and a Risk Treatment Options Worksheet. Risk Treatment Plan Template: ### Risk Treatment Options Worksheet: ### 6. Monitoring & review Periodically, the team will re-assess risks and decide whether new risks are affecting or could affect quality processes and systems as part of the cycle of continuous quality process improvement. 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