Risks and opportunities according to clause 6.1 of ISO 9001:2015

Answer:

Clause 6.1 of ISO 9001:2015 has two parts. The first part is about determining risks and opportunities that an organization needs to address, according to its potential impact on the intended results, and seize relevant opportunities. The second part is about planning what to do to handle critical risks and opportunities.

What is a risk? ISO 9000:2015 defines risk as the effect of uncertainty on an expected result. What are the expected results of your company? What can affect those desired results? For example: One company can fail to deliver on time because raw-materials were delivered in an insufficient quantity. So, I would recommend that you start, one process at a time, to identify risks (what can go wrong with each process).

Then you look to all your identified risks and come up with a way to prio ritize them. Some risks occur more frequently than others, some risks have consequences much more serious than others. A common way is to classify risks considering the likelihood of happening and the potential consequences of that event.

Opportunities have a positive connotation and occur, for example, because new technology becomes available and allow a process to deliver a higher level of service, or a circumstance change and open a possibility. For example, a competitor decides to concentrate the business in a particular economic sector opening market for your company in other sectors.

Consider the risks classified as critical and decide what to do. You can act to reduce the likelihood of occurrence and/or act to reduce the potential consequences of those risks. For example, those actions can be implementation of controls, definition of methodologies or practices; substitution of a productive method for a more robust one, identification of alternative or complementary suppliers… You should plan the implementation of those actions and the evaluation of its effectiveness.

These materials will also help you regarding the topic of opportunities and risks:

- article - 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/
- article - Methodology for ISO 9001 Risk Analysis - https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
- 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/
- free online training - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/