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6.1 Actions to address risks and opportunities in ISO 9001:2015

Identifying and addressing risks and opportunities is critical to the development of the organization

When we plan something in our companies, we always focus on achieving some objective. During the way to reach our goals, we can be surprised by situations that harm and interfere with our planning. In today’s article we will talk about risks and opportunities.

When an organization applies actions to address risks and opportunities in its QMS, it is seeking to increase the occurrence of positive events and decrease the occurrence of negative events.

This means that actions to address risks are aimed at preventing these “stumbling blocks” and ensuring that the ultimate goal is achieved.


ISO 9001 Requirement 6.1

The requirement states that the organization must determine its risks and opportunities so that the objectives present in items “a, b, c, d,” are met. Let’s see the item in full:

6.1 Actions to address risks and opportunities

6.1.1 When planning the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2, and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result (s);

b) enhance desirable effects;

c) prevent, or reduce, undesirable effects;

d) achieve improvement.


Understanding item by item of requirement 6.1.1

It is necessary for the organization to apply the good practices that the standard indicates. In addition, it is necessary for her to follow the process to identify whether these actions taken were effective. For this, we understand each of the requirements.


a) give assurance that the quality management system can achieve its intended result (s);

When the quality management system is implemented, it carries certain objectives. It is therefore necessary to take steps to ensure that these objectives are achieved.

Among these actions, of course, risks and opportunities must be addressed. For example, imagine that one of the goals of the QMS is to ensure that a company’s machines run efficiently and are not damaged during production processes.

This objective may be at risk if the organization purchases second-line machinery that has problems and requires frequent maintenance. Consequently, the QMS objective will not be achieved, as production lines may stop frequently.


b) enhance desirable effects;

This requirement brings with it something fundamental for the organization that wants to go one step further. I’m referring to taking advantage of opportunities that arise in the course of the processes. When an organization has a system that evaluates the results and identifies something that is working, it is necessary to take advantage of this situation.

The focus of this requirement is to make the organization take advantage of and achieve more positive effects by creating and taking advantage of the opportunities that are identified. For example, a sales network has realized (through its performance analysis systems) that it is selling a lot in a certain region.

One of the ways to take advantage of this situation is to focus more on this area and understand the reason for this high performance. This is to apply the good performance in other places, where sales are down.


c) prevent, or reduce, undesirable effects

Organizations are subject to undesirable effects that may occur. Not all risks can be completely eliminated. However, they can be predicted in advance, analyzed and treated to reduce their effects.

For example, the organization identifies that the useful life of one of its machines is coming to an end. Then begins the process of preventing the risk of processes stopping due to machine failures. The risk has already been identified in advance and, to address it, the organization will replace the machine with a new one.

If the organization did not have a risk prevention and identification system, it would probably have to deal with an undesirable effect, consequently having its processes affected, which could result in lost profits and even bigger problems.


d) achieve improvement

With risks identified and minimized and opportunities maximized, the likelihood of achieving improvements is much greater. It is essential that these improvements are continuous, although a positive result is already being obtained, there is always something that can be improved.

Improvements can be identified through system analysis, quality research, among other ways.

Let’s assume that the strength of a shipping company is the speed of delivery. However, it is identified through analysis that the speed of delivery can improve with the hiring of another delivery person. Despite already providing an excellent service, this company is always looking to improve and can analyze this fact.


Treat the risks and seize the opportunities

This requirement shows that being able to identify and address risks and opportunities is fundamental for the development of the organization. In addition, the fact that we are constantly changing can be crucial for the emergence of risk and, of course, help lead to the much sought-after competitive edge.

When the organization has a contingency plan to deal with its risks and take advantage of the opportunities that arise, it is ready for eventual situations that could harm the progress of the processes. The organization avoids the surprise effect and absorbs the positive facts of opportunities. In short: more and more positive results always!

QMS Certification

QMS Certification

QMS is an accredited third party certification body, it is currently present in 33 countries and focuses on the certification of management systems. QMS America is managed by the US office and has consistently grown in market recognition by technical level, customer satisfaction and competitive pricing.

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