Free Quality Management System Course- Addressing Risks and Opportunities
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Free Quality Management System Course- Addressing Risks and Opportunities

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Free Training Course -Foundations of Quality Management System (QMS) According to ISO 9001:2015 - Addressing Risks and Opportunities

In the last module (Free Training Course -Foundations of Quality Management System (QMS) According to ISO 9001:2015 - module 4) we took Leadership, in this module we will take Addressing risks and opportunities.

- Addressing risks and opportunities.

The first part of sex clauses cover the requirements to address risks and opportunities. This is a completely new requirements for ISO 9001:2015 version of standard. 

During the plan phase the organization determine risks and opportunities regarding its QMS and its ability to achieve intended results.

Risks and opportunities to be consider are the ones emerging from the internal and external context of the organization as well as for requirements of interested parties.

For example, risk emerging from external context can be changes in local legislation or actions of competitors, and risk emerging from internal context can be obsolete equipment that increases the number of nonconforming products over the year.

- Purpose for addressing risks and opportunities.

The purpose for addressing risks is ensure that the QMS will provide the intended results and prevent to reduce undesired effects. This mean to prevent everything that can prevent organization from delivering quality product or service.

For example, the risk can be in production or in outsource processes so some additions control must be established to avoid the risk.

The next important aspect to addressing risks and opportunities is to enhance the desirable effects and achieve improvement

For example, analysis of need expectation of interest parties there can be some indications on what part of product or service should be improved and this can be opportunities to increase a market share of the company.

In order to affective the actions to address risks and opportunities should be planed with emphasis on implementing and integrating actions in QMS. Because if actions are not part of everyday QMS they would not be effective and in some point to be neglected. But not all identify risks and opportunities must be address, the company will decide what risks and opportunities are significant and address it accordantly.

Actions to address risks are appropriate if they apparitional to potential impact in products, services, or in other elements of QMS.

- Options to avoid risks.


Options to avoid risks can include:

Avoiding the risk.

Taking the risk.

Eliminating the risk source.

Changing the likelihood and consequences.

Sharing the risk

Retaining the risk.


And last important activities is reviewing the action regarding the risks and opportunities and this usually done during the management review.

ISO 9001:2015 not required for organization to establish full risk management. The decision of what to document and to which level depend on the context of the organization.

For example, some small companies may arrange only a brainstorming session regarding the risks and opportunities and records from that meeting can be evidences for applying the risks and opportunities. On the other hand, some mid-size company will develop a full procedure to address the risks and opportunities. 



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