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.