ISO9001 UPDATE- Clause 6

BY Becky ON February 11, 2015.

Clause 6

6.1 Actions to address risks and opportunities


Organizations are required to consider their context when planning for their quality management systems. This means thinking about the internal and external issues they face and the relevant requirements of their interested parties and how this may impact on their quality management system. The organization must then determine the risks and opportunities that need to be addressed within this context. This is in order to provide assurance that the quality management system can achieve its intended outcomes and to achieve continual improvement.


Once the organization has identified the risks and opportunities it faces, it must then determine how it wishes to address these; however the organization may take an informed decision to keep the risk, in effect taking no action beyond identifying and evaluating the risk or opportunity.

6.2 Quality objectives and planning to achieve them


This Clause requires an organization to set quality objectives for relevant functions, levels and processes within its quality management system. It is for the organization to decide which functions, levels and processes are relevant. The quality objectives must be consistent with the organization’s quality policy and be relevant to the conformity of products and services, and the enhancement of customer satisfaction. Quality objectives must be measurable, take into account applicable customer and statutory and regulatory requirements, and be monitored in order to determine whether they are being met. They must also be communicated across the organization and be updated as and when the need arises.


The organization must undertake planning in order to determine how its quality objectives will be achieved.

6.3 Planning of changes

When the organization determines there is a need to change the quality management system, they are to be carried out in a controlled manner. Changes need to be planned and then enacted. The organization needs to be clear as to what it is attempting to achieve. It needs to assess whether the integrity of the quality management system could be compromised as a result of making the change. The organization must also consider whether there are sufficient resources available to effect the change and whether any changes in responsibilities or authority levels are necessary to drive the change through.