ISO 9001:2015 – Clause 6

6.1 Actions to address risks and opportunities

Organisations are required to think 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 organisation must then determine the risks and opportunities that need to be addressed. This is in order to provide confidence that the quality management system can achieve its intended outcomes and to achieve continual improvement.

Once the organisation has identified the risks and opportunities it faces, it must then determine how it wishes to address these; however the organisation 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 organisation to set quality objectives for relevant areas within its quality management system. It is for the organisation to decide which areas are relevant. The quality objectives must be consistent with the organisation’s quality policy and be relevant to products and services it provides, and the enhancement of customer satisfaction. Quality objectives must be measurable, take into account applicable customer, statutory and regulatory requirements and be monitored in order to determine whether they are being met. They must also be communicated across the organisation and be updated as and when the need arises.

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

6.3 Planning of changes

When the organisation decides that 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 acted upon. The organisation needs to be clear as to what it is attempting to achieve.