ISO 9001 Clause 6
This clause requires the organisation to plan how it will address risks and opportunities, set quality objectives, and manage changes to the QMS in a controlled way.
ISO 9001 Clause 6 - Planning
Clause 6 sits at the heart of the quality management system. It sets out how the organisation determines the risks and opportunities affecting its QMS, how quality objectives are set and pursued, and how changes to the management system are planned and controlled. The clause splits into three sub-clauses, each covered in its own article below.
Sub-clauses of ISO 9001 Clause 6
Clause 6.1 - Actions to Address Risks and Opportunities requires the organisation to determine the risks and opportunities relevant to the QMS, and to plan actions to address them and integrate those actions into the management system.
Clause 6.2 - Quality Objectives and Planning to Achieve Them requires the organisation to establish quality objectives at relevant functions and levels, and to plan how those objectives will be achieved.
Clause 6.3 - Planning of Changes requires changes to the QMS to be planned and carried out in a controlled way to maintain the integrity of the management system.
