ISO 9001-2015 Requirement: Organizational Quality Management System Planning to address organizational risks, opportunities, changes and quality objectives
Primary Section(s): 6.1
Secondary Section(s): 8.1,8.3.2,9.1.3,9.2.2,10.2.1,A4
Section 6 Planning
Section 6.1: Actions to Address Risks and Opportunities
A separate section named planning is new for the 2015 update of ISO 9001 (though planning is addressed in the ISO 9001 2008 standard in sections such as 8.5.3, 5.4.2 and 7.1), emphasizing planning as a key dictate in achieving and maintaining ISO 9001 2015 registration.
Building upon the need to include the influence of the wider elements of the organization (See Section 4: Context of the Organization ), planning now fully embraces the risk and opportunity management concept. This is to be implemented as a key activity to achieve quality goals on a continuously improving basis, including a self-evaluation of the value of the risk management process and a priority/scaling of when, how, where and to what level it should be applied.
Section 6.2: Quality Objectives and Planning to Achieve Them
This subsection builds upon an accurate definition and plan to achieve specific quality objectives including:
- Being directly driven by the quality policy itself
- More accurate measuring, monitoring and updating
- Being applied to ensure product and service consistency and customer satisfaction
- Having a sufficiently wide scope to ensure quality performance success
- Quality objectives and planning to achieve them
- Specific quality objective documentation
There is to be a conscious approach to changing the QMS itself, using a controlled process that constantly considers the reason and impacts of the considered change, as well as how it may affect the level and allocation of resources and assignments
The standard requires taking the general concepts of planning into the operations realm by defining the needs associated with service or product provision, creating supportive processes, determining customer acceptance criteria and the needed assets to ensure compliance with quality standards.
Section 6.3: Planning of Changes
The standard mandates this same planning instrument be used to manage these processes, including an ongoing refinement and update of the plan (based on continuous monitoring) as part of management’s responsibility. This includes any services or products that are contracted as part of the organization’s product/service creation.
Also, the impacts of risks and opportunities must be updated within the plan based on any corrective actions taken.
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