Clause 6 Planning
Clause 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 continual basis, including an evaluation of the risk management process and a priority/scaling of when, how, where and to what level it should be applied.
Clause 6.2: Quality Objectives and Planning to Achieve Them
This subsection builds upon an accurate definition and plan to achieve specific quality objectives including:
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.
Clause 6.3: Planning of Changes
When changes to the QMS are needed, they must be carried out in a planned manner. Examples of QMS changes include plans to transition from ISO 9001:2008 to 9001:2015 or make improvements to your existing QMS. Risks, resources needed, re-assignment of employee responsibility and the integrity of the QMS all need to be considered with developing plans for implementing changes.
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