How Change is addressed within ISO 9001:2015

Purpose of this paper:  To explain the new requirement for Change (6.3 Planning of changes, 8.1 Operational planning and control, 8.3.6 Design and development changes and 8.5.6 Control of changes in ISO 9001:2015).

Purpose of this new requirement:

One of the goals of the ISO 9001:2015 revision  is to enhance the requirements for addressing changes at system and operational levels. The ISO 9001:2015 requirements provide a strong basis for a management system for business that supports the strategic direction of the organization.  Once the organization has identified its context and interested parties and then identified the processes that support this linkage, addressing changes becomes an increasingly important component of continued success.
 

Once its processes are determined, an organization will need to identify the risks and opportunities associated with these processes.  To achieve the benefits associated with the determination of risks and opportunities, changes may be needed. These changes can be related to any element of the process, such as inputs, resources, persons, activities, controls, measurements, outputs, etc.

Changes are intended to be beneficial to the organization and need to be carried out as determined by the organization. In addition, consideration of new introduced risks and opportunities need to be taken into account.

To achieve the benefits associated with changes, the organization should consider all types of changes that may need to occur.  These changes may be generated, for example, in:

• Processes

• Documented information

• Tooling

• Equipment

• employee training

• supplier selection

• supplier management

• and many others

The successful management and control of these changes has become a core requirement within the organization’s QMS.

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