Understanding ISO 9001:2015
Clause 6.3 Planning for
Here is ISO’s guidance on Change
Organization for Standardization
BIBC II, Chemin de Blandonnet 8 , CP 401, 1214 Vernier, Geneva ,
Tel: +41 22 749 01 11, Web: www.iso.org
How Change is addressed within ISO
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
One of the goals of
the ISO 9001:2015 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 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
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:
• Documented information
• employee training
• supplier selection
• supplier management
• and many others
management and control of these changes has become a core requirement within the organizations QMS.
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article discusses in detail the various
factors that may cause changes to your QMS and how to address them as per the requirements of clause