Organizations preparing to implement a QMS

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.

− For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:

determining the processes necessary for the effective implementation of the quality management system
determining the interactions between these processes.
documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)

− These processes include the management, resource, product realization and measurement processes that are relevant to the effective operation of the QMS.

− Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.

Title: Organizations preparing to implement a QMS
Article From: ISO/TC 176/SC 2/N 525R2