4.1 General Requirements
This requirement in ISO 9001:2008 and ISO/TS 16949:2009 requires organizations to
go beyond QS-9000. They have to identify the processes within their hierarchical
organizational structure. The organizational structure and the chain of command
follow Fredrick Winslow Taylor's theory of "specialization". It is what we call
in the automotive industry - organizational silos or Chimney's. (See picture).
Products are "realized" by processes. ISO/TS 16949:2009 would force QS-9000 registered
organizations to identify the "product realization" processes and the "support"
processes. These processes provide for the product and are responsible for satisfying
Two ISO 9001:1994 paradigms need to be discarded at this stage. One is that the
organization can scope out processes not required by the elements of ISO/TS 16949:2009.
1.2 Application in ISO 9001:2008 and ISO/TS 16949:2009 is careful to point out that
only processes that do not "affect the organization's ability or responsibility
to provide product that meets customer and applicable regulatory requirements" can
be scoped out. "Requirements" are defined as "need and expectation". In other words,
an organizational entity or a process can only be scoped out if it does not affect
customer expectations. Now, it is questionable if organizations can scope out R&D
Centers or Sales offices. Furthermore, ISO/TS 16949:2009 has defined 7.3 Design
and Development as product and process design. No organizations implementing ISO/TS 16949:2009 can exclude 7.3 Design and Development from process design.
Two, ISO 9001:2008 and ISO/TS 16949:2009 clearly state that the organization needs
to maintain control of the outsourced processes that "affect product conformity."
Organizations will need to include outsourced processes in their process map including
heat treating or plating or any component of an assembly manufactured by a supplier.
Organizations need to go beyond the elements of ISO/TS 16949:2009 when creating
the process map. Telltale signs to auditors are process maps that only include elements
related to the standard. Inherently, a "process focus" is different from a "departmental"
focus. Worse yet is the compliance-driven approach of many companies who implemented
QS-9000 with procedures solely based upon elements of the standard.
Omnex recommends that organizations study four types of processes for inclusion
in the process map - ISO/TS 16949:2009 Processes, Product Realization Processes,
Support Processes and Business Processes. ISO/TS 16949:2009 processes inherently
fulfill the requirements of the standard. The Product Realization Processes include
product ideation, research & development, marketing input, design & development
all the way through to delivery of product and post delivery services. The Support
Processes aid the overall organization -these include operations like training,
purchasing, and document control. The Business Processes are those processes that
differentiate you from your competitor and those that help fulfill "customer needs
and expectations." The Business Processes are the most important processes for the
success of a business. Of course, there is overlap in the four types of processes.
In fact a picture of the relationship between the four types of processes is shown
in the attached figure. By definition, Product Realization and Support Processes
are exclusive. In other words, a process can either be a support process or a product
realization process. ISO and Business Processes can be both product realization
or support processes.
After studying the different processes, the organization can create a process map
that "identifies the processes" in the organization. The process map also can show
the "sequence and interaction" of these processes. The figure of a process map was
included in the first series article of this series in May 2001 volume of the Informed