ISO 9001:2008 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2009) R9 07.

09
Instructions
Work as a group for 35 minutes and plan 10 minutes for your presentation and discussion.
As a consultant, you have been asked to offer advice to an organization regarding which ISO/TS
16949:2009 processes must be included and which may be excluded in their QMS
implementation. Indicate which sub-clauses may be excluded in the provided situations. Be
prepared to state reasons behind your choice and share questions you might ask in order to make
the proper determination. Indicate if ISO/TS 16949:2009 applies for each organization. Record
your answers on a flip chart.
Please note that the organization may not have made the correct decision regarding scope.
Refer to ISO/TS 16949:2009 as needed for Application (clause 1.2), Outsourcing (clause 4.1) and
all of Product Realization (clause 7), especially Design and Development (clause 7.3).
Breakout 1
Exclusions
Intent
Understand the circumstances under which an organization may exclude specific requirements,
i.e., exclusions.
Time: 45 minutes
Page 2 of 4 Breakout 1: Exclusions
R9 07.09 ISO 9001:2008 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2009)
XYZ Stamping supplies automotive parts per customer-provided prints. They have excluded all of
clause 7.3 because they outsource manufacturing process design and product approval.





1. DEF Automotive Fastener Company excludes 7.3 Design and Development; even though they
have a design department, the design has not changed in years.





2. Sticky Stuff Inc. provides automotive adhesives and sealant. They claim they are not design
responsible. The customer provides Sticky Stuff Inc. with performance specifications (strength,
salt-spray, temperature, etc.). They select from their catalog of products a formulation that
best matches the particular requirements. Sticky Stuff Inc. develops the formulation.
Breakout 1: Exclusions Page 3 of 4
ISO 9001:2008 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2009) R9 07.09
3. TCH Sound Systems has launched a new automotive CD player for SUVs and trucks. TCH owns
the design of the product. The design is sub-contracted to HT&T. The manufacturing is
outsourced to CBB Manufacturing Inc., who produces the entire product. Define to whom the
following sub-clauses apply:

TCH HT&T CBB Comments
7.1 Planning of
Product
Realization

7.2 Customer-
Related
Processes

7.3 Design and
Development

7.4 Purchasing

7.5 Product
and Service
Provision

7.6 Control of
Monitoring and
Measuring
Equipment




4. Nizzo Manufacturing has two plants and a design center that includes corporate functions,
purchasing and sales. There is also a warehouse in a different state as well. They are planning to
have both plants become certified to ISO/TS 16949:2009 first and then address the design center
and corporate functions six months later. They are planning not to certify the warehouse at this
time. Is there a problem here?
Page 4 of 4 Breakout 1: Exclusions
R9 07.09 ISO 9001:2008 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2009)