Quality Progress - August 2015 - (Page 8)
ISO 9001 internal audit
Also, consider reviewing the eight
quality management principles provided
more complicated to try to have two sys-
can we include the total quality manage-
in subclause 0.2 of the introduction to
tems for automotive and nonautomotive
ment (TQM) function? If so, which clause
ISO 9000:2005. These principles are ap-
products. If you have only one certifica-
of ISO 9001 refers to it?
plicable to all the whole family of quality
tion, the scope of your audits should
management system standards.
include your whole product line, not just
A: With regard to the ISO 9001:2008
internal audit process and its relationship
to TQM, it should be noted that TQM was
Aston Technical Consulting Services LLC
a concept used by many organizations
worldwide prior to the existence of ISO
9001 quality management systems.
include their focus on:
* Reducing costs.
FOR MORE INFORMATION
shared between TQM and ISO 9001:2008
* Increasing profits.
* Leadership's involvement.
* Ensuring customer satisfaction.
your automotive products.
The answer to your second question
also is related to the scope of your certification. If you are not design-responsible for
the automotive side of your business, there
1. Joseph M. Juran, Juran's Quality Handbook, fifth edition,
2. International Organization for Standardization, ISO
9000:2005-Quality management systems-Fundamentals and vocabulary, Introduction, subclause 0.2.
A few of the commonalities that are
is a risk that your TS 16949 audits (internal
and external) do not include your design
If you want your design activity in
scope, work with your registrar to roll it
For more information about TQM, visit ASQ's Knowledge
Center TQM page at http://bit.ly/TQMresources.
into your scope of certification.
Find more information about ISO 9000 at http://bit.
it under one certification, it will be up to
* Ensuring employee competency and
Although you should be able to cover
the registrar if it will want you to split it
out into a separate ISO 9001 certification.
* Resource management.
Q: Our company designs and manufac-
The impact of that difference should be
* Quality system planning.
tures commercial and automotive semi-
* Developing of mutually beneficial sup-
conductor products. We used to maintain
Denis J. Devos
dual certification (ISO 9001 and TS 16949)
for all of our manufacturing and assembly
Devos Associates Inc.
* Accomplishing of objectives that support the organization's mission (such
locations, but recently dropped the ISO
as quality policy).
9001 certification. My questions are:
The primary difference that sets ISO
1. If we manufacture automotive and
Raw data required?
9001:2008 apart from TQM is that ISO
nonautomotive products in the same lo-
Q: I sent a sample for testing to a lab
9001 has defined requirements for es-
cation site, without dedicated separation,
that is ISO/IEC 17025-accredited, and it
tablishing documented procedures and
does the TS 16949 certification eligibility
provided me with the test results. How-
records to provide evidence of confor-
apply to the entire site?
ever, when I asked the lab for the raw
mance. The concepts of TQM permeate
2. Can we include the nonautomotive
data to support the testing performed
quality systems that are based on ISO
designs in the TS 16949 certificate scope,
so I could keep it on record for future
or would we need a separate ISO 9001
investigational use, it refused and stated
certificate to cover those activities?
it is not a good manufacturing practices
If your internal audit criteria are
based on ISO 9001, you're also verifying
way you'd want to do it-it would be
Q: In an ISO 9001 internal audit process,
(GMP) lab, and as an ISO/IEC 17025-ac-
that TQM concepts are being used in the
A: Yes, TS 16949 requirements would
credited lab, it is not obligated to provide
quality system. More information regard-
apply to all of your automotive processes
the raw data. It said the raw data could
ing TQM is provided in Juran's Quality
whether they produce or support only
be shown to the regulatory authorities. Is
Handbook, fifth edition.1
automotive products. This is actually the
QP * www.qualityprogress.com
Table of Contents for the Digital Edition of Quality Progress - August 2015
Mr. Pareto Head
Creative by Design
All the Right Moves
3.4 per Million
Quality in the First Person
One Good Idea
Back to Basics
Quality Progress - August 2015