OBJECTIVE OF THE CHECKLIST DOCUMENT

The objective of these checklists is to assist you in the planning, implementation, and internal auditing
of your ISO/TS 16949:2002 quality management system. In particular, the checklists can be used
effectively in the following three ways:

1. Establishing a Baseline and Action Plan: The checklists provide a baseline at the start of
implementation to identify what needs to be done to revise or develop your quality management
system to meet the ISO/TS 16949:2002 Standard.

2. Implementation Guidelines and Checks: The checklists provide a reference to measure

progress and to verify that your quality management system, documentation, and practices are
complete and correct as you proceed in establishing and implementing your ISO/TS 16949:2002
quality management system.

3. Internal Auditing: The checklists clearly define what to audit and how to document that your
quality management system is conforming to ISO/TS 16949:2002.

Checklists help to ensure that the audit is conducted in a systematic and comprehensive manner, and the
proper evidence and documentation are obtained. More specifically, comprehensive checklists guide the
auditor (or audit team) in the following ways:

1. Checklists specify what elements of the quality management system need to be observed, and
what levels of performance or adherence are required to satisfy the Standard.

2. Checklists specify what personnel need to be interviewed, and the types of questions or issues to
address.

3. Checklists specify the relevant quality system procedures and/or work instructions that need to
be evaluated for effectiveness and adherence under routine and non-routine conditions.

4. Checklists specify what evidence needs to be obtained to properly sample and document the
performance and effectiveness of your quality management system.

5. Checklists assist in developing an audit schedule, and in pacing the audit to complete your
objectives in the allotted time.

Checklists help you do a better job with much less effort.

 NOTE
The checklists in this document are not intended to substitute for the ISO/TS 16949:2002 Standard. It is
highly recommended that you purchase this standard from the Automotive Industry Action Group
(AIAG), 26200 Lahser Road, Suite 200, Southfield, MI 48034, P: (248) 358-3570, F: (248) 358-3253
to supplement the checklists and to provide the baseline from which the checklists were written. Within
the checklists, major excerpts from ISO/TS 16949:2002 are shown in italics to clearly identify their
source.

USING STANDARD CHECKLISTS

Standard checklists can be a valuable tool to assist you in the planning, implementation, and internal
auditing of your ISO/TS 16949 quality management system. Since individual companies need to
interpret and “fine-tune” the implementation of the Standard to meet their individual needs and unique
characteristics, standard checklists also need to be “fine-tuned”.

The CD allows you to select and modify these checklists to incorporate your specific quality policies,
procedures, work instructions, and other unique characteristics, and to sample and select the checklists
needed to audit “taking into consideration the status and importance of the processes and areas to be
audited”. Use the CD to select and modify the checklists to best suit your needs.

DISCLAIMER
The material presented in this document is based upon the requirements of ISO/TS 16949:2002 and our
experiences gained through successful application and implementation of quality management system
requirements. Every organization is different, however, in terms of its needs, its culture, and its level of
quality management system development. These differences may require that the generalized guidelines
in this document be applied with special considerations. Readers are advised and cautioned that Steudel
and Mann, LLC nor Steudel & Schultz, LLC will accept no responsibility for the way in which these
guidelines are applied in an organization, or the problems which may arise, unless we are contracted to
assist in the implementation and management of these activities.
 STATUS CODE DEFINITIONS

N: “Nonconformance”. Indicates a nonconformance of some aspect of the Quality

Management System to the ISO/TS 16949:2002 Standard. Examples include, but
are not limited to, system absences and nonconformance of company employees to
follow documented policies, procedures, and work instructions.

W: “Weakness”. Indicates a weakness of the Quality Management System. This

means that the element under consideration may conform to the letter of the
ISO/TS 16949:2002 Standard, but has the potential to fail under certain
circumstances; for example, system elements which are in place but under-
developed and/or misunderstood.

O: “Opportunity”. Indicates an opportunity to improve the Quality Management

System, including findings which may not be specifically required by the ISO/TS
16949:2002 Standard or findings that could “pass a registrar’s audit”, but
undermine the effectiveness of the Quality Management System. An example
would be a finding where documentation could be streamlined or simplified to
facilitate understanding or better reflect organizational practice. Another example
would be an opportunity to increase the effectiveness of the Quality Management
System, utilizing the approaches and guidelines provided in the ISO 9004:2000
document.

C: “Compliance”. Indicates that the Quality Management System element has been
examined under the guidelines of the checklist and that no nonconformances were
found. Note, however, that this does not necessarily mean that there are no
nonconformances in the Quality Management System element, only that none were
found under the scope of the examination.

X: “Not Applicable”. Indicates that the particular element or checklist question is not
applicable to the organization or department being audited.
 TABLE OF CONTENTS
NUMBER OF CHECKLIST ITEMS BY ISO/TS 16949:2002 CLAUSE/REQUIREMENT

Number of
Clause/Requirement Checklist Items Page

4 QUALITY MANAGEMENT SYSTEM 40 1

4.1 General Requirements 5 2

4.2 Documentation Requirements 35 5

5 MANAGEMENT RESPONSIBILITY 37 22

5.1 Management Commitment 2 23

5.2 Customer Focus 1 24

5.3 Quality Policy 7 25

5.4 Planning 7 28

5.5 Responsibility, Authority and Communication 10 32

5.6 Management Review 10 38

6 RESOURCE MANAGEMENT 24 44

6.1 Provision of Resources 1 45

6.2 Human Resources 14 46

6.3 Infrastructure 5 53

6.4 Work Environment 4 56

 Number of
Clause/Requirement Checklist Items Page

7 PRODUCT REALIZATION 247 59

7.1 Planning of Product Realization 16 60

7.2 Customer-related Processes 21 69

7.3 Design and Development 65 80

7.4 Purchasing 27 116

7.5 Production and Service Provision 84 130

7.6 Control of Monitoring and Measuring Devices 34 172

8 MEASUREMENT, ANALYSIS & IMPROVEMENT 123 190

8.1 General 7 191

8.2 Monitoring and Measurement 52 195

8.3 Control of Nonconforming Product 24 223

8.4 Analysis of Data 8 235

8.5 Improvement 32 239

Total Checklist Items 471

8.2 MONITORING AND MEASUREMENT
 QMS CHECKLIST QUESTION
REMARKS & EVIDENCE STATUS
(ISO/TS 16949 REQUIREMENT) **
AUDITING GUIDELINES
1. Does the organization have a
documented procedure for
identifying and controlling
nonconforming, unidentified and
suspect product to prevent its
unintended use or delivery?
(Clause 8.3)
Ensure this documented procedure exists
and verify it addresses the controls and
related responsibilities and authorities
for dealing with nonconforming,
unidentified and suspect product.

2. Are criteria defined to specify under

what circumstances the procedure for
control of nonconforming product is
to be initiated, and when the operator
can simply perform the necessary
activities to make the material
conform to the specified
requirements?
(Measure of Effectiveness: Clause 8.3)
Review the procedure and verify that
people agree when material is
nonconforming versus in-process.
 8.2 MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION

REMARKS & EVIDENCE STATUS
(ISO/TS 16949 REQUIREMENT) **
AUDITING GUIDELINES
3. Is nonconforming, unidentified and
suspect product being reported
correctly?
(Measure of Effectiveness: Clause 8.3)
Review a random sample of
nonconforming material reports and
state the results.

4. Are all relevant personnel aware of a

“Stop Order” (or some equivalent
means) to stop production on a given
order when quality problems are
identified?
(Measure of Effectiveness: Clause 8.3)
Interview personnel on this issue and
verify that the method used is effective in
preventing further processing.
 8.2 MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION

REMARKS & EVIDENCE STATUS
(ISO/TS 16949 REQUIREMENT) **
AUDITING GUIDELINES
5. Is nonconforming, unidentified and
suspect material properly identified
with a “Do Not Use” tag (or
equivalent) and/or does the
organization have clearly identified
“Bond Areas” to prevent inadvertent
use of this material?
(Clause 8.3)
Interview personnel on this issue and
review nonconforming, unidentified and
suspect material for suitable
identification and segregation.

6. Does the procedure for control of

nonconforming product provide for
notifying affected personnel of
nonconformities to prevent
disruptions in production schedules
and customer deliveries?
(Measure of Effectiveness: Clause 8.3)
Review the procedure, trace a sample of
recent nonconforming material incidents
to verify, and state the evidence.
 8.2 MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION

REMARKS & EVIDENCE STATUS
(ISO/TS 16949 REQUIREMENT) **
AUDITING GUIDELINES
7. Does the procedure for control of
nonconforming, unidentified and
suspect product address the
responsibilities and steps to follow in
order to identify and assemble
personnel with appropriate
knowledge, responsibility, and
authority to determine the products’
disposition?
(Clause 8.3)
Review the procedure and state the
evidence.
Note that nonconforming product can be
dealt with by taking action to eliminate
the detected nonconformity (rework); by
authorizing its use, release or
acceptance under concession by a
relevant authority and, where
applicable, by the customer (use as-is or
repair); or by taking action to preclude
its original intended use or application
(scrap or regrade).

8. Are records of the nature of

nonconformities and any subsequent
actions taken, including concessions
obtained, maintained?
(Clause 8.3)
State the evidence based on a random
sample of nonconforming material
reports. Also comment on how the
information in these records is utilized
for data analysis and ongoing
improvement efforts (see Clause 8.4).
 8.2 MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION

REMARKS & EVIDENCE STATUS
(ISO/TS 16949 REQUIREMENT) **
AUDITING GUIDELINES
9. Is there evidence to suggest that the
review and disposition of
nonconforming product are not being
completed in a timely manner?
(Measure of Effectiveness: Clause 8.3)
Review a sample of nonconforming
material reports and also assess bond or
hold areas to determine the amount of
time materials have been staged there.

10. Are all nonconforming products that

are reworked or repaired then
reinspected to demonstrate
conformity?
(Clause 8.3)
Review a sample of nonconforming
material reports and verify that any
required re-inspections have been
performed and recorded.

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