OBJECTIVE OF THE CHECKLIST DOCUMENT

The objective of these checklists is to assist you in the planning,

implementation, and internal auditing of your QS-9000 quality assurance
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 assurance system to meet the
requirements of QS-9000:1998.

2. Implementation Guidelines and Checks: The checklists provide a

reference to measure progress against and to verify that your quality
system, documentation, and practices are complete and correct as you
proceed in establishing and implementing your QS-9000 quality
assurance system.

3. Internal Quality Auditing: The checklists clearly define what to audit

and how to document that your quality system is conforming to QS-
9000:1998.

Checklists are especially useful as a means "for planning and implementing

internal quality audits to verify whether quality activities and related results
comply with planned arrangements and to determine the effectiveness of
the quality system," as required by QS-9000:1998. 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 assurance system need

to be observed, and what levels of performance or adherence are
needed to satisfy the requirements of QS-9000:1998.

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, non-routine, and crisis conditions.

4. Checklists specify what evidence needs to be obtained to properly

sample and document the performance and effectiveness of your
quality assurance 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 be a substitute for the
Quality System Requirements QS-9000:1998. It is highly recommended that
you purchase this document from the Automotive Industry Action Group to
supplement the checklists and provide the baseline from which the checklists
were written.

USING STANDARD CHECKLISTS

Standard checklists can be a valuable aid to assist you in the planning,

implementation, and internal auditing of your QS-9000 quality assurance
system. Since individual companies need to interpret and "fine-tune" the
implementation of the QS-9000 requirements to meet their unique
characteristics, standard checklists also need to be "fine-tuned."

The diskette allows you to select and modify these checklists to incorporate
your specific quality policy, procedures, work instructions, and other unique
characteristics, and to sample and select the checklists needed for auditing
your quality system activities/elements "on the basis of the status and
importance." Use the diskette to select and modify the checklists to best suit
your needs.

DISCLAIMER

The material presented in this document is based upon the requirements of

QS-9000:1998 and our experiences gained through successful application.
Every company is different, however, in terms of its needs, its culture, and its
level of quality system development. These differences may require that the
generalized checklists in this document be applied with special
considerations. Readers are advised and cautioned that H.J. Steudel &
Associates, Inc. will accept no responsibility for the way in which these
checklists are applied in a company, or the problems which may arise, unless
we are contracted to assist in the implementation and management of these
activities.
 TABLE OF CONTENTS
NUMBER OF CHECKLIST ITEMS BY ELEMENT/REQUIREMENT
IN QUALITY SYSTEM REQUIREMENTS QS-9000:1998.

Number of
Element/Requirement Checklist Items Page

4.1 MANAGEMENT RESPONSIBILITY 43

4.1.1 Quality Policy 6 1
4.1.2 Organization 11 3
4.1.3 Management Review 6 7
4.1.4 Business Plan 9 9
4.1.5 Analysis and Use of Company-Level Data 4 12
4.1.6 Customer Satisfaction 7 14

4.2 QUALITY SYSTEM 71

4.2.1 General 5 17
4.2.2 Quality System Procedures 4 19
4.2.3 Quality Planning 35 20
4.2.4 Product Approval Process 8 32
4.2.5 Continuous Improvement 9 34
4.2.6 Facilities and Tooling Management 10 37

4.3 CONTRACT REVIEW 16

4.3.1 General 1 41
4.3.2 Review 11 41
4.3.3 Amendment to a Contract 1 45
4.3.4 Records 3 45

4.4 DESIGN CONTROL 50

4.4.1 General 3 47
4.4.2 Design and Development Planning 7 48
4.4.3 Organizational and Technical Interfaces 2 50
4.4.4 Design Input 6 51
4.4.5 Design Output 7 54
4.4.6 Design Review 5 56
4.4.7 Design Verification 4 58
4.4.8 Design Validation 6 59
4.4.9 Design Changes 6 61
4.4.10 Customer Prototype Support 3 63
4.4.11 Confidentiality 1 64
 Number of
Element/Requirement Checklist Items Page

4.5 DOCUMENT AND DATA CONTROL 23

4.5.1 General 2 65
4.5.2 Document and Data Approval and Issue 15 66
4.5.3 Document and Data Changes 6 71

4.6 PURCHASING 25
4.6.1 General 3 73
4.6.2 Evaluation of Subcontractors 12 74
4.6.3 Purchasing Data 6 78
4.6.4 Verification of Purchased Product 4 80

4.7 CONTROL OF CUSTOMER SUPPLIED 5 82

PRODUCT

4.8 PRODUCT IDENTIFICATION 12 84

AND TRACEABILITY

4.9 PROCESS CONTROL 52 89

4.10 INSPECTION AND TESTING 38

4.10.1 General 5 109
4.10.2 Receiving Inspection and Testing 8 111
4.10.3 In-process Inspection and Testing 4 113
4.10.4 Final Inspection and Testing 9 114
4.10.5 Inspection and Test Records 3 117
4.10.6 Supplier Laboratory Requirements 8 118
4.10.7 Accredited Laboratories 1 121

4.11 CONTROL OF INSPECTION, MEASURING, AND 34

TEST EQUIPMENT
4.11.1 General 6 122
4.11.2 Control Procedure 19 124
4.11.3 Records 5 130
4.11.4 Measurement System Analysis 4 131

4.12 INSPECTION AND TEST STATUS 5 133

4.13 CONTROL OF NONCONFORMING PRODUCT 26

4.13.1 General 9 135
4.13.2 Review and Disposition of Nonconforming 7 136
Product
4.13.3 Control of Reworked Product 4 141
4.13.4 Engineering Approved Product Authorization 6 142
 Number of
Element/Requirement Checklist Items Page #

4.14 CORRECTIVE AND PREVENTIVE ACTION 23

4.14.1 General 7 145
4.14.2 Corrective Action 11 147
4.14.3 Preventive Action 5 151

4.15 HANDLING, STORAGE, PACKAGING, 28

PRESERVATION AND DELIVERY
4.15.1 General 2 154
4.15.2 Handling 3 154
4.15.3 Storage 5 155
4.15.4 Packaging 5 158
4.15.5 Preservation 1 158
4.15.6 Delivery 12 159

4.16 CONTROL OF QUALITY RECORDS 16 164

4.17 INTERNAL QUALITY AUDITS 14 170

4.18 TRAINING 12 175

4.19 SERVICING 7 180

4.20 STATISTICAL TECHNIQUES 12

4.20.1 Identification of Need 3 183
4.20.2 Procedures 4 184
4.20.3 Selection of Statistical Tools 1 185
4.20.4 Knowledge of Basic Statistical Concepts 4 185

Total Checklist Items 512

 STATUS CODE DEFINITIONS

NI: Needs Improvement. Indicates a weakness of the quality system. This means that the
element under consideration may conform to the letter of the QS-9000 Requirements, but
has the potential to fail under certain circumstances. Examples include, but are not limited
to, system elements which are in place but under-developed and/or misunderstood, as well
as other findings of the auditors which may not be specifically required by the QS-9000
Requirements, but undermine the effectiveness of the quality system.

UF: Unacceptable Findings. Indicates a nonconformance of the quality system to the QS-
9000 Requirements. Examples include, but are not limited to, system absences and
nonconformance of company employees to documented policies, procedures, and work
instructions.

NUF: No Unacceptable Findings. Indicates that the 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 system
element, only that none were found under the scope of the examination.

NA: Not Audited/Assessed. Indicates that the element has not been examined under the
scope of the audit or for other reasons which should be documented.

XX: Not Applicable. Indicates that the particular element or checklist question is not
applicable to the organization or department being audited. Examples possibly include, but
are not limited to, aspects of Design Control, Control of Customer-Supplied Product,
Servicing, and possible aspects of Statistical Techniques.
 4.17 INTERNAL QUALITY AUDITS

QMS CHECKLIST QUESTION

(QS-9000 REQUIREMENT) REMARKS & EVIDENCE STATUS
AUDITING GUIDELINES **
1. Does the company have a
documented Internal Quality Audit
(IQA) Procedure (QSP 17.1) that is
understood by all affected personnel?

(Requirement of Element 4.17)

Check the procedure register and

interview the Manager of Quality.
2. Are the IQAs conducted by
trained and qualified auditors?

(Measure of Effectiveness for

Element 4.17)

Review recent audit reports and

records of 2-day IQA training.
3. Are IQA records (such as the
completed audit checklists, audit
report, etc.) signed and dated by the
responsible personnel?

(Requirement of Elements 4.17 &

4.16)

Review recent audit reports.

**STATUS CODES
NI - Needs Improvement UF - Unacceptable Findings NUF - No Unacceptable Findings
NA - Not Audited / Assessed XX - Not Applicable
 4.17 INTERNAL QUALITY AUDITS

QMS CHECKLIST QUESTION

(QS-9000 REQUIREMENT) REMARKS & EVIDENCE STATUS
AUDITING GUIDELINES **
4. Are company personnel involved
in the IQA well informed about the
purpose and scope of the audit?

(Measure of Effectiveness for

Element 4.17)

Interview recent auditees and assess

the findings.
5. Does the company follow a formal
audit schedule, and set IQA
objectives based on the status and
importance of the quality system
activities?

(Requirement of Element 4.17)

Review of the long term audit plan

and recent audit reports.
6. Are IQAs performed by personnel
not having direct responsibility for
the activities being audited, and not
reporting to the managers of the areas
audited?

(Requirement of Element 4.17)

Review recent audit reports and their

organizational positions.

**STATUS CODES
NI - Needs Improvement UF - Unacceptable Findings NUF - No Unacceptable Findings
NA - Not Audited / Assessed XX - Not Applicable
 4.17 INTERNAL QUALITY AUDITS

QMS CHECKLIST QUESTION

(QS-9000 REQUIREMENT) REMARKS & EVIDENCE STATUS
AUDITING GUIDELINES **
7. Are predefined checklists and/or
other established criteria consistently
used in conducting IQAs?

(Measure of Effectiveness for

Element 4.17)

Review recent audit reports and look

for the checklists/criteria used. Note,
however, that auditors may audit
beyond the bounds of the checklists.
8. Do defined guidelines exist (e.g.,
in a procedure) governing what
records shall be kept to document the
audit process and results?

(Measure of Effectiveness for

Element 4.17)

Review the QSP and interview the

person responsible for IQAs.
9. In cases where deficiencies or
nonconformances are identified (in
either lack of compliance with or
effectiveness of the quality system),
are timely corrective actions taken in
accordance with the Corrective
Action Procedure (QSP 14.1)?

(Requirement of Element 4.17)

Review a recent IQA report and the

CA status report, and interview the
people responsible for IQAs.

**STATUS CODES
NI - Needs Improvement UF - Unacceptable Findings NUF - No Unacceptable Findings
NA - Not Audited / Assessed XX - Not Applicable
 4.17 INTERNAL QUALITY AUDITS

QMS CHECKLIST QUESTION

(QS-9000 REQUIREMENT) REMARKS & EVIDENCE STATUS
AUDITING GUIDELINES **
10. Are the results of IQAs clearly
documented and brought to the
attention of company personnel
having responsibility in the areas
audited?

(Requirement of Element 4.17)

Review a recent IQA report and

interview the people auditees.
11. Do follow-up audit activities
verify and record the implementation
and effectiveness of prior corrective
actions?

(Requirement of Element 4.17)

Review a recent IQA report and

check that the investigation included
audited closed out CAs.
12. Are senior management personnel
actively involved in and concerned
with the internal quality audit
process?

(Measure of Effectiveness for

Element 4.17)

Review a recent IQA program and

report, looking for a management
closing meeting and management
participation as auditors or
observers.

**STATUS CODES
NI - Needs Improvement UF - Unacceptable Findings NUF - No Unacceptable Findings
NA - Not Audited / Assessed XX - Not Applicable
 4.17 INTERNAL QUALITY AUDITS

QMS CHECKLIST QUESTION

(QS-9000 REQUIREMENT) REMARKS & EVIDENCE STATUS
AUDITING GUIDELINES **
13. Are the IQAs used as a means to
identify opportunities for and drive
improvements in the quality system?

(Measure of Effectiveness for

Element 4.17)

Review a recent report, looking for

improvement ideas and effective
follow through.
14. Does the audit schedule cover all
shifts, and is the schedule updated at
least annually?

(Requirement of Element 4.17.1)

Review the audit schedule, and state

the evidence.
15. Are planned audit frequencies
increased when significant
nonconformances and/or customer
complaints occur?

(Requirement of Element 4.17.1)

Review the audit schedule, and

compare to the results of customer
complaint and NCMR analysis
results.

**STATUS CODES
NI - Needs Improvement UF - Unacceptable Findings NUF - No Unacceptable Findings
NA - Not Audited / Assessed XX - Not Applicable
To order this Internal Quality Audit Checklist or any of our other documentation for
QS-9000:1998

Contact:
Laura Schultz
Steudel & Schultz, LLC
6417 Normandy Lane, Suite 200
Madison, WI 53719
Tel: 608-271-3121 / Toll Free Tel: 866-271-3121
Fax: 608-271-4755
www.isopocketguides.com
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