Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Automobilindustrie
Quality management
in the automotive industry
1
QM system audit
Exclusion of Liability
VDA volumes are recommendations available for general use. Anyone ap-
plying them is responsible for ensuring that they are used correctly in each
case.
This VDA volume takes into account state of the art technology, current at
the time of issue. Implementation of VDA recommendations relieves no one
of responsibility for their own actions. In this respect everyone acts at their
own risk. The VDA and those involved in VDA recommendations shall bear
no liability.
Referenced standards
The quotations from standards identified with their DIN number and issue
date are reproduced with the permission of the DIN Deutsches Institut für
Normung e.V.
The version with the latest issue date, available from the publishers Beuth
Verlag GmbH, 10772 Berlin, is definitive for the use of the standard.
Copyright
This publication including all its parts is protected by copyright. Any use
outside the strict limits of copyright law, is not permissible without the con-
sent of VDA-QMC and is liable to prosecution. This applies in particular to
copying, translation, microfilming and the storing or processing in electronic
systems.
Translations
This publication will also be issued in other languages. The current status
must be requested from VDA-QMC.
3
ISSN 0943-9412
Copyright 2000 by
www.vda-qmc.de
4
Foreword to the 4th Edition
Quality assurance has a new dimension today - it covers and integrates all
divisions of the organization in its vertical and horizontal structures (cross-
sectional function).
VDA Volume 6 very quickly received a good response both within and out-
side the automotive sector and on an international level. Practical experi-
ence has shown that this publication is not only suitable for the preparation
of internal audits, but also represents an excellent aid to preparation for cer-
tification.
The practical experience of auditors led to the volume being revised and
defined in more precise terms as a second edition (12/92). Thus, simplified
operation and a uniform assessment method were achieved.
The new edition of the standard series DIN EN ISO 9000 (Edition 8/94)
made revision of the second edition necessary.
The 3rd Edition also includes requirements from the guidelines EAQF/94
(France) and QS-9000/95 (America). This allows comparison of the audit
results. Furthermore, certification notes were incorporated.
5
In the 4th Edition further corrections and up-dates were included. Comments
from the users and the auditor’s symposia were considered (see Para. 12.1).
The element Z1, so far only required for organizations with international
business activities, now has to be considered generally during audits/certifi-
cation.
In order to make the decision on the issuance of a VDA 6.1 certificate sup-
plement even more definite certain questions which are particularly impor-
tant for product and process and for which noncompliance could lead to the
failure of the quality management system have been specially identified.
These questions lead to determined consequences during the overall
evaluation, see Para. 3.3.3. and 3.3.4.
DIN EN ISO 9001 (Edition 8/94) was used as the basis for the Quality man-
agement system audit which describes a comprehensive system of indus-
trial quality management with its elements. Questions were formulated from
the requirements profile of this standard relating to the explanation of a
quality management system, together with specific requirements from DIN
EN ISO 9004 (Edition 8/94) and supplemented with the practical experience
of the automotive industry. In contrast to the standard which treats the
same subject matter partially in various places and varying depth the ques-
tionnaire in this publication normally contains the subject matter only once
in order to, as far as possible, avoid the repetitions contained in the stan-
dard.
The 4th Edition 2003 is identical in content to the 2000 edition but with up-
dated references and terminology according to ISO9001:2000.
6
This VDA Volume represents a supplement to those volumes already pub-
lished and serves the evaluation of quality management systems under
comparable conditions. It is intended to help identify weaknesses, to rem-
edy them through corrective actions and thereby continually improve the
organization's productivity.
The aim of this work is to unify the necessary audits in order to reduce the
workload for the auditor as well as for those to be audited. Vehicle manu-
facturers and suppliers agree to mutually recognize, as far as possible, au-
dits carried out on the basis of this uniform questionnaire and evaluation
system for rationalization reasons. Recognition of the system-related audit
allows concentration on more specific product- and process-related audits.
QUALITY STANDARD
OF THE GERMAN AUTOMOTIVE INDUSTRY (VDA 6)
7
Our thanks go to the following companies, in particular to the employees in-
volved, for their participation in the preparation of this document:
Thanks are also due to all who have provided suggestions for improvement
as well as those organizations represented in the editorial circle.
8
Contents Page
1 Introduction 13
9
4.4 Terms relating to process and product according to ISO
9000:2000 (extract) 29
#3.4.1 Process 29
#3.4.2 Product 30
#3.4.5 Procedure 30
4.5 Terms relating to conformity according to ISO 9000:2000 (extract)
31
#3.6.5 Corrective action 31
4.6 Terms relating to documentation according to ISO 9000:2000
(extract) 31
#3.7.4 Quality manual 31
4.7 Terms relating to examination according to ISO 9000:2000
(extract) 31
#3.8.1 Objective evidence 31
#3.8.2 Inspection 32
#3.8.4 Verification 32
#3.8.5 Validation 32
4.8 Terms relating to audit according to ISO 9000:2000 (extract) 32
#3.9.1 Audit 32
#3.9.5 Audit findings 33
4.9 Additional Terms (Definitions for the present volume) 33
4.9.1 System 33
4.9.2 Method 33
4.9.3 Serial Production 33
4.9.4 Quality Management (QM) Procedures 33
4.9.5 Work Instructions (Test and Inspection Instructions) 34
4.9.6 Unit 34
4.9.7 Service 34
10
7 Quality Management System Audit Questionnaire 39
01 Management Responsibility 40
02 Quality management system 48
03 Internal Quality Audits 58
04 Training 63
05 Financial Considerations regarding Quality Management
Systems 71
06 Product Safety 75
Z1 Corporate Strategy 81
07 Contract Review, Quality in Marketing 87
08 Design Control, (Product Design and Development) 93
09 Process Planning (Process Development) 101
10 Document and Data Control 111
11 Purchasing 117
12 Control of Customer-Supplied Product 125
13 Product Identification and Traceability
(Process Control, Inspection and Test Status) 129
14 Process Control 137
15 Inspection and Testing (Product Verification) 147
16 Control of Inspection, Measuring and Test Equipment 153
17 Control of Nonconforming Product 159
18 Corrective and Preventive Action 163
19 Handling, Storage, Packaging, Preservation and Delivery 169
20 Control of Quality Records 175
21 Servicing, (After Sales, Post-production Activities) 181
22 Statistical Methods 187
9 Literature 199
9.1 VDA-Series "Quality Management in the Automotive Industry": 199
11
12 Appendix 207
12.1 Changes of the 4th Edition compared to the 3rd Edition 207
12.2 Comparison Tables 210
12.2.1 Comparison Matrix VDA 6.1 / DIN EN ISO 9001 210
a) DIN EN ISO 9001:1994 210
b) ISO 9001:2000 214
12.2.2 Comparison Matrix DIN EN ISO 9004 / VDA 6.1 218
a) 9001:1994 218
b) DIN EN ISO 9001:2000 221
12
1 Introduction
Management must prove that due diligence has been shown in all areas of
the business, from planning to design, procurement, production, sales and
user information through to the observation of a product's market position.
This applies especially in the event of a claim for damages.
It is not only sensible, but essential that all quality management activities be
planned, implemented and combined in a quality management system.
Only a well planned and purposefully selected quality management system
gives business partners, authorities and, increasingly, insurers confidence
in the business's ability to comply with quality requirements.
*
Note: The terms "Quality Management“, "Quality System" and "Quality Manual", according to
DIN EN ISO 8402 replace the earlier used terms "Quality Assurance“, "Quality Assur-
ance System" and "Quality Assurance Manual".
13
- Definition and monitoring of quality-related costs
- Consideration of product safety and product liability
- Involving all employees in the responsibility for quality
These duties are covered in part M of the questionnaire with respect to the
quality management system.
Through the evaluation of the quality management system with the help of
the questionnaire, the customer is given a general view of the supplier's
ability to deliver products and services which meet his quality requirements.
The purpose of this volume is to define an agreed general procedure for the
uniform evaluation of a defined quality management system. In this way,
the workload required for further quality management system audits, for ex-
ample, by other customers, can be reduced.
The result of the evaluation shall show the audited organization where its
quality management system meets the requirements and in which elements
improvements are necessary.
The audit result is signed by the auditor and the audited organization. The
audited organization confirms with its signature that the identified result has
been discussed with him. He is free to provide his own response.
Information acquired during the performance of the audit is, other than for
the use of the audit itself, to be handled confidentially.
Following written release by the auditing organization, or respectively, the
certification body, in the appropriate field of the coversheet of the quality
management system audit, the audited organization is free to present the
audit result to other customers.
This VDA Volume 6, Part 1 is the basis for internal quality manage-
ment system audits (1st Party), customer/supplier audits (2nd Party)
and for audits with VDA 6.1 Certificate Supplement through VDA ap-
proved certification bodies (3rd Party).
14
2 Quality management system according to the
DIN EN ISO 9000 Series
The DIN EN ISO 9000 series is applied as a standard in the European Un-
ion (EU) and EFTA. The German edition is identical in Austria, Germany
and Switzerland.
Users of this standard are enabled to select from the presented basis of
elements according to extent, depth and overall requirements of the busi-
ness in order to be able to completely fulfill the tasks of their own organiza-
tion-specific quality management system.
15
2.2 Quality Assurance Model
(according to the introduction to DIN EN ISO 9001)
The scope and depth of the quality management system may depend on
the type of products to be supplied, the applied technology and the size of
the evaluated organization.
The following paragraphs are taken from the national foreword and the in-
troduction of DIN EN ISO 9001: 1994-08. There it is appropriately stated:
1)
According to DIN EN ISO 8402 1.4 (and ISO 9000:2000, 3.4.2), may include product as
well as services.
16
The following alternative models for quality assurance described in three in-
ternational standards represent three differing forms of "the functional or
organizational quality capability" which are suitable for use in contracts be-
tween two partners (see Chapter 5: Cross-Reference List of Clause Numbers)
2) DIN EN ISO 9001, 9002, 9003 (Edition 08/94) are equivalent to modules E, D and H ac-
cording to 93/465/EEC, see also Foreword and Clause 1.2 of DIN EN ISO 9001:2000
17
3 Quality Management System Audit
3.1 General
- management responsibility
- quality management system
- internal quality audits
- training/personnel
- financial considerations regarding quality management sys-
tems
- product safety
- corporate strategy
18
If the quality management system of an organization, on the occasion of a
system audit, has been found to be satisfactory in accordance with Para-
graph 3.3, then a periodic quality management system audit is to be carried
out at appropriately defined intervals.
During internal quality audits (1st Party) and customer audits (2nd Party) fur-
ther quality elements and questions may also be added. Furthermore, ele-
ments of a quality management system may be adapted, deleted (in excep-
tional cases) or extended to meet organization or product-specific needs.
Additional questions regarding the quality management system must be
communicated to the organization to be audited beforehand.
Individual questions can only be omitted if they are unusual or not able to
be evaluated for the organization size or branch. In cases of doubt, clarifi-
cation with the customer is appropriate.
19
In the following questionnaire, elements of a quality management sys-
tem which have a particular influence on product and process or
which can lead to the failure of the quality management system are
identified by an asterisk (*). Non compliance with these requirements
has particular influence on the overall grade or awarding of a VDA 6.1
Certificate Supplement (see 3.3.3 and 3.3.4).
The auditor evaluates the definition and effectiveness of the quality mana-
gement activities in complying with the respective requirements by initially
determining:
20
According to the following table, answers to the questions lead to a rating
for each relevant question. This rating can result in 0, 4, 6, ,8 or 10 points
per question. The following point rating method is valid for each question:
Point score 10 8 6 4 0
Rating
The element rating is expressed as a percentage which results from the to-
tal points assessed for all relevant questions related to the total points pos-
sible for all relevant questions.
21
If all relevant answers in an element achieve 10 points, then the level of
compliance CE is 100%.
For the two parts of the audit, M (management) and P (product and pro-
cess), the individual levels of compliance CM and CP are calculated. They
are established by calculating the average value of the levels of compliance
for the relevant evaluated quality elements
CM + 2 * CP
CTOT = ——————— [%].
3
The rating system may also be applied if further elements or questions are
added or if elements or questions are omitted. If additional questions relate
to product, services or applied process technology, it may then be neces-
sary to adapt the point and rating system accordingly.
22
Note on the formula for CTOT*:
The formula arises from the following consideration:
On condition that the 7 quality elements concerning management and the 16 quality elements
concerning product and process (from Chapter 6) are equally weighted in CTOT
Then: 7 * CM + 16 * CP
CTOT = ———————— = 0,30 * CM + 0,70 * CP
23
should be calculated.
In order to retain a simple formula and also to give more weight to the Part M quality elements,
the committee defined the formula for CTOT as presented above (no mathematical background).
The elements of CM are therefore more heavily weighted by a factor of 0.33/0.30 = 1,1.
Thereby the elements of management, as an essential part of quality assurance, are treated
with more importance in the quality rating system.
• CTOT is referred to as EGES in the original German version
*) Notes
1. Organizations audited and having received an overall level of compli-
ance exceeding 90 % (or 80 % respectively), but which have a level of
compliance for one or more elements of less than 75 %, will have their
grading dropped from A to AB (or AB to B respectively).
2. If a question marked with * which has particular influence on product
and process or which can lead to a failure of the quality management
system is rated with less than 8 points, then the organization is to be
downgraded from A to AB or from AB to B respectively.
3. If a question not marked with * is rated with 0 points, then the audited
organization is to be downgraded from A to AB.
4. Downgrading according to notes 1, 2 or 3 above may be applied only once.
5. Downgrading is to be justified in a commentary sheet.
23
3.3.4 Awarding of the VDA 6.1 Certificate Supplement (3rd Party):
Exception:
2. Follow-up /Re-audit
A follow-up audit is not possible if more than one question marked with *
is rated with 0 points (Status: failed)
A re-audit is only possible at the earliest after 90 days. The same rules
apply as for a follow-up audit.
24
3.4 Summary of Results
In the course of a close out meeting regarding the quality management sys-
tem audit, the auditor informs the audited organization's management
which nonconformances are present and to what extent corrective actions
are necessary. These will be presented in a summary sheet "Nonconfor-
mances/
Corrective Actions". After completion of the quality management system
audit, the auditor raises an audit report and establishes a time schedule
with the audited organization for the corrective actions (see sample forms
- Chapter 8). If necessary, a follow-up audit date is agreed.
A VDA 6.1 certificate can only be awarded if the overall grade achieved is A
(see 3.3.3). A precondition for this is that the auditor is registered as a
Lead Auditor with the VDA. The representative of the certifying body ap-
plies to the VDA for the VDA 6.1 certificate at the request of the organiza-
tion being audited.
The awarding of a VDA 6.1 certificate may also be carried out under con-
sideration of existing certificates according to DIN EN ISO 9001/9002 or QS
9000 with supplementary auditing (see VDA Volume 6).
The certificate is valid for 3 years after the date of issue, however not
longer than the validity of the ISO certificate being supplemented.
25
VERBAND DER
VDA AUTOMOBILINDUSTRIE E. V.
Sub-organization:
Product group(s):
___________________________
Company / Signature of authorized person VDA-Stamp
26
4 Terms and Definitions
#3.1.2 Requirement
Note 1: "Generally implied" means that it is custom or common practice for the oganization
(#3.3.1), its customers (#3.3.5) and other interested parties (#3.3.7), that the need
or expectation under consideration is implied.
Note 2: A qualifier can be used to denote a specific type of requirement, e.g. product re-
quirement, quality management requirement, customer requirement.
Note 3: A specified requirement is one that is stated, for example, in a document (#3.7.2).
Note 4: Requirements can be generated by different interested parties.
Note: The quality policy is an element of the corporate policy and is approved by the
management.
27
#3.2.8 Quality management
Note: Direction and control with regard to quality generally includes establishment of the
quality policy (#3.2.4) and quality objectives (#3.2.5), quality planning (#3.2.9),
quality control (3.2.10), quality assurance (3.2.11) and quality improvement
(3.2.12).
#3.3.1 Organization
Example: Company, corporation, firm, enterprise, institution, charity, sole trader, association,
or parts or combinations thereof.
Note 1: The arrangement is generally orderly.
Note 2: An organization can be public or private.
Note 3: This definition is valid for the purposes of quality management system (#3.2.3)
standards. The term "organization" is defined differently in ISO/IEC Guide 2.
28
#3.3.5 Customer
#3.3.6 Supplier
#3.4.1 Process
29
#3.4.2 Product
#3.4.5 Procedure
30
4.5 Terms relating to conformity according to ISO 9000:2000 (ex-
tract)
Note: Quality manuals can vary in detail and format to suit the size and complexity of an
individual organization.
31
#3.8.2 Inspection
#3.8.4 Verification
#3.8.5 Validation
#3.9.1 Audit
Note: Internal audits, sometimes called first-party audits, are conducted by, or on behalf
of, the organization (#3.3.1) itself for internal purposes and can form the basis for
an organization's self-declaration of conformity (#3.6.1).
∗
Owing to the more precise structure and revised allocation of the Terms
and Definitions in ISO 9000:2000, the previous sub-chapters 4.2, 4.3
and 4.4 have been removed.
32
#3.9.5 Audit findings
Note: Audit findings can indicate either conformity or nonconformity with audit criteria or
opportunities for improvement.
4.9.1 System
4.9.2 Method
33
4.9.5 Work Instructions (Test and Inspection Instructions)
4.9.6 Unit
4.9.7 Service
34
5 Cross-reference List of Paragraph Numbers for Corresponding
Subjects (according to DIN EN ISO 9000-1, Appendix D, 1994-
08), supplemented by ISO 9001:2000*
35
VDA- Paragraph Title Corresponding Corresponding paragraph or sub-
Ques- paragraph no. in the standard
tion- according to 9001 / (9004-1) clause in
naire ISO 9001:2000 DIN EN ISO
N°. (8/94)
9004-1 9001 9002 9003
36
6 Structure and Number of Questions per Quality Element
Page No. of
questions
01 Management Responsibility 39 6
DIN EN ISO 9001, Clause 4.1
DIN EN ISO 9004-1, Chapter 4
02 Quality Management System 47 6
DIN EN ISO 9001 Clause 4.2
DIN EN ISO 9004-1, Chapter 5
03 Internal Audits 57 4
DIN EN ISO 9001, Clause 4.17
DIN EN ISO 9004-1, Chapter 5
04 Training, Personnel 63 7
DIN EN ISO 9001, Clause 4.18
DIN EN ISO 9004-1, Chapter 18
05 Financial Considerations regarding Quality 71 4
Management Systems
DIN EN ISO 9004-1, Chapter 6
06 Product Safety 75 4
DIN EN ISO 9004-1, Chapter 19
Z1 Corporate Strategy 81 5
37
Page No. of
questions
38
7 Quality Management System Audit Questionnaire
STRUCTURE
For every quality element the general requirements are described in an in-
troduction, the subject in its context is briefly explained and the questions
are stated..
In addition, reference is made to other applicable VDA Volumes which are
to be considered during the realization of the quality management system.
Equivalent procedures and processes are permitted.
Questions on the quality management system which have a special influ-
ence on the product or process or may lead to the failure of the quality
management system are marked with an *.
Each question is structured as follows:
1. The Question
2. Definition
Where required, the terms used in the question are defined according to
the relevant standard and the standard or an extract thereof is cited. The
source is stated respectively.
Explanation of terms
Where required, the terms used in the question are explained, if no defini-
tion is given, to provide a better understanding.
3. Requirements/Explanations
In the section ‘Requirements/Explanations’, requirements on the quality
management system are defined and supplemented by explanations, if
necessary.
Note: For each applicable question, the auditor has to evaluate the definition and the ef-
fectiveness of the quality measures.
39
Part M: Management of the organization
01 Management Responsibility
ISO 9001:2000, Clause 5; 6; 8.5.1
and ISO 9004:2000
Reference
ISO 9001:2000
01.1 Has the quality policy been defined by mana-
* gement and has it been made known to all 5.1, 5.3, 5.4.1
levels?
01.2 Have quality objectives been defined within
* the scope of corporate planning and the qual- 5.1, 5.3, 5.4.1
ity policy and are the results monitored?
01.3 Is a continual improvement process part of the
5.1, 8.5.1
* quality policy?
01.4 Have the necessary resources been provided 5.1, 6.1, 6.2.1,
by the management of the organization? 6.3
01.5 Has a management representative been as-
* signed and are his duties, authorities and re- 5.5.2
sponsibilities defined?
01.6 Does management regularly evaluate the ef-
5.6.1, 5.6.2,
* fectiveness of the quality management sys-
5.6.3
tem?
40
01.1* Has the quality policy been defined by management and has
it been made known to all levels?
Definition:
Note 1: Generally the quality policy is consistent with the overall policy of the organization
and provides a framework for the setting of quality objectives (#3.2.5).
Note 2: Quality management principles presented in this International Standard can form a
basis for the establishment of a quality policy.
Requirements/Explanation:
The quality policy must be formulated in such a way that it can be under-
stood, implemented and applied by employees at all levels The principles of
the quality policy are to be described in a quality manual or an equivalent
document (see Question 02.1).
- notices
- memoranda
- organizational guidelines and instructions
- informative presentations about the quality policy.
The quality objectives of the organization follow the quality policy (see
Question 01.2), are decisive for the organization and incorporate the expec-
tations of the customer(s).
41
01.2* Have quality objectives been defined within the scope of cor-
porate planning and the quality policy and are the results
monitored?
Explanation of terms:
Requirements/Explanation:
Objectives for quality within the scope of the quality policy might be, for ex-
ample:
a) Corporate-wide objectives
• Fulfillment of the general organization requirements (laws, regulations,
directives)
• Improving market acceptance
• Making profit
• Ensuring the continued viability of the organization
• Continual quality improvement (see Question 01.3).
b) Product-related objectives
• Scrap-/ failure rates (%)
• Supplier delivery quality (ppm)
• Improving product quality
• Improving process capability (Cpk)
• Improving reliability
• Environmental tolerance.
c) Customer-related objectives
• Shortening of order processing time (inquiries, orders etc.)
(difference in days)
• Improving customer satisfaction (e.g. reducing the number of customer
complaints change %)
• Reduction in the reaction time when dealing with complaints
(difference in days)
• Improving delivery reliability (on-time performance).
42
d) Higher objectives
• Reducing costs but not to the detriment of quality
• Advance quality planning (see Question 02.5)
• Increasing improvement suggestion activities (methods, equipment,
operations etc.)
• Calculating and evaluating the costs assigned to all quality elements
in order to minimize any loss of quality
• Monitoring the effectiveness of corrective actions on the basis of audit
results
• Quality of the development of products and processes (time, imple-
menation, practicability, feasibility etc.)
• Quality management system upgrade from ISO 9001/2 to VDA 6.1.
Further development towards TQM, EQA etc.
43
01.3* Is a continual improvement process part of the quality policy?
Requirements/Explanation:
Improvement programs for the operating units and for the commercial and
technical functional units of the organization must be introduced and main-
tained. The methods cited elsewhere (see Questions 04.2 and 04.5) must
be used here.
Items for improvement include, for example:
- Reducing non-value-adding activities (e.g. rework, repairs)
- Simplification of processes/Optimization of production meth-
ods.
- Minimization of waste
- Reducing unplanned down-time of machines
- Shortening setting-up and tool change times
- Increasing service life/cycle times of products and equipment
- Improving the ease of repair of products and equipment
- Reducing water, air and energy expenditures
- Optimization of activity times
- Improved handling in all areas
Note: Connections to Question 01.2 are possible. The working methods applied can be
selected on an organization-specific basis.
44
01.4 Have the necessary resources been provided by the man-
agement of the organization?
Requirements/Explanation:
Note: This question cannot be finally evaluated until the entire quality management sys-
tem has become transparent as a result of the audit and until it has been ascer-
tained that all necessary resources are available.
45
01.5* Has a management representative been assigned and are his
duties, authorities and responsibilities defined?
Explanation of terms:
Requirements/Explanation:
Note: The representative may at the same time be responsible for the organizational
functions "quality department", "quality assurance", "quality management" etc.
46
01.6* Does management regularly evaluate the effectiveness of the
quality management system?
Definition:
Requirements/Explanation:
The Management of the organization must periodically (at least once each
year) assess and satisfy itself about the effectiveness of the established
quality management system. The aim of this assessment is to achieve a
continuous optimization and adaptation to changed conditions (market,
technology etc.). This can be done by collecting and evaluating the follow-
ing information, for example:
The review is carried out by comparing the findings with the objecti-
ves of the quality policy and usually results in preventive and correc-
tive actions.
47
02 Quality management system
ISO 9001:2000, Clause 4; 5.4.2; 7.1
Reference
ISO 9001:2000
02.1 Is the quality management system described
4.1; 4.2.1;
* in a quality manual or an equivalent docu-
4.2.2
ment?
02.2 Does the quality management system en-
compass all areas, levels and employees of 4.2.1, 4.2.2
the organization?
02.3 Are there documented procedures defining
* duties, responsibilities and authority levels for 5.5.1
quality activities?
02.4 Is there a cross-functional project manage-
* ment established which includes the quality 7.3.1
planning process?
02.5 Is there a quality planning process for the
* necessary measures and procedures for 5.4.2; 7.1
fulfilling quality requirements?
02.6 Are there quality plans resulting from the qual-
5.4.2, 7.1
* ity planning process?
48
02.1* Is the quality management system described in a quality
manual or an equivalent document?
Definition:
Note: Quality manuals can vary in detail and format to suit the size and complexity of an
individual organization.
Requirements/Explanation:
All quality elements necessary for conducting the business of the organiza-
tion must be described in the quality manual with reference to applicable in-
ternal and external instructions, standards, regulations etc.
- Organizational structure
- Names of responsible individuals
- Implementation process for all activities affecting quality in the
organization.
The manual must display the approval of the organization management, the
validity date and the revision status. Responsibility for its updating, revision
service and the distribution list must be defined. The main purpose of a
quality manual is to define the structure of the quality management system
and, at the same time, to serve as a permanent reference for the implemen-
tation and maintenance of this system.
49
02.2 Does the quality management system encompass all areas,
levels and employees of the organization?
Definition:
Requirements/Explanation:
The quality management system extends to all phases of the life cycle of a
product (DIN EN ISO 9004-1 Paragraph 5.1) and all value-adding proc-
esses involved. Its interacting functions are a precondition for the continu-
ous compliance with the requirements of customers, legislators and society.
Job descriptions and organization charts serve, among other things, to en-
dorse employees, clarify relationships at interfaces and provide evidence of
relevant duties. They make the organization transparent, simplify personnel
qualification and assignment and promote motivation and enthusiasm for
decision-making.
50
02.3* Are there documented procedures defining duties, responsi-
bilities and authority levels for quality activities?
Explanation of terms:
Requirements/Explanation:
which come into effect when signed. Hereby, it must be ensured that duties
are clearly defined with the necessary independence to fulfill stipulated re-
quirements. This requires a definition as to who, for example:
51
02.4* Is there a cross-functional project management established
which includes the quality planning process?
Explanation of terms:
"Project management“ is defined as the management of activities across
several departments within an organization, aimed at the realization of a
particular project (e.g. introduction of a new product [see Question 08.1], a
new process, start of a series [see Element 14]). This task begins as early
as possible and encompasses the concept/design phase, the manufactur-
ing process, through to product utilization and disposal. It includes, among
other things, quality planning (see Question 02.5) and the quality plan (see
Question 02.6).
Requirements/Explanation:
Project flow charts with the main details, among other things for the mana-
gement of a project, must be raised and developed at a very early stage.
Here, the joint activities include:
- raising the specification
- concept / design,
- development
- production
- utilization
- disposal
which must be outlined and explained in the context of simultaneous engi-
neering taking interface issues into account. Quality methods (such as
QFD, DFMEA, PFMEA, DOE,...) must be applied on a project-specific ba-
sis. Depending on the task, the project team should include staff from De-
velopment, Production Planning, Quality and Production departments etc.
The Purchasing department and suppliers must be included when neces-
sary.
The duties and responsibilities must, for example, be defined in project
plans or respectively, in product and process development plans. The ap-
pointment of a project representative (project manager) is advantageous for
all projects. In the case of new projects, it must be ensured that confidenti-
ality, protection and security of data is guaranteed through appropriate
procedures for those involved in the project. Suppliers, if necessary, are
also be included.
Note: The requirement for a "Configuration management" in the standard DIN EN -
ISO 9004-1, Chapter 5.2.6 and 8.10, is interpreted as "Project management" in this
questionnaire (also see DIN 69905[12.90] - Project implementation). See also
ISO 10006:1997, Quality management - Guidelines to quality in project manage-
ment.
52
02.5* Is there a quality planning process for the necessary measu-
res and procedures for fulfilling quality requirements?
Definition:
Requirements/Explanation:
Quality planning must take into account the tasks and deadlines stipulated
by the customer and must contain specially defined methods.
Interdisciplinary teams must be used for the activities to be carried out (e.g.
Product Development, Process Planning, Quality, Marketing).
53
The quality planning phases for new products are:
54
Activities include, for example,:
02.6* Are there quality plans resulting form the quality planning
process?
Definition:
Note 1: These procedures generally include those referring to quality management proc-
esses and to product realization processes.
Note 2: A quality plan often makes references to parts of the quality manual (#3.7.4) or to
procedure documents.
Note 3: A quality plan is generally one of the results of quality planning (#3.2.9).
Requirements/Explanation:
55
The quality plan must normally be drawn up for the following 3 phases:
• Prototype phase
A description of the dimensional, material and functional inspec-
tions and tests which must be carried out during prototype con-
struction (when required by the customer).
• Pre-series phase
A description of the dimensional, material and functional inspec-
tions and tests which must be carried out after prototype construc-
tion and before series production.
• Series phase
Comprehensive documentation of the product and process char-
acteristics, the process control measures, the inspections and
tests and measuring systems which must be observed during se-
ries production.
When quality plans are drawn up, a distinction is made between various
versions. These are related to tangible products in
a) plans for a part manufacturing process with, for example, the follow-
ing content:
• Part name
• Process plan (manufacture / inspection / storage)
• Process stages (working steps)
• Work instructions
• Identification of the quality-relevant characteristics which have to
be monitored during production.
• Process monitoring
- Process description
- Monitoring methods (quality control charts, automatic recor-
dings etc.)
- Responsibilities (operator inspection, quality inspection etc.)
- Inspection instructions
• Inspection
- Parameters
- Geometric/material/functional characteristics
• Documentation,
56
b) plans for a finished product with, for example, the following content:
• Responsibilities (organizational units)
• Review of the customer requirements
• Contract review
• Design review
• Production
• Product inspection and testing
including
If required, the quality plan must be agreed upon with the customer.
Quality plans are living documents and must be reviewed and updated if:
57
03 Internal Quality Audits
ISO 9001:2000, Clause 8.2
Reference
ISO 9001:2000
03.1 Are the personnel (auditors) who perform in-
* ternal quality audits qualified and independent 8.2.2
of the areas being audited?
03.2 Are all elements of the quality management
* system regularly subjected to internal audits 8.2.2; 4.2.4
and evaluated according to an audit plan?
03.3 Do deviations lead to corrective actions and
* are these documented? 8.2.2; 8.5.2
03.4 Are the demands placed on products and
* processes audited and evaluated internally on 8.2.3; 8.2.4
the basis of an audit plan?
58
03.1 * Are the personnel (auditors) who perform internal quality au-
dits qualified and independent of the areas being audited?
Definition:
Auditor (according to ISO 9000:2000/3.9.9):
Person with the competence (#3.9.12) to conduct an audit (#3.9.1).
Explanation of terms:
"Quality auditors" (see DIN ISO 10011, Part 2) must be impartial and free
from any influences which might affect their objectivity.
Personnel tasked with carrying out audits must be independent of the areas
on which they are reporting. They must not come from the organizational
unit to be audited.
Requirements/Explanation:
Auditors must be qualified to manage and perform internal quality audits.
The required qualification profile must be defined. Depending on the type of
audit and size of the organization , the following aspects are particularly
relevant:
• Qualification in accordance with DIN ISO 10011-2 and training in
accordance with EOQ or equivalent guidelines. Evidence of train-
ing can also be supplied through internal training courses.
• Knowledge and understanding of the standards which might form
the basis for audits of quality management systems (DIN EN
ISO 9000 - 9004, VDA Volume 6, Part 1)
• Evidence about the methods of assessment through investigation,
interview, evaluation and reporting (e.g. auditor training in accor-
dance with VDA 6.1)
• Skills that are essential for the management of a quality audit,
such as planning, organization, communication and leadership
• Experience in quality management and quality techniques
• Personal characteristics, such as, e.g. integrity, good judgement,
analytical ability, open-mindedness
• Upholding of relevant qualifications with certificates.
59
03.2* Are all elements of the quality management system regularly
subjected to internal audits and evaluated according to an
audit plan?
Explanation of terms:
The different types of audits with scheduled dates and the areas to be au-
dited have to be defined in an "audit plan“ (according to DIN ISO 10011-1).
This auditing is the systematic review of all quality elements with regard to
their effectiveness, compliance with the requirements and their topicality.
Requirements/Explanation:
Individual quality elements or parts thereof can also be inspected and eva-
luated at different times. All quality elements, in all areas, and at all sites of
the organization must be audited within 3 years.
60
03.3* Do deviations lead to corrective actions and are these docu-
mented?
Definition:
Requirements/Explanation
A plan of action must be presented within an agreed time regarding the de-
viations and proposed corrective actions. The action plan contains, for ex-
ample:
a) Deviations
- Non-compliance with a requirement of a standard
- Instructions are not suitable to achieve the objective
- Activity does not correspond to the instructions
- Instructions not actually implemented
b) Evaluating / weighting deviations with respect to
- Image
- Risk/product safety
- Economy
c) Remedial measures
d) Responsibilities/deadlines
e) Effectiveness check
f) Reporting
g) Adapting the documentation (including the quality management
system)
61
03.4* Are the demands placed on products and processes audited
and evaluated internally on the basis of an audit plan?
Explanation of terms:
A "process audit" serves to check whether the product complies with the
quality requirements and that the process is mastered and capable.
Requirements/Explanation
Audit plans must be defined for products and processes and must include
the following information:
- Audit aim
- Reference documents
- Products/processes to be audited
- Audit sequence
- Questionnaire/checklist
- Deadlines
- Auditors
- Reporting with distribution list
- Pursuit of corrective measures
62
04 Training
ISO 9001:2000 Clause 5.5.3; 6.2
Reference
ISO 9001:2000
04.1 Are training requirements regularly deter-
mined on an individual and function-related
basis and is a differentiated training program 6.2.2
for all levels of the organization derived from
this?
04.2 Does the training program also include ac-
6.2.2
tions for further training in quality techniques?
04.3 Are top management and other management
staff included in the vocational training pro- 6.2.2
gram?
04.4 Are there introduction and instruction pro-
* grams for new and transferred employees and
6.2.2; 4.2.4
for the introduction of new or modified pro-
cesses, business procedures etc.?
04.5 Do employees possess the formal qualifica-
6.2.1; 6.2.2
* tion for their activities?
04.6 Are there measures for the motivation and
6.2.2
promotion of quality awareness?
04.7 Do clear and understandable representations
* of the achieved quality compared to the set 5.5.3
objectives exist in the organization?
63
04.1 Are training requirements regularly determined on an indivi-
dual and function-related basis and is a differentiated train-
ing program for all levels of the organization derived from
this?
Explanation of terms:
Requirements/Explanation:
All employees at all levels who carry out activities which affect quality must
be included. Requirement profiles must be defined on a function-related
basis. The training and further training activities must be summarized on an
individual basis. The summary should clearly show completed and still-
open training measures, and the qualification status must be clearly recog-
nizable.
The training program encompasses all internal and external training activi-
ties and its effectiveness should be examined periodically.
64
04.2 Does the training program also include actions for further
training in quality techniques?
Requirements/Explanation:
- risk analyses
- design of experiments
- test and measurement technology
- capability studies
- statistical process control
- quality control chart system
- system, process and product audit
- supplier evaluation
- problem solving techniques
- evaluation procedures.
65
04.3 Are top management and other management staff included in
the vocational training program?
Requirements/Explanation:
- Quality objectives
- Quality management / TQM
- Quality development
- Quality related costs
- Quality information
- Tools and methods of quality assurance
- Product safety
66
04.4* Are there introduction and instruction programs for new and
transferred employees and for the introduction of new or
modified processes, business procedures etc.?
Explanation of terms:
Requirements/Explanation:
Special attention should be paid to the selection and training of new per-
sonnel, workers on temporary contracts, workers on loan and personnel en-
trusted with new duties.
67
04.5* Do employees possess the formal qualification for their ac-
tivities?
Explanation of terms:
Requirements/Explanation:
For auditors who carry out external quality audits, records for the following
are to be provided:
68
Evidence must be provided for development and testing activities, for ex-
ample:
04.6 Are there measures for the motivation and promotion of qual-
ity awareness?
Explanation of terms:
Requirements/Explanation:
- Improvement suggestions
- Quality circles
- Zero defect programs
- Poster campaigns, competitions
- Training, information meetings
- Awards
- Workshops.
The quality and performance capabilities of the organization are not only
dependent on technical and organizational capabilities and business re-
sources, rather more on the qualification and readiness of employees to
perform well.
69
04.7* Do clear and understandable representations of the achieved
quality compared to the set objectives exist in the organiza-
tion?
Requirements/Explanation:
70
05 Financial Considerations regarding Quality Management Sys-
tems
Reference
ISO 9001:2000
05.1 Is there a procedure for financial reporting of
the effectiveness of the quality management ---
system?
05.2 Does regular financial reporting and evalua-
5.6
* tion by the persons responsible take place?
05.3 Is there evidence about internal losses as a
* result of unacceptable quality (nonconfor- ---
mity)?
05.4 Is there evidence of external losses as a re-
---
* sults of unacceptable quality (nonconformity)?
71
05.1 Is there a procedure for financial reporting of the effective-
ness of the quality management system?
Requirements/Explanation:
There are various methods for collecting, analyzing and displaying financial
data about the quality elements.
The financial reporting methods used depend on the individual structure of
the organization, its activities and the maturity of its quality management
system.
Traditional methods do not exclude the use of others, or their adaptation
and/or combination.
The appropriate procedure, method and cost structure (see Questions 05.2
to 05.4) must be defined (e.g. with instructions, distribution list, cost center
and cost plan and a summary of all financial outlays for the organizational
management).
Methods of financial reporting on activities in the quality management sys-
tem include, for example:
• Quality-related costs
- Fault prevention
- Inspection and testing
- Internal and external faults
Note: Detailed information is only the subject of internal audits. Only the existence of the
procedure must be proven to an external auditor.
72
05.2* Does regular financial reporting and evaluation by the per-
sons responsible take place?
Explanation of terms:
Financial reports on quality-related activities should be compiled and eva-
luated regularly by the persons responsible. Improvements and objectives
can be derived from this.
Requirements/Explanation:
The reports must relate clearly to business parameters, such as sales,
turnover or value-added figures, in order to provide a realistic view of the
organization. Characteristic parameters and measured values must be in
line with target values. Trends and potential areas for improvement must be
identifiable. Quality and cost targets and improvement measures must be
defined for the subsequent period.
05.3* Is there evidence about internal losses as a result of unac-
ceptable quality (nonconformity)?
Explanation of terms:
"Internal losses“ are losses before delivery as a result of unacceptable qua-
lity. They may arise from reduced work efficiency caused by rework, poor
ergonomics etc. They also include nonconformity costs resulting from the
non-fulfillment of quality requirements by a product prior to delivery (e.g. re-
peated performance of a service, renewed production, rework, re-inspec-
tion and testing, rejects).
Requirements/Explanation:
These costs/expenditures include, for example:
- Rejects
- Rework
- Quantity deviation
- Value reduction
- Unplanned sorting action
- Re-inspection and testing
- Investigation of the problem
- Down-time caused by failures
- Development targets not achieved.
Key cost items must be shown with their causes, in a time-, production- and
product-related manner.
73
05.4* Is there evidence about external losses as a result of unac-
ceptable quality (nonconformity)?
Explanation of terms:
"External losses“ are tangible and intangible losses which are identified as
resulting from unacceptable quality.
Tangible losses are nonconformity costs which result from the non-
fulfillment of quality requirements by a product after delivery (e.g. sorting,
rework and repair, warranty performances and return shipments, direct
costs and compensation, costs of product recalls, product liability costs).
Typical intangible losses include, for example, lost future sales as a result
of customer dissatisfaction.
Requirements/Explanation:
- Loss of image
- Loss of customers due to dissatisfaction.
Key cost items must be shown with their causes, in a time-, production- and
product-related manner.
74
06 Product Safety
Reference
ISO 9001:2000
06.1 Are the principles of product liability known
5.1
throughout the organization?
06.2 Is there a procedure to define and identify
products and special characteristics, for which 4.2.3; 4.2.4;
special documented evidence of the quality is 7.2.1
required?
06.3 Have procedures for identifying product risks
---
* been defined?
06.4 Do emergency plans and procedures for con-
5.6.2
taining nonconforming products exist?
75
06.1 Are the principles of product liability known throughout the
organization?
Definition:
Product liability (according to DIN EN ISO 8402/2.12):
A generic term used to describe the onus on a producer or others to make
restitution for loss related to personal injury, property damage or other harm
caused by a product.
Note: The legal and financial implications of product liability may vary from one jurisdic-
tion to another.
Requirements/Explanation:
Indications concerning the knowledge of the principles of product liability
can be, amongst others, evidence of:
- Instruction and qualification of responsible individuals
- Legal services (internal / external)
- Product liability insurance
- Observation of science and technology
Product safety deficiencies can lead to liability claims against the organiza-
tion. For this reason, the organization's employees, particularly the man-
agement personnel, in accordance with their activities, must have appropri-
ate knowledge of the principles of product liability.
Principles of product liability are (amongst others):
- Liability dependent on blame (characterized by the reversal of
the burden of proof. i.e. the burden of proof lies with the de-
fendant)
- Liability independent of blame (new product liability law), liabil-
ity for direct damages and consequential damages caused by
a defect
- It must be demonstrated that the manufacturing process (de-
sign, manufacturing and testing) is "state of the art" - simply
complying with the applicable standards is not sufficient
- Responsibilities must be defined in writing
- Inspection and testing documentation with archiving
- Traceability must be ensured (limitation of damages)
- Warning of possible risks when the product is put into action
by the user.
76
06.2 Is there a procedure to define and identify products and spe-
cial characteristics, for which special documented evidence
of the quality is required?
Explanation of terms:
Requirements/Explanation:
77
A retention period of 15 years (differences specified by the customer must
be taken into account) is also valid after discontinuation of production (for
further instructions, see VDA Volume 1).
The organization obligates itself with the order confirmation to follow the
appropriate procedure, if agreed.
Explanation of terms:
"Product Risks" are safety risks that are involved in the product fulfilling its
own function. Furthermore, this also refers to the risks that a component
brings to a complete assembly.
Requirements/Explanation:
The applicable procedures serve to identify and estimate the potential dan-
gers, which arise from an incorrectly developed, manufactured and/or de-
scribed product. If necessary, they must lead to decisions regarding actions
to be taken.
78
06.4 Do emergency plans and procedures for containing noncon-
forming products exist?
Explanation of terms:
Requirements/Explanation:
79
80
Z1 Corporate Strategy
Reference
SO 9001:2000
Z1.1 Is there a strategic business plan in the or-
ganization which contains aspects relating to ---
costs, sales, quality etc.?
Z1.2 Are there methods to measure business re-
sults and are they used regularly in order to 8.4; 8.5.1
introduce improvements?
Z1.3 Is organization-wide performance data com-
pared with results from benchmarking or simi-
---
lar methods and are improvement measures
derived from this, if necessary?
Z1.4 Is there a procedure which enables customer
* satisfaction to be measured and changes to 8.2.1; 8.4
be detected?
Z1.5 Is employee satisfaction in the organization
one of the principles of management and is it 6.2.2
maintained on a continuous basis?
81
Z1.1 Is there a strategic business plan in the organization which
contains aspects relating to costs, sales, quality etc.?
Definition of terms:
Requirements / explanation:
a) Cost aspects
- Finance and cost planning (investments, personnel and mate-
rial costs)
- Cost targets
d) Development aspects
- Development and trial projects
- Product analyses of competition results
82
All aspects should:
Note: External auditors are to be provided with evidence of: characteristic figures, time
frame, tendencies, trend analyses but not absolute values/amounts and also not
for all aspects. Attention must be paid to organization-specific matters.
Z1.2 Are there methods to measure business results and are they
used regularly in order to introduce improvements?
Definition of terms:
The "business result" expresses what the organization achieves with re-
spect to its planned performance.
Requirements/Explanation:
- Profit − Capital
- Cash flow − Liquidity
- Turnover − Dividends
- Value added − Shareholder long-term
value
In practice, these values are shown partly as absolute values and partly as
ratios per capital unit or per employee.
83
Cycle times such as:
- Innovation time
- Time until the profit threshold is reached
- Stock turnover frequency
Requirements/Explanation:
The evaluation, analysis and use of organization-wide performance data in
comparison with the data of competitors or other organizations through
benchmarking must give information on, for example:
- Productivity
- Economy
- Quality situation
- Efficiency
Trends in the data and information should be compared with the progress
made towards the organization's overall targets and converted into useable
information for the purpose of:
- development of priorities for the rapid solving of customer-
related problems
- determining the important customer-related trends and inter-
relationships in order to make a review of the organization's
situation, decision-making policies and long-term planning
possible.
Note 1: Only the existing system is to be evaluated, not the absolute values/results.
Note 2: This question can be omitted for organizations (particularly small businesses)
which do not operate on international markets.
84
Z1.4* Is there a procedure which enables customer satisfaction to
be measured and changes to be detected?
Requirements/Explanation:
- Method application
- Recognition frequency
- Data evaluation and representation
- Interpretation of trends
- Responsibility
- Distribution list
Note: Only the existing system is to be evaluated, not the absolute values / results.
85
Z1.5 Is employee satisfaction in the organization one of the prin-
ciples of management and is it maintained on a continuous
basis?
Definition of terms:
Requirements/Explanation:
Note: Only the existing system is to be evaluated, not the absolute values / results.
86
Part P: Product and Process
The marketing function should take priority when defining the qua-
lity requirements of the product. They determine the requirements
for a product, the market demand and the customer requirements.
Reference
ISO 9001:2000
07.1 Has a function ‘marketing’ been incorporated
5.2; 7.2.1
into the process organization?
07.2 Are inquiries, quotations, contracts/orders
* checked for completeness and feasibility and 7.2.2
approved?
07.3 Are technical and commercial costs ascertai-
---
ned when preparing a quotation?
07.4 Are the customer's quality requirements on
the product and the quality management sys- 7.2.3
tem available?
07.5 Is a procedure available that ensures the early
and clear notification of all product specifica- 7.2.1; 7.2.2
tions to all areas involved?
87
07.1 Has a function ‘marketing’ been incorporated into the opera-
tional organization?
Definition:
Requirements/Explanations:
88
07.2 * Are inquiries, quotations, contracts/orders checked for com-
pleteness and feasibility and approved?
Definition:
Contract Review (according to DIN EN ISO 8402/3.10):
Systematic activities carried out by the supplier prior to signing the contract
to ensure that the quality requirements are adequately defined, free from
ambiguities, documented and can be realized by the supplier.
Requirements/Explanations:
Prior to the submittal of a quotation or the acceptance of a contract/order
the contract documents (specifications, drawings, requirement specifica-
tions, standards, quality agreements, logistical stipulations etc.) must be
checked for completeness.
Hereby it must be ensured that, e.g.:
- requirements are complete, appropriate and documented
- agreement exist for verbally placed orders prior to acceptance
- ambiguities and deviations are clarified early.
For this a system must be in place in which all responsible functions of the
organization (e.g. sales, development, production, production preparation,
quality department and material management) confirm that they are able to
fulfill customer requirements. The interfaces to the customer are to be de-
fined.
The contract review includes, for example:
- a defined sequence of events in the quality manual/procedures
(flow chart)
- Approval ruling prior to submittal of quotation to the customer
(form with approval by the responsible organizational units)
- Review of contract documents, among others, for:
• clarity of the individual requirements
• inconsistency of individual requirements
• missing of individual requirements
• given deadlines.
89
07.3 Are technical and commercial costs ascertained when pre-
paring a quotation?
Definition:
In a quotation a customer (the market) is offered a product for purchase or
it is provided to him as property or for use.
Products can be tangible or non-tangible.
Requirements/Explanations:
For a quotation, all decisive cost elements must be established and taken
into consideration. The costs are compiled by the responsible divisions and
are incorporated into the overall calculation.
The individual cost elements contain, for example:
- development costs
- material costs
- investments (including hardware/software)
- costs for quality measures
- transportation costs
- packaging costs
- value-added portions/calculated profit
- overheads (administration and marketing cost)
Note: The procedures in practice must be proven to the auditor, rather than the absolute
values.
Definition:
Requirements for quality management systems and requirements for prod-
ucts (see ISO 9000:2000/2.2).
Requirements/Explanations:
The quality requirements for a product must be documented, defined and
thereby the customer’s requirements completely taken into account. All
relevant functional/organizational units are to be included in these se-
quences.
90
The quality requirements (of the customer) are described, for example, in:
- Specifications
- Quality agreements
- Drawings
- Performance specifications
- Standards
- Purchasing conditions
- Order documents.
Special requirements with regard to type, scope and structure of the quality
management system are to be agreed separately.
07.5 Is a procedure available that ensures the early and clear noti-
fication of all product specifications to all areas involved?
Definition:
The entirety of the customer requirements concerning the supplies and ser-
vices of the supplier.
91
Performance Specification (according to DIN 69905):
All the realization requirements worked out by the supplier based on the
implementation of the requirements specification.
The performance specification defines how and with what the require-
ments are to be realized.
Requirements/Explanations:
92
08 Design Control, (Product Design and Development)
ISO 9001:2000 Clause 7.1; 7.3
The quality element design control also called the quality at inter-
pretation and design describes the quality-ensuring tasks in the
area of product design and development. These should take care
of the transferal of the customer needs from the requirements
specification into a performance specification and technical speci-
fications for products and prepare for a timely realization in con-
formance with customer requirements. The provision of resources
for, e.g.: personnel, equipment, trials is a precondition for product
development.
Note 1: This element is to be evaluated except when design responsibilities
are contractually defined. It is not applicable when a completed
product design is adopted.
Note 2: VDA Volumes 2, 3, and 4 Parts 1, 2 and 3 are applicable references.
Reference
ISO 9001:2000
08.1 Does an appropriate product development 7.1; 7.3.1;
* plan for a new product exist? 7.3.7
08.2 Is it ensured that all product requirements can
7.3.2; 7.3.7
be realized?
08.3 Are product trials planned during the develop- 7.3.3; 7.3.5;
ment and pre-series phase? 7.3.7
08.4 Are procedures and methods available to
* carry out a quality evaluation of designs, de- 7.3.4; 7.3.6;
sign models and pre-series products in accor- 7.3.7
dance with the particular project phase?
08.5 Are all responsible functions involved in the
7.3.4; 7.3.5;
release of the product design and its realiza-
7.3.6; 7.3.7
tion?
08.6 Is the result of the product design and devel-
7.3.3; 7.3.7
opment documented in specifications?
08.7 Are the experiences of product design and
development experiences of products docu- ---
mented and are they available to other areas?
93
08.1* Does an appropriate product development plan for a new
product exist?
Requirements/Explanations:
For the product development plan current milestone plans, network plans
etc. with detailed plans must be produced which show all activities from
placement (design and development) through to start of series. The syste-
matic processing of the planned tasks (project planning) must be guaran-
teed. A person responsible for the project and all involved areas with their
tasks must be name (see Question 02.4). Central monitoring of the project’s
progress must be guaranteed (specified/actual comparison). Monitoring
must cover the compliance with all given targets such as, e.g.:
- deadlines
- product qualifications
- costs.
94
08.2 Is it ensured that all product requirements can be realized?
Definition:
"Quality Requirements" (see also definition in Para. 4.1/ #3.1.2) are des-
cribed, e.g. in:
- laws, ordinances, etc.
- general standards, guidelines, specifications
- special standards or requirements specifications (these may
contain special inspection and test instructions also for hard-
ware and software).
Requirements/Explanations:
08.3 Are product trials planned during the development and pre-
series phase?
Requirements/Explanations:
The trial conditions for the product are to be determined and agreed with
the customer.
The product trials may also be performed by an external body (e.g. inde-
pendent inspection agencies, customers). The competence of external bod-
ies must be proven; if required, accredited bodies are to be used.
- assembly trials
- functional testing
- durability testing
- environmental simulation testing.
96
08.4 * Are procedures and methods available to carry out a quality
evaluation of designs, design models and pre-series pro-
ducts in accordance with the particular project phase?
Requirements/Explanations:
"Design" Phase
97
"Production prior to series start“ phase (see also Quality Element 09):
- Process analyses
- Process optimization
- Process review
- Compliance with specification limits.
Note: Procedure for release of series production see Question 14.2 (Product) and Ques-
tion 09.5 (Process).
Requirements/Explanations:
98
08.6 Is the result of the product design and development docu-
mented in specifications?
Definition:
Requirements/Explanations:
For products that are not clearly specified in the customer's drawings ("as
delivered", "as per manufacturer's choice", “without information on inspec-
tion and test instructions“ etc.), the corresponding information in the organi-
zation’s detailed drawings and the finished part drawings must be com-
pleted. Furthermore, the narrowing of tolerances on the customer's draw-
ings might be necessary. The organization's specifications must cover the
requirements specified by the customer.
99
08.7 Are the experiences of product design and development ex-
periences of products documented and are they available to
other areas?
Requirements/Explanations:
- design manuals
- data bases for design FMEA
- product life cycles with, for example, product optimization/
improvements, adaptation through modified/improved produc-
tion procedures
- documentation of test results
- corresponding reports on materials and procedures.
100
09 Process Planning (Process Development)
ISO 9001:2000 Clause 7.1; 7.3; 7.5
Reference
ISO 9001:2000
09.1 Does an appropriate process development plan for 7.1; 7.3.1;
* new/modified products exist? 7.3.7
09.2 Are production, assembly and maintenance pro-
cesses and the material flow planned according to
7.5.1; 7.3.7
quality aspects and are process control require-
ments defined?
09.3 Is it ensured that all product requirements are met 7.3.2; 7.3.7;
by the process? 7.5.1
09.4 Are procedures and methods available to carry out
7.3.4; 7.3.5;
* a quality evaluation of processes and procedures
7.3.7; 7.5.2
in accordance with the respective project phases?
09.5 Are all responsible functions involved in the re-
7.3.7; 7.5.2
lease of processes and procedures?
09.6 Is the result of process planning/development
documented in process specifications/ proce- 7.3.3; 7.3.7
dures?
09.7 Are the experiences from process planning and
development documented and are they available 7.3.1; 7.3.3
to all relevant areas?
101
09.1 * Does an appropriate process development plan for new/
modified products exist?
Requirements/Explanations:
For the process development plan, current milestone plans, network plans
etc. with detailed plans must be produced which show all activities from
placement (development) to series start. The personnel and finance resour-
ces are also to be considered in the development plan. The systematic
processing of the planned tasks (project planning) must be guaranteed. A
project manager and all involved areas with their tasks must be named.
Central monitoring of the project’s progress must be ensured (specified/ ac-
tual comparison). Monitoring must cover compliance with all stated targets
such as, e.g.:
- Deadlines
- Process Qualifications
- Costs.
- Production planning
- Equipment/tool design and construction
- Procurement (of products, materials, components) from sup-
pliers
- Operating equipment construction
- External developments
- Purchasing and the procurement of production and manufac-
turing equipment
- Updating the process development plan.
For this, suitable technical resources are to be used. To limit costs it is ap-
propriate to design testing tools and equipment (including software) so that
most of it can be reused for series production.
102
09.2 Are production, assembly and maintenance processes and
the material flow planned according to quality aspects and
are process control requirements defined?
Definition:
Process control
Requirements/Explanations:
103
To achieve and maintain controlled processes, it is also necessary to carry
out a systematic planning for, e.g.:
- material control
- release of equipment for production, assembly and mainte-
nance
- approval of procedures and work instructions
- quality plans
- computer software
- documentation requirements
They make the decision-making easier when carrying out activities in pro-
duction, especially where special visual requirements and damage risks ex-
ists.
09.3 Is it ensured that all product requirements are met by the pro-
cess?
Definition:
"Quality Requirements" (see also definition in Para. 4.1/ #3.1.2) are des-
cribed, e.g. in:
- Laws, ordinances, etc.
- General standards, guidelines, specifications
- Special standards or requirements specifications (these may
contain special inspection and test instructions).
104
Requirements/Explanations:
The quality requirements (compare Question 07.4) as described in, for ex-
ample, the requirements specification must be checked for their ability to be
complied with within the scope of a process review (compare DIN EN
ISO 9004, Part 1/8.5.2).
Tasks for suppliers are also to be included in the review. Overall responsi-
bility remains with the organization. In cases of noncompliance, compre-
hensive measures are to be taken.
The process requirements must take into account the bases and results of
the contract review (compare Questions 07.2 to 07.4).
1
* see footnote to question 08.2
105
09.4 * Are procedures and methods available to carry out a quality
evaluation of processes and procedures in accordance with
the respective project phases?
Requirements/Explanations:
The method of quality evaluation for processes is applied to ensure that all
quality-relevant findings from the various phases of product development
can be realized.
• ensure that the best possible and most comprehensive picture of the
desired quality of the new product is produced by involving and system-
atically questionning all affected functional areas,
• identify potential weak spots early through the appropriately timed appli-
cation corresponding to each project phase and initiate the introduce of
corrective actions
• guarantee and clarify the implementation of corrective actions (e.g. re-
sults from FMEA, fatigue test, field trial and assembly test)
• document all important results of the quality assurance activities during
the development of a new process/procedure
• include the practical preliminary planning for the quality of the series and
purchasing.
• “Design“ Phase:
- Risk analyses (e.g. Failure Mode and Effects Analysis, Fault Tree
Analysis) (compare VDA Volume 4, Part 1 and 2)
- Design of Experiments (statistical test methodology, e.g. accord-
ing to Taguchi, Shainin)
106
• “Production prior to series start“ Phase:
- Process analyses
• Causes of dispersions
• Appropriate inspection and test methods, e.g. fault tree analy-
sis, test methodology, cause/effects diagram
- process optimization
- process review
- compliance with specification limits
Requirements/Explanations:
107
09.6 Is the result of process planning/development documented in
process specifications/ procedures?
Definition:
Requirements/Explanations:
- description of process
- process parameters
- important product and process characteristics
- inspection and test plans and work plans/instructions
108
09.7 Are the experiences from process planning and development
documented and are they available to all relevant areas?
Requirements/Explanations:
109
110
10 Document and Data Control
ISO 9001:2000 Clause 4.2
Reference
ISO 9001:2000
10.1 Are the responsibilities and procedures for
* the identification, maintenance, review and 4.2.3
approval of the documents defined?
10.2 Is there a distribution and maintenance sys-
tem with revision service available for the 4.2.3
documents?
10.3 Is it defined, where, how and for how long the
4.2.3; 4.2.4
documents are to be archived?
10.4 Is the timely introduction and control of exter-
4.2.3
nal documents ensured?
10.5 Is it ensured that invalid documents are not
4.2.3
used?
111
10.1* Are the responsibilities and procedures for the identification,
maintenance, review and approval of the documents de-
fined?
Definition:
“Identification" serves the clear relation to events, processes or products.
"Maintenance" encompasses the revision service and archiving whereby
the ability to retrieve records must be guaranteed.
"Review" includes, among others, the comparison and translation between
internal and customer specifications, as well as the formal and contextual
review of documents.
"Release" is the approval given by the responsible departments.
Requirements/Explanations:
The processes are to be comprehensively laid out from the customer to the
organization integrating all relevant internal departments. For the following
documents, procedures and responsibilities are to be defined:
Affected are, for example:
- documents for contract review
- specifications
- drawings
- formulations
- standards, regulations, internal standards
- inspection and test instructions
- inspection and test plans, control plans, inspection and test in-
structions
- work instructions
- work procedures, measuring programs
- quality plans
- quality procedures
- quality manual
- procedures for quality verification
- reference samples
- trial procedures.
Documents must be available with the valid revision status to all involved
organizational units. Special identification instructions from customers are
to be followed
A clear presentation of all types of documents is advisable.
112
10.2 Is there a distribution and maintenance system with revision
service available for the documents?
Requirements/Explanations:
- distribution, availability
- completeness (reference documents)
- safeguarding the latest revision status (current revision status)
- approval of changes
- method of identifying changes in the document
- invalidation.
The regulations relating to the approval and distribution system must des-
cribe a process which ensures that the correct documents are available at
the correct time, in the correct place and that a confusion with invalid docu-
ments is excluded.
113
10.3 Is it defined, where, how and for how long the documents are
to be archived?
Requirements/Explanations:
- retention period
- filing system
- filing location.
The retention time (archiving) must also be in line with, amongst other
things, requirements of laws, general guidelines, customers and product li-
ability aspects (see VDA Volume 1).
114
10.4 Is the timely introduction and control of external documents
ensured?
Requirements/Explanations:
The organization must set up a procedure which ensures that all external
documents such as, e.g., standards, specifications, documented procedu-
res and their revisions are reviewed, distributed or introduced at the appro-
priate time. Records of this must be kept in the same way as for internal
documents. Summary of the external documents at a central location is
possible.
Requirements/Explanations:
Immediately after new documents are received, the invalid documents must
be recalled and destroyed by the person responsible.
115
116
11 Purchasing
ISO 9001:2000 Clause 7.4; 7.5
Reference
ISO 9001:2000
11.1 Are the quality requirements on the products
7.4.1; 7.4.2;
and services clearly and completely specified
7.4.3
in the order documents for suppliers?
11.2 Are the evaluation and selection of suppliers
7.4.1
* defined?
11.3 Are sample tests for purchased products de-
7.4.1
fined?
11.4 Does the organization provide procedures for
7.4.1
the regular evaluation of its suppliers?
11.5 Do agreements with the suppliers regarding
the method and responsibilities for quality in- 7.4.1; 7.4.3
spections exist?
11.6 Is the quality of delivered products and ser-
7.1; 7.4.1; 8.1
* vices ensured?
11.7 Is the traceability of delivered products to the
7.5.3
* suppliers ensured?
117
11.1 Are the quality requirements on the products and services
clearly and completely specified in the order documents for
suppliers?
Requirements/Explanations:
Specifications which are clearly defined and easily understood by the sup-
pliers must be an integral part of orders (drawings, standards, requirements
of test certificates, quality agreements, work and inspection and test
instructions, packaging and dispatch instructions, etc.).
The organization must agree these specifications with the supplier. Prior to
release of the order documents, these must be checked for clarity and com-
pleteness. Specifications passed on to suppliers may exceed the quality
requirements of the organization’s customers, but must at least contain all
these requirements on which the supplier has an influence or which affect
him.
Only an order or order confirmation which is completed with all details con-
tributes to the complete fulfillment of the purchasing and quality require-
ments. Hereby, a defined and continually updated revision status is impor-
tant.
When purchasing tools and capital goods the following must be considered
and defined, among others:
118
11.2* Are the evaluation and selection of suppliers defined?
Requirements/Explanations:
(Such system audits also serve as a support for the supplier in setting
up its quality management system. They also serve the purpose of sys-
tem consultancy.)
- product audits
- initial sample testing (compare Question 11.3)
- quality assessments of capital goods (compare Question 14.2)
Special care is to be paid to the selection of suppliers for products with spe-
cial characteristics, the documentation of which requires special archiving.
119
11.3 Are sample tests for purchased products defined?
Definition:
Initial samples are products and materials which have been completely
manufactured with standard equipment under series conditions.
Requirements/Explanations:
- geometry
- material (special attention to hazardous material)
- function
- reliability.
Initial sampling provides evidence that the supplier is able to fulfil the re-
quired specifications with the applied procedures and equipment. The initial
120
samples give the organization important evidence on the quality of the se-
ries to be expected. A release of the initial samples by the inspector does
not relieve the supplier of the responsibility for the series of these products.
Note: Depending on the application purpose, there are various types of samples. In
many branches other designations are used instead of "initial sample" such as, for
example, "initial lot", "initial delivery". The above requirements apply in correspond-
ing form to all sample types.
Definition:
Requirements/Explanations:
Note 1: The assessment of the supplier’s quality management system is performed by au-
dits (compare Question 11.2) and forms part of the overall assessment.
Note 2: The suppliers should be informed about their evaluation on a regular basis.
121
11.5 Do agreements with the suppliers regarding the method and
responsibilities for quality inspections exist?
Requirements/Explanations:
Where necessary, the organization has to set up clear agreements with its
suppliers, regarding e.g.:
Requirements/Explanations:
When the supplier provides quality records (e.g. test certificates according
to DIN EN 10204/3.1b), then control tests are to be performed periodically.
The characteristics to be shown on the quality records are to be agreed.
The certificate must be based on tests carried out on goods ready for deliv-
ery.
If it has been agreed with the supplier that product inspections are only car-
ried out at his premises, then the organization has to satisfy itself as to the
proper execution at the supplier. The visits shall be carried out depending
on the quality capability of the supplier and on the importance of the prod-
uct. The organization must demonstrate this by means of visit reports.
122
A clear identification of the identity of the delivery lots and a differentiation
of released and non-released lots is to be carried out. The material receiv-
ing system must bar goods that have not been released. In the event of use
of the delivered product prior to the completion of inspection, a procedure
(special concession) must be implemented (traceability).
Definition:
Ability to trace the history, application or location of that which is under con-
sideration
Requirements/Explanations:
123
124
12 Control of Customer-Supplied Product
ISO 9001:2000 Clause 7.5.4
The customer has full quality responsibility for the products pro-
vided.
Products sold by the customer to the organization are not the sub-
ject of this quality element as the normal customer/supplier rela-
tionship applies.
Reference
ISO 9001:2000
12.1 Do agreements with the customer on quality
measures for customer-supplied products ex- 7.5.4
ist?
12.2 Is a definition available for the control, verifi-
* cation, storage and receipt of customer- 7.5.4
supplied products?
12.3 Is a procedure defined for reporting noncon-
formities or losses of customer-supplied prod- 7.5.4
ucts to the customer?
12.4 Does a documentation on the quality of
7.5.4
customer-supplied products exist?
125
12.1 Do agreements with the customer on quality measures for
customer-supplied products exist?
Definition:
Requirements/Explanations:
Where no agreements exist, the organization can only take quality respon-
sibility for his value- added activities (compare Question 12.2).
Requirements/Explanations:
In the event that no special agreements with the customer have been
made, a documented procedure must define responsibilities for at least the
following measures:
126
12.3 Is a procedure defined for reporting nonconformities or
losses of customer-supplied products to the customer?
Requirements/Explanations:
When nonconforming products are delivered or when products are lost the
customer must be informed of the following, for example:
- Delivery condition/damage
- Incorrect delivery
- Quantity deviation/lost goods
- malfunction
- Deterioration of quality during processing
- Rework.
Definition:
The documentation describes the quality history of customer-supplied pro-
ducts. It provides a summary of the quality situation during a particular pe-
riod.
Requirements/Explanations:
The delivery quality of customer-supplied products can have a significant
influence on further processing. Deviations from defined quality characte-
ristics are, for example, to be:
- documented upon receipt
- recorded within the area of the production process
- recorded in the case of a product ready for dispatch
- assigned to the delivery lot
- stored for a defined period.
The recordings showing the type of deviation may be carried out, for exam-
ple, in:
- nonconformity tally cards
- quality control charts
- Statistics.
127
128
13 Product Identification and Traceability (Process Control, In-
spection and Test Status)
ISO 9001:2000 Clause 7.5
Reference
ISO 9001:2000
13.1 Is the identification of products for internal 7.5.3
processes defined?
13.2 Is the fulfillment of the quality requirements on 7.5.1
the product ensured through process control
measures?
13.3 Are process parameters recorded and devia- 7.5.2; 4.2.4
tions including corrective actions reported?
13.4 Are production as well as inspection, mea- 7.5.1; 7.5.4;
suring and test equipment appropriately 7.6
stored and protected during interruptions in
use?
13.5 Is it guaranteed that only products which fulfill 7.5.1; 7.5.2
* the quality requirements reach the next pro-
cess/process phase and dispatch?
13.6 Is the known product data traceable from dis- 7.5.3, 4.2.4
patch to material receiving?
13.7 Is there a procedure available for the re- 7.5.2
* release to serial production?
129
13.1 Is the identification of products for internal processes de-
fined?
Definition:
Requirements/Explanations:
The relation to the lot or batch must be traceable. The corresponding work
instructions must be available at site.
Note 1: The identification system used by the organization must allow the clear relation to
the customer’s drawing with revision index at the interface to the customer (dis-
patch).
Note 2: Identification for traceability, see Question 13.6
130
13.2 Is the fulfillment of the quality requirements on the product
ensured through process control measures?
Definition:
Requirements/Explanations:
The documentation must also contain the results from manual and/or auto-
matic 100 % inspections. In the case of an automated 100 % inspection, a
recording of inspected and rejected products must be carried out.
131
13.3 Are process parameters recorded and deviations including
corrective actions reported?
Definition:
Requirements/Explanations:
- Pressure
- Temperature
- Time
- Torque
- Distance
- Electric current
- Voltage
- Frequency
- Humidity
- Velocity.
Note: The control elements for process-influencing should be protected from unautho-
rized interference.
132
13.4 Are production as well as inspection, measuring and test
equipment appropriately stored and protected during inter-
ruptions in use?
Requirements/Explanations:
Production and inspection and test equipment must be appropriately stored
and protected from damage and dirt so that the performance capability is
not affected. This also applies to computers and data storage media.
Tools specifically linked to parts and inspection and test equipment must be
related to a defined release or revision status of the related product. The
revision status must be securely attached to the production mean or, e.g.,
must be included in the file for production means.
In the production means store, the tool crib etc. the difference between
tools ready for production and those still to be inspected and reconditioned
must be identifiable (release status).
Mix-ups lead to nonconforming production, complaints, rework costs, addi-
tional set-up costs etc. This can only be excluded through a clear process
organization.
13.5* Is it guaranteed that only products which fulfill the quality re-
quirements reach the next process/process phase and dis-
patch?
Requirements/Explanations:
Products must be given an inspection status after each process step (ex-
cept for interlacing) which shows whether the products have been in-
spected, which quality inspections have been carried out and whether or
not they meet the quality requirements (see Question 13.1). Hereby cus-
tomer requirements must be considered.
The sequence organization, with responsibilities, must be defined. This ap-
plies particularly where operator inspection is practiced.
This is intended to ensure that only those products which have been re-
leased in accordance with the work instructions and which are usable reach
the next operational stage or dispatch.
Where the identification of products is not possible or economically justifi-
able the type of identification must be agreed and proven.
133
13.6 Is the known product data traceable from dispatch to mate-
rial receiving?
Definition:
Requirements/Explanations:
134
The FIFO principle must be followed in all production areas (material re-
ceiving, in-process, delivery and external stores) (for example through tran-
sient or electronically controlled stores with storage date as a sorting crite-
ria, etc.). Instructions must be available at the individual work stations. A
clear date identification on the material traveler cards is required, especially
for reserved and fixed storage areas and products with a expiration date.
The individual production lots and batches are to be identified and kept
sepaate. The identification applies to all areas of the organization (material
receiving, production, stores, etc.) up to the point of use. Identification is
placed directly on the parts and/or on the containers/ packaging (compare
Question 13.1).
Definition:
"Re-release for serial production" is the order-related release for the re-
newed start of production. The release is required for product and process.
Requirements/Explanations:
The renewed release of the production start shall be carried out by an “au-
thorized“ employee who performs quality assurance functions in a res-
ponsible position. If a release cannot be given directly for time reasons,
then the products must definitely be clearly identified and barred until their
release is granted. The particular proceedings are to be collated in a pro-
cedure.
135
- Completeness of equipment and documents for production
and inspection and testing
- Determination of responsibilities for release after set-up
- Determination of the treatment of lead products and set-up
scrap
- Proof of release at site
- Setting of process parameters
Note: The release of the serial production for products manufactured for the first time is
evaluated in Question 14.2.
136
14 Process Control
ISO 9001:2000 Clause 7.5
Remark: Activities which are necessary for restart of series production are
treated under Question 13.7
Reference
ISO 9001:2000
14.1 Are capability studies carried out on new/over-
hauled machines (plants) and also on new/ 7.5.2; 8.2.3
modified products?
14.2 Are the conditions for a release to series pro-
* duction for new and modified products/proc-
7.5.2
esses regulated and are they agreed with the
customer)?
14.3 Is the monitoring and control (regulation) of
the relevant process parameters and product 7.5.2; 8.2.3
characteristics ensured?
14.4 Does a tool management and a planned
maintenance/servicing for equipment and 7.5.1; 6.3
tools exist?
14.5 Are the requirements on special processes
7.5.1
defined?
14.6 Are the environmental conditions which influ-
6.3; 6.4; 7.5.5
ence product and process controlled?
14.7 Is the effectiveness of production processes
7.5.2
evaluated with suitable methods?
137
14.1 Are capability studies carried out on new/overhauled ma-
chines (plants) and also on new/modified products?
Explanation of terms:
Machine Capability
Process Capability
Requirements/Explanations:
The characteristics and method for performing the capability study are to be
defined.
Machine Capability
138
Under specific conditions, capability studies must be repeated in coordi-
nation with the customer, e.g., for:
Process capability
All characteristic values must generally lie within the tolerance range. The
characteristics important to product quality must be defined and agreed with
the customer. If process capability cannot be proven for important charac-
teristics measures must be defined. These can be, for example:
139
For cost and risk reasons, a 100% inspection requires process optimiza-
tion. In the case of non-capable processes, the 100% inspection is the only
procedure for sorting out defective products and introducing fault analysis
and corrective actions. Thereby, all actions should have the aim to conti-
nually improve the processes within the scope of a zero-failure strategy.
14.2 * Are the conditions for a release to series production for new
and modified products/processes regulated and are they
agreed with the customer)?
Requirements/Explanations:
For release to series production (see Definition, Section 4.5.3) all produc-
tion factors must be available. Only the consideration of all production fac-
tors ensures the problem-free start of series. When determining capacities
all production factors must be considered. Bottlenecks lead to quality im-
pairments and additionally to exceeding of costs and deadlines.
140
- Product qualification review
• Acceptance criteria
• Functional performance
- Initial sample with initial sample inspection report (VDA Volume 2)
• geometric
• material
• functional
• visual
- Production release
• provisional
• final
The conditions for a release and the type of documentation (e.g. checklist)
must be defined. It is advisable and in certain cases (e.g. modified / relo-
cated processes) it is necessary to agree the release conditions (series and
modifications) with the customer in advance. This includes, among other
things, the production process and product approval procedure (PPA)
(compare VDA Volume 2) and the procedures/methods prior to start of se-
ries (compare VDA Volume 4, Part 1, 2 and 3).
141
14.3 Is the monitoring and control (regulation) of the relevant
process parameters and product characteristics ensured?
Requirements/Explanations:
Documentation must also contain and justify every change to the defined
production parameters. A change to the production parameter may require
a new process capability study.
142
14.4 Does a tool management and a planned maintenance/ser-
vicing for equipment
Explanation of term:
Definition:
Note: This serves to ensure the continuing quality capability of the process and may also
include computer and software.
Requirements/Explanations:
143
Based on a risk analysis a minimum amount of spare parts must be kept in
stock for bottleneck machines and equipment.
Definition:
“Special processes“ are processes the results of which can only be verified
(checked) on the product at a later time or not at all.
Requirements/Explanations:
- Characteristics
- Parameters
- Sequences
- Targets.
The control and monitoring of the processes must correspond to the pro-
cess situation. Personnel assigned for these processes must be appropria-
tely qualified and trained. The unambiguous allocation of the documentation
for processes, equipment and personnel must be given.
144
14.6 Are the environmental conditions which influence product
and process controlled?
Requirements/Explanations:
The environmental conditions must be tailored to the work contents and
products in order to prevent contamination, damage and mix-ups. Products
with "special visual requirements" have to fulfill special requirements. Crite-
ria are, e.g.:
- definition of the responsibilities for order and cleanliness
- clean, intact transport and operating equipment
- clean, well-illuminated workplaces and inspection places
- clear identification systems (e.g. escape routes)
- clear, ordered, if possible synchronous material flow
- appropriate disposal containers
- appropriate room and storage conditions.
Requirements/Explanations:
The production process must be continually monitored for deviations from
requirements and possible improvement potential.
Personnel active in the process must be involved in the evaluation so that
their experiences are taken into account. Recognized improvement possi-
bilities must be implemented without delay according to a plan to be de-
fined.
Potential methods are, e.g:
- process audit (compare Question 03.4)
- CIP (compare Question 01.3)
- Quality circle (compare Question 04.6)
The following must be evaluated, among others:
- production/work plan
- adapted automization
- ergonomic and human factors
- value-adding work
- inventory management system.
145
146
15 Inspection and Testing (Product Verification)
ISO 9001:2000 Clause 7.1; 8.2.4
DIN EN ISO 9004-1, Chapter 12
Reference
ISO 9001:2000
15.1 Are all inspection activities covered by control
7.1
plans with inspection instructions?
15.2 Are the quality inspections in the process and
the appropriate methods/techniques defined 7.1; 8.1
in inspection instructions?
15.3 Are the defined quality records maintained for
7.4.3; 8.2.4
all incoming products?
15.4 Are the defined quality records maintained
7.1; 8.1; 8.2.4
during the processes/working stages?
15.5 Are the defined quality records maintained on
8.2.4; 7.5.3
* the end product?
15.6 Are there records about periodic inspections
8.2.4
and tests?
147
15.1 Are all inspection activities covered in control plans with in-
spection instructions?
Explanation of Terms:
The "control plan" is a product-related representation of all quality inspec-
tions, with reference to inspection instructions, from incoming goods
through to delivery.
Requirements/Explanation:
All inspections (including destructive testing) during the construction pro-
cess of a product must be recorded in control plans and these plans must
be kept available on site. The control plans must include, among other
things:
- specific parts data (part number, designation)
- quality characteristics at the relevant process stage
- reference to supplementary process descriptions
- reference to supplementary inspection descriptions/inspection
instructions
- references to decision possibilities (release, place on hold, re-
work).
If inspections are carried out externally, the same regulations apply. The
organization must regularly satisfy itself of the correctness of the operations
performed. When required by the customer, accredited laboratory facilities
are to be used.
A single inspection control plan can apply to a group or family of parts
which are manufactured using the same process and the same equipment.
When drawing up control plans, different information is used and obtained
from, e.g.:
- Process plan
- System-/Product-/Process-FMEA
- Special characteristics which were agreed upon
- Knowledge obtained from similar parts / processes
- Knowledge obtained from the development phases
- Other analytical techniques (optimization methods, QFD,
DOE).
The inspection control plan must be in line with the quality management
plan. It can also be included within the quality management plan.
148
15.2 Are the quality inspections in the process and the appropri-
ate methods/techniques defined in inspection instructions?
Requirements/Explanation:
Inspection instructions are also necessary for repeat inspections (e.g. in-
spections following rework), or as a result of particular knowledge obtained
(e.g. from series production).
149
15.3 Are the defined quality records maintained for all incoming
products?
Requirements/Explanation:
It has to be ensured, that only released products are submitted for further
processing.
In order to fulfill the obligation to show due care and attention, periodic
cross-checks and repeated inspections and tests must be performed.
150
15.4 Are the defined quality records maintained during the pro-
cesses/working stages?
Requirements/Explanation:
151
15.5* Are the defined quality records maintained on the end product?
Requirements/Explanation:
The inspections must be carried out in accordance with the inspection con-
trol plan and inspection instructions. Refer to Question 15.4 for further re-
quirements/explanation.
The defined evidence must be provided for repeat inspections (rework).
Quality evidence also includes, for example, results from
- final inspections and tests
- functional inspections (under conditions of use)
- acceptance tests
- product audits
- reliability testing.
Note: It must be guaranteed that all inspections and tests are carried out before the
goods are dispatched to the customer. Special agreements must be made, if this
does not apply.
Requirements/Explanation:
Periodic inspections and tests should also be defined in the control plan or
quality management plan; the results are to be documented.
These periodic inspections and tests should prove that all quality require-
ments of the product are fulfilled. The type and scope of these inspections
go beyond the normal inspections and tests during production.
They can be performed at different times for differing requirements.
"Periodic inspections" are inspections, for example, such as:
- long term tests (weathering, ozone, corrosion testing)
- re-qualification tests
- durability tests
Records about verification checks on products which are delivered with
quality evidence conforming to DIN EN 10204 are included in the periodic
inspections.
Repeated inspections, performed as and when required, can also become
necessary and be carried out for a limited period as a result of special find-
ings, e.g. from serial inspections.
152
16 Control of Inspection, Measuring and Test Equipment
ISO 9001:2000 Clause 7.6
153
16.1* Is there a procedure for the approval, identification, calibration.
control and maintenance of inspection and test equipment?
Requirements/Explanation:
The control of all inspection and test equipment in all areas, e.g. in develop-
ment, tool making, maintenance, production, assembly, quality and custo-
mer services, must be guaranteed in order to provide confidence in deci-
sions and actions based on the measured results of tests and inspections.
Inspection and test equipment must be approved for use and calibrated
regularly in order to guarantee its accuracy throughout its entire service life.
The control must cover, among other things:
- standard inspection and test equipment of all kinds
- gauges
- measuring instruments
- sensors
- measurement recorders
- special test equipment and the corresponding software.
In addition, devices, inspection and test records, comparison references
and process monitoring instruments which might influence the quality of a
product or a process must be controlled in the same way.
The system for controlling equipment must be described in a documented
procedure or similar, including the following, for example:
- initial inspection and approval for use of new test equipment
- identification system
- recording of the equipment in a supply source record/approval list
- inspection instructions for the testing/calibration of inspection
and test equipment with defined inspection intervals and
documentation (see VDI / VDE / DGQ Guideline 2618 for "In-
spection instructions for the control of inspection and test
equipment")
- internal/external control body
- reference standards, master gauges
- control of test equipment used by customer services
- control of supplied inspection and test equipment with clear
regulation in the contract permitting its use
- definition of the testing/calibration intervals dependent on the
wear and tear and frequency of use
- examination of the equipment following changes, damage, and
suspicion of false indications
- maintenance of inspection, measuring and test equipment.
154
Gauges linked to specific parts must be able to be clearly cross-referenced
to the subject numbers of the parts, as well as their current revision status
in order to prevent confusion.
The test and calibration intervals depend on the frequency of use and must
be evident from the files or directly on the equipment itself. Actual calibra-
tion and measurement values are to be documented (including initial cali-
bration values prior to first use). The results provide additional information
about wear and tear and the likely time the inspection and test equipment
will become obsolete.
Access to technical data and records about inspection, measuring and test
equipment has to be provided, when required by the customer.
Definition:
The set of operations which establish, under specified conditions, the rela-
tionship between values indicated by a measuring device or system, or val-
ues represented by a material measure or a reference material on the one
hand, and the corresponding values of a quantity realized by a reference
standard on the other.
155
Examples: a) 1 kg mass standard; b) standard gauge block; c) 100 Ω
standard resistor; d) Weston standard cell; e) cesium atomic
frequency standard; f) solution of cortisol in human serum
as a standard of concentration.
Requirements/Explanation:
The uninterrupted chain goes in rising form (calibration hierarchy) from the
used standard, to the reference standard, via the national standard through
to the primary standard.
16.3 Are only pieces of inspection and test equipment used that
have a sufficiently low measurement uncertainty.
Definition:
Result of the evaluation aimed at characterizing the range within which the
true value of a measure is estimated to lie, generally with a given likelihood.
156
Requirements/Explanation:
Testing equipment must be selected so that the characteristics to be tested
can be measured with an acceptable level of uncertainty, which must be
known.
The highest permissible measuring uncertainty is dependent on the proc-
ess/product specification and the inspection instructions of the customer.
These factors and the corresponding surrounding conditions (e.g. tempera-
ture, humidity) must be taken into account when selecting the necessary in-
spection and test equipment.
16.4 Is there a procedure defined to record the inspection and test
equipment capability?
Explanation of Terms:
The "capability of inspection and test equipment" is determined from the
measurement uncertainty of the inspection and test equipment in relation to
the tolerance of the characteristic to be measured.
Requirements/Explanation:
The capability study of inspection and test equipment is to be proven on the
basis of the statistical evaluation of ranges of measurements. This may be
done by calculation or graphically (correlation diagram). Special customer
requirements must also be considered here, as far as possible and other
procedures are to be agreed, if necessary.
The inspection and test equipment capability is determined using the re-
peatability or comparability of measurements, with the help of the range
method or the mean value and range method under consideration of the
random variability (95% / 97,5% / 99%).
The result of the study is not only determined by the test equipment itself,
but also through other influences, for example:
- composition of the tested products
- operator
- measurement records
- holding devices
- surrounding conditions.
The necessity for evidence of the capability of inspection and test equip-
ment is dependent on:
- the measurement uncertainty of the inspection and test equip-
ment
157
- the complexity of the inspection and test equipment
- the use of interlocking inspection and test equipment/methods.
This applies especially to complex inspection and test equipment such as:
- measuring machines
- multi-point measuring devices
- measuring equipment for statistical recording
- test equipment for electrical quantities.
Note: When technical modifications are made to products, the inspection and test
equipment capability must, if necessary, be reassessed.
Requirements/Explanation:
When it is determined that inspection and test processes are no longer con-
trolled or the inspection and test equipment can no longer maintain its high-
est permissible level of measurement uncertainty or is damaged, corrective
actions are required .
An evaluation is to be carried out to determine the effects on finished pro-
ducts, calculate the deviations and to initiate suitable measures, such as,
e.g.:
- rework,
- re-testing
- complete rejection
- informing the customer.
158
17 Control of Nonconforming Product
ISO 9001:2000 Clause 8.3
The quality control systems must initiate cause analyses and cor-
rective actions and prevent, on a long term basis, the recurrence
of identified nonconformities.
Reference
ISO 9001:2000
17.1 Are there procedures for the handling of non-
8.3
* conforming units?
17.2 Is the agreement of the customer obtained,
prior to shipment of products which deviate 8.3
from the specification?
17.3 Is rework executed according to a plan and
8.3
documented?
17.4 Is there a procedure for the identification of
8.3
recurrent nonconformities?
159
17.1* Are there procedures for the handling of nonconforming
units?
Requirements/Explanation:
- rework
- acceptance with or without repair on the basis of a concession
- downgrade for another use
- rejection
- scrap.
The processes addressed here must describe all activities which are car-
ried out in conjunction with the control of nonconforming products in order
to remedy faults. This must also include units which are suspected of being
nonconforming. This can necessitate an inspection of other products which
have been developed and manufactured using the same process and/or of
preceding lots of the same product.
160
17.2 Is the agreement of the customer obtained, prior to shipment
of products which deviate from the specification?
Definition:
Note: A concession is generally limited to the delivery of a product that has noncon-
forming characteristics (#3.5.1) within specified limits for an agreed time or
quantity of that product
Requirements/Explanation:
The internal and external concession procedure until the agreed delivery to
the customer (internal/external) must be defined.
The deviation from the specification must be presented in detail to the cus-
tomer and documented. If necessary, the products must be identified and
the approved, as well as the dispatched quantity is to be recorded.
Products deviating from the specification - even where the deviation does
not appear critical to the organization - may only be shipped if the customer
has given his agreement. This procedure, if necessary including the validity
period of the concession, must be documented.
Requirements/Explanation:
For any required rework, the working and inspection steps, together with
the associated production and testing equipment, must be defined. Quali-
fied staff must be used. The performance of the orderly work is to be moni-
tored and documented.
161
Documentation should include, for example:
Note: The responsibilities for the initiation and monitoring of corrective actions are evalu-
ated in Question 18.1.
Explanation of Terms:
Requirements/Explanation:
The procedure must describe the activities regarding further analyses and
corrective actions. The evaluation should consider internally and externally
encountered nonconformities, for example, by means of:
162
18 Corrective and Preventive Action
ISO 9001:2000 Clause 8.5
- Development evaluations
- Analyses of potential nonconformity possibilities
- Quality inspections and audits
- Reports on process nonconformities
- Feedback from the market
- Service reports
- Customer complaints
- Management reviews (see Question 01.6).
Reference
ISO 9001:2000
18.1 Are the responsibilities for the initiation and
* monitoring of corrective actions clearly de- 5.6.3; 8.5
fined?
18.2 Are there procedures to estimate potential
nonconformity risks and to implement corres- 8.5
ponding preventive actions?
18.3 Are there procedures for the analysis of non-
8.5
conformity causes?
18.4 Are there procedures to prevent recurrent
8.5
* nonconformities?
163
18.1* Are the responsibilities for the initiation and monitoring of
corrective actions clearly defined?
Definition:
Requirements/Explanation:
The responsibility and authority for the initiation of corrective actions must
be defined. Responsible persons must be also defined for the coordination,
recording and monitoring of corrective actions. The monitoring activity inclu-
des both the performance of the remedial action and the check of its effec-
tiveness.
164
18.2 Are there procedures to estimate potential nonconformity
risks and to implement corresponding preventive actions?
Explanation of Terms:
- process costs
- quality-related costs,
- performance, functional capability and safety of the product,
- customer satisfaction.
Requirements/Explanation:
Risk analyses, for example, form the basis for the optimization of and
changes to:
- specifications
- operations
- test and manufacturing equipment
- instructions.
165
18.3 Are there procedures for the analysis of nonconformity
causes?
Requirements/Explanation:
When a quality problem occurs, the actual root cause must be determined
by analysis before corrective actions are planned. Often the root cause is
not obvious; which necessitates a thorough analysis of, for example,:
166
18.4* Are there procedures to prevent recurrent nonconformities?
Explanation of Terms:
Requirements/Explanation:
167
168
19 Handling, Storage, Packaging, Preservation and Delivery
ISO 9001:2000 Clause 7.5.5
Reference
ISO 9001:2000
19.1 Are there instructions for the handling of prod-
7.5.5
ucts?
19.2 Is the packing and identification process prior
7.5.5
to delivery defined and monitored?
19.3 Is it ensured that damage or deterioration in
quality during storage and transport is pre- 7.5.5
vented?
19.4 Is there a procedure to record, rectify and ini-
tiate corrective actions on packaging non- 7.5.5
conformities and transport related damage?
19.5 Is the identification of products during trans- 7.5.5
port and storage ensured?
19.6 Is there a procedure which documents deliv-
--
* ery reliability?
169
19.1 Are there instructions for the handling of products?
Explanation of Terms:
Requirements/Explanation:
The instructions must contain orderly planning and control for incoming ma-
terials, their further processing, and for end products up to the point of use
by the final customer. The methods and responsibilities must be defined for,
e.g.:
170
19.2 Is the packing and identification process prior to delivery de-
fined and monitored?
Requirements/Explanation:
- initial packing
- final packaging / repackaging for shipment container
- identification,
171
19.3 Is it ensured that damage or deterioration in quality during
storage and transport is prevented?
Requirements/Explanation:
- condition of containers
- cleaning and preservation
- filling of containers
- methods of transport (temperature, vibrations, etc.)
- protective measures for products and personnel
- effects of humidity
- padding
- secure fixing
- collective packaging
- instructions for handling (e.g. assembly, delivery).
Requirements/Explanation:
172
19.5 Is the identification of products during transport and storage
ensured?
Requirements/Explanation:
It must be ensured that products are identifiable at all times during transport
and storage. Customer requirements must be taken into account.
Note: The identification should be sufficient to allow for the identification of an individual
product, if a recall or a special inspection is necessary.
Explanation of Terms:
Requirements/Explanation:
173
174
20 Control of Quality Records
ISO 9001:2000 Clause 4.2.4
Note: For this element VDA Volumes 1 and 7 are appllicable references.
Reference
ISO 9001:2000
20.1 Are procedures and responsibilities defined
for the identification, review and approval of 4.2.4
quality records?
20.2 Are there procedures and responsibilities de-
fined for the evaluation and distribution of 4.2.4
quality records?
20.3 Is it defined where, how and for how long
4.2.4
quality records are retained?
20.4 Is the manner in which quality records are
made accessible to the customer defined, if ---
this has been contractually agreed?
175
20.1 Are procedures and responsibilities defined for the identifi-
cation, review and approval of quality records?
Explanation of Terms:
Requirements/Explanation:
176
20.2 Are there procedures and responsibilities defined for the eva-
luation and distribution of quality records?
Explanation of Terms:
Requirements/Explanation:
The quality records of the supplier and customer must be incorporated into
this process.
177
20.3 Is it defined where, how and for how long quality records are
retained?
Explanation of Terms:
Requirements/Explanation:
- retention period
- filing system
- filing location.
Thereby the following, for example must be considered:
The retention (or archiving) period must be defined, among other things, on
the basis of the requirements of legislation, general guidelines, customers
and product liability aspects (see VDA Volume 1).
178
The destruction of quality records after the defined archiving period must be
regulated.
Requirements/Explanation:
179
180
21 Servicing, (After Sales, Post-production Activities)
ISO 9001:2000 Clause 7.5; 8.4
Note: If only the Question 21.3 is relevant for the evaluation of this element,
then this question can also be considered and evaluated as an addi-
tional question 18.5 under Element 18. In this case the individual
evaluation of Element 21 is no longer applicable.
Reference
ISO 9001:2000
21.1 Is the preparation of operation and assambly
instruction defined and are these clear and 7.5.1
understood?
21.2 Is there a procedure for product surveillance
and an early warning system for product fail- ---
ures in use?
21.3 Is there a procedure to analyze product non-
conformities during use, as well as to imple- 8.4; 8.5.2
ment and monitor corrective actions?
21.4 Is the customer service function included in
7.5.1
the information flow system?
21.5 Is there a procedure for maintenance activi-
7.5.1
ties, if these are agreed?
181
21.1 Is the preparation of operation and assembly instruction de-
fined and are these clear and understood?
Requirements/Explanation:
It must be noted that the operating and assembly instructions must be avail-
able and, if necessary, agreed with the customer in good time, that is, prior
to the introduction of the product.
Note: Regarding products within the automotive industry, this question applies primarily
to organizations active in the accessory business sector. The necessity of this
question is to be agreed upon in individual cases.
Requirements/Explanation:
The procedure for this must be defined and, if necessary, agreed with cus-
tomers that further process delivered products. Thereby, not only the war-
ranty period but also the entire utilization period should be taken into ac-
count (e.g. also long-term evaluations).
Every organization must be aware of how its products behave in use. The
activities undertaken by the organization, in order to obtain information
about the quality of its products in use, must be evidenced.
182
This includes for example:
An early warning system must be agreed and built up between the organi-
zation and the customer. This should include, e.g.:
The information must be available to, among others, the following organi-
zational units:
- Development
- Work planning
- Production
- Quality management.
Note: It is especially important that systems suppliers and suppliers of complex products
establish a quick feedback system for the introduction of new products. See Ques-
tion 21.3 concerning the analysis and evaluation of nonconformities.
183
21.3 Is there a procedure to analyze product nonconformities dur-
ing use, as well as to implement and monitor corrective ac-
tions?
Requirements/Explanation:
The results of the analysis of the nonconformity and the corrective actions
must be informed to the customer and, if necessary, to the development
department.
Note: The procedure for the above is to be defined with the customer.
184
21.4 Is the customer service function included in the information
flow system?
Explanation of Terms:
"Customer service“ is the care of the products at the customer (including in-
tangible products - see Definitions in Chapter 4).
Requirements/Explanation:
- identified responsibilities
- discussion notes
- check lists
- meeting reports
- travel reports.
185
21.5 Is there a procedure for maintenance activities, if these are
agreed?
Requirements/Explanation:
The following must also be taken into account, among other things,
- special tools
- inspection measuring and testing equipment
- work instructions for commissioning
- administration of spare parts
186
22 Statistical Methods
ISO 9001:2000 Clause 8
Reference
ISO 9001:2000
22.1 Are the possibilities for using statistical meth-
8.1
ods determined and is their use planned?
22.2 Are statistical methods used for planning and
8.2.3; 8.2.4;
evaluating experiments and estimating prod-
8.4
uct risks during development?
22.3 Are statistical methods used for the evaluation 8.2.3; 8.2.4;
of quality inspections on deliveries? 8.4
22.4 Are statistical methods used for process opti- 8.2.3; 8.2.4;
mization and for process control? 8.4
22.5 Are statistical methods used for the evaluation 8.2.3; 8.2.4;
of quality test at final inspection? 8.4
22.6 Are statistical methods used for the evaluation 8.2.3; 8.2.4;
of product failures during use? 8.4
187
22.1 Are the possibilities for using statistical methods determined
and is their use planned?
Requirements/Explanation:
The need for statistical methods to determine, monitor and examine proc-
ess and product within the process chain must be defined.
It is to be defined, dependent on the results of the risk analysis (e.g.
FMEA), which processes and characteristics have to be tested and evalu-
ated and with which methods.
The appropriate method must be defined and used for the particular appli-
cation.
Statistical methods allow the user to assess processes taking into account
economic aspects within the process chain.
Statistical methods are planned within the framework of project planning in
the form of a advanced quality plan (quality planning).
The results of the statistical evaluation must be considered within the scope
of quality improvement programs.
Wherever possible and economically viable, the statistical evaluation of pro-
cess parameters must be given precedence over the evaluation of quality
results on products.
22.2 Are statistical methods used for planning and evaluating ex-
periments and estimating product risks during development?
Requirements/Explanation:
Typical methods are e.g.:
- Design of Experiments / analysis of influencing variables
- variance and regression analysis
- significance studies
- calculation of failure probability
- FMEA
- failure tree analysis
- system optimization.
Statistical methods must be used both for product and process develop-
ment in testing, design and model construction.
188
22.3 Are statistical methods used for the evaluation of quality in-
spections on deliveries?
Requirements/Explanation:
The evaluation of quality evidence for deliveries also forms part of this.
22.4 Are statistical methods used for process optimization and for
process control?
Requirements/Explanation:
189
22.5 Are statistical methods used for the evaluation of quality test
at final inspection?
Requirements/Explanation:
Requirements/Explanation:
190
8 Forms for the Quality Management System Audit - tangible
products -
The use of forms to correctly carry out the quality management system au-
dit is advantageous because they enable the results to be gathered quickly,
rationally and clearly for all parties involved. The forms shown below show
examples of possibilities.
The set of forms: Quality management system audit for material products in
accordance with VDA 6.1 consisting of :
Assessment documents
Overall evaluation of the quality management system
Overall compliance
Summary of results
Summary of evaluated questions
Corrective actions
Corrective actions - summary
DIN A4, block of 10 sets, 5 pages each set.
Reference sources:
Druckerei Henrich
D-60528 Frankfurt am Main, Schwanheimer Str. 110
(0 69)67 80 06-0
(0 69)67 80 06-30
191
VDA 6, Part 1- Quality Management System Audit
Overall Evaluation of the Quality management system
of the Organization
Customer/Certification body
Area / Plant Location
Auditor
Report No. of System Audit:
Audit period: starting ending
Audited/Certified Organization
Area / Plant Location
Audited Products / Product groups
Address
Contact person
Audit Result
Signature of audited/certified
organization/date Signature Auditor(s) / Date
................................................. .................................................
.................................................
Signature
192
VDA 6, Part 1- Quality Management System Overall Compliance
- only for Customer / Supplier Audits (2nd Party)
Customer: Supplier:
Report No. of System Audit: Date:
Grade:
System evaluation:
193
VDA 6, Part 1 - Quality Management System Audit:
Summary of Results
194
VDA 6, Part 1- Quality Management System Audit:
Summary of Evaluated questions
Customer / Audited/Certified
Certification body: organization:
Report N°. of System Audit: Date:
Certificate N°.: DIN EN ISO:
Valid to:
195
VDA 6, Part 1- Quality Management System Audit:
Remarks on Status
Customer / Audited/Certified
Certification body: organization:
196
VDA 6,Part 1- Quality Management System Audit:
Corrective Actions
Q-Element Deviations, proposed correc- Response and actions of the au- Deadline
seq. No. tive actions dited / certified organization
.
197
VDA 6, Part 1- Quality Management System Audit:
Corrective action - Summary
Customer / Audited/Certified
Certification body: organization:
further in-
VDA
Element J F M A M J J A S O D formation
No. on sheet
no.
Part M: Management
01 Management Responsibility
02 Quality Management System
03 Internal Audits
04 Training, Personnel
05 Financial considerations reg. QMS
06 Product Safety
Z1 Corporate Strategy
Part P: Product and Process
07 Contract Review, Quality in Market-
ing
08 Design Control (Product design)
09 Process Planning,(Process dev.)
10 Document and Data Control
11 Purchasing
12 Control of custom-supplied Prod.
13 Identification, Traceability, etc..
14 Process Control
15 Inspection + Test (Product testing)
16 Control of Insp.+Test Equipment
17 Control of non-conforming Prod.
18 Corrective + Preventive Actions.
19 Handling., Storage, Pack., etc.
20 Control of Quality records
21 Servicing (Post-Production Activity)
22 Statistical Methods
198
9 Literature
199
Volume 9 Quality Assurance
Emissions and Consumption
QMC Report
200
9.9 DIN EN ISO 9000 Teil 3 (06/92)
Qualitätsmanagement- und Qualitätssicherungsnormen; Leitfaden
für die Anwendung von ISO 9001 auf die Entwicklung, Lieferung
und Wartung von Software
201
9.18 DIN ISO 10011 Teil 1 (06/92)
Leitfaden für das Audit von Qualitätssicherungssystemen; Audit-
durchführung
References
202
10 Agreement with Industrial Associations
10.1 Introduction
• Deutscher Schraubenverband e. V
Hagen (German Association of Fasteners)
203
• Verband der Deutschen Federnindustrie (VDFI)
Hagen (Association of the German Spring Industry)
- Fachvereinigung Präzisionsrohrwerke e. V.
(Association of Precision Tube Works)
204
AGREEMENT
on mutual recognition
PSA Peugeot Citroën, Renault, FIEV and Verband der Automobilindustrie (VDA)
205
11 Notes on a Certification according to VDA 6.1
Certification audits must only be carried out by "certified VDA 6.1 auditors"
with the corresponding branch expertise.
206
12 Appendix
Further corrections and updating have been incorporated. The audited or-
ganization is from now on generally referred to as "the organization".
The factual content of the chapters, elements and questions has widely re-
mained unchanged. Changes have been made in:
Foreword
"Quality Standards of the German Automotive Industry" updated
3. Quality System Audit
Scope of application for all 3 audit types (1st-, 2nd– and 3rd-party)
determined.
207
3.7 VDA 6.1 Certificate
The text of the certificate has been changed. The statement of the
level of compliance has been dropped.
7 Questionnaire
Question 01.6: Management review "with all elements" dropped
Question 03.1: Qualification requirements for internal auditors up-
dated. External auditors now defined under 04.5.
Question 04.5 Qualification requirements for external auditors
newly included.
Question 06 The circle of persons to be informed has been
newly formulated.
Question 06.4 Definition for "Emergency Plans" revised.
Element Z1 Is now generally to be taken into account during
audits/certification.
Question Z1.3 Examples for data have been supplemented.
Question 07.5 Formulation: "early" has been added.
Question 09.4 Quality evaluation "at least three times" has been
dropped.
Element 10 VDA Volume 1 has been added as being applica-
ble.
Element 11 "Supplier" is generally used instead of "Subsup-
plier". The note was added that the element is
also applicable for internal customer/supplier rela-
tionships.
Question 11.6 "inspected“ and "not inspected" has been re-
placed by "released" and "not released".
Question 13.2 "Inspection and test plan" has been replaced by
"inspection and test instruction".
Question 13.3 Formulation: "Production parameters of the proc-
ess“ has been replaced with "process parame-
ters“.
Question 13.4 Formulation: "Manufacturing means" has been re-
placed by "production means".
208
Question 14.1 Explanation to "Process Capability" added.
Question 14.2 PPA Process according to VDA Volume 2 and
note on process changes added.
Question 14.7 Note on applicable methods added.
Question 15.1 "Destructive testing" added.
Question 15.2 Procedure for rework added.
Question 15.6 "Durability test" added, "Product audit" dropped
(compare 03.4).
Element 20 "Quality-relevant records" changed into "Quality
records". Note on VDA Volume 1 added.
Question 20.1 Formulation: "maintenance" has been dropped.
Question 20.3 Definition for DwSpA added (compare VDA 1).
Element 21 Note on procedure when only Question 21.3 is
relevant.
8 Forms
In the form "Corrective actions" the word "deviations" has been added.
11 Notes on Certification
This section has been updated. VDA Volume 6, Basics for Quality Audits is
referenced.
12 Appendix
The notes on changes made from 2nd Edition to the 3rd Edition have been
dropped.
209
12.2 Comparison Tables
In the following, the comparison tables to DIN EN ISO 9001 are shown.
210
VDA 6 Subject of the Question DIN EN
ISO 9001
Z1. Corporate Strategy
Z1.1 Business plan on costs, sales, quality etc. --
Z1.2 Measuring methods for business results and CIP use --
Z1.3 Performance data, organization-wide / comparison --
Z1.4 Customer satisfaction, measurement and modification --
Z1.5 Personnel satisfaction --
P Product and Process
07. Contract Review / Quality in Marketing 4.3
07.1 Marketing function --
07.2 Contract review 4.3.1, 4.3.2
07.3 Structure quotation --
07.4 Quality requirements of the customer 4.2.3, 4.3.2a,
07.5 Requirements and performance specification known 4.3.2c
08. Design Control 4.4
08.1 Product/process development plan 4.4.1, 4.4.2,
4.4.4, 4.4.5
08.2 Quality requirements fully considered 4.4.4, 4.3.2c
08.3 Product/process trial 4.4.7, 4.4.8
08.4 Management review 4.4.6
08.5 Design approval 4.4.8, 4.4.3,
4.4.5
08.6 Result of design work 4.4.5
08.7 Transfer of development experience 4.4.3, 4.4.5
09 Process Planning (Process Development) 4.4, (4.9)
09.1 Process development Plan for new/modified products 4.4.1, 4.4.2,
4.4.4, 4.4.5
09.2 Production plans, work instructions 4.9 Abs.1,
4.9a
09.3 Quality requirements fully considered 4.4.4, 4.3.2c
09.4 Management review of processes and procedures 4.4.6
09.5 Approval of processes and procedures 4.4.8, 4.4.3,
4.4.5
09.6 Result of process planning and development work 4.4.5
09.7 Transfer of experiences from process planning 4.4.3, 4.4.5
10. Document and Data Control 4.5,
10.1 Quality-relevant documents, responsibility, procedures, .. 4.5.1 to -3
10.2 Approval and revision 4.5.2, 4.5.3
10.3 Archiving 4.3.4
10.4 Appropriately times introduction of customer documents 4.5.2
10.5 Non-use of invalid documents 4.5.3
11. Purchasing 4.6
11.1 Order documents 4.6.2, 4.6.3,
4.6.4.2
11.2 Supplier selection 4.6.1, 4.6.2a
11.3 Sample test 4.6.1, 4.6.2b
11.4 Supplier quality performance 4.6.1, 4.6.2c
211
VDA 6 Subject of the Question DIN EN
ISO 9001
11.5 Agreements on quality inspections 4.6.2b, (4.6.4)
11.6 Material receiving inspection 4.6.4, 4.10.1
11.7 Traceability 4.8
12 Control of customer-supplied Products 4.7
12.1 Agreed quality measures 4.7
12.2 Minimum scope of inspection and testing 4.7
12.3 Reporting of nonconformities 4.7
12.4 Quality history 4.7
13. Process Control/Identification and Traceability/Inspection and Test 4.9, (4.8,
Status 4.11, 4.12,
4.19´6)
13.1 Product identification 4.8, 4.12
13.2 Process control measures 4.9d
13.3 Records of process parameters 4.9 (Para.4)
4.16
13.4 Production means – Storage 4.11.2h
13.5 Quality objective/subsequent process, dispatch 4.12
13.6 Traceability 4.8 (Para.2)
13.7 Release on restart 4.9e
14. Process Control 4.9
14.1 Machine/process capability tests 4.9b
14.2 Production release 4.9c, -d, -e
14.3 Control of relevant process parameters 4.9d, 4.9f
14.4 Maintenance, preventive servicing 4.9g
14.5 Special processes 4.9 Para. 2, 3
14.6 Environmental conditions specified/complied with 4.9b, 4.11.2g
14.7 Evaluation of the effectiveness of production processes --
15. Inspection and Testing 4.10, (4.2.3)
15.1 Inspection and test plans 4.2.3b,-c,-d,-e
15.2 Inspection and test plans and instructions 4.10.1
15.3 Quality evidence for external purchases 4.6.4.1,
4.10.1, 4.10.2
15.4 Quality evidence according to work steps 4.10.1,4.10.3,
4.12
15.5 Quality evidence on the final product 4.10.1, 4.10.4
15.6 Periodic inspections and tests (4.10.1)
16. Control of Inspection, Measuring and Test Equipment 4.11
16.1 Control and calibration system 4.11.1,4.11.2
b,-c,-d,-e,-g,-i
16.2 Connection to national/international standards 4.11.2b
16.3 Measurement uncertainty of inspection, measuring and test equip- 4.11.2a
ment
16.4 Inspection, measuring and test equipment capability (4.11.2a)
16.5 Measures to be taken in case of nonconforming inspection, 4.11.2f
measuring and test equipment
212
VDA 6 Subject of the Question DIN EN
ISO 9001
17. Control of Nonconforming Products 4.13
17.1 Treatment of nonconforming units 4.13.1, 4.13.2
17.2 Concessions 4.13.2
17.3 Carrying out of corrective actions 4.13.2
17.4 Identification of reoccurring nonconformities 4.14.2a
18. Corrective and Preventive Actions 4.14
18.1 Initiation of corrective actions 4.14.1, 4.14.2
18.2 Estimating the nonconformity risk 4.14.3
18.3 Analysis of the cause of nonconformities 4.14.2b
18.4 Prevention of nonconformity reoccurrence 4.14.2d
19. Handling, Storage, Packaging, Preservation and Delivery 4.15
19.1 Product handling 4.15.1,4.15.2,
4.15.3
19.2 Packaging and identification process 4.15.4
19.3 Prevention of transport damage 4.15.4,4.15.5,
4.15.6
19.4 Correction of packaging errors 4.15.1 with
4.14.1
19.5 Product identification 4.15.4
19.6 Delivery reliability --
20. Control of Quality Records 4.16
20.1 Quality-relevant documents 4.16
20.2 Evaluation of quality records 4.16
20.3 Archiving 4.16, 4.3.4
20.4 Customer access to quality records 4.16
21 Quality in the application phase/Servicing/Customer Service (4.19)
21.1 Users manual and installation instructions (4.19)
21.2 Product observation/Field failure-early warning system --
21.3 Field failure analysis (4.14.2b)
21.4 Customer service information --
21.5 Servicing 4.19
22. Statistical Methods 4.20
22.1 Method planning 4.20.1
22.2 Development/Trial 4.20
22.3 External sources 4.20
22.4 Process development and control 4.20
22.5 Final inspection 4.20
22.6 Evaluation of field failures 4.20
213
b) ISO 9001:2000
VDA ISO
6.14 Subject of the Question 9001:2000
M Management of the Organization
01. Management Responsibility 5, 6, 8.5.1
01.1 Quality policy 5.1, 5.3, 5.4.1
01.2 Quality objectives 5.1, 5.3, 5.4.1
01.3 Continual improvement 5.1, 8.5.1
Quality management system, resources for personnel and material 5.1, 6.1, 6.2.1,
01.4
costs 6.3
01.5 Management representative 5.5.2
01.6 Management review 5.6.1, 5.6.2,
5.6.3
02. Quality Management System 4, 5.4.2, 7.1
02.1 Quality manual 4.1, 4.2.1,
4.2.2
02.2 Scope of the quality management system 4.2.1, 4.2.2
02.3 Responsibility and authority 5.5.1
02.5 Project management 7.3.1
02.4 Quality planning 5.4.2, 7.1
02.6 Quality plans 5.4.2, 7.1
03. Internal Audits 8.2
03.1 Auditor qualification 8.2.2
03.2 Internal quality audits 8.2.2, 8.2.4
03.3 Corrective actions and their documentation 8.2.2, 8.5.2
03.4 Product and process audits 8.2.3, 8.2.4
04. Training 5.5.3, 6.2
04.1 Training program 6.2.2
04.2 Further training in quality techniques 6.2.2
04.3 Further training - Executives 6.2.2
04.4 New appointments, realization 6.2.2, 4.2.4
04.5 Qualification 6.2.1, 6.2.2
04.6 Promotion of quality awareness 6.2.2
04.7 Presentation of the quality achieved 5.5.3
05. Financial Considerations regarding Quality Management Systems
05.1 Methods of reporting --
05.2 Regularity of reporting 5.6
05.3 Nonconformity costs internal --
05.4 Nonconformity costs external --
1)
VDA requirements concerning Process Audits extend beyond those of ISO (see VDA 6.3).
2)
Financial Considerations regarding Quality Management Systems are not seperately
treated in the ISO standard.
214
VDA ISO
Subject of the Question
6.14 9001:2000
06. Product Safety
06.1 Product liability - Basics 5.1
4.2.3, 4.2.4,
06.2 Products requiring documentation
7.2.1
06.3 Identification of product risks --
06.4 Localization of nonconforming units 5.6.2
Z1. Corporate Strategy
Z1.1 Business plan on costs, sales, quality etc. --
Z1.2 Measuring methods for business results and CIP use 8.4, 8.5.1
Z1.3 Performance data, organization-wide / comparison --
Z1.4 Customer satisfaction, measurement and modification 8.2.1, 8.4
Z1.5 Personnel satisfaction 6.2.2
P Product and Process
07. Contract Review / Quality in Marketing 5.2, 7.2
07.1 Marketing function 5.2, 7.2.1
07.2 Contract review 7.2.2
07.3 Structure quotation --
07.4 Quality requirements of the customer 7.2.3
07.5 Requirements and performance specification known 7.2.1, 7.2.2
08. Design Control 7.1, 7.3
7.1, 7.3.1,
08.1 Product/process development plan
7.3.7
08.2 Quality requirements fully considered 7.3.2, 7.3.7
7.3.3, 7.3.5,
08.3 Product/process trial
7.3.7
7.3.4, 7.3.6,
08.4 Management review
7.3.7
7.3.4, 7.3.5,
08.5 Design approval
7.3.6, 7.3.7
08.6 Result of design work 7.3.3, 7.3.7
08.7 Transfer of development experience --
09. Process Planning (Process Development) 7.1, 7.3, 7.,5
7.1, 7.3.1,
09.1 Process development Plan for new/modified products
7.3.7
09.2 Production plans, work instructions 7.5.1, 7.3.7
7.3.2, 7.3.7,
09.3 Quality requirements fully considered
7.5.1
7.3.4, 7.3.5,
09.4 Management review of processes and procedures
7.3.7, 7.5.2
09.5 Approval of processes and procedures 7.3.7, 7.5.2
09.6 Result of process planning and development work 7.3.3, 7.3.7
09.7 Transfer of experiences from process planning 7.3.1, 7.3.3,
3)
Business results are not seperately treated in the ISO standard.
4)
Special documentation requirements are not seperately treated in the ISO standard.
5)
The ISO standard contains only rudimentary treatment of Process Planning.
215
VDA ISO
Subject of the Question
6.14 9001:2000
10. Document and Data Control 4.2
10.1 Quality-relevant documents, responsibility, procedures, .. 4.2.3
10.2 Approval and revision 4.2.3
10.3 Archiving 4.2.3, 4.2.4
10.4 Appropriately times introduction of customer documents 4.2.3
10.5 Non-use of invalid documents 4.2.3
11. Purchasing 7.4, 7.5
Order documents 7.4.1, 7.4.2;
11.1
7.4.3
11.2 Supplier selection 7.4.1
11.3 Sample test 7.4.1
11.4 Supplier quality performance 7.4.1
11.5 Agreements on quality inspections 7.4.1, 7.4.3
11.6 Material receiving inspection 7.1, 7.4.1, 8.1
11.7 Traceability 7.5.3
12. Control of customer-supplied Products 7.5.4
12.1 Agreed quality measures 7.5.4
12.2 Minimum scope of inspection and testing 7.5.4
12.3 Reporting of nonconformities 7.5.4
12.4 Quality history 7.5.4
Process Control/Identification and Traceability/Inspection and Test
13. Status 7.5
13.1 Product identification 7.5.3
13.2 Process control measures 7.5.1
13.3 Records of process parameters 7.5.2, 4.2.4
Production means – Storage 7.5.1, 7.5.4,
13.4
7.6
13.5 Quality objective/subsequent process, dispatch 7.5.1, 7.5.2
13.6 Traceability 7.5.3, 4.2.4
13.7 Release on restart 7.5.2
14. Process Control 7.5
14.1 Machine/process capability tests 7.5.2, 8.2.3
14.2 Production release 7.5.2
14.3 Control of relevant process parameters 7.5.2, 8.2.3
14.4 Maintenance, preventive servicing 7.5.1, 6.3
14.5 Special processes 7.5.1
14.6 Environmental conditions specified/complied with 6.3, 6.4, 7.5.5
14.7 Evaluation of the effectiveness of production processes 7.5.2
216
VDA ISO
Subject of the Question
6.14 9001:2000
15. Inspection and Testing 7.1, 8.2.4
15.1 Inspection and test plans 7.1
15.2 Inspection and test plans and instructions 7.1; 8.1
15.3 Quality evidence for external purchases 7.4.3, 8.2.4
15.4 Quality evidence according to work steps 7.1, 8.1, 8.2.4
15.5 Quality evidence on the final product 8.2.4, 7.5.3
15.6 Periodic inspections and tests 8.2.4
16. Control of Inspection, Measuring and Test Equipment 7.6
16.1 Control and calibration system 7.6
16.2 Connection to national/international standards 7.6
Measurement uncertainty of inspection, measuring and test equip-
16.3 ment 7.6
16.4 Inspection, measuring and test equipment capability 7.6
Measures to be taken in case of nonconforming inspection, meas-
16.5 uring and test equipment 7.6
17. Control of Nonconforming Products 8.3
17.1 Treatment of nonconforming units 8.3
17.2 Concessions 8.3
17.3 Carrying out of corrective actions 8.3
17.4 Identification of reoccurring nonconformities 8.3
18. Corrective and Preventive Actions 8.5
18.1 Initiation of corrective actions 5.6.3, 8.5
18.2 Estimating the nonconformity risk 8.5
18.3 Analysis of the cause of nonconformities 8.5
18.4 Prevention of nonconformity reoccurrence 8.5
19. Handling, Storage, Packaging, Preservation and Delivery 7.5.5
19.1 Product handling 7.5.5
19.2 Packaging and identification process 7.5.5
19.3 Prevention of transport damage 7.5.5
19.4 Correction of packaging errors 7.5.5
19.5 Product identification 7.5.5
19.6 Delivery reliability --
20. Control of Quality Records 4.2.4
20.1 Quality-relevant documents 4.2.4
20.2 Evaluation of quality records 4.2.4
20.3 Archiving 4.2.4
20.4 Customer access to quality records --
217
VDA ISO
Subject of the Question
6.14 9001:2000
21. Quality in the application phase/Servicing/Customer Service 7.5, 8.4
21.1 Users manual and installation instructions 7.5.1
21.2 Product observation/Field failure-early warning system --
21.3 Field failure analysis 8.4; 8.5.2
21.4 Customer service information 7.5.1
21.5 Servicing 7.5.1
22. Statistical Methods 8
22.1 Method planning 8.1
Development/Trial 8.2.3; 8.2.4;
22.2
8.4
External sources 8.2.3; 8.2.4;
22.3
8.4
Process development and control 8.2.3; 8.2.4;
22.4
8.4
Final inspection 8.2.3; 8.2.4;
22.5
8.4
Evaluation of field failures 8.2.3; 8.2.4;
22.6
8.4
a) 9001:1994
DINEN Element according to DIN EN ISO 9001 VDA6
ISO9001
4.1 Management Responsibility 01
.1.1 Quality policy 01.1, 01.2
.2.1 Organization, responsibility and authority 01.5, 02.2,
02.3,
.2.2 Organization, resources 01.4, 02.2,
04.3
.2.3 Organization, management representative 01.5, 02.2,
.3 Management review 01.6, (05.2)
4.2 Quality Management System 02
.1 General 02.1, 02.2
.2 Documented quality procedures 02.1,
.3 Quality planning 02.5, 02.6,
07.4, [06.2, ],
15.1
4.3 Contract Review 07
.1 General 07.2
.2a Review, requirements documented and understood 07.2, 07.4
.2b P. nonconformities quotation/order 07.2
.2c Capability to meet the requirements 07.2, 07.5,
08.2, 09.3
218
DINEN Element according to DIN EN ISO 9001 VDA6
ISO9001
.3 Amendment See introductory
comment.
.4 Records 20.3, 09.3
4.4 Design Control 08, 09
.1 General 08.1, 09.1
.2 Design and development plan (04.5), 08.1,
09.1
.3 Organizational and technical interfaces (02.4), 08.5,
08.7, 09.5,
09.7
.4 Design input 08.1, 08.2,
09.1
.5 Design result 08.1, 08.5,
08.6, 08.7,
09.1, 09.5,
09.6, 09.7
.6 Design review 08.4, 09.4
.7 Design verification 08.3
.8 Design validation 08.3, 08.5,
[09.3], 09.5
.9 Design modifications [08.1 - 08.7,
09.1 - 09.7]
See introductory
comment.
4.5 Document and Data Control 10
.1 General 10.1
.2 Approval and issue of D. & D. 10.1, 10.2,
10.4
.3 Amendments to documents and data 10.2, [07.2 with
introductory
comment], 10.5
4.6 Purchasing 11
.1 General 11.2, 11.3,
11.4
.2a Evaluation of subcontractors 11.1, 11.2
Suitability: evaluate and select
.2b Monitoring: Capabilities and performance 11.3, 11.5
.2c Record corresponding data 11.4
.3 Purchasing information 11.1
.4.1 Inspection of purchased products (Supplier at the subcontractor). [11.5], 11.6
.4.2 Inspection of purchased products [11.1, 11.5],
(Inspection by the customer). 11.6
4.7 Control of Customer-supplied Products 12
4.8 Identification and Traceability of Products (06.3), 11.7,
13.1, 13.6
4.9 Process Control 9, 13, 14
Para.1 Planning of quality-influencing assembly and servicing 9.1, 13.2
a Documented procedures 9.2, 13.2
219
DINEN Element according to DIN EN ISO 9001 VDA6
ISO9001
b Suitable equipment and environmental conditions 9.4, 14.1,
14.6
c Compliance of standards, quality plans, documented procedure. 9.3, 9.5, 14.2
d Matching process parameters 9.5, 13.2,
14.2, 14.3,
(13.4)
e Approval of processes and equipment 9.4, 9.5, 13.7,
14.2,
f Criteria for work performance 9.2, 14.3
g Maintenance 14.4
e Release 9.5, 13.7,
14.2
Para.2,3 Special processes 9.4, 14.5
Para.4 Recordings of quality processes, equipment, personnel 9.6, 9.7, 13.3
4.10 Inspection and Testing 15
.1.1 General 11.6, 15.2,
15.3, 15.4,
15.5, (15.6)
.2.1 Receiving inspection and testing 15.3
.2.1 Application after verification 15.3
.2.2 Scope and type of receiving inspection 15.3,
.2.3 Pre-release and concession 15.3
.3 In-process inspection and testing 15.4
.4 Final inspection and testing 15.5
.5 Inspection and test records (Records al-
ways)
4.11 Control of Inspection, Measuring and Test Equipment 16
.1 General 16.1
.2a Determination of control procedure, inspection and testing and in- 14.2 with
spection, measuring and test equipment 16.3, (16.4)
.2b Determination and calibration of inspection, measuring and test 16.1, 16.2
equipment
.2c Determination of corresponding procedures 16.1
.2d Identification of calibration status 16.1, 16.4
.2e Archiving of records on calibration 16.1, 20.1
.2f Evaluation and recording of previous measurement results for non- 16.5
conformities on inspection, measuring and test equipment
.2g Environmental conditions for measurements 14.6, 16.1
.2h Handling, protection and storage of inspection, measuring and test 13.4
equipment
.2i Protection of the calibration status 16.1
4.12 Inspection and Test Status 13.1, 15.4
4.13 Control of Nonconforming Products 17
.1 General 17.1
.2 Evaluation and handling of nonconforming products 17.1, 17.2,
17.3
220
DINEN Element according to DIN EN ISO 9001 VDA6
ISO9001
4.14 Corrective and Preventive Action 18
.1 General 18.1, 19.4
.2a Corrective actions, effective treatment of nonconformities 17.4, 18.1
.2b Corrective action – cause of nonconformity in relation to production, 18.1, 18.3,
process, system (21.3)
.2c Corrective action – Determination of... 18.1
.2d Corrective action – Monitoring of their effectiveness 18.1, 18.4
.3 Preventive actions 18.2
4.15 Handling, Storage, Packaging, Preservation and Delivery 19
.1 General 19.1, 19.4
.2 Handling 19.1
.3 Storage 19.1
.4 Packaging 19.2, 19.3,
19.4
.5 Preservation [07.5], 19.3
.6 Delivery [07.5], 19.3
4.16 Control of Quality Records 12.3, 20
221
ISO Element VDA 6.14
9001:2000
5 Management Responsibility
5.1 Management Commitment 01.1, 01.2, 01.3,
01.4, 06.1
5.2 Customer Focus Z1.4, 07.1
5.3 Quality Policy 01.1, 01.2
5.4 Planning
5.4.1 Quality Objectives 01.1, 01.2
5.4.2 Quality Mangement System Planing 02.5, 02.6,
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority 02.3
5.5.2 Management Representative 01.5
5.5.3 Internal Communication 04.7
5.6 Management Review
5.6.1 General 01.6, 05.6
5.6.2 Review Input 01.6, 05.6
5.6.3 Review Output 01.6, 05.6, 18.1
6 Resource Management
6.1 Provision of Resources 01.4
6.2 Human Resources
6.2.1 General 01.4, 04.1
6.2.2 Competence, Awareness and Training 04.1 - 04.6, Z1.5
6.3 Infrastructure 01.4, 14.4, 14.6
6.4 Work Environment 14.6
7 Product Realization
7.1 Planning of Product Realization 02.5, 02.6, 08.1,
09.1, 11.6, 15.1,
15.2, 15.4
7.2 Customer-related Processes
7.2.1 Determination of Requirements related to the Product 06.2, 07.1, 07.5
7.2.2 Review of Requirements related to the Product 07.2, 07.5
7.2.3 Customer Communication 07.4
7.3 Design and Development
7.3.1 Design and Development Planning 02.4, 08.1, 09.1,
09.7
7.3.2 Design and Development Inputs 08.2, 09.3
7.3.3 Design and Development Outputs 08.3, 08.6, 09.6,
09.7
7.3.4 Design and Development Review 08.4, 08.5, 09.4
7.3.5 Design and Development Verification 08.3, 08.5, 09.4
7.3.6 Design and Development Validation 08.4, 08.5
222
ISO Element VDA 6.14
9001:2000
7.3.7 Control of Design and Development Changes 08.1 – 08.6, 09.1
– 09.6
7.4 Purchasing
7.4.1 Purchasing Process 11.1 - 11.6
7.4.2 Purchasing Information 11.1
7.4.3 Verification of Purchased Product 11.1, 11.5
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision 09.2, 09.3, 13.2,
13.4, 13.5, 14.4,
21.4, 21.5
7.5.2 Validation of Processes for Production and Service Provi- 09.4, 09.5, 13.3,
sion 13.5, 13.7, 14.1
–14.3, 14.7
7.5.3 Identification and Traceability 11.6, 13.1, 13.6,
15.5
7.5.4 Customer Property 12.1 –12.4, 13.4
7.5.5 Preservation of Product 14.6, 19.1 –19.5
7.6 Control of Measuring and Monitoring Devices 13.4, 16.1-16.5
8 Measurement, Analysis and Improvement
8.1 General 11.6, 15.2, 15.4,
22.1
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction Z1.4
8.2.2 Internal Audit 03.1, 03.2, 03.3
8.2.3 Monitoring and Measurement of Processes 03.4, 14.1, 14.3,
22.2-22.6
8.2.4 Monitoring and Measurement of Product 03.4, 15.3, 15.4
- 15.6, 22.2-22.6
8.3 Control of Nonconforming Product 17.1 – 17.4
8.4 Analysis of Data Z1.2, 21.3, 22.2
- 22.6
8.5 Improvement
8.5.1 Continual Improvement 01.3, Z1.2, 18.1
– 18.4
8.5.2 Corrective Action 18.1 - 18.4,
21.3
8.5.3 Preventive Action 18.1 - 18.4
223
Other VDA-FORMS
224
Quality Management in the Automotive Industry
225
Note regarding VDA Volume 6 Part 1, 4th Edition
Since the publication of the first edition in 1991, the current volume on audi-
ting/certification of quality management systems has attracted great attenti-
on beyond the automotive industry. This was also the reason why quality
work groups from various trade and industrial associations have tackled its
content and preparation. Thereby, it was found that the checklist contains
questions that are atypical for the industry and must not be used for audi-
ting/certification and evaluation. The following associations have prepared
appropriate interpretation guides agreed with the VDA:
226
Trough its training center estabished in 2001, the
Quality Managment Center (VDA-QMC) offers a
fund of knowledge covering the entire spectrum of
quality in the automobile industry.
The focus is on communicating this comprehensive
quality know-how to users.