Quality management
in the automotive industry
QM system audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
Verband der Automobilindustrie Verband der Automobilindustrie
QM system audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
Non-binding VDA Standard recommendation
The Association of the German Automotive Industry (VDA) recommends its members to apply the following standard for the implementation and main-tenance of quality management systems.
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.
If during the use of VDA recommendations, errors or the possibility of mis-interpretation are found, it is requested that these be notified to the VDA immediately so that any possible faults can be corrected.
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
ISSN 0943-9412 Copyright 2000 by
Verband der Automobilindustrie e. V. (VDA) Quality Management Center (QMC)
D-61440 Oberursel, An den Drei Hasen 31 www.vda-qmc.de
Printed and published by: Druckerei Henrich GmbH
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).
Quality assurance has become an interdisciplinary key function (coopera-tion of all involved divisions at the right time) and therefore has a decisive influence on the organization's result.
Shorter model cycles and development times, greater international competi-tion and increasing cost pressure, new organizacompeti-tional forms (just in time), greater expectations placed on products and stricter product liability all de-mand highly effective quality assurance systems (quality management sys-tems) in all areas of the automotive industry among automotive manufac-turers as well as their suppliers. In order to do justice to this development, a working circle of the VDA/DGQ specialist group "Quality Control in the Automotive Industry" has drawn up a questionnaire on quality management system evaluation based on DIN EN ISO 9004 (Edition 5/90) which was published with the first edition in 1991.
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
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.
Quality and quality management problems are predominantly not of a purely technical nature, but often related to management, organization and structure. The questionnaire is therefore divided into the following two parts: - M Management of the organization
- P Product and Process.
Since the organization management and the lower management levels have a decisive influence on the definition, implementation and monitoring of quality assurance, its incorporation is the fundamental requirement of the standard. This is expressed in the structure of the questionnaire and is taken into account in the questions accordingly. The questions are there-fore to be answered by the person responsible for the particular division of
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. The Quality Standard of the German Automotive Industry encompasses fur-ther types of audit, which are described in the following VDA volumes.
QUALITY STANDARD
OF THE GERMAN AUTOMOTIVE INDUSTRY (VDA 6)
VDA 6 VDA 6
Part 1 QM system audit VDA 6 Part 2 QM system audit Services Quality audit
funda-mentals VDA Part 3 6 Process audit
VDA 6 Part 4 QM system audit Production equipment Certification require-ments VDA 6
Our thanks go to the following companies, in particular to the employees in-volved, for their participation in the preparation of this document:
- Audi AG, Ingolstadt
- Adam Opel AG, Rüsselsheim - BMW AG, Munich
- BOGE GmbH, Eitorf
- Robert Bosch GmbH, Stuttgart - DaimlerChrysler AG, Stuttgart
- DNV (Det Norske Veritas Zertifizierung GmbH, Essen
- DQS (Deutsche Gesellschaft zur Zertifizierung von Qualitätssi-cherungssystemen mbH), Frankfurt, Berlin
- Edscha Gruppe, Remscheid - FORD-Werke AG, Cologne - General Motors Europe, Zurich
- GLYCO-Metall-Werke, GLYCO B.V. & Co. KG, Wiesbaden - Happich Fahrzeug und Industrieteile GmbH, Wuppertal - Hella KG, Hueck & Co., Lippstadt
- ITT Automotive Europe GmbH, Frankfurt - Keiper Recaro GmbH & Co., Remscheid
- Lemförder AG & Co., Fahrwerktechnik Lemförde - Mahle GmbH, Stuttgart
- Mannesmann Sachs AG, Schweinfurt
- Siemens VDO Automotive AG, Babenhausen - Pierburg AG, Neuss
- Dr. Ing. h.c. F. Porsche AG, Stuttgart - Siemens VDO Automotive AG, Würzburg - SKF GmbH, Schweinfurt
- Teroson GmbH, Heidelberg
- TRW Fahrwerkssysteme GmbH & Co. KG, Düsseldorf
- WABCO Standard GmbH, UB Fahrzeugbremsen, Hannover - Volkswagen AG, Wolfsburg
- YMOS AG, Obertshausen.
Thanks are also due to all who have provided suggestions for improvement as well as those organizations represented in the editorial circle.
Frankfurt/Main, February 2003
Contents Page
1 Introduction 13
2 Quality management system according to the
DIN EN ISO 9000 Series 15
2.1 Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Management and Quality System Elements,
Part 1: Guideline 15
2.2 Quality Assurance Model (according to the introduction to DIN
EN ISO 9001) 16
3 Quality Management System Audit 18
3.1 General 18
3.2 Selection of the Quality Elements and Relevant Questions 19
3.3 Evaluation and Rating 20
3.3.1 Individual Rating of Questions and Quality Elements 20
3.3.2 Overall Rating of Audit Result 22
3.3.3 Grading for Customer/Supplier Audits (2nd Party) 23 3.3.4 Awarding of the VDA 6.1 Certificate Supplement (3rd Party): 24
3.4 Summary of Results 25
3.5 Close out Meeting and Report 25
3.6 Corrective Actions 25
3.7 VDA 6.1 Certificate 25
4 Terms and Definitions 27
4.1 Terms relating to quality according to ISO 9000:2000 (extract) 27
#3.1.2 Requirement 27
4.2 Terms relating to management according to ISO 9000:2000 (extract) 27
#3.2.3 Quality management system 27
#3.2.4 Quality policy 27
#3.2.8 Quality management 28
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
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 6 Structure and Number of Questions per Quality Element 37
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
8 Forms for the Quality Management System Audit
- tangible products - 191
9 Literature 199
9.1 VDA-Series "Quality Management in the Automotive Industry": 199 10 Agreement with Industrial Associations 203
10.1 Introduction 203
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
1 Introduction
Quality management*is an interdisciplinary key function. The quality of pro-ducts and services is always the combined result of activities in every phase of the total business process. Effective quality management assigns priority to planning and prevention activities for identification of interrela-tions and interdependencies, as well as for appropriate measures to pre-vent nonconformities occurring - in contrast to the previous practices of identifying, analyzing and rectifying nonconformities which have already oc-curred.
A well-functioning quality management system* described in a quality man-ual,* is an essential requirement for every business in order to fulfil the de-mands for quality deliveries and services in a proactive and economic way. Quality management affects all areas of the business. It is therefore a pri-mary function of business management.
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.
The original understanding of quality, mainly shaped by the product, and the associated duties of quality management have changed in recent years and include new additional content and dimensions.
The main duties of management are, therefore:
- Definition of the quality policy, agreeing and monitoring quality objectives
- 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.
As operations and the interrelations of systems and processes become more extensive and complex, cross-functional activities gain in importance. Here, many resources are available, which have a great influence on pro-ductivity, overall economic performance and quality.
The product- and process-related elements are covered in part P 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
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 editUn-ion is identical in Austria, Germany and Switzerland.
When delivering in accordance with the regulations of the EU it is compul-sory to comply with the contents of the EN standard in order to guarantee free movement of goods under the same conditions. This also applies to the contents of the European Standard on quality management. Their com-pliance is therefore to be proven upon request.
2.1 Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Management and Quality System Elements, Part 1: Guideline
This standard is an internationally agreed guideline in which the elements of a quality management system (quality elements) are described. It repre-sents a further development of formerly known national and branch-specific regulations with the express objective of showing, descriptively and clearly, which quality elements may nowadays be included in a quality manage-ment system corresponding to the "State of the Art".
In addition, it describes the obligations of the business with respect to qual-ity management, in fulfillment of which the critical preconditions for achiev-ing quality capability within the organization should be created.
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.
The scope of application is not limited. The standard is to be viewed as a universal set of regulations for quality management to achieve the quality of products and services. It can be assumed that branch-specific quality
regu-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:
Gaining confidence in the supplier’s ability to fulfill the defined minimum requirements on his quality system is nowadays be-coming more and more a precondition throughout the world for cooperation between the customer and his supplier. This con-fidence can be built up by presenting the quality system to the customer or an authorized body. All systematic and confidence-building activities planned within the scope of this are designated by DIN EN ISO 8402 as quality assurance or quality management systems (or quality systems).
The standards DIN EN ISO 9001, DIN EN ISO 9002 and DIN EN ISO 9003 each contain a quality assurance model. Only these three standards of the DIN EN ISO 9000 series are intended for demonstration purposes. They show a way to create confidence in the capability of a supplier.
It has to be emphasized that the quality system requirements specified in the International Standards ISO 9001, ISO 9002 and ISO 9003 are a supplement (not an alternative) to the established quality requirements (on products1)).
It is intended that these International Standards are applied in their present form. However, occasionally they may need to be tailored for special contractual situations by the addition or omis-sion of certain requirements. ISO 9000-1 provides guidance on such tailoring as well as on the selection of the appropriate model, … namely ISO 9001, ISO 9002 or ISO 9003.
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)
ISO 9001 Quality systems -
Model for quality assurance in design2), development, production, installation and servicing.
To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during design, develop-ment, production, installation and servicing.
ISO 9002 Quality systems -
Model for quality assurance in production, installation and ser-vicing.
To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during production, in-stallation and servicing.
ISO 9003 Quality systems -
Model for quality assurance at final inspection and testing.
To be applied, when conformance to specified requirements is to be ensured by the supplier/contractor only during final inspection and testing.
3 Quality Management System Audit 3.1 General
Evaluation of the quality management system is performed with the help of a questionnaire. The questions of the present VDA 6.1 volume are pri-marily applicable to the evaluation of organizations producing mate-rial (or tangible) products (For non-matemate-rial or non-tangible prod-ucts/services - see VDA Volume 6, Part 2).
The evaluation of an organization is performed either as an internal audit by the organization itself (1st Party), through a representative of the customer (2nd Party) or through an accredited certification body (3rd Party). Auditors must be competent in the elements which they have to evaluate, as well as in the quality techniques used. They must be qualified to judge the suitabil-ity of the implemented qualsuitabil-ity measures, taking into account the production processes used, the technology and the required product quality.
The extensive commercial and technical evaluation of an organization in line with this quality management system audit places considerable re-quirements on the auditor. In addition to this, the auditor must possess, among other things, relevant training and industrial experience, integrity and the ability to deal with people.
Particularly the following quality elements: - management responsibility - quality management system - internal quality audits
- training/personnel
- financial considerations regarding quality management sys-tems
- product safety - corporate strategy
demand special qualification requirements of the auditors, as they must be competent to discuss the above topics with the organization’s management. Department-specific questions are to be answered by the persons respon-sible in the organization for marketing, design, procurement, production planning, production or personnel and not by the Quality Manager. He, gen-erally, only answers specific questions about quality function issues, e.g.
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.
In the case of an unsatisfactory result during a quality management system audit, corrective actions and a time schedule are to be established to im-prove the system. The evaluation of their effectiveness is the subject of a follow-up audit that examines the unsatisfactory areas.
3.2 Selection of the Quality Elements and Relevant Questions The relevant elements and corresponding questions for the evaluation of the quality management system of an organization are to be defined. The elements 08, 12 and 21 can, under special circumstances, be completely/ partly omitted. Comments regarding this are given with the relevant ele-ments.
During internal quality audits (1st Party) and customer audits (2nd Party) fur-ther quality elements and questions may also be added. Furfur-thermore, 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.
During certification audits (3rd Party) additional requirements can only be added if they form part of the quality management system of the organiza-tion to be audited. In this case, their compliance and effectiveness are to be assessed. The points rating according to VDA 6 Part 1, Paragraph 3.3.1 is not applicable.
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.
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 "Requirements/Explanations" to the question are always to be seen as an example and not as a complete checklist. The type of evi-dence or records listed as examples do not have to be supplied if they are not appropriate to the industry sector.
Some questions concerning the quality management system can only be answered in conjunction with an evaluation of the product to be supplied and/or the corresponding technology or process applied. This can make a separate assessment (product / process audit) necessary.
3.3 Evaluation and Rating
3.3.1 Individual Rating of Questions and Quality Elements
The auditor evaluates the definition and effectiveness of the quality mana-gement activities in complying with the respective requirements by initially determining:
- Is the subject in question defined in writing in the quality man-agement system, in operational procedures with relationships and responsibilities? (e.g.: in the quality manual, in a docu-mented procedure or work instruction)?
He must then further evaluate:
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:
Subject in question Evaluation of answer Defined completely in the
quality management system yes no yes no yes/no
Proven effective in practice yes yes mostly *) no
Point score 10 8 6 4 0
*) Under "mostly" it is understood that all applicable requirements are proven effective in more than 3/4 of all relevant application cases and that no particular risk exists.
Rating
10 points: completely defined in the quality management system and proven to be effective
8 points: not completely defined in the quality management system but proven to be effective
6 points: completely defined in the quality management system and mostly proven to be effective
4 points: not completely defined in the quality management system but mostly proven to be effective
0 points: not proven to be effective regardless of completeness of definition in the quality management system
If all relevant answers in an element achieve 10 points, then the level of compliance CE is 100%.
Calculation of element ratings:
total points assessed for relevant questions
CE = ——————————————————— x 100 [%] total possible points for relevant questions
3.3.2 Overall Rating of Audit Result
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
sum of levels of compliance of all relevant elements CM or CP = ——————————————————————— [%]
no. of relevant quality elements
The two levels of compliance CM and CP are combined to give an overall
rating, whereby the management-specific section is given one third weigh-ting and the product-related and process-related section is given a two thirds weighting:
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.
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
3.3.3 Grading for Customer/Supplier Audits (2nd Party) Overall level of compliance
in percent Assessment of quality management system Designation of grading 90 to 100 full compliance A *)
80 to less than 90 mostly compliant AB *) 60 to less than 80 conditionally compliant B
less than 60 not compliant C
*) 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.
3.3.4 Awarding of the VDA 6.1 Certificate Supplement (3rd Party): 1. A VDA 6.1 Certificate Supplement to an ISO 9001/9002* certificate is
awarded at an overall level of compliance exceeding 90% (the level of compliance [%] is not shown on the VDA 6.1 Certificate Supplement). *) Note: as of 15 December 2003 only in connection with an ISO 9001:2000
certifi-cate Exception:
A VDA 6.1 Certificate Supplement will not be awarded, if
- one or more quality elements achieve a level of compliance below 75 %
or
- one or more questions marked with * are rated with less than 8 points or
- one question not marked with * is rated with 0 points. 2. Follow-up /Re-audit
A follow-up audit is possible within 90 days after completion of the audit under the following conditions (Status: Open):
a) a maximum of one question marked with * was rated with 0 points and/or
b) one or more questions marked with * were rated with 4 or 6 points and/or
c) one or more questions not marked with * were rated with 0 points and/or
d) no element achieved a level of compliance below 75 %
A VDA 6.1 Certificate Supplement is awarded after a follow-up audit, if all questions marked with * are rated with at least 8 points and all ques-tions not marked with * are rated with at least 4 points.
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.
3.4 Summary of Results
The results of the quality management system audit of Part M (manage-ment) and Part P (product and process) are to be presented as shown in the sample forms (Chapter 8). The results of each element will be entered on the sheet "Summary of Results".
3.5 Close out Meeting and Report
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.
3.6 Corrective Actions
The result of the quality management system audit, presented as shown in the main paragraphs 3.4 and 3.5 above, serves the management of the dited organization as a basis for corrective actions. It is the duty of the au-dited organization to work out and implement an improvement program. This has to be communicated to the lead auditor responsible for heading the audit. The auditor decides on the basis of the presented improvement program to what extent a follow-up audit is to be carried out.
3.7 VDA 6.1 Certificate
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.
VDA
VERBAND DER AUTOMOBILINDUSTRIE E. V.VDA 6.1 CERTIFICATE
Organization: Sub-organization: Product group(s):The organization has provided evidence of effective
implementation of a Quality Management System
according to VDA 6, Part 1 of the Quality Standard
of the German Automotive Industry, on the basis of
DIN EN ISO 9001 / 9004-1.
Audit with/without Product Design and Development.
Date of issue: valid until:
Audit performed by: VDA Registration No. _______
___________________________ Company / Signature of authorized person Lead Auditor(s): __________________ _________________________________
Date: ___________________ Signature ______________________
_______________________________________________________________________________ VDA-Stamp
4 Terms and Definitions
For each of the individual elements, definitions and explanations of terms are given within the questionnaire. Generic terms are briefly summarized in the following. (The numbering according to # corresponds to the ISO 9000:2000 Standard).
4.1 Terms relating to quality according to ISO 9000:2000 (extract) #3.1.2 Requirement
Need or expectation that is stated, generally implied or obligatory.
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 rere-quirement, 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.
4.2 Terms relating to management according to ISO 9000:2000 (extract)
#3.2.3 Quality management system
Management system (#3.2.2) to direct and control an organization (#3.3.1) with regard to quality (#3.1.1).
#3.2.4 Quality policy
Overall intentions and direction of an organization (#3.3.1) related to quality (#3.1.1) as formally expressed by top management.
#3.2.8 Quality management
Coordinated activities to direct and control an organization (#3.3.1) with re-gard to quality (#3.1.1).
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).
4.3 Terms relating to organization according to ISO 9000:2000 (extract)
#3.3.1 Organization
Group of people and facilities with an arrangement of responsibilities, au-thorities and relationships.
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.
#3.3.2 Organizational structure
Arrangement of responsibilities, authorities and relationships between peo-ple.
Note 1: The arrangement is generally orderly.
Note 2: A formal expression of the organizational structure is often provided in a quality manual (#3.7.4) or a quality plan (#3.7.5) for a project (#3.4.3).
Note 3: The scope of an organizational structure can include relevant interfaces to external organizations (#3.3.1).
#3.3.5 Customer
Organization (#3.3.1) or person that receives a product (#3.4.2). Example: Consumer, client, end-user, retailer, beneficiary and purchaser. Note: A customer can be internal or external to the organization. #3.3.6 Supplier
Organization (#3.3.1) or person that provides a product (#3.4.2).
Example: Producer, distributor, retailer or vendor of a product, or provider of a service or in-formation.
Note 1: A supplier can be internal or external to the organization.
Note 2: In a contractual situation a supplier is sometimes called "contractor".
4.4 Terms relating to process and product according to ISO 9000:2000 (extract)
#3.4.1 Process
Set of interrelated or interacting activities which transforms inputs into out-puts.
Note 1: Inputs to a process are generally outputs of other processes.
Note 2: Processes in an organization (#3.3.1) are generally planned and carried out under controlled conditions to add value.
Note 3: A process where the conformity (#3.6.1) of the resulting product (#3.4.2) cannot be readliy or economically verified is frequently referred to as a "special process".
#3.4.2 Product
Result of a process (#3.4.1).
Note 1: There are four generic product categories, as follows: - services (e.g. transport);
- software (e.g. computer program, dictionary); - hardware (e.g.engine mechanical part); - processed materials (e.g. lubricant)
Many products comprise elements belonging to different generic product catego-ries. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product "automobile" consists of hardware (e.g. tires), processed materials (e.g. fuel, cool-ing liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman).
Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier (#3.3.6) and customer (#3.3.5) and is generally intangible. Provision of a service can involve, for example, the following:
- an activity performed on a customer-supplied tangible product (e.g. auto-mobile to be repaired);
- an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
- the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
- the creation of ambience for the customer (e.g. in hotels and restaurants). Software consists of information and is generally intangible and can be in the form of approaches, transactions, or procedures (#3.4.5).
Hardware is generally tangible and its amount is a countable characteristic (#3.5.1). Processed materials are generally tangible and their amount is a continu-ous characteristic. Hardware and processed materials are often referred to as goods.
Note 3: Quality assurance (#3.2.11) is mainly focused on intended product. #3.4.5 Procedure
Specified way to carry out an activity or a process (#3.4.1). Note 1: Procedures can be documented or not.
Note 2: When a procedure is documented, the term "written procedure" or "documented procedure" is frequently used. The document (#3.7.2) that contains a procedure can be called a "procedure document".
4.5 Terms relating to conformity according to ISO 9000:2000 (ex-tract)
#3.6.5 Corrective action
Action to eliminate the cause of a detected nonconformity (#3.6.2) or other undesirable situation.
Note 1: There can be more than one cause for a nonconformity.
Note 2: Corrective action is taken to prevent recurrence whereas preventive action (#3.6.4) is taken to prevent occurrence.
Note 3: There is a distinction between correction (#3.6.6) and corrective action (#3.6.5).
4.6 Terms relating to documentation according to ISO 9000:2000 (extract)
#3.7.4 Quality manual
Document (#3.7.2) specifying the quality management system (#3.2.3) of an organization (#3.3.1).
Note: Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.
4.7 Terms relating to examination according to ISO 9000:2000 (extract)
#3.8.1 Objective evidence
Data supporting the existence or verity (applicability) of something.
Note: Objective evidence may be obtained through observation, measurement, test (#3.8.3) or other means
#3.8.2 Inspection
Conformity evaluation by observation and judgment accompanied by meas-urement, testing or gauging.
#3.8.4 Verification
Confirmation, through the provision of objective evidence (#3.8.1), that specified requirements (#3.1.2) have been fulfilled.
Note 1: The term "verified" is used to designate the corresponding status. Note 2: Confirmation can comprise activities such as:
- performing alternative calculations;
- comparing a new design specification (#3.7.3) with a similar proven design specification;
- undertaking tests (#3.8.3) and demonstrations; - reviewing documents prior to issue.
#3.8.5 Validation
Confirmation, through the provision of objective evidence (#3.8.1), that the requirements (#3.1.2) for a specific intended use or application have been fulfilled.
Note 1: The term "validated" is used to designate the corresponding status. Note 2: The use conditions for validation can be real or simulated.
4.8 Terms relating to audit according to ISO 9000:2000 (extract)∗
#3.9.1 Audit
Systematic, independent and documented process (#3.4.1) for obtaining audit evidence (#3.9.4) and evaluating it objectively to determine the extent to which audit criteria (#3.9.3) are fulfilled.
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).
∗
#3.9.5 Audit findings
Results of the evaluation of the collected audit evidence (#3.9.4) against audit criteria (#3.9.3).
Note: Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.
4.9 Additional Terms (Definitions for the present volume) 4.9.1 System
The structure of an organization (#3.3.1), in which responsibilities, authori-ties and interrelationships, as well as procedures (#3.4.5) and processes (#3.4.1) are defined together with the necessary resources for the realiza-tion of an objective.
4.9.2 Method
A scheduled procedure (#3.4.5), to given means and a given purpose which leads to the technical proficiency in the solution of theoretical and practical tasks.
4.9.3 Serial Production
The fabrication of products (#3.4.2) of similar type and design, in recurrent orders.
4.9.4 Quality Management (QM) Procedures
QM procedures are specific instructions that are required in order to fulfill a defined quality-related activity. They come into effect when signed.
4.9.5 Work Instructions (Test and Inspection Instructions)
Detailed description of the working steps of an activity. Definition of indivi-dual activities and detailed instructions, order-neutral, as well as order-re-lated.
4.9.6 Unit
That which can be individually described and examined. Note: A unit can be e.g.:
- an activity or a process (#3.4.1) - a product (#3.4.2)
- an organization (#3.3.1), a system (4.9.1) or a person or any combination thereof.
4.9.7 Service
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*
Cross-reference of the paragraph numbers for corresponding subjects of the questionnaire of Chapter 7 to the paragraphs and subparagraphs of the standards DIN EN ISO 9001, 9002, 9003 and 9004-1.
VDA- Ques- tion-naire N°. Paragraph Title according to 9001 / (9004-1) Corresponding clause in ISO 9001:2000
Corresponding paragraph or sub-paragraph no. in the standard
DIN EN ISO (8/94)
9004-1 9001 9002 9003
01 Management responsibility 5; 6; 8.5.1 4, 5 4.1 z z
02 QM system (quality management
system elements)
4; 5.4.2; 7.1 5 4.2 z z
03 Internal quality audits (auditing the
QM system)
8.2.2 5.4, 5.5 4.17 z z
04 Training (Personnel) 5.5.3; 6.2 18 4.18 z z 05 Financial considerations regarding
QM systems --- 6 − − − − 06 Product safety --- 19 − − − − Z1 Corporate strategy --- − − − − − 07 Contract review (Quality in marketing) 5.2; 7.2 7 4.3 z z z
08 Design control - product design (Quality in specification and design)
7.1; 7.3 8 4.4 z − −
09 Process planning - process design 7.1; 7.3, 7.5 (8) (4.4) − − −
10 Document and data control (Quality documents)
4.2 17, 17.3, 5,3
4.5 z z z
11 Purchasing (Quality in purchasing) 7.4; 7.5 9 4.6 z z −
12 Control of customer-supplied product
VDA- Ques- tion-naire N°. Paragraph Title according to 9001 / (9004-1) Corresponding clause in ISO 9001:2000
Corresponding paragraph or sub-paragraph no. in the standard
DIN EN ISO (8/94)
9004-1 9001 9002 9003
13 Product identification and traceabil-ity (Material control, traceabiltraceabil-ity and identification)
7.5 11.2 4.8 z z
(Process control) 7.5
11.4-11.6
4.9 z z −
Insp. and test status
(control of insp. & test status)
7.5 11.7 4.12 z z z
14 Process control (quality of processes)
7.5 10 4.9 z z −
15 Inspection and testing (Product verification)
7.1, 8.2.4 12 4.10 z z
16 Control of inspection, measuring and test equipment
7.6 13 4.11 z z z
17 Control of nonconforming product 8.3 14 4.13 z z
18 Corrective and preventive action 8.5 15 4.14 z z
19 Handling, storage, packaging, preservation and delivery (post-production activities) 7.5.5 16.1, 16.2 10.4 4.15 z z z
20 Control of quality records
(quality documents/records) 4.2.4 17, 17.2 4.16 z z 21 Servicing, (post-production activities) 7.5; 8.4 16.4, 16.5, 16.6, 7.3 4.19 z z − 22 Statistical techniques 8 20 4.20 z z
Italic: Elements which extend beyond the scope of the standard * see also comparison tables in Chapter 12
Key:
z
full requirement
less comprehensive than ISO 9001 and 90026 Structure and Number of Questions per Quality Element
Page No. of questions M Management of the Organization
01 Management Responsibility
DIN EN ISO 9001, Clause 4.1 DIN EN ISO 9004-1, Chapter 4
39 6
02 Quality Management System
DIN EN ISO 9001 Clause 4.2 DIN EN ISO 9004-1, Chapter 5
47 6
03 Internal Audits
DIN EN ISO 9001, Clause 4.17 DIN EN ISO 9004-1, Chapter 5
57 4
04 Training, Personnel
DIN EN ISO 9001, Clause 4.18 DIN EN ISO 9004-1, Chapter 18
63 7
05 Financial Considerations regarding Quality Management Systems
DIN EN ISO 9004-1, Chapter 6
71 4
06 Product Safety
DIN EN ISO 9004-1, Chapter 19
75 4
Z1 Corporate Strategy 81 5
Page No. of questions P Product and Process
07 Contract Review, Quality in Marketing 9001, Clause 4.3 / 9004-1, Chapter 7
87 5 08 Design Control (Product Design)
9001, Clause 4.4 / 9004-1, Chapter 8
93 7 09 Process Planning (Process Design)
9001, Clause 4.4 / 9004-1, Chapter 8
101 7 10 Document and Data Control
9001, Clause 4.5 / 9004-1, Chapter 17.3
111 4 11 Purchasing
9001, Clause 4.6 / 9004-1, Chapter 9
117 7 12 Control of Customer Supplied Product.
9001, Clause 4.
125 4 13 Product Identification and Traceability
(Process Control, Inspection and Test Status) 9001, Clause 4.8 (4.9, 4.11, 4.12) / 9004-1, Chapter 11 129 7 14 Process Control 9001, Clause 4.9 / 9004-1, Chapter 10 137 7 15 Inspection and Testing (Product Verification)
9001, Clause 4.10 / 9004-1, Chapter 12
147 6 16 Control of Inspection, Measuring and Test
Equipment.
9001, Clause 4.11 / 9004-1, Chapter 13
153 5
17 Control of Nonconforming Product
9001, Clause 4.13 / 9004-1, Chapter 14
159 4 18 Corrective and Preventive Action
9001, Clause 4.14 / 9004-1, Chapter 15
163 4 19 Handling, Storage, Packaging, Preservation
and Delivery
9001, Clause 4.15 / 9004-1, Chapter 16
169 6
20 Control of Quality Records
9001, Clause 4.16 / 9004-1, Chapter 17.2
175 4 21 Servicing, (After Sales and Post-production
Ac-tivities) 9001, Clause 4.19 / 9004-1, Chapter 16
181 5 22 Statistical Techniques
9001, Clause 4.20 / 9004-1, Chapter 20
187 6
7 Quality Management System Audit Questionnaire
For application in organizations which manufacture tangible products
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.
Part M: Management of the organization 01 Management Responsibility
ISO 9001:2000, Clause 5; 6; 8.5.1 and ISO 9004:2000
The Management (e.g. Board of Management, Plant Manage-ment, Section Management) develops the quality policy for the organization, defines it and commits all areas and levels to it. Hereby specific quality objectives and a quality management sys-tem are to be agreed. Quality must be regarded as an overall management task.
"Management" describes the organizational unit that is responsi-ble for profit and loss.
Reference
ISO 9001:2000 01.1
*
Has the quality policy been defined by mana-gement and has it been made known to all levels?
5.1, 5.3, 5.4.1 01.2
*
Have quality objectives been defined within the scope of corporate planning and the qual-ity policy and are the results monitored?
5.1, 5.3, 5.4.1 01.3
*
Is a continual improvement process part of the
quality policy? 5.1, 8.5.1
01.4 Have the necessary resources been provided by the management of the organization?
5.1, 6.1, 6.2.1, 6.3
01.5 *
Has a management representative been as-signed and are his duties, authorities and re-sponsibilities defined?
5.5.2 01.6
*
Does management regularly evaluate the ef-fectiveness of the quality management sys-tem?
5.6.1, 5.6.2, 5.6.3
01.1* Has the quality policy been defined by management and has it been made known to all levels?
Definition:
Quality Policy (according to ISO 9000:2000/3.2.4):
The overall intentions and direction of an organization related to quality as formally expressed by top management.
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).
The publication of the quality policy is achieved, for example, by - 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).
Evidence is given by, for example, a declaration of commitment from man-agement within the scope of the quality policy, according to which all quality requirements for activities, not only in production but in all organizational
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:
"Quality objectives" are specifications for products, processes, operations and services, that are defined for all levels. These objectives are derived from customer requirements, the competitive situation, the legal environ-ment and internal requireenviron-ments, as well as adherence to the "zero defect strategy.“
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)
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.
Note: The demonstration of achieved quality in comparison to objectives - see Question 04.7
The quality objectives to be agreed must be achievable and, if possible, measurable, as well as periodically revised and presented in a suitable for-mat, e.g. using data processing systems. The achievement of objectives must be monitored thoroughly at all management levels (specified/actual comparison).
The objectives must be practically, clearly and comprehensively explained to the employees during informative discussions.
Without the definition of objectives, an efficient improvement in quality and increase in productivity in all areas of the organization cannot be followed or achieved.
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.
In the continual improvement process, careful handling and economical use of resources must also be taken into account. This includes, for example:
- the logistical chain
- the building / factory area - the equipment
- environmental protection
The strategy of continual improvement applies to employees, all production processes, services and business operations of the organization. It does not replace necessary innovative improvements. Improvements refer to, for example:
- Quality - Price - Service
01.4 Have the necessary resources been provided by the man-agement of the organization?
Requirements/Explanation:
For the quality management system to operate effectively, the management of the organization has the task of providing the financial and personnel re-sources needed to fulfil the requirements in the quality elements. These in-clude, for example:
- qualified staff with task-related capabilities for management, implementation and inspection activities (including project management)
- inspection and testing equipment for product development and manufacture
- computer support, e.g. for data analysis, graphic displays, sta-tistics, quality plans.
The effectiveness and efficiency of the quality management system de-pends on the provision of the necessary resources for the realization of the quality policy and the quality objectives.
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.
01.5* Has a management representative been assigned and are his duties, authorities and responsibilities defined?
Explanation of terms:
The "Management representative" is the person who represents the inte-rests of management regarding strategic quality management at all mana-gement levels.
The representative must belong to the management team of the organiza-tion, but does not have to be a member of the management. He/she always reports to that level of management, which is responsible for profit and loss. Requirements/Explanation:
Responsibilities and authorities of the representative include: - Reporting on the quality situation
- Defining, realizing and maintaining the quality management system in accordance with the requirements of this question-naire, which includes branch-specific adjustments
- Monitoring the strategic quality objectives
- Controlling and coordinating quality activities using interdisci-plinary cooperation
- Demonstrating the effectiveness of the quality management system and determining possible improvements.
Note: The representative may at the same time be responsible for the organizational functions "quality department", "quality assurance", "quality management" etc.
01.6* Does management regularly evaluate the effectiveness of the quality management system?
Definition:
Review (in accordance with ISO 9000:2000/3.8.7):
Activity undertaken to detrminie the suitability, adequacy and effectiveness (#3.2.14) of the subject matter to achieve established ojectives.
Note: Review can also include the detrmination of effieciency (#3.2.15). 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:
- Reports on the quality situation
- Regularly scheduled quality meetings
- Quality indices with respect to objectives (see Question 01.2) - Internal quality audit reports with derived measures (see
Ques-tion 03.2 and 03.3)
- Status of the continual improvement process (see Question 01.3)
- Results of product and process analysis with corrective actions - Reports on customer satisfaction (see question Z1.4).
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.
02 Quality management system
ISO 9001:2000, Clause 4; 5.4.2; 7.1
A quality management system consists of the organizational structure, the responsibilities, procedures, processes and re-sources for the implementation of quality management.
The quality management system is intended to promote continual quality improvement.
The quality management system shall be defined and imple-mented by management, preferably in a quality manual and in supplementary documented procedures or equivalent documenta-tion.
Note: VDA Volume 4.3 is an applicable reference.
Reference ISO 9001:2000 02.1
*
Is the quality management system described in a quality manual or an equivalent docu-ment?
4.1; 4.2.1; 4.2.2 02.2 Does the quality management system
en-compass all areas, levels and employees of the organization?
4.2.1, 4.2.2 02.3
*
Are there documented procedures defining duties, responsibilities and authority levels for quality activities?
5.5.1 02.4
*
Is there a cross-functional project manage-ment established which includes the quality planning process?
7.3.1 02.5
*
Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements?
5.4.2; 7.1 02.6
*
Are there quality plans resulting from the
02.1* Is the quality management system described in a quality manual or an equivalent document?
Definition:
Quality manual (according to ISO 9000:2000/3):
Document (#3.7.2) specifying the quality management system (#3.2.3) of an organization (#3.3.1).
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 exin-ternal instructions, standards, regulations etc.
The documentation covers:
- 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.
In addition, special processes can be separately defined in documented procedures, quality assurance plans etc. This also include instructions on project management (see Question 02.4).
