OBJECTIVE OF THE SAMPLE MANUAL

The objective of the QS-9000 Sample Quality Manual is to provide an easy-to-follow, step-by-step, comprehensive guide to assist you in either writing or revising your quality system manual. The sample manual was written to satisfy the intent and requirements of QS-9000:1998. Since both QS-9000 and the sample manual are generic in nature, the sample manual and accompanying instructions, suggestions, and comments should be used to modify or create your own company manual in a manner which reflects the unique characteristics and quality requirements of your organization.

The sample manual and supporting guidelines are not intended to be a substitute for QS-9000. It is highly recommended that you purchase this standard from the Automotive Industry Action Group to supplement the quality manual and provide the baseline from which the sample manual was written. Within the sample manual, excerpts from QS-9000:1998 are shown in bold italics and excerpts from ISO 9001-1994 and the ANSI/ASQC Standard Q9001-1994 are shown in italics to clearly identify their sources.

The ISO 9001-1994 Standard (as adopted by QS-9000) requires a company to prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.

To meet this requirement, some companies may elect to reformat their existing quality manual and develop a cross-reference between the requirements of QS-9000 and the related policy pages in their manual. Other companies elect to completely rewrite their existing manual into the standardized format (shown in the sample manual) to provide external auditors with what they expect to see. In either case, the sample manual and supporting instructions, suggestions, and comments are intended to provide you guidelines and examples to serve as useful references and assist you in this process. On the other hand, if your company does not currently have a well-defined and well-written quality manual, the sample manual can be used as the framework on which to add (or delete) material to accurately describe your quality system and the unique requirements of your organization. In general, your quality manual needs to reflect that you are aware of the requirements of QS-9000, have interpreted them correctly for your organization, and have incorporated them into implemented policies in your operations.

Remember, your quality manual is a personal document. In effect, no one can write your final quality manual for you. The objective of this package is to assist you in that task.

DISCLAIMER

The material presented in this manual and its accompanying instructions, suggestions, and comments is based upon the requirements of QS-9000:1998 and our experiences gained through successful application. Every company is different, however, in terms of its needs, its culture, and its level of quality system development. These differences often require that the generalized guidelines in this manual be applied with special approaches. Readers are advised and cautioned that H.J. Steudel & Associates, Inc. will accept no responsibility for the way in which these guidelines are applied in a company, or the problems which may arise, unless we are contracted to assist in the implementation and management of these activities. For a detailed description of our services, please call (608) 271-3121 or fax (608) 271-4755.

[Company Name][Company Address]

QUALITY MANAGEMENTSYSTEM MANUAL

Based on Quality System RequirementsQS-9000:1998

Issue Date _______________

Issued To _______________

Controlled Y N

Copy No. _______________

Controlled issues of the QMS Manual may not be copied.

REVISIONS

DATE SECTION NO.

PAGE NO.

COMMENTS

APPROVAL:

NAME SIGNATURE

INSTRUCTIONS, SUGGESTIONS, AND COMMENTS

The sample manual is organized into twenty sections corresponding to the twenty requirement elements of QS-9000:1998. It may be necessary for you to add an additional section (or sections) to your manual to cover customer-specific requirements. You may also want to include the following activities in your manual if they are important and actively used as key components of your quality program:

* Cost of Quality

* Health and Safety

* Product Safety and Liability

* And Others

Although your quality manual may be organized in any format or style you prefer, it is important that an external auditor be able to identify and locate the sections of your quality manual that relate directly to and show compliance with the requirements of QS-9000. If you do not follow the sequence of elements given, then you should provide a cross-reference index in the manual. The best choice, however, is to organize your quality manual into sections corresponding to the structure of QS-9000.

[Company Name]QUALITY MANUAL INDEX

MANUAL QS-9000SECTION ELEMENT TITLE

REVISION

0 ---- Foreword/Mission Statement 0

1 I.4.1 Management Responsibility 0

2 I.4.2 Quality System 0

3 I.4.3 Contract Review 0

4 I.4.4 Design Control 0

5 I.4.5 Document and Data Control 0

6 I.4.6 Purchasing 0

7 I.4.7 Control of Customer-Supplied Product 0

8 I.4.8 Product Identification & Traceability 0

9 I.4.9 Process Control 0

10 I.4.10 Inspection & Testing 0

11 I.4.11 Control of Inspection, Measuring & Test Equipment 0

12 I.4.12 Inspection & Test Status 0

13 I.4.13 Control of Nonconforming Product 0

14 I.4.14 Corrective and Preventive Action 0

15 I.4.15 Handling, Storage, Packaging, Preservation and Delivery 0

16 I.4.16 Control of Quality Records 0

17 I.4.17 Internal Quality Audits 0

18 I.4.18 Training 0

19 I.4.19 Servicing 0

20 I.4.20 Statistical Techniques 0

INSTRUCTIONS, SUGGESTIONS, AND COMMENTSFor Section 0, Page 1

MISSION STATEMENT

Your company's mission statement is one of the most significant statements the company can make. It reflects your vision of excellence, reason for being, and the way the company views itself, its employees, and its customers.

If your company has a well-defined mission statement, then it should be stated in the quality manual, and communicated and displayed openly in all areas of the company. If no mission statement is explicitly defined, then develop one considering the following key concepts for reflecting your policy and commitment to quality:

* Providing customers with products and services that address the needs of the market niche the company serves.

* Striving to exceed customer needs and expectations (customer satisfaction).

* Fostering an atmosphere/culture for continuous improvement.

* Cultivating cooperation and mutual respect with all employees and suppliers.

COMPANY PROFILE

It is appropriate to include a description of your company's scope of registration in this section (e.g., "the design, production, servicing, and installation of..."). You may also wish to provide a brief description of your company's history, products, plant locations, etc.

"NAME" OF QUALITY SYSTEM MANUAL

QS-9000 is best defined as a standard (or model) for the implementation and management of a quality assurance system that ensures that a company can satisfy its customers' requirements. The Standard is not a model for total quality management (TQM), although implementing QS-9000 does include team efforts, management involvement and commitment, and the elimination of waste and improvement of quality - key components of TQM. Thus, what to "name" the quality system manual is a choice you need to make based upon your values, beliefs, convictions, culture, and existing quality program. Some options are:

* Quality Management System (QMS) Manual* Quality System Manual* Quality Assurance System Manual* Quality Manual* Quality System Requirements Manual* QS-9000 Manual

[Company Name]SECTION 0Page 1 of 1

Rev. 0 Date _________

FOREWORD

The purpose of this manual is to describe the policies and company-wide control structure of the quality management system (QMS) used to achieve the corporate mission at [Company Name].

[Company Name] Mission Statement

See Comments

Because the quality of our products and services is and will continue to be the key to competitiveness in the 1990's and beyond, it is increasingly vital for all of us at [Company Name] to understand and use our quality management system to do a good job, the first time, every time.

[Company Name] Profile

See Comments

The quality management system described in this manual addresses the requirements of Quality System Requirements QS-9000:1998.

INSTRUCTIONS, SUGGESTIONS, AND COMMENTSFor Section 1, Page 1

QUALITY POLICY

A company's policy for quality includes its objectives for quality and its commitment to quality. Like its mission statement, a company's objectives for quality need to be personal statements, reflecting how the company really views itself and its commitment to quality. Thus, a company's objectives for quality need to be developed, communicated, and fostered by top management.

Ideally, your company has already articulated its "Objectives for Quality." In this case, the objectives listed on pages 1 and 2 in Section 1 should be replaced by your company's objectives, or by similar policy statements for quality.

If your company has not defined its "Objectives for Quality," the objectives listed in the sample manual serve as a good "prime for the pump." Use them to develop "personal objectives" for your organization.

[Company Name]SECTION 1Page 1 of 11Rev. 0 Date _________

1.0 MANAGEMENT RESPONSIBILITY

Section 1 of the QMS Manual addresses the requirements of Section I, Elements 4.1.1 (Quality Policy), 4.1.2 (Organization), 4.1.3 (Management Review), 4.1.4 (Business Plan), 4.1.5 (Analysis and Use of Company-Level Data), and 4.1.6 (Customer Satisfaction) in QS-9000:1998.

1.1 QUALITY POLICY

a. The commitment to and policy for quality by [Company Name]'s executive management are reflected in the company's mission statement, and in the objectives for quality listed below.

[Company Name] Objectives for Quality

Provide quality products and services by striving to exceed the defined needs and expectations of our customers.

Develop a quality system based on QS-9000:1998 to foster continuous process improvement and problem prevention instead of problem detection.

Define and implement our quality system based upon employee involvement and a commitment to excellence.

Give all employees the training and support needed to provide quality products and services to all customers.

Communicate our mission and quality objectives to all employees, and assign individual responsibilities for quality and accountability.

Use statistical methods to monitor quality performance and isolate major problems for immediate solution.

Establish and maintain a working environment that supports the production and delivery of high quality products and services.

Form relationships with both customers and subcontractors that will improve quality in all aspects of product usage and purchased parts.

INSTRUCTIONS, SUGGESTIONS, AND COMMENTSFor Section 17, Page 1

INTERNAL QUALITY AUDITS

Your company needs to specify the steps for conducting internal quality audits within a documented quality system procedure. Section 17 of the quality manual could thus be very brief, and simply refer to the appropriate procedure(s). As a guide to companies in addressing the requirements of this element of the Requirement QS-9000:1998, the sample manual takes a second common approach of specifying in detail the manner in which the quality audit is conducted and the associated responsibilities.

Internal Audit Schedules

The Third Edition of QS-9000 has added a requirement that the audit schedule covers all shifts.

[Company Name]SECTION 17Page 1 of 2Rev. 0 Date _________

17.0 INTERNAL QUALITY AUDITS

Section 17 of the QMS Manual addresses the requirements of Section I, Element 4.17 (Internal Quality Audits) in QS-9000:1998.

17.1 GENERAL

a. [Company Name] plans and conducts internal quality audits according to the Internal Quality Audit Procedure QSP 17.1 for the following purposes:

1. To verify whether quality activities and related results comply with planned arrangements.

2. To determine the overall effectiveness of the quality system.

3. To ensure the continuing suitability of the working environment.

b. A minimum of two internal audits are conducted per year and every element of the quality system is audited at a minimum of once per year. The frequency at which an individual element is audited is based upon the importance and status of the element.

Internal audits cover all shifts and are conducted according to an audit schedule which is updated annually. Planned audit frequencies are increased when a significant number of nonconformances or customer complaints occur, as identified through the Quality Failure Code Reporting and Feedback Procedure QSP 13.1 and the Customer Complaint System Procedure QSP 19.3.

d. An audit team consists of one or more qualified auditors (trained in QS-9000 requirements and auditing) and the Manager of Quality Assurance (or an assigned representative of Quality Assurance). An officer of the company and a selected employee of the company also participate periodically to foster management and employee involvement and awareness. The manager of the department being audited acts as an observer to answer questions. One or more teams are used depending on the status and progress of the quality system elements.

e. Audits are carried out by personnel independent of those having direct responsibility for the activity being audited.

INSTRUCTIONS, SUGGESTIONS, AND COMMENTSFor Section 17, Page 2

RESPONSIBILITIES

Given the importance of internal quality audits, the manual should clearly identify the primary responsibilities for planning, conducting, and documenting the company's audits. Although these responsibilities are defined in detail in the procedural statements addressing who does what, when, and how it is documented, it is often beneficial to provide a statement of responsibilities in the quality manual. It informs your registrar, your employees, and your customers of your understanding and commitment to internal auditing.

AUDIT RESULTS

Note that the corrective action procedure is referenced in order to deal with deficiencies or noncompliances identified in the quality audit; the preventive action procedure is referenced in regards to weaknesses.

Note the direct tie between internal quality audits and the management review process.

The retention period of records documenting the quality audit process and results must be at least three years to meet the requirements of Element 4.16 of QS-9000:1998. The sample manual specifies five years, which is a common retention period.

[Company Name]SECTION 17Page 2 of 2Rev. 0 Date _________

17.2 RESPONSIBILITIES

The Manager of Quality Assurance (QA) is responsible for organizing and coordinating the internal audit to ensure that the requirements of the Internal Quality Audit Procedure QSP 17.1 are followed.

17.3 AUDIT RESULTS

a. The results in the audit report are reviewed and approved by the Manager of Quality Assurance. The audit results are then distributed to senior management and to the managers of the audited departments and their immediate supervisors.

b. In the case of noncompliances or weaknesses (in either the quality system and procedures, or the performance and adherence to those systems and procedures), timely action is taken by the relevant department manager according to the Corrective Action Procedure QSP 14.1 and/or Preventive Action Procedure QSP 14.3, and the implementation and effectiveness of the corrective and preventive actions are verified and recorded (reference Section 16).

c. The results of the internal audit are used as key input information for conducting the management reviews.

d. Records documenting the audit process and results are kept for a period of five (5) years by Quality Assurance.

To order this manual or any of our other documentation for QS-9000:1998

Contact:Laura Schultz

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