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ISO9001 Quality Manual

The Quality Manual outlines Quality Machine & Tool Works' commitment to producing high-quality products while adhering to ISO9001:2000 and TS16949:2002 standards. It details the policies, procedures, and responsibilities necessary for maintaining an effective quality management system aimed at enhancing customer satisfaction and ensuring compliance with regulatory requirements. The document also includes specific quality objectives and supporting documentation for various operational processes.

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0% found this document useful (0 votes)
35 views10 pages

ISO9001 Quality Manual

The Quality Manual outlines Quality Machine & Tool Works' commitment to producing high-quality products while adhering to ISO9001:2000 and TS16949:2002 standards. It details the policies, procedures, and responsibilities necessary for maintaining an effective quality management system aimed at enhancing customer satisfaction and ensuring compliance with regulatory requirements. The document also includes specific quality objectives and supporting documentation for various operational processes.

Uploaded by

Thế Phong
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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ISO9001:2000

TS16949:2002
QUALITY MANUAL
QUALITY MANUAL
ISO9001:2000
TS16949:2002

Revision: 1

October 13, 2006

CONTROLLED COPY

Corporate Headquarters
Quality Machine & Tool Works
1201 Michigan Ave.
Columbus, Indiana,
47201
Quality Policy

The quality policy and mission statement are recorded on QM1083

Mission Statement

We at Quality Machine & Tool Works, Inc. are committed to producing products
of superb quality at reasonable prices and to the delivery of our products to
satisfy the needs of every customer.
By accomplishing this, we will be able to operate at a profit sufficient to provide
growth in our business, personal development opportunities for our employees,
and a satisfactory return on our investment.

1 SCOPE
This Quality Manual provides specifics on the policies and procedures Quality Machine
& Tool Works Inc. (QMTW) uses to meet ISO9001:2000 TS16949:2002 requirements

The intent of these policies and procedures is to demonstrate Quality Machine & Tool
Work’s ability to consistently provide product that meets or exceeds customer and
applicable regulatory requirements and to enhance customer satisfaction through the
effective application of the quality system, including processes for continual
improvement of the system and the assurance of conformity to customer and applicable
regulatory requirements.

Due to the nature of our products and organization, product design is not
included in our management system; Quality Machine & Tool Works does not
have the authority to authorize changes to product specifications.

2 NORMATIVE REFERENCE
The following normative documents contain provisions, which, through reference
in this text, constitute provisions TS16949
ISO Q9000-2000, Quality Management Systems - Fundamentals and
Vocabulary.

3 TERMS AND DEFINITIONS


The term "organization" used in this Quality Manual refers to Quality Machine &
Tool Works, Inc.
"Supplier" and "Vendor" are synonymous and refer to the external source(s) used
to acquire purchased products and/or services by QMTW
Throughout the text of this Quality Manual wherever the term "product" occurs, it
can also mean "service".
The term "Process Map" refers to a procedure represented by flow chart.
The term "Management Team" is synonymous with "top management".

4 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS


Quality Machine & Tool documents, implements, and maintains a quality
management system and continually improves its effectiveness in accordance
with the requirements of ISO9001, TS16949
QMTW:
a) identifies the processes needed for the quality management system and their
application throughout this organization (see section 1),
b) determines the sequence and interaction of these processes,
c) determines criteria and methods needed to ensure that both the operation
and control of these processes are effective,
d) ensures the availability of resources and information necessary to support the
operation and monitoring of these processes,
e) monitors, measures and analyzes these processes, and
f) implements actions necessary to achieve planned results and continual
improvement of the system.

Quality Machine & Tool manages these processes in accordance with


ISO9001:2000 /TS16949:2002
Where Quality Machine & Tool chooses to outsource any process that affects
product conformity with requirements, Quality Machine & Tool ensures control
over such processes. Control of such outsourced processes is identified with the
quality management system.
NOTE: Processes needed for the quality management system referred to above
include processes for management activities, provision of resources,
product realization and measurement.
4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL
The quality management system documentation includes:
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by ISO9001:2000/TS16949:2002,
d) documents needed by Quality Machine & Tool to ensure the effective
planning, operation and control of its processes, and

e) records required by ISO9001:2000/TS16949:2002 (see section 4.2.4).


NOTE 1: Where the term "documented procedure" appears within this Quality
Manual, this means that the procedure is established, documented,
implemented and maintained.
NOTE 2: The extent of the quality management system documentation can differ
due to:
a) the complexity, volume and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3: The documentation can be in any form or type of medium.

4.2.2 QUALITY MANUAL


Quality Machine & Tool established and maintains a Quality Manual that
includes:
a) the scope of the quality management system, including details of and
justification for any exclusions (see section 1)
b) the documented procedures established for the quality management system,
or reference to them (see reference below), and
c) a description of the interaction between the processes of the quality
management system (see description and representation below).

REFERENCE TO DOCUMENTED PROCEDURES ESTABLISHED FOR THE


QUALITY MANAGEMENT SYSTEM, QUALITY POLICY, AND QUALITY
OBJECTIVES
4.2.2 QUALITY MANUAL
Supporting Documentation
Quality Manual
4.2.3 CONTROL OF DOCUMENTS
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
C0 Document Control Process Map
4.2.4 CONTROL OF RECORDS
Supporting Documentation
SOP 16.01 Quality Records
C05 Record Retention Process Map
5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
Supporting Documentation
SOP 01.01 Management Responsibility
5.2 CUSTOMER FOCUS
Supporting Documentation
SOP 01.05 Customer Satisfaction
SOP 24.01 Customer Specific Requirements
5.3 QUALITY POLICY (QM 1083)

Quality Machine and Tool produces products and provides services that
consistently conform to customer expectations. Our quality system is compliant with
ISO 9001-2000 and ISO/TS-16949, and regulatory requirements, and our company
continually improves the system. Clear objectives have been established in support
of this policy, and management reviews the system and objectives on a periodic
basis.

5.4 PLANNING
Supporting Documentation
SOP 02.02 Quality Planning

5.4.1 QUALITY OBJECTIVE (QM 1083)


Quality Objectives:
* Purchasing:
To measure suppliers as to their on time delivery and quality of parts supplied.

* Production Control:
To continually improve delivery, inventory control, and scheduling methods.

* Operations:
To monitor and improve process capability, operator training, safety and labor
performance.

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING


Supporting Documentation
SOP 02.02 Quality Planning
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 RESPONSIBILITY AND AUTHORITY
Supporting Documentation
SOP 01.01 Management Responsibility
5.5.2 MANAGEMENT REPRESENTATIVE
Supporting Documentation
SOP 01.01 Management Responsibility
5.5.3 INTERNAL COMMUNICATION
Supporting Documentation
SOP 01.04 Analysis and Use of Company Level Data
5.6 MANAGEMENT REVIEW
Supporting Documentation
SOP 01.02 Management Review
5.6.1 GENERAL
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 01.02 Management Review
5.6.2 REVIEW INPUT
Supporting Documentation
SOP 01.02 Management Review
5.6.3 REVIEW OUTPUT
Supporting Documentation
SOP 01.02 Management Review
6 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES
Supporting Documentation
SOP 01.01 Management Responsibility
6.2 HUMAN RESOURCES
SOP 18.01 Training
C12 Training Process Map
C17 Human Resources Process Map
6.2.1 GENERAL
6.2.2 COMPETENCE, AWARENESS, AND TRAINING
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 18.01 Training
SOP 14.01 Corrective and Preventive Action
SOP 22.01 Continuous Improvement Program
C12 Process Map
6.3 INFRASTRUCTURE
6.3.1 PLANT, FACILITY, AND EQUIPMENT PLANNING
Supporting Documentation
SOP 23.01 Manufacturing Capacity
SOP 15.01 Scheduling Production
6.3.2 CONTINGENCY PLANS
Supporting Documentation
SOP 09.05 Contingency Plan to Protect the Customer’s Supply of Product
6.4 Work Environment
Supporting Documentation
SOP 09.03 Governmental Safety and Environmental Regulations
ISO 14001 EMS Manual
C18 Environmental and Safety Process Map
C31 Maintenance Process Map
7 PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 02.02 Quality Planning
C20 APQP Process Map
7.2 CUSTOMER RELATED PROCESSES
Supporting Documentation
SOP 24.01 Customer Specific Requirements
SOP 07.01 Customer Owned Castings, Stampings, and Finished
SOP 07.02 Control of Customer Owned Tooling
SOP 07.03 Control of Customer Owned Packaging
7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT
Supporting Documentation
SOP 03.01 Quotation Procedure
7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 24.01 Customer Specific Requirements
SOP 03.02 Review of Contract
7.2.3 CUSTOMER COMMUNICATION
Supporting Documentation
SOP 21.01 PPAP Request from Subcontractor
SOP 21.02 PPAP Requirements to Customer
7.4 PURCHASING
7.4.1 PURCHASING PROCESS
Supporting Documentation
SOP 06.01 Purchasing
C11 Purchasing Process Map
7.4.2 PURCHASING INFORMATION
Supporting Documentation
SOP 06.01 Purchasing
C11 Purchasing Process Map
7.4.3 VERIFICATION OF PURCHASED PRODUCT
Supporting Documentation
SOP 10.01 Receiving Inspection
SOP 06.01 Purchasing
C11 Purchasing Process Map
C50 Receiving Process map
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION
Supporting Documentation
SOP 15.05 Scheduling Production
SOP 09.01 Process Control
C30 Process Map
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE
PROVISION
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 10.02 In Process Inspection
7.5.3 IDENTIFICATION AND TRACEABILITY
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 08.01 Product ID & Traceability
SOP 20.01 Statistical Techniques
C 32 ID and Traceability Process Map
7.5.4 CUSTOMER PROPERTY
Supporting Documentation
SOP 07.01 Customer Owned Castings, Stampings, and Finished
SOP 07.02 Control of Customer Owned Tooling
SOP 07.03 Control of Customer Owned Packaging
7.5.5 PRESERVATION OF PRODUCT
Supporting Documentation
SOP 15.01 Product Handling and Preservation
SOP 15.02 Product Storage
SOP 15.03 Product Packaging
C5 Shipping Process Map
7.6 CONTROL OF MONITORING AND MEASURING DEVICES
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 11.01 Control of Insp, Meas, and Test Equip
SOP 10.06 Laboratory Requirements
C35 Measuring Equipment Process Map
ISO 10012-1:1992(E), Quality Assurance Requirements for Measuring Equipment - Part
1: Metrological Confirmation System for Measuring Equipment
8 MEASUREMENT, ANALYSIS, AND IMPROVEMENT
C35 Measuring Equipment Process Map
8.1 GENERAL
8.1.1 IDENTIFICATION OF STATISTICAL TOOLS
Supporting Documentation
SOP 20.01 Statistical Techniques
8.1.2 KNOWLEDGE OF BASIC STATISTICAL CONCEPTS
Supporting Documentation
SOP 20.01 Statistical Techniques
8.2 MONITORING AND MEASUREMENT
8.2.1 CUSTOMER SATISFACTION
Supporting Documentation
SOP 01.05 Customer Satisfaction
8.2.2 INTERNAL AUDIT
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 17.01 Internal Quality Audits
C06 Internal Audit Process Map
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 23.01 Manufacturing Capacity
SOP 14.01 Corrective and Preventive Action
SOP 12.01 Inspection and Test Status
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 14.01 Corrective and Preventive Action
SOP 12.01 Inspection and Test Status
SOP 23.01 Manufacturing Capacity
8.3 CONTROL OF NONCONFORMING PRODUCT
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 13.01 Control of Non-Conforming Product
8.4 ANALYSIS OF DATA
Supporting Documentation
SOP 02.02 Quality Planning
SOP 24.01 Customer Specific Requirements
SOP 03.02 Review of Contract
SOP 06.01 Purchasing
SOP 01.05 Customer Satisfaction
SOP 17.01 Internal Quality Audits
SOP 13.01 Control of Non-Conforming Product
SOP 14.01 Corrective and Preventive Action

8.5 IMPROVEMENT
8.5.1 CONTINUAL IMPROVEMENT
8.5.2 CORRECTIVE ACTION
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 14.01 Corrective and Preventive Action
C09 Corrective Action Process Map
8.5.3 PREVENTIVE ACTION
Supporting Documentation
SOP 05.01 Quality Systems Document and Data Control
SOP 14.01 Corrective and Preventive Action
C09 Corrective Action Process Map

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