DMS-2.1 - 1.1 MAN QM Quality Manual

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MAN – Quality Manual

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File: "1.1 MAN QM Quality Manual.doc"
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Published by OQUMA.com © - All rights reserved Page 1 of 8
Licensed by Prieco S.A. – Version 1.0 2010-01-06
Table of Contents
MAN – Quality Manual

Introduction
Purpose
General
Access and Control
Terms and Definitions
Company Profile
Description
Mission Statement
Vision Statement
Quality Policy
Scope of the System
Organization and Responsibility
Organizational Chart
Responsibilities
Top Management
Management Representative
QMS Responsible
All Personnel
Management System
General Processes Diagram
Quality Management Process Diagram
Procedures List
Continual Improvement
Appendix
Acronyms
Introduction
Purpose
The purpose of this manual is to describe the processes and procedures included
within the boundaries of the Quality Management System (QMS), which complies with
ISO 9001:2008 requirements. This manual also contains company policies regarding
quality.
General
[Company] has established this Quality Management System as a strategic decision of
the organization in order to:
● Demonstrate our capability to consistently provide [products/services] that meet
customer requirements.
● Enhance customer satisfaction through the effective application of the QMS.
● Fulfill applicable regulatory requirements within Quality Areas.
● Provide all the employees with a clear understanding of the QMS and the
importance of adhering to the procedures and policies of the company.
Access and Control

The current controlled documents reside within the OQUMA System
http://www.oquma.com/ and are available to all [Company]'s employees.
Controlled copies of QMS documents are made available according to the
requirements of the employee job description and the Control of Documents
Procedure.

Our QMS uses the same internationally recognized terms, vocabulary and definitions
included in ISO 9000:2005 Standard.
Acronyms, terms, vocabulary and definitions specific to this manual are referred to in
Appendix A.
Company Profile
Description
Our organization provides [products/services] to the [area] markets, which demand
high quality and leading edge products as well as on time delivery.
Mission Statement
[mission statement]
Vision Statement
[vision statement]
Quality Policy
[Policy]
Our Quality Policy is focused on achieving customer satisfaction by continually
improving our processes and products and meeting all contractual and legislative
requirements regarding them.
[Company] makes sure this policy is effective by:
● Ensuring that this policy is known to all our employees.
● Providing all necessary resources in order to enhance customer satisfaction
and to meet customer requirements.
● Continual improvement of processes based on objectives measurement.
● Compliance with legislative requirements.
● Encouraging feedback from both customers and providers.
The organization management is responsible for implementing and periodically revising
this Quality Policy.
Our Quality objectives defined by Top Management are:
● To satisfy our customer needs and expectations assuring our fulfillment, by
giving them competitive products and solutions.
● To increase our company value in order to continue expanding our
opportunities.
● To maintain and expand the QMS.
● To develop and implement basic quality training for all our employees.
● To execute a third party customer satisfaction survey and driving improvements
based on the result.
Scope of the System

The QMS is applied to all production and administration processes, and it
encompasses our operations at our facilities located at [location].
[Company] exercises no exclusions in reference to the ISO 9001:2008 standards, since
all of its requirements are in effect within our facilities.
Organization and Responsibility

Organizational Chart
Responsibilities
Top Management
Top Management demonstrates its commitment to the QMS, and improves its
effectiveness by:
● QMS implementation and it continuous improvement.
● Appointing a member of the Top Management as the Management
Representative.
● Communicating to the organization about the importance of fulfilling customer
quality requirements.
● Ensuring that the company complies with all applicable regulatory requirements
in regards to Quality issues.
● Definition and implementation of Policies.
● Ensuring Quality objectives are established.
● Ensuring all required resources (human, infrastructure, and work environment)
are available in order to implement and maintain the QMS, to continually
improve its effectiveness and to achieve Quality objectives.
● Reviewing the [company]'s QMS periodically, to ensure it continuous suitability,
effectiveness and adequacy.
Management Representative
[Position] of [Company] reports directly to the General Manager, as the Management

Representative, who is responsible for:
● Ensuring that processes needed for the quality management system are
established implemented and maintained.
● Reporting to top management on the performance of the quality management
system and any need for improvement.
● Ensuring the promotion of awareness of customer requirements throughout the
organization.
QMS Responsible
[Position] of [Company] reports directly to the Management Representative, as the
QMS Responsible, who is responsible for:
● QMS implementation and maintenance
All Personnel
All personnel, whether staff, contract or subcontractor employees are responsible for:
● Planning and performing their work in accordance with the Company’s policies
and procedures as laid down in the QMS.
● Proposing changes, where opportunities for improved performance, loss
reduction, or increased efficiency are identified.
In addition the roles and responsibilities of personnel are defined and documented
within Job Description Record held for each position.
Management System
The structure of the QMS is based on processes and roles, responsibilities and
authorities of all employees. The processes of the QMS, their interactions, and the
procedures list are shown in the sections below.
General Processes Diagram

[Company Processes Diagram]
Quality Management Process Diagram
Procedures List
Order Number Type Concept Code
1.2 Standard Operating Procedures
1.2.1 SOP Control of Documents QSCD
1.2.2 SOP Internal Audit QSIA
1.2.3 SOP Corrective and Preventive Action QSCP
1.2.4 SOP Control of Nonconforming Product QSNP
1.2.5 SOP Objectives, Targets and Planning QSOT
1.2.6 SOP Training QSTR
1.2.7 SOP Management Review QSMR
1.3 Work-Instructions QW
1.3.1 WI Procedure Writing QWPW
Continual Improvement
Top management is committed to the continual improvement of its quality management
system, and to the products and services offered to our Customers.
In order to achieve this, we shall:
● Perform Management Reviews with senior management;
● Set achievable objectives and targets based on our policies for improvement;
● Measure our ongoing performance through audit, inspection, assessment and
feedback;
● Report our findings to management on a regular basis; and
● Implement corrective and preventive actions to achieve performance
improvement.
Appendix
Top management: person within a group of people who directs and controls an
organization at the highest level.
Acronyms
QMS: Quality Management System
SOP: Standard Operational Procedure
WI: Work Instruction
REC: Record

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[Company] [DocumentName] Version: [Version]

[System] Revision: [Revision]

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

MAN – Quality Manual

File: "1.1 MAN QM Quality Manual.doc"

Version / Revision History

Version Revision Date Modification

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

MAN – Quality Manual

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

Access and Control

Terms and Definitions

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

Scope of the System

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

Organization and Responsibility

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

[Position] of [Company] reports directly to the General Manager, as the Management

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

General Processes Diagram

Quality Management Process Diagram

Reviewed: [ReviewedBy] Approved: [ApprovedBy] Date: [Date]

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