DMS-2.1 -- 1.1 MAN QM Quality Manual

8/8/2019 DMS-2.1 -- 1.1 MAN QM Quality Manual

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[Company]

[System]

[DocumentName] Version: [Version]

Revision: [Revision]

Type : [DocumentType]

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

http://www.oquma.com

MAN Quality ManualSystem: [Company] [System]

File: "1.1 MAN QM Quality Manual.doc"

Version / Revision History

Version Revision Date Modification

TIP: Please, fill and upload the template to the OQUMA system.

When the document is approved, youll have access to the final publisheddocument version.

Support: support@ oquma .com

[SYSTEM] de [Company]Published by OQUMA.com - All rights reservedLicensed by Prieco S.A. Version 1.0 2010-01-06

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Table of Contents

MAN Quality Manual

Introduction

Purpose

General

Access and Control

Terms and Definitions

Company ProfileDescription

Mission Statement

Vision Statement

Quality Policy

Scope of the System

Organization and Responsibility

Organizational Chart

Responsibilities

Top Management

Management RepresentativeQMS Responsible

All Personnel

Management System

General Processes Diagram

Quality Management Process Diagram

Procedures List

Continual Improvement

Appendix


Acronyms

[SYSTEM] de [Company]

Published by OQUMA.com - All rights reservedLicensed by Prieco S.A. Version 1.0 2010-01-06

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Introduction

Purpose

The purpose of this manual is to describe the processes and procedures includedwithin the boundaries of the Quality Management System (QMS), which complies withISO 9001:2008 requirements. This manual also contains company policies regardingquality.

General

[Company] has established this Quality Management System as a strategic decision ofthe organization in order to:

Demonstrate our capability to consistently provide [products/services] that meetcustomer 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 theimportance of adhering to the procedures and policies of the company.

Access and Control

The current controlled documents reside within the OQUMA Systemhttp ://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 DocumentsProcedure.


Our QMS uses the same internationally recognized terms, vocabulary and definitionsincluded in ISO 9000:2005 Standard.Acronyms, terms, vocabulary and definitions specific to this manual are referred to inAppendix A.

Company Profile

Description

Our organization provides [products/services] to the [area] markets, which demandhigh quality and leading edge products as well as on time delivery.

Mission Statement

[mission statement]

Vision Statement



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[vision statement]

Quality Policy

[Policy]Our Quality Policy is focused on achieving customer satisfaction by continuallyimproving our processes and products and meeting all contractual and legislativerequirements 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 satisfactionand 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 revisingthis Quality Policy.Our Quality objectives defined by Top Management are:

To satisfy our customer needs and expectations assuring our fulfillment, bygiving them competitive products and solutions.

To increase our company value in order to continue expanding ouropportunities.

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 improvementsbased on the result.

Scope of the SystemThe QMS is applied to all production and administration processes, and itencompasses 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.


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Organization and Responsibility

Organizational Chart

Responsibilities

Top Management

Top Management demonstrates its commitment to the QMS, and improves itseffectiveness 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 continuallyimprove its effectiveness and to achieve Quality objectives.

Reviewing the [company]'s QMS periodically, to ensure it continuous suitability,effectiveness and adequacy.

Management Representative



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[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 theQMS 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 Companys policiesand procedures as laid down in the QMS.

Proposing changes, where opportunities for improved performance, lossreduction, or increased efficiency are identified.

In addition the roles and responsibilities of personnel are defined and documentedwithin Job Description Record held for each position.

Management SystemThe structure of the QMS is based on processes and roles, responsibilities andauthorities of all employees. The processes of the QMS, their interactions, and theprocedures list are shown in the sections below.



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General Processes Diagram

[Company Processes Diagram]

Quality Management Process Diagram

Procedures ListOrder 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 QSMR1.3 Work-Instructions QW

1.3.1 WI Procedure Writing QWPW

Continual ImprovementTop management is committed to the continual improvement of its quality managementsystem, and to the products and services offered to our Customers.In order to achieve this, we shall:

Perform Management Reviews with senior management;


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Set achievable objectives and targets based on our policies for improvement;

Measure our ongoing performance through audit, inspection, assessment andfeedback;

Report our findings to management on a regular basis; and

Implement corrective and preventive actions to achieve performanceimprovement.

Appendix


Top management: person within a group of people who directs and controls an

organization at the highest level.

Acronyms

QMS: Quality Management SystemSOP: Standard Operational ProcedureWI: Work InstructionREC: Record



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DMS-2.1 -- 1.1 MAN QM Quality Manual

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