Académique Documents
Professionnel Documents
Culture Documents
MANUAL
QM1
Your Company
The signatures below certify that this Quality Manual has been reviewed and accepted, and demonstrates that the
signatories are aware of all the requirements contained here in and are committed to ensuring their provision.
Signature
Position
Prepared By
Reviewed By
Approved By
Quality Manual
Date
ISO 9001:2008
GUIDANCE
ISO 9001:2008 is intended to be generic and therefore applicable to all organizations,
regardless of type, size and product category. However, not all requirements in the
Standard will necessarily be relevant to all organizations. Under certain circumstances,
an organization may exclude some specific requirements, such as Product Realisation.
This document is a stand-alone quality manual template and is to be used in
developing or upgrading your ISO 9001:2008 Quality Management System. Review the
text in the quality manual, quality objectives and quality policy, replace the text to match
your quality system requirements. At a minimum, the blue text should be replaced with
your information. Your Company indicates that you should use your Companys name
in that location.
You will need to develop the relevant procedures and forms and reference them in the
related documents tables throughout this document.
Various guidance paragraphs are provided within this document and should be deleted
as the Quality Manual is compiled.
To aid in the navigation of this document; the headings in the contents page are
hyperlinked to the relevant sections. Further to this, it is suggested that you choose
view from the main menu and then document map, the section headings are now
displayed as bookmarks on the left hand side.
It is also useful to display the text boundaries of each page, choose tools then
options, click the view tab, select text boundaries.
Approved:
Page 2 of 37
www.iso-9001-checklist.co.uk
[Your Company]
Quality Manual
ISO 9001:2008
Disclaimer
The material presented in this manual and its accompanying instructions, suggestions and comments
are based on the requirements of ISO 9001:2008 and our experiences gained through its successful
application. Every company is different, however, in terms of its needs, its culture, and its level of
management system development. These differences often require that the generalised guidelines in
this manual be applied with special approaches. Readers are advised and cautioned that Endeavour
Technical Ltd will accept no responsibility for the way in which these guidelines are interpreted and
applied, or the problems which may arise henceforth.
Approved:
Page 3 of
37
www.iso-9001-checklist.co.uk
Quality Manual
[Your Company]
ISO 9001:2008
Amendment Record
This Quality Manual is reviewed annually to ensure relevance to the systems and process that it
defines. A record of contextual additions or omissions is given below.
Amendment
Date
Guide Page
(Numbers)
Context
Initial
www.iso-9001-checklist.co.uk
Approved:
Page 4 of
[Your Company]
Quality Manual
ISO 9001:2008
Table of Contents
INTRODUCTION.................................................................................................................... 7
1. SCOPE............................................................................................................................ 8
2. REFERENCES.................................................................................................................. 8
3. TERMS & DEFINITIONS..................................................................................................... 8
4. QUALITY MANAGEMENT SYSTEM..................................................................................... 9
4.1 INTRODUCTION............................................................................................................... 9
4.2 DOCUMENTATION REQUIREMENTS........................................................................................ 9
4.2.1 General.............................................................................................................. 9
4.2.2 Quality Manual.................................................................................................... 9
4.2.3 Control of Documents.......................................................................................... 10
4.2.4 Control of Records.............................................................................................. 11
5. MANAGEMENT RESPONSIBILITIES...................................................................................12
5.1 MANAGEMENT COMMITMENT............................................................................................. 12
5.2 CUSTOMER FOCUS.........................................................................................................13
5.3 QUALITY POLICY............................................................................................................14
5.4 PLANNING................................................................................................................... 15
5.4.1 Quality Objectives................................................................................................. 15
5.4.2 Quality Management System Planning...................................................................... 15
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION.................................................................. 15
5.5.1 Responsibility and Authority.................................................................................... 15
5.5.2 Management representative.................................................................................... 15
5.5.3 Internal Communication..........................................................................................15
5.6 MANAGEMENT REVIEW.................................................................................................... 16
5.6.1 General...............................................................................................................16
5.6.2 Review Input........................................................................................................ 16
5.6.3 Review Output......................................................................................................16
6. RESOURCE MANAGEMENT..............................................................................................17
6.1 PROVISION OF RESOURCES.............................................................................................. 18
6.2 HUMAN RESOURCES.......................................................................................................18
6.2.1 General.............................................................................................................18
6.2.2 Competence, Awareness & Training........................................................................ 18
6.3 INFRASTRUCTURE.......................................................................................................... 19
6.4 WORK ENVIRONMENT..................................................................................................... 19
7. PRODUCT REALISATION..................................................................................................20
7.1 PLANNING................................................................................................................... 20
7.2 CUSTOMER RELATED PROCESSES...................................................................................... 21
www.iso-9001-checklist.co.uk
Approved:
Page 5 of 37
[Your Company]
Quality Manual
ISO 9001:2008
9.2
QUALITY GLOSSARY.................................................................................................33
9.3
Approved:
Page 6 of 37
www.iso-9001-checklist.co.uk
Quality Manual
[Your Company]
ISO 9001:2008
Introduction
Your Company has developed and implemented a Quality Management System in order to document the
companys best business practices, better satisfy the requirements and expectations of its customers and
to improve the overall management of the company.
The Quality Management System of Your Company meets the requirements of the international standard
ISO 9001:2008. This system addresses the design, development, production, installation, and servicing of
the companys products.
This manual describes the Quality Management System, delineates authorities, inter relationships and
responsibilities of the personnel responsible for performing within the system. The manual also provides
procedures or references for all activities comprising the Quality Management System to ensure
compliance to the necessary requirements of the standard.
This manual is used internally to guide the companys employees through the various requirements of the
ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous
improvement and provide the necessary instructions that create an empowered work force.
This manual is used externally to introduce our Quality Management System to our customers and other
external organizations or individuals. The manual is used to familiarise them with the controls that have
been implemented and to assure them that the integrity of the Quality Management System is maintained
and focused on customer satisfaction and continuous improvement.
Quality Management System (QMS) Process Map
Approved:
Page 7 of 37
www.iso-9001-checklist.co.uk
Quality Manual
[Your Company]
ISO 9001:2008
1. Scope
The International Organization Standard ISO 9001:2008 describes the requirements for a Quality
Management System by addressing the principles and processes surrounding the design development
and delivery of a general product or service. The activity covered by Your Company is for the provision of
and/or [delete as appropriate] supply of [Specify business/industry/sector].
The Quality Management System complies with all applicable requirements contained in ISO 9001:2008,
covers the design and provision of all products and/or services, and encompasses all operations at our
facility located at [insert address of your facilities here]. The following table identifies ISO 9001:2008
requirements not applicable to Your Company and provides a brief narrative justifying their exclusion from
the scope of the Quality Management System. Exclusions are limited to Clause 7, Product Realisation
where such processes are not performed or managed by the organization.
Exclusion
Clause Justification
2. References
In addition to ISO 9001:2008 standard the company will also make reference to relevant British and or
International Standards as well as customer specifications appropriate to the product and its market.
ISO 9000:2005 | Quality management systems | Fundamentals and
vocabulary ISO 9001:2008 | Quality management systems | Requirements
ISO 9004:2000 | Quality management systems | Guidelines for performance improvements
Clause
Definition
Document
3.7.2
Procedure
3.4.5
Quality Manual
3.7.4
Quality Plan
3.7.5
Record
3.7.6
Specification
3.7.3
Approved:
Page 8 of 37
www.iso-9001-checklist.co.uk
Quality Manual
[Your Company]
ISO 9001:2008
4. Quality Management System
4.1 Introduction
Your Company operates and maintains a Quality Management System in accordance with the
requirements of ISO 9001:2008 and through its application will ensure that both the operation and control
of relevant processes is effective; by ensuring the availability of resources and information needed to
support the QMS. Your Company monitors, measures and analyses relevant processes and takes action
to achieve planned results and the continual improvement of our QMS. Any outsourced process or activity
is controlled as per applicable ISO 9001 requirements.
GUIDANCE: Outsourced Processes
You must be able to demonstrate sufficient controls over outsourced processes to ensure
that those processes are performed according to the relevant requirements of ISO
9001:2008.
Outsourced processes may be controlled in any number of ways, e.g. by providing the
supplier/subcontractor with product specifications or by requesting inspection and test
results or certificates of compliance or by conducting product and QMS audits of your
supplier/subcontractor.
The expectation here is that your QMS flows down to your supplier/subcontractor, the
relevant ISO 9001 requirements that you would have to implement had the process been
performed in-house under your QMS control.
General
In order to maintain this assurance a documented quality system has been developed to ensure
and demonstrate that all work undertaken conforms to specification requirements. The system is
structured in five levels.
4.2.2
Quality Manual
This Quality Manual has been prepared to describe Your Companys Quality Management
System. The scope and permissible exclusions of the QMS are described in section one of this
manual. Each section of the manual references mandatory procedures, forms, and process
diagrams relating to the requirements outlined in that section.
Approved:
Page 9 of 37
www.iso-9001-checklist.co.uk
Quality Manual
[Your Company]
ISO 9001:2008
Controls applied concerning the attainment of quality and the overall process is described in a
process map (Appendix 9.1). In addition, the following procedures are implemented:
Ref.
4.2.3
Document Control
4.2.4
Control of Records
8.2.2
Internal Audits
8.3
Control of Non-conformances
8.5.2
Corrective Action
8.5.3
Preventive Action
4.2.3
Control of Documents
All of the Quality Management System documents are controlled according to the Document
Control Procedure [Define]. This procedure defines the process for:
The company uses standard forms and a local area network computer system with an electronic
document management system which are updated as required. Documents which must be
controlled but are not limited to:
Controlled documents are identified with a document name and document number
Approved:
Page 10 of 37
www.iso-9001-checklist.co.uk
Quality Manual
[Your Company]
ISO 9001:2008
4.2.4
Control of Records
The records established to provide evidence of conformity to the requirements specified by the
standard and of the effective operation of the quality management system is formally controlled
through the effective application of the Control of Records Procedure [Define].
Related Documents
www.iso-9001-checklist.co.uk
Approved:
Page 11 of 37