ISO 9001 quality manual template example

QUALITY SYSTEM
MANUAL
QM1
BS EN ISO 9001:2008

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
Date
Prepared By



Reviewed By



Approved By



COMPANY PROPRIETARY INFORMATION

This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to
use, ensure this document is the most recent revision by checking the Master Document List. To request changes,
submit a Document Change Request to the Document Control Representative.

www.iso-9001-checklist.co.uk

---

Quality Manual
[Your Company]
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 Company’s 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’.

[Insert document No. here]
Approved:

Page 2 of 37


www.iso-9001-checklist.co.uk

---

Quality Manual
[Your Company]
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.

[Insert document No. here]
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
Guide Page
Context
Initial
Date
(Numbers)













































[Insert document No. here]
Approved:

Page 4 of 37


www.iso-9001-checklist.co.uk

---

Quality Manual
[Your Company]
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

[Insert document No. here]
Approved:

Page 5 of 37


www.iso-9001-checklist.co.uk

---

Quality Manual
[Your Company]
ISO 9001:2008


7.2.1
Determination of Requirements Related to Product ........................................................... 21
7.2.2
Review of Requirements Related to Product...................................................................... 21
7.2.3
Customer Communication.................................................................................................. 21
7.3 DESIGN & DEVELOPMENT.................................................................................................................... 22
7.3.1
Planning ............................................................................................................................. 22
7.3.2
Input ................................................................................................................................... 22
7.3.3
Output ................................................................................................................................ 22
7.3.4
Review ............................................................................................................................... 22
7.3.5
Verification ......................................................................................................................... 22
7.3.6
Validation ........................................................................................................................... 23
7.3.7
Change Control .................................................................................................................. 23
7.4 PURCHASING ..................................................................................................................................... 23
7.4.1
Purchase Orders ................................................................................................................ 23
7.4.2
Purchasing Information ...................................................................................................... 23
7.4.3
Verification of Purchased Product ...................................................................................... 24
7.5 PRODUCTION & SERVICE PROVISION.................................................................................................... 24
7.5.1
Control of Production & Service Provision.......................................................................... 24
7.5.2
Validation of Processes for Production & Service Provision............................................... 24
7.5.3
Identification & Traceability ................................................................................................ 24
7.5.4
Customer Property ............................................................................................................. 24
7.5.5
Preservation of Product...................................................................................................... 25
7.6 CALIBRATION ..................................................................................................................................... 25
8. MEASUREMENT, ANALYSIS & IMPROVEMENT................................................................................ 26
8.1 GENERAL .......................................................................................................................................... 26
8.2 MONITORING & MEASUREMENT ........................................................................................................... 27
8.2.1
Customer Satisfaction ........................................................................................................ 27
8.2.2
Internal Audit ...................................................................................................................... 27
8.2.3
Process Monitoring & Measurement .................................................................................. 28
8.2.4
Product Monitoring & Measurement ................................................................................... 28
8.3 CONTROL OF NONCONFORMING PRODUCTS .......................................................................................... 28
8.4 ANALYSIS OF DATA ............................................................................................................................. 29
8.5 IMPROVEMENT ................................................................................................................................... 30
8.5.1
Continual Improvement ...................................................................................................... 30
8.5.2
Corrective Action ................................................................................................................ 30
8.5.3
Preventative Action ............................................................................................................ 31
APPENDICES............................................................................................................................................ 32
9.1
EXAMPLE PROCESS MAP............................................................................................................ 32
9.2
QUALITY GLOSSARY................................................................................................................... 33
9.3
ABBREVIATIONS & DEFINITIONS................................................................................................... 37


[Insert document No. here]
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
company’s 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 company’s 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 company’s 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



[Insert document No. here]
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

3. Terms & Definitions

Our Quality Management System uses the same internationally recognised terms, vocabulary and
definitions given in ISO 9000:2005. Acronyms, terms, vocabulary and definitions unique to our
organization, customers, industry and region and referenced throughout our Quality Management System
are contained in Appendix 9.3. [Define your unique terms/definitions, if any, in Appendix 9.3]
The following terms and definitions are taken from ISO 9000:2005:
Term
Clause
Definition
Document
3.7.2
Information and its supporting medium
Procedure
3.4.5
Specified way to carry out an activity or a process
Quality Manual
3.7.4
Document specifying the quality management system of an organization
Quality Plan
3.7.5
Document specifying how procedures and resources shall be applied
Record
3.7.6
Document stating results achieved or evidence of activities performed
Specification
3.7.3
Document stating requirements

[Insert document No. here]
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.
4.2 Documentation Requirements
4.2.1 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.


Level 1: Policies – key system objectives

Level 2: Quality Manual – approach & responsibility

Level 3: Procedures – methods (Who, What, Where & When)

Level 4: Work Instructions – description of processes (How)

Level 5: Forms, Data & Records – evidence of conformance
4.2.2 Quality
Manual

This Quality Manual has been prepared to describe Your Company’s 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.


[Insert document No. here]
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.
ISO Clause
Definition
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

GUIDANCE: Quality Procedures
Your company may well require more procedures to operate effectively than the six
mandatory procedures listed above.


If, for instance, your company operates a training procedure or a procedure to evaluate
suppliers, they should be listed here and then referenced in the relevant section of the
quality manual. Remember, only six procedures are mandatory.
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:


Approving documents for adequacy prior to issue

Reviewing and revising as necessary and re-approving documents

Ensuring that changes and current revision status of documents are identified

Ensuring that relevant versions of applicable documents are available at points of use

Ensuring that documents remain legible and readily identifiable

Ensuring that documents of external origin are identified and their distribution controlled

Preventing the unintended use of obsolete documents

Ensuring that documents of external origin are identified and their distribution controlled

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:


Specifications and drawings

Process work instructions

Quality manual, mandatory procedures and associated forms

External documents

Controlled documents are identified with a document name and document number


Procedures are referenced according to the ISO 9001:2008 element number

Procedures are prefixed [Define]

Forms are prefixed with [Define]

[Insert document No. here]
Approved:

Page 10 of 37


www.iso-9001-checklist.co.uk

---