ISO 9001:2008

Quality Manual

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Document No
Uncontrolled Copy

Rev
Controlled Copy

Date

COMPANY PROPRIETARY INFORMATION

Prior to use, ensure this document is the most recent revision by checking the Master Document List. To request a change, submit a
Document Change Request to the Document Control Representative.

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ISO 9001:2008 Quality Manual

Approvals
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 herein and are committed to ensuring their provision.

Name

Signature

Position

Date

Prepared by
Reviewed by
Approved by

Amendment Record
This quality manual is reviewed to ensure its continuing relevance to the systems and process that it describes. A
record of contextual additions or omissions is given below:
Page No.

Document No:

Context

Revision

Date

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ISO 9001:2008 Quality Manual

Contents
Introduction ................................................................................................................................................................. 5
1. Scope ....................................................................................................................................................................... 6
2. References ............................................................................................................................................................... 7
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 Document Control ............................................................................................................................................ 10
4.2.4 Control of Records ............................................................................................................................................ 10
5. Management Responsibilities ................................................................................................................................ 11
5.1 Management Commitment ..................................................................................................................................... 11
5.2 Customer Focus ....................................................................................................................................................... 11
5.3 Quality Policy ........................................................................................................................................................... 11
5.4 Planning ................................................................................................................................................................... 12
5.4.1 Quality Objectives ............................................................................................................................................. 12
5.4.2 Quality Management System Planning ............................................................................................................. 12
5.5 Responsibility, Authority and Communication ........................................................................................................ 12
5.5.1 Responsibility and Authority ............................................................................................................................. 12
5.5.2 Management representative ............................................................................................................................ 12
5.5.3 Internal Communication ................................................................................................................................... 13
5.6 Management Review ............................................................................................................................................... 13
5.6.1 General.............................................................................................................................................................. 13
5.6.2 Review Input ..................................................................................................................................................... 13
5.6.3 Review Output .................................................................................................................................................. 14
6. Resource Management .......................................................................................................................................... 15
6.1 Provision of Resources ............................................................................................................................................. 15
6.2 Human Resources .................................................................................................................................................... 15
6.2.1 General.............................................................................................................................................................. 15
6.2.2 Competence, Awareness & Training ................................................................................................................. 15
6.3 Infrastructure ........................................................................................................................................................... 15
6.4 Work Environment ................................................................................................................................................... 16
7. Product Realization ................................................................................................................................................ 17
7.1 Planning ................................................................................................................................................................... 17
7.2 Customer Related Processes .................................................................................................................................... 17
7.2.1 Determination of Requirements Related to Product ........................................................................................ 17
7.2.2 Review of Requirements Related to Product .................................................................................................... 17
7.2.3 Customer Communication ................................................................................................................................ 18
7.3 Design & Development ............................................................................................................................................ 18
7.3.1 Planning ............................................................................................................................................................ 18
7.3.2 Input .................................................................................................................................................................. 18
7.3.3 Output ............................................................................................................................................................... 18
7.3.4 Review ............................................................................................................................................................... 19
7.3.5 Verification ........................................................................................................................................................ 19
7.3.6 Validation .......................................................................................................................................................... 19
7.3.7 Control of Design & Development Changes...................................................................................................... 19
7.4 Purchasing ................................................................................................................................................................ 19

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7.4.1 Purchasing Process ........................................................................................................................................... 19

7.4.2 Purchasing Information .................................................................................................................................... 20
7.4.3 Verification of Purchased Product .................................................................................................................... 20
7.5 Production & Service Provision ................................................................................................................................ 20
7.5.1 Control of Production & Service Provision ........................................................................................................ 20
7.5.2 Validation of Processes for Production & Service Provision ............................................................................. 21
7.5.3 Identification & Traceability.............................................................................................................................. 21
7.5.4 Customer Property............................................................................................................................................ 21
7.5.5 Preservation of Product .................................................................................................................................... 21
7.6 Control of Monitoring & Measuring Equipment ...................................................................................................... 22
8. Measurement, Analysis & Improvement ................................................................................................................ 23
8.1 General..................................................................................................................................................................... 23
8.2 Monitoring & Measurement .................................................................................................................................... 23
8.2.1 Customer Satisfaction ....................................................................................................................................... 23
8.2.2 Internal Audit .................................................................................................................................................... 24
8.2.3 Process Monitoring & Measurement ................................................................................................................ 24
8.2.4 Product Monitoring & Measurement ............................................................................................................... 24
8.3 Control of Non-conforming Products ...................................................................................................................... 25
8.4 Analysis of Data ........................................................................................................................................................ 25
8.5 Improvement ........................................................................................................................................................... 26
8.5.1 Continual Improvement .................................................................................................................................... 26
8.5.2 Corrective Action .............................................................................................................................................. 26
8.5.3 Preventive Action .............................................................................................................................................. 27
Appendices ................................................................................................................................................................ 28
A.1 Abbreviations & Acronyms ...................................................................................................................................... 28
A.2 Sequence and Interaction of Quality Management System Processes ................................................................... 29
A.3 List of Key QMS Documents .................................................................................................................................... 30
Procedures ................................................................................................................................................................. 30
Forms ......................................................................................................................................................................... 31
A.4 Organization Chart ................................................................................................................................................... 33

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ISO 9001:2008 Quality Manual

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 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 also 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 our quality management system is maintained and focused on customer
satisfaction and continuous improvement.

Quality Management System Process Approach

The model above illustrates that effectiveness and improvement can be represented as a cyclical process that uses
components of the quality management system to analyze data and then direct changes and initiatives that ensure the
systems continual improvement. This ensures a proactive approach to meeting the quality management system
objectives and customer requirements.

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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 [amend 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:
Clause

Justification

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2. References
In addition to ISO 9001:2008, 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.
Standard

Title

Title & Description

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

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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 are referenced throughout our quality manual and are contained in Appendix A.1.
The following terms and definitions are taken from ISO 9000:2005:
Term

ISO 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

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4. Quality Management System

4.1 Introduction
Your Company has implemented a quality management system that exists as part of a larger, overall management
system which has established, documented and implemented our quality policy and related processes for providing
products and services which meet or exceed customer requirements, whilst satisfying the requirements of ISO
9001:2008.
Your Company has adopted the process approach advocated by ISO 9000:2005, by defining and managing process
inputs, controls and outputs to ensure the desired results are achieved and by managing the interfaces between
interrelated processes to ensure system effectiveness is maintained.
Your Company monitors, measures and analyzes relevant processes and takes action to achieve planned results and
ensures the continual improvement of our quality management system. Any outsourced process or activity is
controlled as per applicable ISO 9001 requirements.
Specific responsibilities for, and the sequence and interaction of key quality management system processes are
detailed in the quality procedures, some of which contain or reference deployment flow charts depicting the process
or which is also described in the narrative of the procedure. Appendix A.2 describes the sequence and interaction of
our organizational processes.

4.2 Documentation Requirements

4.2.1 General
This quality manual contains documented statements of our quality policy and quality objectives and references the
documented procedures required by ISO 9001:2008 and other documents needed to ensure effective planning,
operation and control of our key processes.
The level and type of quality management system documentation established for our business is continually reviewed
to ensure it remains appropriate for the complexity of the interactions of our core processes and the competence of
our employees. Quality management system documents and data exist in hard copy and electronic format.
The quality management system documentation includes this quality manual, quality procedures, forms and other
internal and external documents and data needed to manage, perform or verify work affecting product quality. Any
quality management system documentation which is utilized or generated is categorised into the following hierarchy:
Quality Management System Documentation Hierarchy:
Tier

Document Type

Purpose

Policy

Key system driver of process inputs and objectives; statement of corporate vision

Quality manual

Describes corporate approach and responsibilities for achieving quality

Procedures

Describe the methods required for process implementation

Work instructions

Describe the operating practices and controls of each process

Forms

Key system outputs; data, records, proof of conformance and evidence of verification

4.2.2 Quality Manual

This manual has been prepared to describe Your Companys quality management system; its associated procedures,
and the processes needed to implement our quality policy in order to achieve our quality objectives. Each section of
the manual makes reference to various procedures, forms and process maps relating to the requirements outlined in
that section.

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4.2.3 Document Control

All quality management system documents are controlled according to the Document Control Procedure (P001) which
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 are controlled include but are not limited to the followings examples:

Quality manual

Procedures

Records

Controlled documents are identified with a document name and document number:

Procedures are prefixed P

Forms are prefixed F

Work instructions are prefixed W

A list of key quality management system documents; including all quality procedures, forms and other key quality
management system documents is located in Appendix A.3.
Supporting documentation:
Ref

Title & Description

P001

Document Control Procedure

4.2.4 Control of Records

Records are established to provide evidence of conformity to the requirements specified by the standard, customer
requirements and of the effective operation of the quality management system are formally controlled through the
application of the Control of Records Procedure (P002).
Records which are controlled include but are not limited to:

Corrective Action Reports

Management Review Reports

Customer Complaints

Calibration Records

Supporting documentation:
Ref

Title & Description

P002

Control of Records Procedure

Document No:

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