Preparing The Quality Manual
The standard requires a quality manual to be established
and maintained that includes the scope of the quality
management system, the documented procedures or refer-
ence to them and a description of the sequence and
interaction of processes included in the quality manage-
ment system.
ISO 9000 defines a quality manual as a document
specifying the quality management system of an organi-
zation. It is therefore not intended that the
manual be a response to the requirements of
ISO 9001. As the top-level document describing
the management system it is a system description
describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9000 :1994, were no
more than 20 sections that paraphrased the requirements of the standard.
Such documentation adds no value. They are of no use to managers, staff or
auditors. Often thought to be useful to customers, organizations would gain
no more confidence from customers than would be obtained from their
registration certificate.
A description of the management system is necessary as a means of showing
how all the processes are interconnected and how they collectively deliver the
business outputs. It has several uses as :
a means to communicate the vision, values, mission, policies and objectives
of the organization
a means of showing how the system has been designed
a means of showing linkages between processes
a means of showing who does what
an aid to training new people
a tool in the analysis of potential improvements
a means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes to
achieve them, the manual provides a convenient vehicle for containing such
information. If left as separate pieces of information, it may be more difficult to
see the linkages.
The requirement provides the framework for the manual. Its content may
therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization – its scope of activity, its products
and services
(b) The organization’s interested parties (customers, employees, regulators,
shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its external
environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how they are
interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order fulfilment process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety,
CAA etc.)
8 Approvals (List of current product, process and system approvals)
The process descriptions can be contained in separate documents and should
cover the topics identified previously (see Documents that ensure effective
planning, operation and control of processes ).
As the manual contains a description of the management system a more apt
title would be a Management System Manual (MSM) or maybe a title reflecting
its purpose might be Management System Description (MSD).
In addition a much smaller document could be produced that does respond
to the requirements of ISO 9001, ISO 14001, and the regulations of regulatory
authorities. Each document would be an exposition produced purely to map
your management system onto these external requirements to demonstrate
how your system meets these requirements. When a new requirement comes
along, you can produce a new exposition rather than attempt to change
your system to suit all parties. A model of such relationships is illustrated in
Figure 4.10. The process descriptions that emerge from the Management
System Manual describe the core business processes and are addressed in
Chapter 4 under the heading of Documents that ensure effective operation and
control of processes.
