Tuesday, August 11, 2009

Preparing the quality manual

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
(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
(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.

Continual improvement in the quality management

The standard requires the organization to continually
improve the effectiveness of the quality management system
in accordance with the requirements of ISO 9001 and to
implement action necessary to achieve planned results and
continual improvement of the identified processes.

ISO 9000 defines continual improvement as a recurring activity to increase the
ability to fulfil requirements. As the organization’s objectives are its require-
ments, continually improving the effectiveness of the management system
means continually increasing the ability of the organization to fulfil its

If the management system is enabling the organization to accomplish its
objectives when that is its purpose, why improve? The need for improvement
arises out of a need to become more effective at what you do, more efficient in
the utilization of resources so that the organization becomes best in its class.
The purpose of measuring process performance is to establish whether or not
the objectives are being achieved and if not to take action on the difference. If
the performance targets are being achieved, opportunities may well exist to
raise standards and increase efficiency and effectiveness.

Documented procedures

The standard requires the management system doc-
umentation to include documented procedures required
by ISO 9001.

ISO 9000 defines a procedure as a specified way to
carry out an activity or a process. This definition is
ambiguous because an activity is on a different scale
than a process. Process outputs are dependent upon
many factors of which activities are but one. An
activity is the smallest unit of work. Several activities accomplish a task and
several tasks reflect the stages in a process but there is more to a process than
a series of tasks. This definition also results in a
belief that procedures are documented processes but this too is inaccurate.

Procedures tell us how to proceed – they are a sequence of steps to execute a
routine activity and result in an activity or a task being performed regardless
of the result.

There are very few procedures actually required by the standard but this
does not imply you don’t need to produce any others. The specific procedures
required are:
(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action

These areas all have something in common. They are what the authors of the
early drafts of ISO 9000 :2000 referred to as system procedures – they apply to
the whole system and are not product, process or customer specific although it
is not uncommon for customers to specify requirements that would impact
these areas. Why procedures for these aspects are required and not for other
aspects of the management system is unclear but it seems that the authors of
ISO 9000 felt these were not processes – a conclusion I find difficult to justify.

They are certainly not business processes but could be work processes.

However, there is another message that this requirement conveys. It is that
procedures are not required for each clause of the standard. Previously,
countless organizations produced a manual of 20 procedures to match the 20
elements of ISO 9001. Some limited their procedures to the 26 procedures cited
by the standard and others produced as many as were necessary to respond to
the requirements.

ISO 14001:2004 Document Control System

Documents required by the environmental management system and by this international standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in 4.5.4 (Control of Records).
The organization shall establish, implement, and maintain a procedure(s) to
a) approve documents for adequacy prior to issue;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revision status of documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and
g) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose. [ISO 14001, 4.4.5]

Document and Data Control in ISO 9000 & ISO 14001

The organization shall establish and maintain procedures for controlling all documents and data required by ISO 9000 & ISO 14001
a) they can be located;
b) they are periodically reviewed, revised as necessary, and approved for adequacy by authorized personnel;
c) current versions of relevant documents and data are available at all locations where operations essential to the effective functioning of the OH&S system are performed;
d) obsolete documents and data are promptly removed from all points of issue and points of use, or otherwise assured against unintended use;
e) archival documents and data retained for legal or knowledge preservation purposes, are suitably identified.
Accidents, incidents, non-conformances and corrective and preventive action
The organization shall implement and record any changes in the documented procedures resulting from corrective and preventive action.
Documents required by the ISO 9000 & ISO 14001 shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements.
The organization shall establish, implement and maintain procedure[s] to:
a) approve documents for adequacy prior to use;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revisions status of documents are identified;
d.) ensure that relevant versions of applicable documents are available at points of use;
e.) ensure that documents remain legible and readily identifiable;
f.) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the ISO 9000 & ISO 14001 management system are identified and their distribution controlled, and
g.) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose.


ISO 14001:2004 requires an organization to make a “commitment” in its environmental policy to comply with applicable legal requirements that relate to its environmental aspects. The organization shall establish, implement and maintain a procedure(s) for periodically evaluating compliance with applicable legal requirements that is consistent with realising this commitment.
The specific clauses of ISO 14001:2004, which are most important with respect to legal compliance are the following EMS elements:
1) public environmental policy commitment to legal compliance (sub-clause 4.2);
2) identification and having access to applicable legal requirements and other requirements related to its environmental aspects (sub-clause 4.3.2 a));
3) how those legal requirements apply to the organisation’s environmental aspects (sub-clause 4.3.2 b));
4) objectives/targets/programs (sub-clause 4.3.3)
5) how legal obligations are routinely managed and monitored (sub-clauses 4.4.6 and 4.5.1);
6) evaluation of legal compliance (sub-clause 4.5.2);
7) corrective and preventive actions where necessary (sub-clause 4.5.3);
8) internal audit (sub-clause 4.5.5); and
9) management review (sub-clause 4.6).

Implementing ISO 14001

ISO 14001 is an internationally recognised standard that provides a framework for a strategic approach to corporate environmental management. This standard gives organisations the means to identify and control their environmental impacts, improve performance and achieve their objectives and targets. The standard is independently audited, giving it great strength and integrity.
Due to its widespread adoption (e.g. Barclays, Credit Suisse and UBS in the financial sector), it now acts as a common reference for communication about environmental issues. ISO 14001 provides assurance to stakeholders on environmental claims and helps organisations meet requirements laid down by clients and investors.
Adoption of ISO 14001 is being driven by stakeholder concerns as well as the significant benefits on offer to adopters. Few companies are now exempt from government, client and investor demands for accountability and improved environmental performance. With brand and reputation on the line, it is a risky strategy to ignore these concerns.
However, choosing how to act is not a straightforward decision. Companies that rushed to announce their green credentials without independent verification and transparency fell foul of greenwash accusations and suffered perhaps more damage to their reputation than had they not acted in the first place. In response to this, many companies are now choosing to implement internationally recognised and independently audited environmental management systems such as ISO 14001.
The benefits of implementing ISO 14001 are extensive:
It immediately enhances corporate reputation and sends a clear signal of commitment to corporate responsibility. Accusations of greenwash are prevented by the transparent and robust approach of the standard.
Proactive environmental management increases attractiveness to investors, especially for Socially Responsible Investment (SRI), an area already accounting for £9 billion investment per year in the UK alone.
ISO 14001 accreditation may also bring financial benefits through increased market share. Firms can differentiate themselves from competitors as responsible companies as well as securing the rewards of first mover advantage in new markets. In addition, many buyers are now implementing sustainable procurement codes and stipulating conditions in Requests for Information (RFIs) where suppliers are required to have environmental credentials. Gaining ISO 14001 accreditation ensures access to environmentally demanding but high reward markets.
Financial benefits are not limited to increased investment and sales. Implementation of an EMS may produce significant cost savings that actually negate the initial outlay. With energy and waste prices rising sharply, environmental responsibility can produce a win:win opportunity.
Perhaps the most significant benefit for many will be the positive effect on attracting and retaining staff. With intense competition for the best staff, corporate responsibility is becoming a key criterion against which employers are judged.
Finally, responsible environmental management is quickly becoming a necessary condition for business, a socially accepted norm of behaviour. Those who fail to follow these norms risk damage to their reputation and the possibility of their social licence to operate being revoked.
A standard as thorough and robust as ISO 14001 has an equally thorough implementation process with extensive requirements for procedures and auditable document trails. Implementation follows the Plan-Do-Check-Review cycle and key required procedures are detailed in the diagram below. Implementation will entail the creation of at least 20 procedures and supporting documents. The procedures are all company-specific and must be tailored to suit individual operations. It is this level of detail that gives the standard such strength and integrity.

The ISO 14000 Challenge

The building blocks of an environmental management system is an understanding of aspects and impacts.
Implementing ISO 14001 begins with identifying how an organisation’s business activities impact on the
Many organisations believe they are already aware of the significant aspects and impacts of their operations.
The process of implementing ISO 14001 may uncover significant impacts not previously identified and allows
for a consistent approach to analysis.
Generally this analysis is done department by department or centre by centre.
It is best if it is a team approach that involves the employees who do the activity. An employee’s
familiarity with a task is essential for both the identification of the environmental impacts of business
activities and the determination or implementation of control measures.
An aspect is any element of an organisation’s activities, products or services that can interact with the
An impact is the change caused to the environment.
Impacts may occur during normal and abnormal operating conditions, such as accidents and
Aspects can often be isolated by analysing the inputs and outputs of an activity.
Once the impacts have been determined they have to be evaluated.
Criteria for evaluation include environmental concerns such as the severity of the impact, and business
concerns such as potential regulatory and legal exposure, the probability of the impact occurring, the
cost of changing the impact and effect on public image.
This type of evaluation highlights the significant impacts. These, in turn, determine the significant
aspects. Once the significant aspects have been determined, targets and objectives can be set.

What Is an Environment Management System (EMS) ?

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business
management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.
The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by
the members of the ISO, while others are in different stages of preparation.
The standards that have been adopted are (as of early 1997):
ISO 14001-1996 Environmental management systems:
specification with guidance for use
ISO 14004-1996 Environmental management systems:
general guidelines on principles, systems, and supporting techniques
ISO 14010-1996 Guidelines for environmental auditing:
general principles of environmental auditing
ISO 14011-1996 Guidelines for environmental auditing:
audit procedures; auditing of environmental management systems.
ISO 14012-1996 Guidelines for environmental auditing:
qualification criteria for environmental auditors Standards currently available as draft international standards:
ISO 14021 Environmental labels and declarations:
self-declaration environmental claims; guidelines and definition and usage of terms.
ISO 14040 Environmental management: life cycle assessment; principles and framework
ISO 14050 Environmental management: vocabulary More than half a dozen others in this series have been drafted and are under discussion.


Firstly ISO 14000 environment system standards was prepared in June of 1992 year in Rio at world apex and this standard brooks decisions of this world apex and Rio contract principles. After 1 year, ISO established one technique committee which is yielded by 50 different country representatives to prepare international environment management system in 1993 year. ISO 14001 environment management system standard was issued in September of 1996 year with works of this committee. ISO 14001 standard is used as voluntary now but ISO 14001 will be burden by coercions of societies, international organizations, states in the future. Levels which environment management system passed are the following briefly:
= Europe community countries issued I action plan in 1973 year (to practice protecting preventions of environment )= BS 7750 Standard in 1992= Rio Declaration in 1992 year= ISO/TC 207. Environmental management technique committee was established in 1993 year to develop ISO 14000 family standards= TS 9719 standard (environment management system – General features) in 1994 year= ISO 14001 standard in 1996 year= ISO 14001 current version in April of 2005 Nisan 2005
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