Quality Management Standard

Standard

A standard was defined by the National Standards Policy Advisory Committee as:

"A prescribed set of rules, conditions, or requirements concerning definitions of terms;

classification of components; specification of materials, performance, or operations;
delineation of procedures; or measurement of quantity and quality in describing
materials, products, systems, services, or practices."

In layman's terms, a standard is a rule or

requirement that is determined by a consensus
opinion of users and that prescribes the
accepted and (theoretically) the best criteria for
a product, process, test, or procedure.

The general benefits of a standard are safety,

quality, inter-changeability of parts or systems,
and consistency across international borders.

The What, Why, and How of Standards

 The inch is a standard of measurement.

 Money is a standard of exchange.
 Words are standards of communication.
 Traffic lights are safety standards.
 Octane numbers of gasoline are quality standards.
 "No more than 1% shrinkage" is a performance standard.
Standardization has a major impact on our lives, yet most people know little about the
process or about the standards themselves. They know that camera film marked "ISO
100" is likely to give good results in a camera with the film speed set at 100. But few
understand that the ISO 100 marking on the package means that the film conforms to a
standard established by the International Organization for Standardization (ISO), an
international organization that writes standards.

Few people question that their ATM card works at every money machine in the world,
but this confidence could not be possible without standards.

International standards contribute to making life simpler by increasing the reliability and
effectiveness of the goods & services.
Why do we use standards?

We use standards to achieve a level of safety, quality, and consistency in the products
and processes that affect our lives. In short, standards make our lives safer, easier,
and better. Standards are also vital tools of industry and commerce. They often
provide the basis for buyer-seller transactions; hence they have tremendous impact on
companies and nations, and even on the economic fabric of the world market.

For example, as global trade increases and companies sell

their products on foreign markets, they must ensure that their
products comply with standards from those foreign countries.
The variety of different standards for different markets means
that some manufacturers must create dozens of variations of
their products, each complying with slightly different
standards. For the sake of shrinking these barriers to trade,
international standards have been developed for use
throughout the world.

Most standards are developed by committees of volunteers,

which can include members of industry, government, and the
public. These bodies act as a "parent" organization, helping
to coordinate volunteers and ensure that the development
process emphasizes four main issues: requirements for due process, appeals
procedures, the mandatory consideration of negative votes or comments, and for
"committee balance." Balance is achieved when all parties having an interest in the
outcome of a standard have an opportunity to participate and where no single interest
can dominate the outcome.

In addition, numerous foreign national, regional and international organizations produce

standards of interest and importance to manufacturers and exporters.

The International Organization for Standardization (ISO) probably produces the largest
number of International Standards, having issued over 10,000 standards. ISO's work is
carried out through some 2,300 technical bodies in which more than 20,000 experts
from all over the world participate annually in the development of ISO standards.

History of standards

Standards are known to have existed as early as 7000 B.C. when cylindrical stones
were used as units of weight in Egypt. One of the first known attempts at
standardization in the Western world occurred in 1120. King Henry I of England
ordered that the ell, the ancient yard, should be the exact length of his forearm, and that
it should be used as the standard unit of length in his kingdom.
The concept of standardisation by itself is not new. Organisations have always been
practising this in one form or other. The concept of Standardisation however had been
confined to product verification for a long time. Thus industrial activities all over the
world attached an extra significance to product inspections and inspection related
activities. Such a special emphasis on product inspection gave rise to the emergence of
product standards.

History also notes that, The first Pyramids of Egypt built 2611 B.C.
clearly shows the presence of Quality control through Standardisation.

In 1653, the Taj was also built with such precision, only because of
the standardisation.

In 1989, the Boston city fathers recognized the need for standardization when they
passed a law making it a civic crime to manufacture bricks in any size other than 9x4x4.
The city had just been destroyed by fire, and the city fathers decided that standards
would assure rebuilding in the most economic and fastest way possible.

What is ISO?

The International Organization for Standardization (ISO) (“IOS” in English, “OIN” in

French for Organisation Internationale de normalisation) Greek “isos”, meaning “equal”.
Therefore, whatever the country, whatever the language, the short form of
organization’s name is always ISO.

ISO was established in 1947 and is (currently) an association of approximately 157

members, which each represent their own country with a Central Secretariat in Geneva,
Switzerland.

ISO employs a system of Technical Committees, Sub-committees and Working Groups

to develop International Standards. Besides the National Standards Bodies, ISO permits
other international organizations that develop standards to participate in its work, by
accepting them as Liaison members. ISO works in accordance with an agreed set of
rules of procedure, the ISO/IEC (International Electro technical Commission) Directives,
which also include requirements on the presentation of standards.

Each country has its own National Standards Body responsible for developing the
standards. The National Standards Body in India is BIS (Bureau of Indian Standards). It
represents our country at ISO.
The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's
management system standards.

Plan – establish objectives and make plans (analyze your

organization's situation, establish your overall objectives and set
your interim targets, and develop plans to achieve them).
Do – implement your plans (do what you planned to).
Check – measure your results (measure/monitor how far your
actual achievements meet your planned objectives).
Act – correct and improve your plans and how
you put them into practice (correct and learn
from your mistakes to improve your plans in
order to achieve better results next time).

Management standards
ISO standards that provide requirements or give guidance on good management
practice are among the best known of ISO's offering.

Of these, two have achieved truly global status and are now thoroughly integrated with
the world economy.

ISO 9001 which gives the requirements for

quality management systems is now firmly
established as the globally implemented
standard for providing assurance about the
ability to satisfy quality requirements and to
enhance customer satisfaction in supplier-
customer relationships ISO 14001.

Management system
Management system refers to what the organization does to manage its processes, or
activities, so that its products or services meet the objectives it has set itself.

Management system standards

Management system standards provide a model to follow in setting up and operating a
management system. This model incorporates the features on which experts in the field
have reached a consensus as being the international state of the art.

ISO 9000 Back Ground

• In 1978, management system standards were planned.
• First series of ISO 9000 standards was released in 1987.
• Phase – I revision took place in 1994.
• Phase – II revision took place in 2000.
• Phase – III revision took place in 2008.
• TC/176- committee under which the ISO 9000 series of quality management and
quality assurance standards are being developed
ISO 9000 essentials features

The ISO 9000 family of standards represents an international consensus on good

quality management practices. It consists of standards and guidelines relating to quality
management systems and related supporting standards.

ISO 9001:2008 is the standard that provides a set of standardized requirements for a
quality management system, regardless of what the user organization does, its size, or
whether it is in the private, or public sector. It is the only standard in the family against
which organizations can be certified – although certification is not a compulsory
requirement of the standard.

The ISO 9000 family addresses "Quality management".

This means what the organization does to fulfill:

 The customer's quality requirements, and
 Applicable regulatory requirements, while aiming to
 Enhance customer satisfaction, and
 Achieve continual improvement of its performance in pursuit of these objectives.

The ISO 9001:2008 standard provides a tried and tested framework for taking a
systematic approach to managing the organization's processes so that they consistently
turn out product that satisfies customers' expectations.

Self Check

ISO 9001:2008 lays down what requirements your quality system must meet, but does
not dictate how they should be met in any particular organization. This leaves great
scope and flexibility for implementation in different business sectors and business
cultures, as well as in different national cultures.

The standard requires the organization itself to audit its ISO 9001:2008 based quality
system to verify that it is managing its processes effectively or, to put it another way, to
check that it is fully in control of its activities.

In addition, the organization may invite its clients to audit the quality system in order to
give them confidence that the organization is capable of delivering products or services
that will meet their requirements.

Lastly, the organization may engage the services of an independent quality system
certification body to obtain an ISO 9001:2008 certificate of conformity. This last option
has proved extremely popular in the market-place because of the perceived credibility of
an independent assessment.
The organization may thus avoid multiple audits by its clients, or reduce the
frequency or duration of client audits. The certificate can also serve as a business
reference between the organization and potential clients, especially when supplier
and client are new to each other, or far removed geographically, as in an export
context.

The ISO 9000 family – core standards

 ISO 9000:2005 - Fundamentals and vocabulary

 ISO 9001:2008 - Quality Management System – Requirements

 ISO 9004:…….*-Guidelines for performance improvements

 ISO 19011:2002 -Guidelines for Auditing Quality and/ or Environmental

Management Systems Auditing

*(Currently under revision - “ Managing for sustained success of an organisation- A quality Management
Approach”

Other related Standards

 ISO 10002:2004 - Guidelines for Complaints handling.

 ISO 10005:2005 - Guidelines for Quality Plans.
 ISO 10006:2003 - Guidelines for Quality management in Projects.
 ISO 10007:2003 - Guidelines for Configuration Management
 ISO 10012:2003 - Measurement Management system
 ISO 10014:2006 - Guidelines for realizing financial & Economic benefits
 ISO 10015:1999 - Guidelines for Training
 ISO 10019:2005 - Selection of QMS consultants and use of their services
 ISO/IEC 17025:2005- Requirements for competency of Testing and calibration labs
 ISO 15161:2001 - Guidelines on application of QMS for Food and drink industry
 ISO/TS 16949:2002- Automotive suppliers
 ISO/TS 29001:2003- Petroleum, petrochemical and natural gas industry

The practices described in ISO 9004 may then be implemented to make quality
management system more effective and efficient in achieving business goals and
objectives.
Process Approach

ISO 9001 and ISO 9004 are compatible and can be used separately or in combination
to meet or exceed expectations of customers and interested parties. Both standards
apply a process approach.

Processes are recognized as consisting of one or more linked activities that require
resources and must be managed to achieve predetermined output. The output of one
process may directly form the input to the next process and the final product is often the
result of a network or system of processes.

The following diagram depicts the process approach and relationships of the standards
in the ISO 9000 family and where they may be applied when implementing your quality
management system.
Eight Quality Management Principles

The eight quality management principles on which the quality management system
standards of the ISO 9000:2000 and ISO 9000:2008 series are based, can be used by
senior management as a framework to guide their organizations towards improved
performance. These are as follows:

Principle 1: Customer focus

Organizations depend on their customers and therefore should understand
current and future customer needs, should meet customer requirements and
strive to exceed customer expectations.

Principle 2: Leadership
Leaders establish unity of purpose and direction of the
organization. They should create and maintain the internal
environment in which people can become fully involved in achieving the
organization's objectives.

Principle 3: Involvement of people

People at all levels are the essence of an organization and their full involvement
enables their abilities to be used for the organization's benefit.

Principle 4: Process approach

A desired result is achieved more efficiently when activities and related
resources are managed as a process.

Principle 5: System approach to management

Identifying, understanding and managing interrelated processes as a
system contributes to the organization's effectiveness and efficiency in
achieving its objectives.

Principle 6: Continual improvement

Continual improvement of the organization's overall performance
should be a permanent objective of the organization.

Principle 7: Factual approach to decision making

Effective decisions are based on the analysis of data and information

Principle 8: Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value
Requirements of ISO 9001:2008

Top Management requirements

5.1 Management Commitment.

5.2 Customer Focus.
5.3 Quality Policy.
5.4 Planning.
5.5 Responsibility, authority and communication.
5.6 Management review.
6. Resource Management.

System Requirements

4.1 General Requirements.

4.2 Documentation Requirements.
8.2.1 Customer Satisfaction.
8.2.2 Internal Audits.
8.2.3 Monitoring and measurement of processes.
8.2.4 Monitoring and Measurement of product.
8.3 Control of Non-conforming product.
8.4 Analysis of data.
8.5 Improvement.

Process Requirements

7. Product realization.
7.1 Planning.
7.2 Customer related processes.
7.3 Design and development.
7.4 Purchasing.
7.5 Production and service provision.
7.6 Control of monitoring and measuring equipment

# - The numbers above refers to the clause no in the ISO 14001

[Link] and maintaining a QMS based on ISO 9001
For a successful implementation of QMS the following 7 steps are recommended:

1. Fully engage top management to:

 Define why you want to implement ISO 9001
 Define your mission, vision, and values in your organization
 Define your organization’s stakeholders: customers, suppliers,
stockholders, employees, society, etc.
 Define your quality policy, and
 Define and align organizational objectives and related product/service
quality objectives

2. Identify key processes and the interactions needed to meet quality objectives

3. Implement and manage the QMS and its processes (using process management
techniques)

4. Build your ISO 9001-based QMS

 Identify ISO 9001 requirements
 Map these requirements with your implemented QMS, where applicable
 Make a gap analysis: identify where in your existing system the
requirements are fulfilled, and where they are not
 Include in your QMS processes the activities, procedures and controls
needed
5. Implement the system, train company staff and verify effective operation of your
processes

6. Manage your QMS

 Focus on customer satisfaction

 Monitor and measure the operation of your QMS
 Strive for continual improvement
 Consider implementing business excellence models in the company
operations

7. If necessary, seek third party certification/registration of the QMS or alternatively,

issue a self-declaration of conformity.
Examples of using the ISO 9000 family of standards

Example 1

A metal parts fabricating company recognized the need to demonstrate their capability
to produce consistent quality product. They first used ISO 9000 to develop a plan to
create an acceptable QMS. Next, they prepared the quality manual and quality system
procedures as required by ISO 9001, excluding the requirements covering product
design and development because their products are made to designs prepared by their
customers. They implemented the QMS described in their manual and procedures and
ensured the system functioned as planned. Later, in order to bid on the supply of parts
to a major automotive company, they upgraded their quality system to meet the
automotive sector specific requirements of ISO/TS 16949.

Example 2

An electrical appliance manufacturer had a well-established company culture of

continual improvement and effective production control. The management decided to
improve the company's development processes and to implement ISO 9001 to obtain
certification for commercial purposes. The company used ISO 9004 to guide its
improvement processes and ISO 10006 to develop a project management plan.
Regulatory agencies demanded products be designed and packaged recognizing the
end of life disposition of products and packaging. The company was able to use the
design and document control requirements in ISO 9001 to satisfy regulators of
compliance to new requirements

Example 3

A large chemical processing company was required by its major customers to gain
certification to ISO 9001 and to be environmentally friendly. To address these issues,
the company leadership planned a comprehensive management strategy linking their
QMS and an environmental management system (EMS). A thorough review of their
business processes indicated that all elements of ISO 9001 were applicable to their
quality management system and the Annex in ISO 9001 provided the information
needed to effectively link it to the ISO 14001 EMS standard. The company used ISO/TR
10013 to guide the development of the required documentation in its various production
divisions, ISO 10015 for guidance in the preparation of training plans for their
employees and ISO 19011 for auditing both the QMS and EMS. Management achieved
additional benefits and continual improvements using ISO 9000 and ISO 9004.
The Key Benefits may typically be achieved by a QMS.

To Customers

 Product conforming to the requirements.

 Dependable and reliable product.
 Improved supply.
 Less noncompliance.
 Competitive pricing.
 Favourable response to changes.

To Organisation

 Reduced rejection rate.

 Improved operational results.
 Consistency in output.
 Improved customer satisfaction.
 Increased market share.
 Increased return on investment.

To Employees

 Defined roles & responsibilities.

 Increased job satisfaction.
 Improved morale.
 Better working conditions.
 Involvement.
 Pride.

Maintaining the benefits and continual improvement

Most new users of the ISO 9000 family of standards obtain measurable benefits early in
the process of implementing the requirements in their operations. These initial benefits
are generally due to improvements in their organization and internal communication.
The benefits must be strengthened through effective internal auditing and management
review of system performance. Like all systems, it either improves or becomes less
effective. It does not remain static for long.

The organisation must strive to satisfy your customers and to achieve continual
improvement of your operations through the QMS. Continual improvement is a process
of increasing the effectiveness of your organization to fulfill to quality policy and your
quality objectives that you have established which are updated periodically. ISO 9001
requires that you plan and manage the processes necessary to continually improve your
QMS.
ISO 14000

In the globalization world, the environmental issues seem to be one of the most
important topics. The pollution created in any manner such as air emission, effluent,
land contamination, etc., have several impacts to people throughout the world. Upon
this pressure, the International Organization for Standardization has developed the
environmental management standards which is known as the “ISO 14000 Series”
ISO14000 - Introduction

After the success of the ISO9000 series of quality standards, the International
Standards Organization published a comprehensive set of standards for environmental
management. This series of standards is designed to cover the whole area of
environmental issues for organizations in the global marketplace.

After the rapid acceptance of ISO 9000, and the increase of environmental standards
around the world, ISO assessed the need for international environmental management
standards. They formed the Strategic Advisory Group on the Environment (SAGE) in
1991, to consider whether such standards could serve to:

 Promote a common approach to environmental management similar to quality

management;
 Enhance organizations' ability to attain and measure improvements in
environmental performance; and
 Facilitate trade and remove trade barriers

In 1992, SAGE's recommendations created a new committee, TC 207, for international

environmental management standards. The committee, and its sub-committees include
representatives from industry, standards organizations, government and environmental
organizations from many countries. The new series of ISO14000 standards are
designed to cover:
 environmental management systems
 environmental auditing
 environmental performance evaluation
 environmental labeling
 life-cycle assessment
 environmental aspects in product standards

The standards apply to all types and sizes of organizations and are designed to
encompass diverse geographical, cultural and social conditions. For ISO14001, except
for committing to continual improvement and compliance with applicable legislation and
regulations, the standard does not establish absolute requirements for environmental
performance.

Any activities of each organization may cause the environmental aspects and impacts
such as noise, dust, waste, contaminants in manufacturing process and un-effectively
resources consumption in servicing. These can be minimized by implementing EMS.
Although each country has already had her own environmental regulations,
organizations are able to apply ISO 14000 series effectively within their system on
voluntary basis and the benefit obtained is not only for organizations themselves but
their society also.

All of the elements (organization's products, services, activities, operations, facilities,

transportation, etc.) sentence should be considered for environmental impact resulting
from current practices, past practices and future practices, and should further be
reviewed for their impact under normal, abnormal and emergency conditions.

Thus General aim of ISO 14000 is to:

- Control Environmental Aspects.
- Improve Environmental Performance.

ISO 14001:2004 specifies the requirements for such an environmental management

system. Fulfilling these requirements demands objective evidence which can be audited
to demonstrate that the environmental management system is operating effectively in
conformity to the standard.

ISO 14001:2004 is a tool that can be used to meet internal objectives:

 provide assurance to management that it is in control of the organizational
processes and activities having an impact on the environment
 Assure employees that they are working for an environmentally responsible
organization.

ISO 14001:2004 can also be used to meet external objectives:

 provide assurance on environmental issues to external stakeholders – such as
customers, the community and regulatory agencies
 comply with environmental regulations
 support the organization's claims and communication about its own
environmental policies, plans and actions
 Provides a framework for demonstrating conformity via suppliers' declarations of
conformity, assessment of conformity by an external stakeholder - such as a
business client - and for certification of conformity by an independent certification
body.
ISO 14000 Series EMS standards

• ISO 14001:2004 EMS - Requirements with guidance for use.

• ISO 14004:2004 EMS - General guidelines on principles,

systems and support techniques.

• ISO 19011:2002 - Guidelines for Quality and/or EMS Auditing

• ISO 14015:2001 - Environmental assessment of sites and

organisations (EASO)
Environmental labels and declarations

• ISO 14020:2000 - General principles.

• ISO 14021:1999 - Self-declared environmental claims

(Type II environmental labeling)

• ISO 14024:1999 - Type 1 environmental labeling

Principles and procedure

• ISO/ TR 14025:2000 - Type III environmental declarations.

Environmental management

• ISO 14031:1999 - Environmental performance evaluation

Guidelines.

• ISO/TR 14032:1999- Examples of Environmental Performance

Evaluation (EPE)
Life cycle assessment

• ISO 14040:1997 - Principles and framework.

• ISO 14041: 1998 - Goal and scope definition and inventory analysis
• ISO 14042:2000 - Life cycle impact assessment.
• ISO 14043:2000 - Life cycle interpretation
• ISO /TR 14047:2003- Examples of application of ISO 14042:2000
• ISO/TS 14048:2002 - Data documentation format
• ISO/TR 14049:2000 - Examples of application of ISO 14041:1998
to goal and scope definition and inventory
analysis.
• ISO 14050:2002 - Vocabulary.
• ISO/TR 14061:1998 - Information to assist forestry organisations in
the use of EMS standard ISO 14001:2004 and
ISO 14004:2004.
• ISO/TR 14062:2002 - EMS integrating environmental aspects
into product design and development
• ISO/TR 14063# - EMS – Environmental communications-
Guidelines and examples
• ISO/TR 14064# - Guidelines for measuring, reporting and
verifying entity and project level green
house gas emissions.
# - Currently under revision

Concepts of EMS are as follows :

1. Environmental policy

Initially, the organization’s top management should have commitment and define the
policy on EMS which is used for the direction of implementing and improving its EMS.

Environment Management Model

2. Planning

In order to achieve environmental policy, at least, the organization should:

 Identify the environmental aspects of its activities and specify those which have
significant impacts on the environment.
 Identify legal and other requirements to which the organization involved.
 Establish objectives and targets of its activities having impacts to environment.
 Establish environmental programmes for achieving its objectives and targets.

3. Implementation

In order to achieve environmental planning, at least, the organization should:

 Define roles, responsibilities and authorities for facilitating EMS effectively.

 Communicate to the staffs at each level for the importance of conformance to the
environmental policy; provide appropriate training to personnel performing the
tasks to gain their knowledge and competence.
 Establish and control documentation relating to EMS.
 Control operations and activities to meet the specified objectives and targets.
 Identify potential accidents and emergency situations for preventing and
mitigating the environmental impacts that may be associated with them and
periodically test such procedures where practicable.

4. Checking and corrective action

To ensure that the organization is performing in accordance with the stated EMS
programmes, at least, the organization should:
 Monitor and measure its operations and activities against the organization’s
plans.
 Identify non-conformance and take action to mitigate any impact caused.
 Record the on-going activities of the EMS.
 Conduct periodic EMS audits.

5. Management review
The organization’s top management should review and continually improve its EMS,
with the objective of improving its overall environmental performance.
Reasons for Implementing

• Supplier relationships. • Improve industry-government relations.

• Company requirements. • Better business process.

• Reduction in liability and risk. • Demonstrate reasonable care.

• Reduce waste and energy bills. • Improved environmental performance.

• Improve internal management. • Marketing.

• Pressure from interested parties. • Public Relations.

• Good neighbourhood relations.

Benefits of implementing an EMS

• World wide focus achieved.

• Promotes voluntary consensus approach which is inherently

flexible and responsive to market forces.

• Commercial benefit due to harmonization of national rules, labels and methods.

• Minimizing trade barriers, by removing complications and ensuring consistency.

• Avoidance of multiple inspections, certifications and labels.

• Will enhance environmental performance.

• Improving Risk Information and understanding.

• Will act as a means to maintain regulatory compliance.

• Provides framework to move beyond compliance.

• competitive advantage.

• Demonstrates commitment to Environmental

Management.

• Helps in implementing Environmental excellence as espoused by International.

Chamber of Commerce Chapter for Sustainable Development and the Global
Environment Management Initiative.
Requirements of ISO 14001:2004

Top Management requirements

4.2 Environmental Policy.

4.4.1 Resources, Roles, Responsibility& authority.

4.4.2 Competence,Training & Awareness

4.6 Management review.

System Requirements

4.1 General Requirements.

4.4.4 Documentation
4.4.5 Control of Documents
4.5.4 Control of Records
4.5.5 Internal Audits.

Process Requirements

4.3.1 Environmental Aspects.

4.3.2 Legal & Other requirements.
4.3.3 Objectives, Targets & Programs.
4.4.3 Communication.
4.4.6 Operational Controls.
4.4.7 Emergency preparedness and Response.
4.5.1 Monitoring & Measurement.
4.5.2 Evaluation of Compliance.
4.5.3 Non Conformity, Corrective & Preventive Action.

# - The numbers above refers to the clause no in the ISO 14001 standard.
ISO 14000 - Implementation

Stipulating the EMS policy

The organization’s top management provides the EMS policy which is appropriate to the
environmental impact.

Planning
 Specifying the aspects of environmental impact(s).
 Considering legislation and other rules relevant to EMS.
 Defining environmental objectives and targets corresponding to the policy.
 Conducting an environmental programme to attain the objectives and targets.
Implementation of the EMS according to the policy
 Defining organizations’ outlines and responsibilities for the effective
implementation of EMS.
 Providing an appropriate training programme relating to environment to the
personnels whose tasks concern environmental impact(s) to build up their
awareness.
 Defining processes for both internal and external communication.
 Conducting and controlling the environmental management documentation
system.
 Controlling the operation of the activities relevant to environmental impact(s) to
attain the specified objectives and targets.
 Being ready to react to the emergency event(s) including the prevention and
mitigation of the environmental impact(s) caused by the above matter(s).

Checking and corrective actions

 Monitoring and measuring the activities which cause environmental impact(s).
 Conducting the corrective and preventive actions of the non-conformity.
 Following up the effectiveness of the corrective and preventive actions.
Environmental management system review
The EMS should be periodically reviewed by the top management of the organization to ensure
that the established system is appropriate, sufficient, implemented effectively and improved
continually.

Taking first steps in EMS

OSHAS 18001 – Investing in your people
It is internationally recognized model for Occupational Health and Safety Assessment
Series (OHSAS) for management systems. It Enable organizations to control their
Occupation Health and Safety (OH&S) risks and improve their performance
Specification is intended to address occupational health and safety rather than
product and services safety

It is
 Structured and planned approach that allows to track
OH&S performance and carry out corrections to achieve
continual improvement

 Management standard

 Not a performance standard / No performance criteria

 Involves all people

It was developed in response to urgent customer demand for a recognizable

occupational health and safety management system standard. Also the need for health
and safety management system that could be audited and certified was felt.

Thirteen co-operating organizations from around the world assisted in development of

this series. Spain, Malaysia, United Kingdom and severalother European standards
organizations are few of them.

The specification is applicable to organisations wishing to

 Establish an OH&S management system to minimise risk

 Implement, maintain and continually improve that system
 Assure conformance with stated OH&S policy
 Demonstrate such conformance to others
 Seek certification/registration of the system or
 Make a self-declaration of conformance

EVOLUTION OF THE OHSAS 18000 SERIES

 1992 British Health & Safety Commission publishes management of health and
safety at work

 1993 British Health and Safety Executive publishes HS(G)65, successful health
and safety management

 1996 British standard BS 8800 launched, used as model OHSMS

 1999 OHSAS 18001 Specification published based on BS8800

  2000 OHSAS 18002 Guidelines published to assist in the implementation of
OHSAS 18001 (Updated in 2008)

OHSAS 18001 was first published in 1999 and was updated in July 2007. OHSAS
18001:2007 is more compatible with ISO 14001:2004 and ISO 9001:2000.

Structure and Elements of OHSAS

It is Intended to address OH&S for

employees, temporary contractors, visitors and personnel on-site
employees, other
Not intended to cover product and service safety
Benefits of OSHAS implementation
Enables an organisation to:
• Effectively manage the safety risks
• establish an H&S policy
• identify H&S hazards and determine risks
• identify priorities and objectives
• establish structures and programmes
• facilitate planning, monitoring, CA, auditing and review activities
• Continually improve H&S performance improve regulatory compliance
• demonstrate you are a responsible employer
• demonstrate due diligence and avoid litigation
• protect and enhance your image and reputation
• improve operational effectiveness, absenteeism and minimise disruption
• reduce costs
• meet customer demands
OSHAS ELEMENTS:
 OH&S management system elements

4.1 General requirements

4.2 OH&S policy & commitment
4.3 Planning
4.3.1 Hazard identification, risk assessment/control
4.3.2 Legal and other requirements
4.3.3 Objectives
4.3.4 OH&S management program(s)

4.4 Implementation and operation

4.4.1 Structure and responsibility

4.4.2 Training, awareness and competence
4.4.3 Consultation and communication
4.4.4 Documentation
4.4.5 Document and data control
4.4.6 Operational control
4.4.7 Emergency preparedness and response

4.5 Checking and corrective action

4.5.1 Performance measurement and monitoring

4.5.2 Accidents, incidents, non-conformances and
corrective and preventive action
4.5.3 Records and records management
4.5.4 Audit

4.6 Management review

Understanding Hazard, Hazard Categories & Risk Acceptors by examples

Hazards
 Object Striking Person
 Person Striking Object
 Fall
o Same or other level
 Caught Between
o Part of body / clothing
 Exposures
 Contact with
 Excessive force causing ergonomic issues
 Repetitive Activity causing ergonomic issues
 Unsafe Act
 Unsafe Condition
 Event
o Fire, Flood, Earthquake
Hazard Categories
 Work Equipment, e.g. entrapment in machinery / rotating parts
 Workplace, e.g. uneven floors, poor lighting / confined space.
 Materials and substances, e.g. odours, dusts, welding fumes.
 Environmental parameters, e.g. temperature extremes, both hot and cold.
 Working practices and procedures, e.g. poor manual handling techniques.

Risk Receptors
 Employees carrying out the task.
 Employees working nearby.
 Employees who may pass through the area.
 Visitors
o Authorised and unauthorised
o Customers
o Suppliers
o Delivery personnel
o Trespassers
 Members of the general public ( On and off site )
HIRA (HAZARD Identification and Risk Analysis) Flowchart
RISK Rating

For each hazard dentified, we calculate Risk & give the rating as per the rating criteria.
It is calculated in the following manner.

Risk rating = severity rating x likelihood rating (probability)

Each organisation defines own risk assessment criteria.

Example:

Severity

Death = 5
Major injury, illness resulting in disability. = 4
Injury requiring hospital treatment, illness = 3
Minor injury requiring first aid only = 2
Delay = 1

Likelihood

Certain to happen = 5
Very likely = 4
Likely = 3
Unlikely = 2
Very unlikely = 1

The above criteria may change from organisation to organisation.

LEGAL AND OTHER REQUIREMENTS

 Identification and access to legal and other OH & S requirements

 ACTS - Enactment by the Local Regulatory Authority (National /

Regional);

 RULES - Regulations, requirements and directions on

environmental matters, issued by the concerned regulatory
authority;

 NOTIFICATIONS - Changes to acts or forming new rules under the

provisions of an act, by notifying through the National Gazettes.
  DIRECTIONS - Instructions to Industries / Organizations given by the
regulatory authorities.

 Up to date

 Communication
 Employees
 Other relevant interested parties

Objective & Programmes

 Documented objectives at each level and function

 Consideration to:
 Legal and other requirements
 OH & S hazards and risks
 Technological options
 Financial, Operational and business requirements
 Views of interested parties
 Consistent with OH & S policy
Example

Policy - To minimize injuries and illnesses to employees.

Objectives -
 To Reduce the Accident Frequency/ Severity Rate by 50%
over the Next 2 Years.

 To reduce the number of hand injuries in the Material Stores

and Maintenance department by 25% for the year 2009.

Occupational Health and Safety Management Programmes (OH&SMPs)

 OH&SMPs for achieving objectives

 Responsibility and authority

 Means and time frame

 Review at regular and planned intervals

 Amendment of OH&SMPs to address changes in the organization

An example

Objective Target Programs

Limit worker exposure to TWA concentration Industrial hygiene program.

Acetone < 750 ppm

Meet or exceed legal Zero non- Internal inspections

requirements compliance External audits
incidents

Improve employee Train 100% of Annual H&S training

awareness of H&S employees by year program
issues end

Eliminate injuries due to Reduce fall injuries Ergonomic study

falls. by 80% by year-end. Monthly inspections.

Operational Control

 Identification of operations and activities associated with identified risks

 Plan these activities and specified conditions:

 Cover situations where absence could lead to deviations
 Stipulate operating criteria
 Communication to suppliers and contractors
 Elimination or reduction of OH & S risks at source

Examples of Operational Control

Machine Safeguarding

Mechanical Hazards

 Point of Operation: e.g., cutting, shaping, boring, punching, or forming

 Power Transmission Apparatus: e.g., flywheels, pulleys, belts, connecting

rods, couplings, cams, spindles, chains, gears

 Moving Parts: e.g., reciprocating, rotating, transverse moving parts as well

as feed mechanisms
Non-Mechanical Hazards

 Electrical power: e.g., improperly grounded, exposed wiring

 Noise / Sound Pressure

 High Pressure Systems: e.g., failure from pulsation, vibration or leaks

 Hazardous Materials: e.g., coolants, cutting fluids

 Safeguarding Minimum Requirements

 Prevent contact with moving parts
 Secure firmly to machine
 Protect moving parts from falling objects
 Create no new hazards e.g., sharp edges
 Create no interference
 Allow safe lubrication

 Controls for Equipments

 Design and Layout
 Equipment Maintenance
 Safety Infrastructure
 Machine Safeguards
 Warning / Alerting systems
 Ventilation
 Illumination
 Personal Protective Equipment (PPE)

Methods of Safeguarding
 Guards
 Fixed
 Interlocked
 Adjustable
 Self-Adjusting

 Location / Distance

 Feed / Ejection Methods

 Automatic
 Semi-automatic
 Robot
 Devices
 Presence Sensing
 Pullback
 Restraint
 Gates
 Safety Trip
 Two-Hand Control
 Two-Hand Trip

Personnel Protective Equipment (PPE)

Use PPE in case last line of defense after engineering and administrative controls

For using PPE, people should have Knowledge of hazards at workplace

 Type of injury / part of the body at risk
 Identify exposure and protection measures
 Issue control, disciplinary action, observation, testing (respiratory,
audiometry etc.)

PPE (examples)
 Hard hats, caps & hair nets
 Safety boots & foot guards
 Face shields
 Safety goggles & glasses
 Hearing protection
 Protective gloves
 Protective jackets & vests
 Respirators

More Operational Controls

Procedural Controls are required for

 Job procedures
 Work permits
 Confined-entry procedures
 Industrial hygiene procedures
 Housekeeping procedures
 Emergency procedures
 Emergency preparedness & Response

 Plans and procedures

 Incidents and emergency situations
 Mitigation of illness and injury
 Review and revision
 Testing

Summary

 Safety at workplace is one of the basic needs for the employees

 Since the Organization is responsible for the safety and occupational health of its
employees, a proper OHSMS should be in place

 Implementation of OHSAS 18001 is a structured and planned approach that

allows to track OH&S performance and carry out corrections to achieve continual
improvement

 The elements of OHSAS 18001 include

 OH&S Policy
 Planning
 Implementation and Operation
 Checking
 Management review

 The elements of the OHSAS 18001 are similar to those of ISO 14001

What OSHAS 18001 elements does your organization already has?

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Case Study

A chemical formulating company carries out the following operations in its factory
premises:

Chemicals A and B are received in drums in its materials department and poured into
two storage tanks using diesel operated fork lifts. Chemical A has a shelf life of 3 days.
Reagent C that is a hazardous powder chemical, is received in plastic bags in powder
form and has to be manually unloaded onto a hopper bottom automatic dispenser that
will feed the powder at a controlled rate to the reactors at the time of production.
Airborne particles of reagent C are known to cause respiratory problems in humans.
The company maintains one week storage of reagent C in its warehouse.

In its production department, chemical A is mixed with certain proportion of water

(based on past experience and judgment of the operators) in a batch process in a steel
reactor tank and then heated to a temperature of 80 degrees Celsius. This heating is
achieved by a burner (operating on furnace oil) that directly heats the reactor tank. If the
temperature rises beyond 90 degrees, there is a possibility that the entire contents of
the reactor tank may produce toxic volatile organic compounds. The burner undergoes
cleaning and maintenance every six months based on monitoring of the burner stack
emissions that are regulated as per the ‘consent to operate’ provided by the pollution
control board.
Then chemical B is added in certain proportion and the combination is fed into plastic
containers after cooling for dispatch and sold as a product called ‘alpha’.

 Identify Hazards and Risks

 Decide criteria for Evaluating Risks
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Shared Focus
ISO 9001

ISO 14001 & OSHAS 18001

 Comparison

Difference (In Planning)

Environmental Aspects & Impacts Job Hazards and Risk assessment Customer and product requirements (9001)