INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ISO STANDARDS

• ISO 19011 • GUIDELINES FOR

AUDITING
MANAGEMENT
SYSTEM
• ISO 9001 • QUALITY
MANAGEMENT
SYSTEM
• ISO14000 • ENVIRONMENTAL
MANAGEMENT
SYSTEM
• ISO 22000 • FOOD SAFETY AND
MANAGEMENT
SYSTEM
• ISO 27000 • INFORMATION
SECURITY
MANAGEMENT
SYSTEM
• ISO 31000 • RISK MANAGEMENT
SYSTEM
• ISO 26000 • SOCIAL
RESPONSIBILITY

OVERVIEW OF ISO 9001 AND ISO 14001

• ISO 9001 AND ISO 14001 are among ISO’s most well-known standards

• They are implemented by more than a million organizations in some 175 countries

• ISO 9001 helps organizations to implement quality management

• ISO 14001 helps organizations to implement environmental management.

ISO is derived from the Greek isos, meaning equal.

QUALITY MANAGEMENT

• ISO 9001 is for quality management

• Quality refers to all those features of a product (or service) which are required by the customer.
 • QUALITY MANAGEMENT means what the organization does to:

– Ensure that its products or services satisfy the customer’s quality requirements and

– Comply with any regulations applicable to those products or services

– Enhances customer satisfaction and achieve continual improvement to its performance.

ENVIRONMENTAL MANAGEMENT

• ISO 14001 is the environmental management

• This means what the organization does to:

– Minimize harmful effects on the environment caused by its activities,

– To conform to applicable regulatory requirements, and to achieve continual

improvement of its environmental performance.

GENERIC STANDARDS

• ISO 9001 and ISO 14001 are generic standards.

• Generic means that the same standards can be applied:

– to any organization, large or small, whatever its product or service,

– In any sector of activity, and

– Whether it is a business enterprise, a public administration, or a government

department.

– No matter what the organization’s scope of activity

– If it wants to establish a quality management system, ISO 9001 gives the essential
features

– Or if it wants to establish an environmental management system, ISO 14001 gives the

essential features.

MANAGEMENT SYSTEMS

• Management system means what the organization does to manage its processes, or activities in
order that its products or services meet the organization’s objectives such as:

– Satisfying the customer’s quality requirements

 – Complying to regulations

– Meeting environmental objectives

– To be really efficient and effective, the organization can manage its way of doing things
by systematizing it.

– Nothing important is left out

– Everyone is clear about who is responsible for doing what, when, how, why and where.

– Management system standards provide the organization with and international, state-
of-the-art model to follow.

WHAT IS QMS (QUALITY MANAGEMENT SYSTEM)?

• Comprises activities by which the organization identifies its objectives and determines the
processes and the resources required to achieve desired results

• Provides the means to identify actions to address identified and unintended consequences in
providing products and services

• Manages the interacting processes and resources required to provide value and realize results
for relevant interested parties

• Enable top management to optimize the use of resources considering the long- and short-term
consequences of their decision

GOAL OF QMS

Aims to increase an organization’s awareness of its duties and commitment in fulfilling the needs and
the expectations of its customers and interested parties, and in achieving satisfaction with its products
and services.

QUALITY MANAGEMENT PRINCIPLES

THE CERTIFICATION JOURNEY

TYPICAL DOCUMENTATION STRUCTURE

QMS ORGANIZATION

ROLES AND RESPONSIBILITIES OF TO MANAGEMENT

• Leads the establishment implementation and monitoring of QMS

• Ensures effectiveness of the QMS through risk-based thinking

• Establishes and communicates quality policy;

• Ensures that quality objectives are established;

• Communicates the importance of meeting customer requirements;

• Determines and provides necessary resources and ensures that they are adequately available

• Conducts management review meetings

ROLES AND RESPONSIBILITIES OF QMS LEADER/HEAD

• Oversees the establishment, documentation and effective implementation of the QMS

• Promotes risk-based thinking in overseeing the effectiveness of the QMS

• Acts as liaison with the external parties on matters relating to QMS

 • Ensures that procedures for IQA, Management review, corrective actions are established and
implemented

• Reports QMS performance to top management for review and continual improvement

• Roles and responsibilities of QMS secretariat

• Provides administrative support to successfully implement the QMS up to the 3rd party
certification

• Facilitates the delivery of specific outputs in-line with the QMS

• Plans and coordinates effective deployment and efficient use of human, financial, and other
physical resources for the QMS

ROLES AND RESPONSIBILITIES OF QMS CORE TEAM

• Ensures that the requirements for maintaining and retaining documented information are
established and implemented

• Roles and responsibilities of risk management team

• Performs oversight function in ensuring that the established risk controls and related activities
are consistently implemented

• Plans and coordinates effective and efficient use of risk control tools

• Ensures that risk-related information is maintained and retained

ROLES AND RESPONSIBILITIES OF TRAINING AND ADVOCACY TEAM

• Provides administrative support in terms of training and advocacy in the successful

implementation and sustenance of the QMS

• Plans and coordinated effective deployment and efficient use of resources in-line with training
and advocacy activities

• Plans and coordinates echoing/cascading sessions on QMS-related training

ROLES AND RESPONSIBILITIES OF KNOWLEDGE MANAGEMENT TEAM

• Ensures that the requirements for maintaining and retaining documented are established and
implemented

• Coordinates and oversees activities related to managing organizational knowledge

• Roles and responsibilities of quality workplace team

• Ensures that the environment for the operation of processes needed to achieve conformity to
service requirements are managed

• Ensures consistent implementation of 5s programs, as applicable

• Monitors and assesses workplace cleanliness, orderliness, and safety

ROLES AND RESPONSIBILITIES OF QMS INTERNAL AUDIT TEAM

• Determines conformance of the QMS to the planned arrangements and to the requirements of
ISO 9001

• Determines whether the QMS is effectively implemented and maintained

• Provides input to management review regarding the results of audits

• Keeps track of the implementation of the corrective and preventive actions for nonconformance
raised during the audits

ROLES AND RESPONSIBILITIES OF EMPLOYEES

• Active involvement and participation in all ISO-QMS related activities

• Sincere commitment in working together with the ISO Core Team towards continual
improvement of the management systems

ELEMENTS OF SUCCESS

• Top management commitment

• Core team commitment

• Organization-wide employee participation, cooperation and support

• Proper time management

• Close coordination

BENEFITS OF ISO 9001 AND ISO 14001

• International, expert consensus on state-of-the-art practices for quality and environmental

management

• Common language for dealing with customers and suppliers worldwide

• Increase efficiency and effectiveness

• Model for continual improvement

• Model for satisfying customers and stakeholders

• Build quality into products and services from design onwards

• Address environmental concerns of customers and public and comply with government
regulations

• Integrate with global economy

• Benefits of iso 9001 and iso 14001

• Sustainable business

• Unifying base for industry sectors

• Qualify suppliers for global supply chains

• Technical support for regulations

• Transfer of good practice to developing countries

• Tools for new economic players

• Regional integration

• Facilitate rise of services