Subject: Quality Management System

Clause 4 - Context of the organization

03.03.2016.
Many are stubborn in pursuit of
the path they have chosen,
few in pursuit of the goal.
Friedrich Nietzsche (German Philosopher, 1844 - 1900)
Quality Management System
Products and services in conformity to requirements!

Quality

?
Time Costs
Objectives of a Quality Management System
Examples

Consistently meeting customer requirements & ensuring “legal compliance”

Increasing customer satisfaction & fulfilling the owners’ awaiting

Acting proactively

Modelling capable processes

Ability to demonstrate conformity

Benefits of Quality Management Systems
Internal advantages

Better Process Improved Increased Increased

process improve- product or producti- legal
control ment service vity certainty
quality

Simplified Easier Reduced Increased

tracea- initiation: costs customer
bility of employe- satisfacti-
processes es on

Secured Support Strengthe-

corporate for ned
know- strategy competiti-
how deployme- veness
nt
Benefits of Quality Management Systems
External advantages

Access to new Increase in the

markets. market share.
Sectors expecting Improvement of
or explicitly customer
requiring satisfaction, product
certification of the quality,
management delivery
system performance
ISO 9000 Family

type (profit-making organizations, non-profit organizations, manufacturing companies,

service providers etc.) and size (micro-enterprises, small and medium-sized enterprises
and large companies) to implement a quality management system.
ISO 9000 Family
ISO 9000 Family
ISO 9000 Family
The quality objectives supplement other objectives of the organization
Design of the quality management system
It is determined by many influencing factors:
ISO 9000

Establishes the fundamentals of quality management.

Defines the relevant terms for quality management.

Important basis of quality management is formed by the 7 principles of quality management.

ISO 9000
The seven principles
ISO 9001

“The organization shall …”

ISO 9001 promotes the process approach and risk-based thinking!

This should help to increase customer satisfaction by meeting the customer expectations.
Visualization of the process approach
Visualization of the structure of ISO 9001
ISO 9004

Sustained success of an organization is achieved by the organization’s ability to meet

the requirements (needs and expectations) of its customers and other interested
parties in the long run.
Interested parties
Needs and expectations

Quality, price, delivery Profitability, increase Good working Mutual benefits, Compliance with legal
performance of shareholder value, conditions, job continuity, fair and statutory
legal security, security, recognition, treatment requirements, ethical
transparency payment behavior (moral
behavior),
environmental
protection
Quality management systems -
Requirements
Contents

Leadership

Context of the
organization
Support

Planning

Operation
Performance evaluation

Improvement
CLAUSE 4 - Context of the organization
Topics
Scope of the quality management system

 the relevant external and internal issues

 the requirements of relevant interested parties
 the products and services of the organization
Context of the organization

Relevant to its purpose and strategic direction and

that affect its ability to achieve the intended result(s) of its
quality management system.
Context of the organization

 Legal
 Technological
 Competitive
 Market
 Cultural
 Social
 Economical
Context of the organization

 Values

 Culture

 Knowledge

 Performance of the organization

Context of the organization

 Customers
 Proprietors
 Employees
 Suppliers
 Banks
 Authorities
 Unions
 Partners
 Society
 Quality management system and its processes
The organization shall

Determine the inputs required and

the outputs expected from these Determine the sequence and Determine and apply the criteria
processes. interaction of these processes. and methods needed to ensure the
effective operation and control of
these processes.
 Quality management system and its processes
The organization shall

Determine the resources needed

for these processes and ensure Assign the responsibilities and
their availability. authorities for these processes. Address the identified risks and
opportunities.
 Quality management system and its processes
The organization shall

Evaluate these processes and

implement any changes needed to
ensure that these processes Improve the processes and the Maintain and retain documented
achieve their intended results. quality management system. information to support the
operation of its processes.
Project Work - instructions
Quality Manual

Select Get a Choose Choose

group group the group the
members number leader example
organizati-
on
Follow Translate Prepare Finalize
instructi- project section by Quality
ons based template section Manual
on ISO on Serbian
9001 lang.
Prepare Pass the
prsentati- exam 
on for the
exam
A Goal is a dream
with a deadline.
Napoleon Hill (American author, 1883-1970)