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

Costs Time

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

Increased legal

certainty

Increased producti-

vity

Improved product or

service quality

Process improve-

ment

Better process control

Benefits of Quality Management Systems Internal advantages

Secured corporate

know-how

Increased customer satisfacti-

on

Reduced costs

Easier initiation: employe-

es

Simplified tracea- bility of

processes

Support for

strategy deployme-

nt

Strengthe-ned

competiti-veness

Benefits of Quality Management Systems External advantages

Access to new markets.

Sectors expecting or explicitly

requiring certification of the

management system

Increase in the market share.

Improvement of customer

satisfaction, product quality,

delivery 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 performance

Compliance with legal and statutory requirements, ethical behavior (moral behavior), environmental protection

Mutual benefits, continuity, fair treatment

Good working conditions, job security, recognition, payment

Profitability, increase of shareholder value, legal security, transparency

Quality management systems - Requirements

Contents

Context of the organization

Support

Operation

Performance evaluation

Planning

Leadership

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

Determine the inputs required and the outputs expected from these

processes.

Determine the sequence and interaction of these processes.

Determine and apply the criteria 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

their availability.

Assign the responsibilities and 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 achieve their intended results.

Improve the processes and the quality management system.

Maintain and retain documented information to support the operation of its processes.

Quality management system and its processes The organization shall

Choose the

example organizati-

on

Choose the group

leader

Get a group

number

Select group

members

Project Work - instructions Quality Manual

Prepare prsentati-on for the

exam

Finalize Quality Manual

Prepare section by

section

Translate project

template on Serbian

lang.

Follow instructi-ons based

on ISO 9001

Pass the exam

A Goal is a dream with a deadline. Napoleon Hill (American author, 1883-1970)