Management System Clause 4 Context of the organization 03032016 Many are stubborn in pursuit of the path they have chosen few in pursuit of the goal Friedrich Nietzsche German ID: 630703
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Slide1
ISO 9001:2015
Subject: Quality
Management System
Clause 4 -
Context of the organization03.03.2016.Slide2
Many are stubborn in pursuit of
the path they have chosen
,
few in pursuit of the goal.
Friedrich
Nietzsche
(
German
Philosopher, 1844 - 1900)Slide3
Objectives OF ISO 9001:2015
Quality
Management SystemSlide4
Products
and services in conformity to requirements!Slide5
Objectives of a Quality Management SystemExamples
Consistently
meeting customer
requirements & ensuring
“legal compliance”
Increasing
customer
satisfaction & fulfilling
the owners’
awaiting
Acting proactively
Modelling
capable processes
Ability
to demonstrate conformitySlide6Slide7
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
E
asier initiation:
employe-es
Simplified
tracea
-
bility
of
processes
Support
for strategy
deployme-nt
Strengthe
-ned
competiti
-
venessSlide8
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.
I
mprovement
of customer satisfaction, product quality,
delivery performanceSlide9
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 of standards was developed to help organizations of
every: Slide10
The quality management system
is the part of an organization's management system that is aimed at
helping to achieve the quality objectives.
ISO 9000 FamilySlide11
Furthermore
, the quality management system tries to meet the requirements of
relevant interested parties.
ISO 9000 FamilySlide12
ISO 9000 Family
The quality objectives supplement other objectives of the organization
…
profitability
growth
financing
occupational
health and
safety
environmentSlide13Slide14
Design of the quality management system
It is determined by many influencing factors:
products provided
context of the organization
customer requirements
organization’s objectives and SIZE
corporate
culture Slide15
ISO 9000
E
D
I
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.Slide16
customer
focus
leadership
engagement
of
people
process approach
improvement
evidence based decision making
relationship
management
ISO 9000
The seven principlesSlide17
ISO 9001
establishes minimum requirements for a quality management system!
“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. Slide18
Visualization of the process approachSlide19
GOAL
Visualization of the structure of ISO 9001Slide20
ISO 9004
provides
top management of an organization with guidance on how
sustained success
can be achieved in a complex, demanding and ever-changing business environment by using a quality management approach.
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.
Slide21
Society
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
Customers
Owners
/ shareholders
employees
Suppliers and partners Slide22
ISO
9001:2015
Quality management systems - RequirementsSlide23
Contents
Clause 4
Context of the organization
Clause 7
Support
Clause 8
Operation
Clause 9
Performance evaluation
Clause 6
Planning
Clause 5
Leadership
ISO 9001:2015 clauses
Clause
10
ImprovementSlide24
CLAUSE 4 - Context of the organization
4.2
4.4
4.1
4.3
Understanding the organization and its context
Understanding the needs and expectations of interested parties
Determining the scope of the quality management system
Quality management system and its processes
TopicsSlide25
Scope of the quality management system
the relevant
external and internal
issues
the requirements of relevant interested partiesthe products and services of the
organization
organization shall
consider
:Slide26
Context of the organization
External and internal issues
Relevant
to its purpose
and strategic direction and that affect its ability to
achieve the intended result(s) of its quality management system. Slide27
Context of the organization
External issues
Legal
Technological
Competitive
Market Cultural Social
Economical
environmentSlide28
Context of the organization
Internal issues
Values
Culture
KnowledgePerformance of the organizationSlide29
Context of the organization
Interested parties (stakeholders)Customers
Proprietors
Employees
SuppliersBanksAuthoritiesUnions
PartnersSocietySlide30
1
Determine the
inputs required and the outputs expected from these processes.
2
Determine the sequence and interaction
of these processes.
3
D
etermine
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 shallSlide31
4
Determine the
resources needed for these processes and ensure their availability.
5
Assign the responsibilities and authorities
for these processes.
6
A
ddress
the
identified risks
and
opportunities
.
Quality management system and its processes
The organization shallSlide32
7
Evaluate these
processes and implement any changes needed to ensure that these processes achieve their intended results
.
8I
mprove the processes and the quality management system.
9
M
aintain
and retain
documented
information
to support the operation of its processes
.
Quality management system and its processes
The organization shallSlide33
Choose the example organizati-on
C
hoose the group
leader
G
et 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
Slide34
A Goal is a dream
with a deadline.
Napoleon Hill
(
American
author, 1883-1970)