1. ISO 9001:2015 Subject: Quality Management System
Clause 4 - Context of the organization 1 1

2. Many are stubborn in pursuit of the path they have chosen, few in pursuit of the goal.
Friedrich Nietzsche (German Philosopher, )

3. Objectives OF ISO 9001:2015
Quality Management System 3 3

4. Products and services in conformity to requirements!?
Quality
Costs
Time

5. 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

6. 6 6

7. Benefits of Quality Management Systems
Internal advantages
Better process control
Process improve-ment
Improved product or service quality
Increased producti-vity
Increased legal certainty
Simplified tracea-
bility of processes
Easier initiation: employe-es
Reduced costs
Increased customer satisfacti-on
Secured corporate know-how
Support for strategy deployme-nt
Strengthe-ned competiti-veness 7

8. 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 8

9. ISO 9000 Family
ISO 9000 family of standards was developed to help organizations of every:
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.

10. ISO 9000 Family
The quality management system is the part of an organization's management system that is aimed at helping to achieve the quality objectives.

11. ISO 9000 Family
Furthermore, the quality management system tries to meet the requirements of relevant interested parties.

12. ISO 9000 Family environment financing occupational health and safety
The quality objectives supplement other objectives of the organization
environment
financing
occupational
health and safety
growth
profitability …

13. 13 13

14. Design of the quality management system
It is determined by many influencing factors:
context of the organization
customer requirements
organization’s objectives and SIZE
products provided
corporate culture 14

15. E D I ISO 9000 Establishes the fundamentals of quality management.
Defines the relevant terms for quality management. I
Important basis of quality management is formed by the 7 principles of quality management.

16. ISO 9000 customer focus leadership engagement of people
process approach
improvement
evidence based decision making
relationship management
The seven principles 16

17. establishes minimum requirements for a quality management system!
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.

18. Visualization of the process approach

19. Visualization of the structure of ISO 9001
GOAL

20. 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.

21. Suppliers and partners
Interested parties
Needs and expectations
Customers
Owners/ shareholders
employees
Suppliers and partners
Society
Quality, price, delivery performance
Profitability, increase of shareholder value, legal security, transparency
Good working conditions, job security, recognition, payment
Mutual benefits, continuity, fair treatment
Compliance with legal and statutory requirements, ethical behavior (moral behavior), environmental protection

22. ISO 9001:2015
Quality management systems - Requirements 22 22

23. Contents Clause 5 Clause 4 Clause 7 Clause 6 Clause 8 Clause 9
ISO 9001:2015 clauses
Clause 4
Context of the organization
Clause 7
Support
Clause 8
Operation
Clause 9
Performance evaluation
Clause 6
Planning
Clause 5
Leadership
Clause 10
Improvement

24. CLAUSE 4 - Context of the organization
Topics
4.1
4.2
4.3
4.4
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

25. Scope of the quality management system
organization shall consider:
the relevant external and internal issues
the requirements of relevant interested parties
the products and services of the organization

26. 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.

27. Context of the organization
External issues
Legal
Technological
Competitive
Market
Cultural
Social
Economical
environment

28. Context of the organization
Internal issues
Values
Culture
Knowledge
Performance of the organization

29. Context of the organization
Interested parties (stakeholders)
Customers
Proprietors
Employees
Suppliers
Banks
Authorities
Unions
Partners
Society

30. Quality management system and its processes
The organization shall 1
Determine the inputs required and the outputs expected from these processes. 2
Determine the sequence and interaction of these processes. 3
Determine and apply the criteria and methods needed to ensure the effective operation and control of these processes. 30

31. Quality management system and its processes
The organization shall 4
Determine the resources needed for these processes and ensure their availability. 5
Assign the responsibilities and authorities for these processes. 6
Address the identified risks and opportunities. 31

32. Quality management system and its processes
The organization shall 7
Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results. 8
Improve the processes and the quality management system. 9
Maintain and retain documented information to support the operation of its processes. 32

33. Project Work - instructions
Quality Manual
Select group members
Get a group number
Choose the group leader
Choose the example organizati-on
Follow instructi-ons based on ISO 9001
Translate project template on Serbian lang.
Prepare section by section
Finalize Quality Manual
Prepare prsentati-on for the exam
Pass the exam  33

34. A Goal is a dream with a deadline.
Napoleon Hill (American author, )