Quality Management System Description and Examples

1. 1

2. What is Quality?
2

3. 3

4. 4

5.  Fitness for purpose
5

6. However, ‘Fitness for Purpose’ needs to be
defined in a ‘Specification of Requirements’
Therefore;
Quality becomes ‘Conformance with Specified
Requirements
 Quality is not Excellence
6

7. 1/7
 Technical specifications
 Service quality
 Communication
 Availability/Continuity
 Reliability
Customer
Loyalty

8. Over Specification
8
Specification
Under Specification
= QUALITY
= No Quality
= No Quality

9.  The degree to which a set of inherent
characteristics fulfils requirements.
ISO 9001:2008
9

10. 10
Scientific
Management
Frederick Taylor
• Scientific
• Standardization
• Production control
• Cost
• Efficiency
Management
Theory
Henry Fayol
• Management
functions
• One superior
• Management
training
Bureaucracy
Max Weber
• Responsibilit
y and
audthorities
• Procedures
• Expertise
1880 1940

11. DETECTING ERRORS
Quality Control
11

12. Detecting Errors
Checking
Backward
12

13. 13
• %1 Nature
• % 4 Personal Reasons
• % 95 Management Systems
3 Root Causes of Errors
%1
%4
%95

14. PREVENTING ERRORS
Quality Assurance
14

15. 15
Detecting errors
• Quality control
Backward
Preventing errors
• Feedback
• Systems
• Quality
assurance/management
Forward

16. 1. Cost of preventing poor quality
2. Cost of poor quality
Cost of Poor Quality;
 Internal Costs
 External Costs
16

17. CONTINUAL IMPROVEMENT
Quality Management
17

18. Continual Improvement
PLAN
CHECK
DO
ACT
PERFORMANCE
TIME

19. 19
 ISO 9001:1987
 ISO 9001:1994
 ISO 9001:2000
 Correct reduction
 Error detection
 Preventing errors (partly)
 + Preventing errors
 + Continual improvement
QMMonitoring
QA TQMQMQC

20. International Organization for
Standardization
20
1947

21. 21
 Customer focus
 Leadership
 Involvement of people
 Process approach
 Systematic approach to management
 Continual improvement
 Factual approach to decision making
 Mutually beneficial supplier relationships

22. A set of interrelated or interacting activities which
transforms inputs into outputs.
ISO 9001:2008
22

23. 23
Process
Input from
previous process
Output to next
process or
customer
Resources
Control Data
and
instructions

24. 24
• Improved financial performance of the business by planning and achieving
results using efficient and effective processes.
• Enhanced sales, as a result of an improved ability to satisfy customers.
• An enhancement to the organisation's reputation for satisfying customers
needs.
• Reduced cost of poor quality.
• A better motivated and trained workforce.
• Improved staff morale and an increase in confidence within the whole
organisation.
• Encourages an open approach to problems and therefore, more chance of
their solution and avoidance of their repetition.

25. 25
%45
%15
%15
%10
%10
%5
% 45 Increase in bureacracy
% 15 Increase in paperwork
% 15 Worthless investment needs
% 10 Excellence
% 10 Loosing flexibility
% 5 Loosing responsibility conciousness

26. 4.1 General Requirements
Scope
Outsourced processes
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
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27. 5.1 Management Committement
5.2 Customer Focus
5.3 Quality Policies
5.4 Planning
 5.4.1 Quality Objectives
 5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
 5.5.1 Responsibility and Authority
 5.5.2 Management Repsentative
 5.5.3 Internal Communication
5.6 Management Review
 5.6.1 General
 5.6.2 Review Inputs
 5.6.3 Review Outputs
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28. 6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
28

29. 7.1 Planning of Product Realization
7.2 Customer Related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Product and Service Provision
7.5.1 Control of Product and Service Provsion
7.5.2 Validation of Processes
7.5.3 Product Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Products
7.6 Control of Monitoring and Measuring
Equipment
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30.  8.1 General
 8.2 Monitoring and Mesurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audits
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Products
 8.3 Control of Nonconforming Products
 8.4 Analysis of Data
 8.5 Improvement
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31.  Gives advice to management on how to
minimise failure
 Deals with the prevention of problems
 Learn from mistakes and prevent recurrence
of failures
 Continual improvement in effectiveness
31

32.  Primary aim is to achieve good management
control
 Standard does not guarantee perfection at all
times
 Standard does not supersede technical
specifications or standards
 ISO 9001 aligns with ISO 14001
32

33.  Where the overall responsibility for product
realisation belongs to the organisation, if a
process such as design is outsourced or
subcontracted, then it can not be excluded
from the scope
 Must include the management of such
processes
33

34. Document what you are doing
Do what you documented
Record what you did !
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35.  may take the form of:
 hard copy (paper)
 electronic data (computer)
 both forms need to be controlled in accordance with
clause 4.2.3 and 4.2.4 of ISO 9001: 2008
35

36.  tool for management control
 as a basis for training
 as an aid to doing the job
 to help think things through
 as an aid to audit
36

37.  LEVEL 1 – Quality Manual
 LEVEL 2 – Quality Procedures
 LEVEL 3 – Detailed Instructions
37

38. 38
Document
 Guide
 Rule
 Descriptive
 Subject to change
Records
 Evidence
 Demonstration
 Subject to maintain

39.  Ensuring that the system is conforming to
ISO 9001 requirements
 Ensuring the system is implemented
 Ensuring the system is effective
 Tool : error detection “not purpose”
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40. Clause 5.4.1 of ISO 9001
Could cover:
• Management Processes
• Reduction in planning time
• Production or service delivery processes
• Reduction in scrap or processing errors
• The product or service itself
• Reduction in customer returns or complaints
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