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EUROPEAN UNION WATER INITIATIVE PLUS
FOR THE EASTERN PARTNERSHIP
Support of Water Policy Reforms towards Integrated Water Resources Management
Workshop on laboratory basics and
fundamentals of ISO Certification
The Principles of Quality
Management
Cristina Trimbacher
2
Overview
 History/Development of Quality Management Systems
 Quality understanding and quality costs
 Development of Quality Management Standards
 The ISO 9000 family of standards
 The PDCA-Circle
 What is Quality?
 Customers?
 The eight ISO 9001 principles of quality management
 Benefits of a quality management system
3
Development of Quality Management
Systems
 Quality, Quality Control and Quality Management are
becoming more and more central tasks of future-
oriented companies !
 Quality Management derived from:
• Quality control/Inspections in industry after the 2nd
world war
• Shift from manufacturing to service orientation
4
5
Development of QMS:
Phase I
Phase I: Insufficient supply of goods/Seller s Market
• Economy of scarcity in post-war period (until 1963)
• Customers must buy what is sold/available
• Customers are seen as „bothersome“ „inconvenient“
• Determination of capability characteristics, design and quality
without involvement of customers
Therefore focus on production/manufacturing
• Volume sales, volume growth
• Quality for staff of minor importance
6
Development of QMS:
Phase II
Phase II: supply and demand balanced/Consumer market
• Through volume growth (Phase I) balance between supply and
demand
• Shifting of quality requirements from seller/producer to
customer/purchaser
• First agreements for Acceptable Quality Levels (AQL)
• And based on this first systematic measures for quality control and
quality assurance
• Beginning of statistical quality assurance !
7
Development of QMS:
Phase III
Phase III: oversupply of goods /competition market:
• Increasing competition of suppliers
• Customers can therefore ask for zero-defect goods
• Customers are also interested in the quality control systems of
suppliers in order to avoid errors = PREVENTION !
• Supplier audits esp. in automobile industry and their suppliers get
established
• First certifications of quality control systems for confidence
building and as a marketing instrument
8
Development of QMS:
Phase IV
Phase IV: change and enhancement of the understanding
of a product
• Quality of goods is self evident
• services = intangible products are criteria for purchase decisions of
customers
• Certification expands to companies in the service sector (tertiary sector)
• Customer satisfaction becomes more and more a measure of quality
• Qualified staff members are necessary resources in companies,
organisational culture and models are developed (up to Total quality
management or TQM)
• Implementation of QMS in administrations
9
Development of QMS:
Phase V
Phase V: linking-up of suppliers/customers, Quality of
services, Environmental aspects, sustainability:
• Optimisation of the customer-supplier system, linking-up of
different companies in the process of product development
• Internationalisation: only certified QM Systems can build up
confidence
• Start of implementation of environmental management systems in
companies and administrations
The Quality Management System becomes part of an
integrative Management System!
10
11
Quality understanding
 Quality has become a question of economic survival
 In previous years, very often production did not match
the market
• Customer needs were not considered
• Instead, technically feasible and economically reasonable goods
were developed
 Result: 90% of customers avoid products or services
12
Quality understanding
 Customer satisfaction
is a matter of great
concern in any Quality
Management System
13
Quality understanding
• Avoid up to 90% the
product/service
Unsatisfied
customers
• Report at least nine other
persons, that they are not
satisfied
Unsatisfied
customers
• Only 4% of customers contact
directly the company for
complaints
Unsatisfied
customers
14
Who are your customers ?
15
hmmm??
Clients….
What??
Who??
Quality costs
 For many companies QM costs are still additional
costs!
• Costs for set-up & implementation of a QMS are known; savings derived
from QMS are considerable, but not well known – barrier !
 Error/failure costs
• Non quality and not detecting errors/failures/deviations in different stages
of a product development process (conception, construction, planning)
lead to enormous costs or inefficient use of human resources
16
Quality costs
 1-10-100 rule
• Costs of one failure increase
with each phase being later
detected by a factor of 10
• One dollar spent on
prevention will save 10 dollars
on correction and 100 dollar
on failure costs  could be
translated: One working day
(wd) spent on prevention will
save 10 wd on correction and
100 wd on failure costs.
Source: Total Quality Management, Joel E.Ross
17
Development of
Quality Management Standards
 First technical guidelines for quality control in the
50ties
 Impulse from the United States
• High quality requirements at the military, in space flight and later
on high safety requirements in nuclear power stations
• 1st QM-Standard MIL-Q- 5 of 1 5 , Title “Quality program
requirements"
• 1987 international series of Quality Management Standard ISO
9000
18
The ISO 9000 family
of standards
 The ISO 9000 family of standards are related to quality
management systems
 and designed to help organizations ensure that they
meet the needs of customers and other stakeholders
 they are not specific to products or services, but
apply to the processes that create them !
19
The ISO 9000 family
of standards
 The standards are of generic nature !
 They can be used by both manufacturing and
servicing organizations.
20
Four Core Standards
1. ISO 9000: definitions, vocabulary, fundamentals incl.
PCDA cycle (Deming cycle)
2. ISO 9001: requirements of the quality management
system, process approach
3. ISO 9004: Guidelines for performance improvements
• The standard is based on a number of quality management principles
including a strong customer focus, the motivation and implication of top
management, the process approach and continual improvement.
4. ISO 19011: guidelines for quality and/or environmental
management systems audit
21
Four Core Standards
 Of these, only ISO 9001 is a certifiable standard
 i.e. ISO 9001 is the only standard that you can be
assessed against
 with the others being for guidance and information
purposes only !
 https://www.iso.org/home.html
22
The PDCA Cycle for
continual improvement
• DO• CHECK
• PLAN• ACT
Request
corrective
actions
Establish
objectives
and
processes
Implement
the plan,
execute the
process
Study actual
results and
compare to
expected
23
 iterative four-step
management method
 for the control and continual
improvement of processes
and products
 Created by Mr. William
Edwards Deming (1900-1993)
• American physicist, statistician
and pioneer in the field of
quality management
How would you define
Quality ?
24
What??
Quality ??
Hmmm, no
idea ??
What is quality ?
 Definition of ‚Quality (ISO 9000:2015)
• The degree to which a set of inherent
characteristics fulfils requirements.
 Customers are interested that the
product/service they buy meets the
expected quality
25
Source: shareicon.net
What is a quality management system?
 a way of defining how an organization can meet
the requirements of its customers and other
stakeholders affected by its work
 In a formalized system
• with documented processes, procedures and
responsibilities for achieving quality goals
• to improve its effectiveness and efficiency on a
continuous basis.
26
The ISO 9001:2015
quality management principles
27
The ISO 9001:2015
quality management principles
1. Customer focus
 Organisations depend on their customers
 should understand current and future customers
needs
 Should meet customers requirements
 And strive to exceed customers expectations
28
The ISO 9001:2015
quality management principles
2. Leadership
 Leaders establish unity of purpose and direction of the
organisation
 They should create and maintain the internal
environment in which people become fully involved in
achieving the organisation s objective
 Increased effectiveness and efficiency
 Better coordination of the organization s processes
29
The ISO 9001:2015
quality management principles
3. Engagement of people
 People at all levels are the essence of an organization !
 Their full involvement enables their abilities to be used
for the organisation s benefit
4. Process approach
 A desired result is achieved more efficiently when
activities and related resources are understood and
managed as interrelated process
 PDCA-Cycle can be applied to all processes and whole
quality management system 30
The ISO 9001:2015
quality management principles
5. Improvement
 Continual improvement of the organization s overall
performance should be permanent objective of the
organisation
 To react on changes
 To create new opportunities
31
The ISO 9001:2015
quality management principles
6. Evidence-based to decision making
 Effective decisions are based on the analysis of data
and information
 Facts, evidence and data analysis lead to greater
objectivity and confidence in decision making
7. Relationship management
 A mutually beneficial relationship with all relevant
interested parties enhances the ability to create value
32
Costs of Quality Management
 Implementation
• Working time of laboratory
staff
• Time of personnel
responsible for quality
management issues
• Training of staff
• Hardware/Software
• External advice
 Certification
• Audit
• Certificate
33
 Maintenance
Regular costs for keeping your QM-
System alive and for further
improvement
• Update of documentation
• Repair & services
• Quality training
• Quality assurance
• Quality planning
Benefits of Quality Management
 Build quality into products and services from design
onwards
 Increase efficiency and effectiveness by early recognizing
problems -> risk based planning!
 Model for continual improvement
 Model for satisfying customers and other stakeholders
 reduce time spent on unproductive tasks
 employees satisfaction and more commitment to the
organisation
 improved promotion of corporate image
34
Thank you for your attention!
Cristina Trimbacher
Quality Manager
 Testing Laboratory for Environmental, GMO & Fuel
Analysis
 Calibration Laboratory for Air Quality Control
T: +43-(0)1-313 04/5868
F: +43-(0)1-313 04/5222
cristina.trimbacher@umweltbundesamt.at
35

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The Principles of Quality Management

  • 1. EUROPEAN UNION WATER INITIATIVE PLUS FOR THE EASTERN PARTNERSHIP Support of Water Policy Reforms towards Integrated Water Resources Management Workshop on laboratory basics and fundamentals of ISO Certification
  • 2. The Principles of Quality Management Cristina Trimbacher 2
  • 3. Overview  History/Development of Quality Management Systems  Quality understanding and quality costs  Development of Quality Management Standards  The ISO 9000 family of standards  The PDCA-Circle  What is Quality?  Customers?  The eight ISO 9001 principles of quality management  Benefits of a quality management system 3
  • 4. Development of Quality Management Systems  Quality, Quality Control and Quality Management are becoming more and more central tasks of future- oriented companies !  Quality Management derived from: • Quality control/Inspections in industry after the 2nd world war • Shift from manufacturing to service orientation 4
  • 5. 5
  • 6. Development of QMS: Phase I Phase I: Insufficient supply of goods/Seller s Market • Economy of scarcity in post-war period (until 1963) • Customers must buy what is sold/available • Customers are seen as „bothersome“ „inconvenient“ • Determination of capability characteristics, design and quality without involvement of customers Therefore focus on production/manufacturing • Volume sales, volume growth • Quality for staff of minor importance 6
  • 7. Development of QMS: Phase II Phase II: supply and demand balanced/Consumer market • Through volume growth (Phase I) balance between supply and demand • Shifting of quality requirements from seller/producer to customer/purchaser • First agreements for Acceptable Quality Levels (AQL) • And based on this first systematic measures for quality control and quality assurance • Beginning of statistical quality assurance ! 7
  • 8. Development of QMS: Phase III Phase III: oversupply of goods /competition market: • Increasing competition of suppliers • Customers can therefore ask for zero-defect goods • Customers are also interested in the quality control systems of suppliers in order to avoid errors = PREVENTION ! • Supplier audits esp. in automobile industry and their suppliers get established • First certifications of quality control systems for confidence building and as a marketing instrument 8
  • 9. Development of QMS: Phase IV Phase IV: change and enhancement of the understanding of a product • Quality of goods is self evident • services = intangible products are criteria for purchase decisions of customers • Certification expands to companies in the service sector (tertiary sector) • Customer satisfaction becomes more and more a measure of quality • Qualified staff members are necessary resources in companies, organisational culture and models are developed (up to Total quality management or TQM) • Implementation of QMS in administrations 9
  • 10. Development of QMS: Phase V Phase V: linking-up of suppliers/customers, Quality of services, Environmental aspects, sustainability: • Optimisation of the customer-supplier system, linking-up of different companies in the process of product development • Internationalisation: only certified QM Systems can build up confidence • Start of implementation of environmental management systems in companies and administrations The Quality Management System becomes part of an integrative Management System! 10
  • 11. 11
  • 12. Quality understanding  Quality has become a question of economic survival  In previous years, very often production did not match the market • Customer needs were not considered • Instead, technically feasible and economically reasonable goods were developed  Result: 90% of customers avoid products or services 12
  • 13. Quality understanding  Customer satisfaction is a matter of great concern in any Quality Management System 13
  • 14. Quality understanding • Avoid up to 90% the product/service Unsatisfied customers • Report at least nine other persons, that they are not satisfied Unsatisfied customers • Only 4% of customers contact directly the company for complaints Unsatisfied customers 14
  • 15. Who are your customers ? 15 hmmm?? Clients…. What?? Who??
  • 16. Quality costs  For many companies QM costs are still additional costs! • Costs for set-up & implementation of a QMS are known; savings derived from QMS are considerable, but not well known – barrier !  Error/failure costs • Non quality and not detecting errors/failures/deviations in different stages of a product development process (conception, construction, planning) lead to enormous costs or inefficient use of human resources 16
  • 17. Quality costs  1-10-100 rule • Costs of one failure increase with each phase being later detected by a factor of 10 • One dollar spent on prevention will save 10 dollars on correction and 100 dollar on failure costs  could be translated: One working day (wd) spent on prevention will save 10 wd on correction and 100 wd on failure costs. Source: Total Quality Management, Joel E.Ross 17
  • 18. Development of Quality Management Standards  First technical guidelines for quality control in the 50ties  Impulse from the United States • High quality requirements at the military, in space flight and later on high safety requirements in nuclear power stations • 1st QM-Standard MIL-Q- 5 of 1 5 , Title “Quality program requirements" • 1987 international series of Quality Management Standard ISO 9000 18
  • 19. The ISO 9000 family of standards  The ISO 9000 family of standards are related to quality management systems  and designed to help organizations ensure that they meet the needs of customers and other stakeholders  they are not specific to products or services, but apply to the processes that create them ! 19
  • 20. The ISO 9000 family of standards  The standards are of generic nature !  They can be used by both manufacturing and servicing organizations. 20
  • 21. Four Core Standards 1. ISO 9000: definitions, vocabulary, fundamentals incl. PCDA cycle (Deming cycle) 2. ISO 9001: requirements of the quality management system, process approach 3. ISO 9004: Guidelines for performance improvements • The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. 4. ISO 19011: guidelines for quality and/or environmental management systems audit 21
  • 22. Four Core Standards  Of these, only ISO 9001 is a certifiable standard  i.e. ISO 9001 is the only standard that you can be assessed against  with the others being for guidance and information purposes only !  https://www.iso.org/home.html 22
  • 23. The PDCA Cycle for continual improvement • DO• CHECK • PLAN• ACT Request corrective actions Establish objectives and processes Implement the plan, execute the process Study actual results and compare to expected 23  iterative four-step management method  for the control and continual improvement of processes and products  Created by Mr. William Edwards Deming (1900-1993) • American physicist, statistician and pioneer in the field of quality management
  • 24. How would you define Quality ? 24 What?? Quality ?? Hmmm, no idea ??
  • 25. What is quality ?  Definition of ‚Quality (ISO 9000:2015) • The degree to which a set of inherent characteristics fulfils requirements.  Customers are interested that the product/service they buy meets the expected quality 25 Source: shareicon.net
  • 26. What is a quality management system?  a way of defining how an organization can meet the requirements of its customers and other stakeholders affected by its work  In a formalized system • with documented processes, procedures and responsibilities for achieving quality goals • to improve its effectiveness and efficiency on a continuous basis. 26
  • 27. The ISO 9001:2015 quality management principles 27
  • 28. The ISO 9001:2015 quality management principles 1. Customer focus  Organisations depend on their customers  should understand current and future customers needs  Should meet customers requirements  And strive to exceed customers expectations 28
  • 29. The ISO 9001:2015 quality management principles 2. Leadership  Leaders establish unity of purpose and direction of the organisation  They should create and maintain the internal environment in which people become fully involved in achieving the organisation s objective  Increased effectiveness and efficiency  Better coordination of the organization s processes 29
  • 30. The ISO 9001:2015 quality management principles 3. Engagement of people  People at all levels are the essence of an organization !  Their full involvement enables their abilities to be used for the organisation s benefit 4. Process approach  A desired result is achieved more efficiently when activities and related resources are understood and managed as interrelated process  PDCA-Cycle can be applied to all processes and whole quality management system 30
  • 31. The ISO 9001:2015 quality management principles 5. Improvement  Continual improvement of the organization s overall performance should be permanent objective of the organisation  To react on changes  To create new opportunities 31
  • 32. The ISO 9001:2015 quality management principles 6. Evidence-based to decision making  Effective decisions are based on the analysis of data and information  Facts, evidence and data analysis lead to greater objectivity and confidence in decision making 7. Relationship management  A mutually beneficial relationship with all relevant interested parties enhances the ability to create value 32
  • 33. Costs of Quality Management  Implementation • Working time of laboratory staff • Time of personnel responsible for quality management issues • Training of staff • Hardware/Software • External advice  Certification • Audit • Certificate 33  Maintenance Regular costs for keeping your QM- System alive and for further improvement • Update of documentation • Repair & services • Quality training • Quality assurance • Quality planning
  • 34. Benefits of Quality Management  Build quality into products and services from design onwards  Increase efficiency and effectiveness by early recognizing problems -> risk based planning!  Model for continual improvement  Model for satisfying customers and other stakeholders  reduce time spent on unproductive tasks  employees satisfaction and more commitment to the organisation  improved promotion of corporate image 34
  • 35. Thank you for your attention! Cristina Trimbacher Quality Manager  Testing Laboratory for Environmental, GMO & Fuel Analysis  Calibration Laboratory for Air Quality Control T: +43-(0)1-313 04/5868 F: +43-(0)1-313 04/5222 cristina.trimbacher@umweltbundesamt.at 35