This presentation discusses quality management systems and ISO 9001 certification. It covers basic service quality concepts like reliability, responsiveness, and empathy. It then discusses the evolution of quality models from artisan craftsmanship to integrated systems focused on stakeholder satisfaction. Key ISO principles like leadership, customer focus, and continual improvement are explained. The presentation also demonstrates how the PDCA cycle of plan, do, check, act can be applied to operationalize the ISO requirements around processes like planning, implementation, monitoring, and improvement.

1. Quality and ISO certification of patent office procedures,
Lisabon, Portugal, October 9 - 11, 2012.
ISO ON QUALITY
Author: K. Gaži - Pavelić, mag.oec.,
Senior Project Manager
EOQ Quality Systems Manager and Auditor
Quality Assurance Auditor in Higher Education

2. Presentation overview
Quality and ISO certification of patent office procedures,
Lisabon, Portugal, October 9 - 11, 2012.
• Basic service quality concepts
• QMS models
• ISO quality management principles
• PDCA: ISO principles and requirements in
practice

3. Basic service quality concepts

4. Service quality
Service quality
What?
Technical quality
Outcome of the
delivered product or
service
How?
Functional
quality
How is the
technical quality
transferred to the
customer
Reliability, competence,
performance, etc..
Responsiveness and
access
4
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

5. Demensions of service quality
Reliability
Responsiveness
Assurance
Empathy
Tangibles
• Ability to perform the promised service
dependably and accurately.
• Willingness to help customers and
provide prompt service.
• Appearance of physical
facilities, equipment, personnel,
and communication materials.
• Knowledge and courtesy of
employees and their ability to
inspire trust and confidence.
• Caring, individualized attention
the organization provides its
customers.

6. Relative importance of service quality
0% 10% 20% 30% 40%
RELIABILITY
RESPONSIVENESS
ASSURANCE
EMPATHY
TANGIBLES
Respondents allocating 100 Points © A. Parasuraman, University of Miami
32%
11%
16%
19%
22%

7. Principles of service quality
• Listening precedes action
• Reliability is the most important
• Flawless execution of the “basics”
• Attention to service design
• Surprising customers
• Promoting teamwork
• Internal service begets external service
Adapted from Zemke, Ron (2002)
7Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

8. Improving service quality
• Design services in cooperation with customers
• Develop proper measurements
• Create a tangible representation of service quality
• Use teamwork to promote service excellence
• Employee selection, job design and training are
crucial to building customer satisfaction and quality
• View service as a process, not a series of functions
• Integrate customer information across all processes
8Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

9. QMS models

10. Period:
Focus:
Model:
13th - middle
18th century
Products
and quality
of service
Artisan
craftsmanship
Guild
standards and
inspection
1980s - end of
the 20th
century
Fulfillment of
customer
requirements
•Process quality
•Continuous
improvement
•Development
of the QMS
1950.-1970.
Quality of the
organisation
Prevention
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.
10
Beginning of
the 21st
century
Stakeholder
satisfaction,
sustainability
and
transparency
•An integrated
quality system
as a part of all
operations
•Value-added
content to all
of the
stakeholders
Inspection
1940s
Statistical
methods
The old quality
concept:
control of the
finished product
Late 1800s to
early 1900s
Evolution of quality

11. Development of a quality management
systems model
• Deming 1951.
• Malcolm Baldrige 1987.
• EQA 1992.
• ISO 9000ff 1987.
11
Dr. Deming in front of his home,
Washington, D.C., January 1957.
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

12. ISO 9001 advantages
Organisation is able to:
• demonstrate the ability to consistently provide product
meeting customer and applicable regulatory
requirements
• enhance customer’s satisfaction
12Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.
There is:
• Less emphasis on procedures and records
• More emphasis on management involvement and a
system that works to achieve business goals

13. Weaknesses of ISO 9001
• Doesn’t concern itself with whether or not an
organisation achieves desired business results
• It is not a holistic approach to business
• Bureaucracy remains a danger (unless
compliance and certification are carefully
controlled and undertaken).
• But, if your QMS covers all aspects of your
business activity including strategy and
planning, it can resolve some of these issues
13
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

14. Achieving business goals
Run properly, by management, your QMS will
help you achieve your business goals.
Course Summary
14Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

15. ISO quality management principles

16. • Leadership
8 quality management principles
ISO
9001
• Customer focus
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships
16Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

17. Customer focus and perception
• “Organizations depend on their customers and
therefore should understand current and future
customer needs, should meet customer
requirements and strive to exceed customer
expectations.”
• Organization has to collect, review and
appropriately act upon information on customer
perception as to whether their requirements are
met.
17
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

18. Effective customer communication
Product information
Enquiries, contracts, and
order handling, including
changes
Customer feedback,
including complaints
7.2.3
18
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

19. Leadership and involvement of people
• “Leaders establish unity of purpose and direction
of the organization. They should create and
maintain the internal environment in which people
can become fully involved in achieving the
organization’s objectives.”
• “People at all levels are the essence of an
organization and their full involvement enables
their abilities to be used for the organization’s
benefit.”
19
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

20. Effective internal communication
One way only:
quarterly meetings?
Does this
communication
effectively reach
everyone?
Multiple communication
methods all the time?
Management
communication is a
process?
5.1,
5.5.3 ,
6.2.2
20
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

21. “A desired result is achieved more efficiently
when activities and related resources are
managed as a process.”
“Identifying, understanding and managing
interrelated processes as a system contributes
to the organization’s effectiveness and
efficiency in achieving its objectives.”
The Process Approach
Process and system approach
21
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

22. Management
responsibility
Measurement,
analysis,
improvement
Product
realization
Resource
management
C
U
S
T
O
M
E
R
S
R
e
q
u
I
r
e
m
e
n
t
s
Input
C
U
S
T
O
M
E
R
S
S
a
t
I
s
f
a
c
t
I
o
n
Output
Product
Continual improvement
of the qms
a p
c d
22Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

23. The process approach is one of the best
methods to implement a business plan.
Implementing a business plan
23
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

24. Interaction of processes
Processes need to be
identified and their
interaction clearly
defined
Interaction should be
defined using inputs and
outputs
Various methods of
describing interaction
between processes
4.1,
4.2.2
24
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

25. A Quality Management System is focussed on meeting customer
requirements.
Meeting customer requirements
Inputs Process A
Inputs Process B
Process C
Process D Outputs
C
u
s
t
o
m
e
r
r
e
q
u
i
r
e
m
e
n
t
s
C
u
s
t
o
m
e
r
s
a
t
i
s
f
a
c
t
i
o
n
25
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

26. Continual improvement
“Continual improvement of the overall
performance should be a permanent
objective of the organization.”
Implementation of actions necessary to
achieve planned results and continual
improvement of the QMS processes
Top management’s commitment to the
development and implementation of the
QMS and continual improvement of its
effectiveness
4.1 ,
5.1
26

27. • Where are we now (measure) and where
do we want to be (goal)?
• Why are we here (causes of failure)?
• What are we doing to improve (plan)?
• How am I personally involved?
Complete path to improvement
27
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

28. Factual approach to decision making
“Effective decisions are based on the analysis
of data and information.”
28
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

29. Process monitoring and measurement
PROCESS:
„Set of interrelated or interacting
activities” - Value-adding
conversion or transformation
activity using resources
PROCEDURE:
„Specified way to
carry out an activity or
a process” – may be
documented or not*
MONITORING AND
MEASUREMENT
Before, during and
after the process
PRODUCT
„Result of a
process”
EFFECTIVENESS
Ability to achieve
desired results
EFFICIENCY
Results
achieved vs.
resources used
Regulatory
compliance
Requirements
specified
(Includes
resources)
Requirements
satisfied
29
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

30. Analysis of data and measurement
Consider all the records and
data that you collect and
store:
- How are each of these used for
analysis, training, and
improvement purposes?
- If you can’t answer this question
for nearly every record you spend
time and money collecting then
why do you do it?
7.2.1,
8.2.1,
8.4
30
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

31. PDCA: ISO principles and requirements
in practice

32. Customer oriented
processes
(COPs)
Clause 7: Product/ service realization processes; Interaction with external customers
Support
oriented
processes (SOPs)
Clauses 4 & 8:
Document,
measure, analyze
and improve all
processes;
Provide quality
management
support and
interact with all
QMS processes
Support
oriented
processes (SOPs)
Clauses 6 & 7: Provide
necessary resources to
COPs; Interaction at an
operational level with COPs
and with other internal QMS
processes (internal
customers)
Clause 5: Provide
commitment,
leadership,
resources, review
and decision-
making by top
management;
Interact with all
QMS processes at
QMS planning and
review level
Management
oriented
processes
(MOPs)
Quality
management
processes
(QMPs)
Organization’s QMS processes
32

33. Plan – Do – Check - Act
PLAN
your quality
system
a p
c d
DO
your every
day tasks
CHECK
the results
ACT
to improve
33
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

34. PLAN your quality system
Establish objectives and
processes necessary to deliver
expected results including:
• customer and their requirements
• who will have responsibility for
what
• inputs, outputs, resources needed
• how it will be documented
• how the effectiveness of the
management system will be
evaluated
34
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

35. • Leadership
ISO
9001
• Customer focus
• Involvement of people
• Process approach
PLAN – ISO principles
35
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

36. 5.4 Planning
4.2 Documentation
7.2 Customer related processes
6 Resource management
7.1 Planning of product realization
PLAN – ISO 9001:2008 requirements
36
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.
ISO
9001

37. DO your every day tasks
a p
c d
Implement the planned
approach with:
• necessary resources,
• operating processes
• measures
• communication to relevant
parties for realization
37
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

38. DO – ISO 9001:2008 requirements
5.5.3 Internal Communication
ISO
9001
7 Product realization
38
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

39. CHECK the results
a p
c d
• Gather information
through various
measurements and
monitoring activities
• Analyze the
information
• Determine whether
the QMS has
achieved what it set
out to do
39
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

40. CHECK – ISO principles
ISO
9001
• Factual decision making
• Supplier relationship
40
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

41. CHECK – ISO 9001:2008 requirements
• 8.4 Analysis of data
• 8.2 Monitoring and measurement
• 8.3 Control of nonconforming product
41
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.
ISO
9001

42. ACT to improve
a p
c d
• Conduct internal audits
• Have management reviews
• Carry out corrective and
preventive actions
• Continually improve the QMS
42
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

43. ACT – ISO principles
ISO
9001 • Continual improvement
43
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.

44. 5.6 Management Review
ACT – ISO 9001:2008 requirements
8.5 Continual Improvement
44
Quality and ISO certification of patent office procedures
Lisabon, Portugal, 9 – 11. 10., 2012.
ISO 9001

45. THANK YOU!