Quality Management I (Part II) : Burkhard Fischer

Quality Management I (Part II)
Burkhard Fischer
Quality Management I
Date Time Description
7 Monday, 18:00-21:20 Welcome and Introduction
10.06.2019 Concepts of Quality and Quality Management
8 Tuesday, 18:00-21:20 Use of statistics, epidemiology and presentation of results
11.06.2019 Quality indicators: methodological issues and case study
9 Wednesday, 18:00-21:20 Clinical guidelines: methodological issues and local
12.06.2019 implementation
Clinical pathways and evidence-based medicine (EbM) in quality
management
10 Thursday, 18:00-21:20 Clinical-financial data management:
13.06.2019 coding, QA, statistical analysis
Corporate data management;
Tools for business intelligence in health
11 Saturday, 09:00-12:20 Concepts of risk management and patient safety
15.06.2019 Electronic tools for pharmacovigilance (drug safety);
Risk management in medical IT networks (ISO 80001)
12 Saturday, 13:40-17:00 Deepening of selected topics
15.06.2019 Revision of QM I Part II and preparation of exam
13 Tuesday, 18:00-20:00 Examination
25.06.2019
10.06.2019 Quality Management I (Part II) | Burkhard Fischer 2

Welcome
Introduce yourself …
1. First name, Family name, Age
2. Last degree in …
3. Working as … at …
4. Quality is an important issue in my work
because…
5. Last situation concerning quality issues in your
daily live?
6. What would you like to learn today and next
week?
Unit 7:
Concepts of Quality and Quality Management
Objectives
You know the definitions of

I. Concepts related to Quality
II. Concepts related to (Quality) Assessment
III. Concepts related to Quality Management

Quality: The „Customer Perspective“
Quality: what is it about?
Is is about reputation?
Is it about satisfaction?

Excercise 1.1
1. Excercise:
Write down at least 3 terms or statements
you are relating to „Quality“ (2 min)
2. Tell the other students the terms and

statements you have written down (Mindmap)
(10 min)

Quality
"Quality of care is the extent to which actual care
is in conformity with preset criteria for good care.“
Reerink (1990), p. 200

Quality: The „Customer Perspective“
Is is about reputation?
Is it about satisfaction?

The „Product Perspective“
• Performance
– Basic operating characteristics
• Features
– “Extra” items added to basic features
• Reliability
– Probability product will operate over time
• Conformance
– Meeting pre-established standards
• Durability
– Meeting pre-established standards
• Serviceability
– Ease of getting repairs, speed & competence of repairs
• Aesthetics
– Look, feel, sound, smell or taste
• Safety
– Absence of injury or harm
• Other perceptions
– Subjective perceptions based on brand name, advertising, etc

Basic Concepts of Quality
Quality Being RIGHT
Speed Being FAST
Dependability Being ON TIME
Flexibility Being ABLE TO CHANGE
Cost Being PRODUCTIVE
Reference: Martin Chesie (2001): Basic Concepts of Quality

Avedis Donabedian (1919-2000)
Profesor Avedis Donabedian (1919-2000)
De familia armenia, nació en Beirut en el año 1919 y

creció cerca de Jerusalén. En 1954 se mudó a Boston y al
año siguiente se graduó en la Universidad de Harvard en
Salud Pública. Trabajó durante 28 años en Ann Harbor en
la Escuela de Salud Pública en la Universidad de Michigan.
To learn more about Donabedian visit https://www.fadq.org/?page_id=1887
„Unfortunately, we have used these

words in so many different ways
that we no longer clearly understand
each other when we say them.“
A. Donabedian (1982)

Terms and Concepts of Quality Management
GMDS German Society of Medical Informatics,
Biometry and Epidemiology
GMDS Working Group
„Medical Management: Medical Controlling,
Quality Management, Risk Management, and
Process Management in Medicine“
GQMG German Society of Quality
Management in Healthcare
Sens B, Pietsch B, Fischer B, Hart D, Kahla-

Witsch HA, von Friedrichs V, Nothacker M,
Schneider K, Paschen U, Rath S, Rode S,
Schrappe M. Begriffe und Konzepte des
Qualitätsmanagements – 4. Auflage. GMS Med
Inform Biom Epidemiol. 2018;14(1):Doc04.
DOI: 10.3205/mibe000182 (with Abstract in
English)
https://www.egms.de/static/en/journals/mi
be/2018-14/mibe000182.shtml
Based on: ISO 9000:2015

https://www.iso.org/obp/ui/#iso:std:45481:en
https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:es
I. Concepts related to Quality II. Concepts related to (Quality)
I.1 Quality Assessment
I.2 Characteristic II.1 Determination
I.3 Quality Characteristic II.2 Review
I.4 Requirement II.3 Monitoring
I.5 Capability II.4 Inspection
I.6 Grade II.5 Measurement
I.7 Interested Party II.6 Effectiveness
I.8 Customer II.7 Efficiency
I.9 Provider II.8 Quality Indicator
I.10 Process II.9 Conformity
I.11 Output, Product, Service II.10 Nonconformity/Defect
I.12 Quality of Structure, Process, Outcome II.11 Quality Circle
I.13 Standard (alternative concept) II.12 Peer Review
I.14 Standard II.13 Audit
I.13 Directive II.14 Self Assessment/External Assessment
I.14 Guideline II.15 Certification
I.15 Option, Recommendation II.16 Accreditation

III. Concepts related to Quality IV. Concepts related to Risik
Management Management
III.1 Quality Management IV.1 Patient Safety
III.2 Quality Policy IV.2 Error
III.3 Quality Objective IV.3 Mistake, Lapsus, Slip
III.4 Quality Planning IV.4 Near Miss
III.5 Quality Control IV.5 Adverse Event
III.6 Quality Assurance IV.6 Preventable Adverse Event
III.7 Quality Improvement IV.7 Negligent Adverse Event
III.8 Continual Improvement IV.8 Incident
III.9 Documented Information IV.9 Critical Incident
III.10 Quality Reporting IV.10 Risk
III.11 Benchmarking IV.11 Risk Management
IV.12 Risk Management Process
IV.13 Risk Identification
IV.14 Risk Analysis
IV.15 Risk Evaluation
IV.16 Risk Treatment
IV.17 Risk Control
IV.18 Risk Communication

Quality
Degree to which a set of inherent characteristics
(3.10.1) of an object (3.6.1) fulfills requirements
(3.6.4).
Note 1: The term “quality” can be used with adjectives such as poor, good or
excellent.
Note 2: “Inherent”, as opposed to “assigned”, means existing in the object (3.6.1).
ISO 9000:2015, Nr. 3.6.2

Characteristic
distinguishing feature
Note 1: A characteristic can be inherent or assigned.
Note 2: A characteristic can be qualitative or quantitative.
Note 3: There are various classes of characteristics, such as the following:
– physical (e.g. mechanical, electrical, chemical or biological
characteristics);
– sensory (e.g. related to smell, touch, taste, sight, hearing);
– behavioral (e.g. courtesy, honesty, veracity);
– temporal (e.g. punctuality, reliability, availability, continuity);
– ergonomic (e.g. physiological characteristic, or related to human
safety);
– functional (e.g. maximum speed of an aircraft)
ISO 9000:2015, Nr. 3.10.1

Quality Characteristic
inherent characteristic (3.10.1) of an object (3.6.1)
related to a requirement (3.6.4)
Note 1: Inherent means existing in something, especially as a permanent
characteristic.
Note 2: A characteristic assigned to an object (e.g. the price of an object) is not a
quality characteristic of that object.

Quality Characteristics of Healthcare
• appropriate, correct care
• availability
• continuity of care
• effectiveness
• efficiency
• equity
• evidence/knowledge based care
• patient-centred care including physical, psychological and social
integrity
• patient involvement
• patient safety
• timeliness/accessibility
Chapter 0.1.4 of EN 15224:2015:

Quality management systems - EN ISO 9001:2015 for healthcare
https://www.sis.se/api/document/preview/8024286/

Requirement
need or expectation that is stated, generally
implied or obligatory
Note 1: “Generally implied” means that it is custom or common practice for the
organization (3.2.1) and interested parties (3.2.3) that the need or
expectation under consideration is implied.
Note 2: A qualifier can be used to denote a specific type of requirement, e.g.
product requirement, quality management requirement, customer
requirement.
Note 3: A qualifier can be used to denote a specific type of requirement, e.g.
product (3.7.6) requirement, quality management (3.3.4) requirement,
customer (3.2.4) requirement, quality requirement (3.6.5).
Note 4: Requirements can be generated by different interested parties or by
the organization itself.
ISO 9000:2015, Nr. 3.6.4

Requirement
need or expectation that is stated, generally
implied or obligatory
Note 5: It can be necessary for achieving high customer satisfaction (3.9.2) to
fulfil an expectation of a customer even if it is neither stated nor
generally implied or obligatory.
Note 6: This constitutes one of the common terms and core definitions for ISO
management system standards given in Annex SL of the Consolidated
ISO Supplement to the ISO/IEC Directives, Part 1. The original definition
has been modified by adding Notes 3 to 5 to entry.
ISO 9000:2015, Nr. 3.6.4

Capability
ability of an object (3.6.1) to realize a output
(3.7.5) that will fulfil the requirements (3.6.4) for
that output
Note: Process (3.4.1) capability terms in the field of statistics are defined in
ISO 3534-2.
ISO 9000:2015, Nr. 3.6.12

Grade
category or rank given to different requirements
(3.6.4) for an object (3.6.1) having the same
functional use
Example: Class of airline ticket and category of hotel in a hotel brochure.
Note: When establishing a quality requirement (3.6.5), the grade is generally

specified.
ISO 9000:2015, Nr. 3.6.3

Customer
person or organization (3.2.1) that could or does
receive a product (3.7.6) or a service (3.7.7) that is
intended for or required by this person or
organization
Example: Consumer, client, end-user, retailer, receiver of a product or a service
from an internal process (3.4.1), beneficiary and purchaser.
Note: A customer can be internal or external to the organization.
ISO 9000:2015, Nr. 3.2.4

Provider or supplier
organization (3.2.1) that provides a product (3.7.6)
or a service (3.7.7)
Example: Producer, distributor, retailer or vendor of a product or a service.
Note 1: A provider can be internal or external to the organization.

Note 2: In a contractual situation, a supplier is sometimes called “contractor”.
ISO 9000:2015, Nr. 3.2.5

Process
set of interrelated or interacting activities that use
inputs to deliver an intended result
Note 1: Whether the “intended result” of a process is called output (3.7.5),
product (3.7.6) or service (3.7.7) depends on the context of the
reference.
Note 2: Inputs to a process are generally the outputs of other processes and
outputs of a process are generally the inputs to other processes.
Note 3: Two or more interrelated and interacting processes in series can also
be referred to as a process.
Note 4: Processes in an organization (3.2.1) are generally planned and carried
out under controlled conditions to add value.
Note 5: A process where the conformity (3.6.11) of the resulting output cannot
be readily or economically validated is frequently referred to as a
“special process”.
Note 6: […]
ISO 9000:2015, Nr. 3.4.1

Output
result of a process (3.4.1)
Note: Whether an output of the organization (3.2.1) is a product (3.7.6) or a
service (3.7.7) depends on the preponderance of the characteristics
(3.10.1) involved, e.g. a painting for sale in a gallery is a product
whereas supply of a commissioned painting is a service, a hamburger
bought in a retail store is a product whereas receiving an order and
serving a hamburger ordered in a restaurant is part of a service.
ISO 9000:2015, Nr. 3.7.5

Product
output (3.7.5) of an organization (3.2.1) that can
be produced without any transaction taking place
between the organization and the customer (3.2.4)
Note 1: Production of a product is achieved without any transaction necessarily
taking place between provider (3.2.5) and customer , but can often
involve this service (3.7.7) element upon its delivery to the customer .
Note 2: The dominant element of a product is that it is generally tangible.
Note 3: Hardware is tangible and its amount is a countable characteristic
(3.10.1) (e.g. tyres). Processed materials are tangible and their amount
is a continuous characteristic (e.g. fuel and soft drinks). Hardware and
processed materials are often referred to as goods. Software consists
of information (3.8.2) regardless of delivery medium (e.g. computer
programme, mobile phone app, instruction manual, dictionary content,
musical composition copyright, driver's license).
ISO 9000:2015, Nr. 3.7.6

Service
output (3.7.5) of an organization (3.2.1) with at least one
activity necessarily performed between the organization and
the customer (3.2.4)
Note 1: The dominant elements of a service are generally intangible.
Note 2: Service often involves activities at the interface with the customer to establish
customer requirements (3.6.4) as well as upon delivery of the service and can involve a
continuing relationship such as banks, accountancies or public organizations, e.g.
schools or hospitals.
Note 3: Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (3.7.6) (e.g. a car to
be repaired);
— an activity performed on a customer-supplied intangible product (e.g. the income
statement needed to prepare a tax return);
— the delivery of an intangible product (e.g. the delivery of information (3.8.2) in the
context of knowledge transmission);
— the creation of ambience for the customer (e.g. in hotels and restaurants);
Note 4: A service is generally experienced by the customer.
ISO 9000:2015, Nr. 3.7.7

Quality of Structure, Process, Outcome
degree to which a set of inherent characteristics
fulfills requirements
– on structure,
– on processes, or
– on (treatment) outcomes, respectively.
GMDS Working Group „Quality Management in Medicine “ (2002)

Standard
A standard is a normative definition of qualitative
and / or quantitative nature regarding the
fulfillment of prerequisite or specified (quality)
requirements.

Directive
Directives are regulations of action or omission,
which are
– consented, documented and published by a
legitimized institution
– binding with respect to the legal area of this
institution and
– its non-compliance will be followed by defined
sanctions.
Guideline
systematically developed statements to assist
practitioner and patient decisions about
appropriate health care for specific clinical
circumstances
Field/Lohr 1990

Option/Recommendation
suggested option of action or omission
GMDS Working Group „Quality Management in Medicine“ (2002)

Concepts related to Quality
from: ISO 9000:2015

from: ISO 9000:2015


from: ISO 9000:2005

Exercise 1.2:
• Choose the three „Concepts related to Quality“
that seem most relevant to you concerning
healthcare (2 min)
• Tell the other students about your choice and
explain it to them (10 min together).



Review
activity undertaken to determine the suitability,
adequacy and effectiveness (3.2.14) of the subject
matter to achieve established objective
Note: Review can also include the determination of efficiency (3.2.15).
Example: Management review, design and development review, review of

customer requirements and nonconformity review.
ISO 9000:2005, Nr. 3.8.7

Effectiveness
extent to which planned activities are realized and
planned results are achieved
ISO 9000:2015, Nr. 3.7.11

Efficiency
relationship between the result achieved and the
resources used
ISO 9000:2015, Nr. 3.7.11

Quality Indicator
An indicator is a quantitative measure that can be
used to monitor and evaluate the quality of
important governance, management, clinical, and
support functions that affect patient outcomes. An
indicator is not a direct measure of quality. Rather,
it is a tool that can be used to assess performance
that can direct attention to potential performance
issues that may require more intense review within
an organization.
JCAHO (1990)

Conformity
fulfilment of a requirement (3.1.2)
Note: The term “conformance” is synonymous but deprecated.
ISO 9000:2005, Nr. 3.6.1

Nonconformity
non-fulfilment of a requirement (3.6.4)
ISO 9000:2015, Nr. 3.6.9
Defect
nonconformity (3.6.9) related to an intended or
specified use
Note 1: The distinction between the concepts defect and nonconformity is
important as it has legal connotations, particularly those associated with
product (3.7.6) and service (3.7.7) liability issues.
Note 2: The intended use as intended by the customer (3.2.4) can be affected by
the nature of the information (3.8.2), such as operating or maintenance
instructions, provided by the provider (3.2.5).
ISO 9000:2015, Nr. 3.6.10

Quality Circle
A quality circle is a small institutionalized group of
5 to 12 employees who meet regularly to work
voluntarily and independently on problems that
occur in their area of work.
Kamiske (2006), p. 248

Peer Review
Peer review is defined as a continuous, systematic,
and critical reflection by a number of care
providers, on their own and colleagues‘
performance, using structured procedures, with
the aim of achieving continuous improvement of
the quality of care.
Grol (1994)

Audit
systematic, independent and documented process
(3.4.1) for obtaining objective evidence (3.8.3) and
evaluating it objectively to determine the extent to
which the audit criteria (3.13.7) are fulfilled
Note 1: The fundamental elements of an audit include the determination (3.11.1)
of the conformity (3.6.11) of an object (3.6.1) according to a procedure
(3.4.5) carried out by personnel not being responsible for the object
audited.
Note 2: An audit can be an internal audit (first party), or an external audit (second
party or third party), and it can be a combined audit (3.13.2) or a joint
audit (3.13.3).
[…]
ISO 9000:2015, Nr. 3.13.1

Audit
systematic, independent and documented process (3.4.1)
for obtaining objective evidence (3.8.3) and evaluating it
objectively to determine the extent to which the audit
criteria (3.13.7) are fulfilled
Note 3: Internal audits, sometimes called first-party audits, are conducted by, or
on behalf of, the organization (3.2.1) itself for management (3.3.3) review
(3.11.2) and other internal purposes, and can form the basis for an
organization’s declaration of conformity. Independence can be
demonstrated by the freedom from responsibility for the activity being
audited.
Note 4: External audits include those generally called second and third-party
audits. Second party audits are conducted by parties having an interest in
the organization, such as customers (3.2.4), or by other persons on their
behalf. Third-party audits are conducted by external, independent
auditing organizations such as those providing certification/registration of
conformity or governmental agencies.
ISO 9000:2015, Nr. 3.13.1

Self-assessment / External Assessment
The self-assessment of an organization is a
comprehensive and systematic evaluation of the
activities and results of the organization in respect
to the quality management system or a model of
excellence.
The external assessment of an organization is the
validation of self-assessment by a third party.

Certification
Procedure by which a third party gives written
assurance that a product, process or service
conforms to specified requirements.
DIN EN 45020:1998

Accreditation
Formal recognition of the competence of an
organization or person to be able to provide
certain services given by an legitimated institution.
It is binding in the legal area of this institution and
the non-compliance is followed by defined
sanctions.

Exercise 1.3:
• Chose the three „Concepts related to (Quality)
Assessment“ that seem most relevant to you
concerning healthcare (2 min)

I.2 Characteristic II.1 Review
I.3 Quality Characteristic II.2 Effectiveness
I.4 Requirement II.3 Efficiency
I.5 Capability II.4 Quality Indicator
I.6 Grade II.5 Conformity
I.7 Customer II.6 Nonconformity /Defect
I.8 Provider II.7 Quality Circle
I.9 Process II.8 Peer Review
I.10 Output, Product, Service II.9 Audit
I.11 Quality of Structure, process, II.10 Selfassessment / External
Outcome Assessment
I.12 Standard II.11 Certification
I.13 Directive II.12 Accreditation
I.14 Guideline
I.15 Recommendation

III.1 Quality Management
III.2 Quality Policy
III.3 Quality Objective
III.4 Quality Planning
III.5 Quality Control
III.6 Quality Assurance
III.7 Quality Improvement
III.8 Continual Improvement
III.9 Quality Manual
III.10 Quality Reporting
III.11 Reviewing the Quality Management System
III.12 Benchmarking
III.13 Total Quality Management
III.14 Integrated Management System

Quality Management
coordinated activities to direct and control an
organization (3.3.1) with regard to quality (3.6.2)
Note 1: Quality management can include establishing quality policies (3.5.9) and
quality objectives (3.7.2), and processes (3.4.1) to achieve these quality
objectives through quality planning (3.3.5), quality assurance (3.3.6),
quality control (3.3.7), and quality improvement (3.3.8).
ISO 9000:2015, Nr. 3.3.4 (combined with 3.3.3 “management”)

Quality Policy
intentions and direction of an organization (3.2.1)
related to quality (3.6.2) as formally expressed by
its top management (3.1.1)
Note 1: Generally the quality policy is consistent with the overall policy of the
organization (3.2.1), can be aligned with the organization’s vision (3.5.10)
and mission (3.5.11) and provides a framework for the setting of quality
objectives (3.7.2).
Note 2: Quality management principles presented in this International Standard
can form a basis for the establishment of a quality policy.
ISO 9000:2015, Nr. 3.5.9 (combined with 3.5.8 “policy”)

Objective
result to be achieved
ISO 9000:2015, Nr. 3.7.1
Quality Objective
objective (3.7.1) related to quality (3.6.2)
Note 1: Quality objectives are generally based on the organization's (3.2.1)
quality policy (3.5.9).
Note 2: Quality objectives are generally specified for relevant functions, levels
and processes (3.4.1) in the organization (3.2.1).
ISO 9000:2015, Nr. 3.7.2

Quality Planning
part of quality management (3.3.4) focused on
setting quality objectives (3.7.2) and specifying
necessary operational processes (3.4.1), and
related resources to achieve the quality objectives
Note: Establishing quality plans (3.8.9) can be part of quality planning.
ISO 9000:2015, Nr. 3.3.5

Quality Control
fulfilling quality requirements (3.6.5)
ISO 9000:2015, Nr. 3.3.7

Quality Assurance
providing confidence that quality requirements
(3.6.5) will be fulfilled
ISO 9000:2015, Nr. 3.3.6

Quality Improvement
increasing the ability to fulfil quality requirements
(3.6.5)
Note: The quality requirements can be related to any aspect such as
effectiveness (3.7.11), efficiency (3.7.10) or traceability (3.6.13).
ISO 9000:2015, Nr. 3.3.8

Continual Improvement
recurring activity to enhance performance (3.7.8)
Note: The process (3.4.1) of establishing objectives (3.7.1) and finding
opportunities for improvement (3.3.1) is a continual process through the
use of audit findings (3.13.9) and audit conclusions (3.13.10), analysis of
data (3.8.1), management (3.3.3) reviews (3.11.2) or other means and
generally leads to corrective action (3.12.2) or preventive action (3.12.1).
ISO 9000:2015, Nr. 3.3.2

Quality Manual
specification (3.8.7) for the quality management
system (3.5.4) of an organization (3.2.1)
Note: Quality manuals can vary in detail and format to suit the size and
complexity of an individual organization (3.2.1).
ISO 9000:2015, Nr. 3.8.8

Quality Reporting
part of quality management that is directed to the
creation of transparency about quality
GMDS Working Group "Quality Management in Medicine" (2006)

Benchmarking
continuous process to measure products, services
and practices against the strongest competitor or
companies that are considered industry leaders
according to Kearns, D. T., cited by Camp (1994), p. 13

ISO High level structure for management system standards
High level structure Example of identical definitions

• Clause 1 - Scope Organization, interested party,
• Clause 2 - Normative references policy, objective, competence,
• Clause 3 - Terms and definitions
conformity.
• Clause 4 - Context of the
organization
Example of identical text
• Clause 5 - Leadership
• Clause 6 - Planning “Top management shall ensure
• Clause 7 - Support that the responsibilities and
• Clause 8 - Operation authorities for relevant roles
• Clause 9 - Performance
are assigned and
evaluation communicated within the
• Clause 10 - Improvement organization.”

ISO High level structure for management system standards
https://www.pauwelsconsulting.com/de/publikationen/iso-9001-2015/

The Evolution from Quality Control to TQM
Source: Mohamed, 2002, p. 1164

The Evolution from Quality Control to TQM
Mangelsdorf D (1999): "Evolution from quality management to an integrative management

system based on TQM and its impact on the profession of quality managers in industry",
The TQM Magazine, Vol. 11 Iss: 6, pp. 419 - 425
Concepts related to Quality Management



Exercise 1.4:
• Chose the three „Concepts related to Quality
Management“ that seem most relevant to you
concerning healthcare (2 min)

III.1 Quality Management
III.2 Quality Policy
III.3 Quality Objective
III.4 Quality Planning
III.5 Quality Control
III.6 Quality Assurance
III.7 Quality Improvement
III.8 Continual Improvement
III.9 Documented Information
III.10 Quality Reporting
III.11 Benchmarking

„Unfortunately, we have used these

words in so many different ways
that we no longer clearly understand
each other when we say them.“
A. Donabedian (1982)

Review
You have learned the definitions of

I. Concepts related to Quality
II. Concepts related to (Quality) Assessment
Any questions?

Quality Management I
Date Time Description
7 Monday, 18:00-21:20 Welcome and Introduction
10.06.2019 Concepts of Quality and Quality Management
8 Tuesday, 18:00-21:20 Use of statistics, epidemiology and presentation of results
11.06.2019 Quality indicators: methodological issues and case study
9 Wednesday, 18:00-21:20 Clinical guidelines: methodological issues and local
12.06.2019 implementation
Clinical pathways and evidence-based medicine (EbM) in quality
management
10 Thursday, 18:00-21:20 Clinical-financial data management:
13.06.2019 coding, QA, statistical analysis
Corporate data management;
Tools for business intelligence in health
11 Saturday, 09:00-12:20 Concepts of risk management and patient safety
15.06.2019 Electronic tools for pharmacovigilance (drug safety);
Risk management in medical IT networks (ISO 80001)
12 Saturday, 13:40-17:00 Deepening of selected topics
15.06.2019 Revision of QM I Part II and preparation of exam
13 Tuesday, 18:00-20:00 Examination
25.06.2019

Unit 7:
Burkhard Fischer | burkhard.fischer@gmx.net

Quality Management I (Part II) : Burkhard Fischer

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Quality Management I (Part II)

10.06.2019 Quality Management I (Part II) | Burkhard Fischer 2

You know the definitions of

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2. Tell the other students the terms and

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Quality Being RIGHT

Speed Being FAST

Dependability Being ON TIME

Flexibility Being ABLE TO CHANGE

Cost Being PRODUCTIVE

Reference: Martin Chesie (2001): Basic Concepts of Quality

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Profesor Avedis Donabedian (1919-2000)

De familia armenia, nació en Beirut en el año 1919 y

„Unfortunately, we have used these

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Sens B, Pietsch B, Fischer B, Hart D, Kahla-

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ISO 9000:2015, Nr. 3.6.2

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ISO 9000:2015, Nr. 3.10.1

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Chapter 0.1.4 of EN 15224:2015:

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ISO 9000:2015, Nr. 3.6.4

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ISO 9000:2015, Nr. 3.6.4

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ISO 9000:2015, Nr. 3.6.12

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Note: When establishing a quality requirement (3.6.5), the grade is generally

ISO 9000:2015, Nr. 3.6.3

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Note: A customer can be internal or external to the organization.

ISO 9000:2015, Nr. 3.2.4

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Note 1: A provider can be internal or external to the organization.

ISO 9000:2015, Nr. 3.2.5

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ISO 9000:2015, Nr. 3.7.6

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ISO 9000:2015, Nr. 3.7.7

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from: ISO 9000:2015

from: ISO 9000:2015

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from: ISO 9000:2005

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Example: Management review, design and development review, review of