Eng 311.158 WS2016

Fundamentals of personnel
certification in the process‐oriented
integrated management systems
311.158
Prof. Dr. Numan DURAKBASA
Fundamentals of personnel certification in the process-oriented integrated management systems

Dr. Gökcen Bas ‐ Dipl.‐Ing. Erol Güçlü
Fundamentals of personnel certification
311.158
What is Management 05.12.2016 and 12.12.2016

13:00 SemR. 311
Management System Standards
ISO 9001, ISO 14001, ISO 18001, ISO 50001, ISO 20000, ISO 27001, ISO 31000, …
Establishing an integrated Management System
Certification of an integrated Quality Management System 11.01.2017 14:00 SemR. 311

Personnel Certification according to the ISO 17024
Quality Manager
Quality Auditor
System Auditor of an integrated Management System
The integrated Quality Management System Audit
Team work 18.01.2017 14:00 SemR. 311
Test (written) 25.01.2017

14:00 SemR. 311
20/10/16 Fundamentals of personnel certification in the process‐oriented integrated management systems 2

Management
• The verb manage comes from the Italian maneggiare
(to handle — especially tools), which in turn derives
from the Latin manus (hand). The French word
mesnagement (later ménagement) influenced the
development in meaning of the English word
management in the 17th and 18th centuries.
• Management :
(Definition according to ISO/ 9000:2015; 3.3.3)
coordinated activities for direct and control an
organization
Defining management
• Organization and coordination of the activities
of an enterprise in accordance with certain
policies and in achievement of clearly defined
objectives.
• Management is often included as a factor of
production along with machines, materials,
and money. According to the management
guru P. Drucker (1909–2005), the basic task of
a management is two fold:
marketing & innovation.

20/10/16 5
Management System
• In some small organizations, there may not be an
official system, just "our way of doing things",
that is mostly kept in the heads of the staff.
• But the larger the organization, the more likely
that procedures need to be recorded to ensure
everyone is clear on who does what.
• This process of systemizing how things are done
is known as a
management system.
20/10/16 6
Managementsystem
• Management system comprises the
organizational structure, procedures, processes
and resources needed to implement quality
management.
• Management system : (Definition according to ISO 9000:2015‐3.5.3)
Set of interrelated or interacting elements of

an organization to establish policies and
objectives and processes to achieve those
objectives

IMS
• The activities in the companies involve
opportunities as well as risks, both arising
from the operations in the processes.
• The aim of the IMS is to recognise potential
business risks at an early stage and to
eliminate or reduce them as far as possible.

20/10/16 8
IMS
• This task, secured by the management, is supported by
considering the fields of quality, environment, energy, safety,
risk, as well as others, in the framework of an “Integrated
management system” (IMS).
QMS
ISO 9001
EMS
RMS ISO 14001
ISO 31000
process approach -
PDCA -
risk-based thinking
OHSAS
EnM
18001
ISO 50001

20/10/16 9
QMS
• The adoption of a QMS is a strategic decision
for an organization that can help to improve
its overall performance and provide a sound
basis for sustainable development initiatives.

20/10/16 10
Benefits implementing of QMS based on ISO 9001: 2015
• the ability to consistently provide products and

services that meet customer and applicable statutory
and regulatory requirements;
• facilitating opportunities to enhance customer
satisfaction;
• addressing risks and opportunities associated with its
context and objectives;
• the ability to demonstrate conformity to specified
QMS requirements.
20/10/16 11
Audits
• Audits are a vital part of the management system
approach as they enable the company or
organization to check how far their achievements
meet their objectives and show conformity to the
standard.
• ISO 19011:2011‐Guidelines for auditing
management systems, provides specific guidance
on internal and external management system
audits.
20/10/16 12
Audits
• audit carried out by an auditing organization
independent of the client and the parties that
rely on certification, for the purpose of
certifying the client’s management system

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Certification
• Certification to management system standards is
not a requirement. You can still benefit from
implementing these standards by undergoing the
conformity assessment without having to be
certified to them.
• In order to get certified to one or more of
management system standards, the organization
or personnel's must contact an external
certification body. (ISO does not perform
certification.)
20/10/16 14
Certification
Certification of a management system provides
independent demonstration that the
management system of the organization:
• conforms to specified requirements
• is capable of consistently achieving its stated
policy and objectives
• is effectively implemented

20/10/16 15
• Management system standards provide a model
to follow when setting up and operating a
management system.
• Management system standards have similar
structure and may contain many of the same
terms and definitions. This makes them easier,
cheaper and quicker for those companies who
use more than one, as well as helping out the
auditors.
20/10/16 16
• The most important management standards:
 ISO 9000 Family – Quality management
 ISO 9001:2015 ‐ Quality management systems ‐ Requirements:
sets out the requirements of a quality management system
 ISO 9000:2015 ‐ Quality management systems ‐ Fundamentals
and vocabulary : covers the basic concepts and language
 ISO 9004:2009 ‐ Managing for the sustained success of an
organization ‐ A quality management approach: focuses on how
to make a quality management system more efficient and
effective
 ISO 19011:2011 ‐ Guidelines for auditing management systems:
sets out guidance on internal and external audits of quality
management systems

20/10/16 17
ISO 9000 Family – Quality management

20/10/16 18
 EFQM Model – Quality management
 The European Foundation for Quality Management
(EFQM) is a not‐for‐profit membership foundation based in
Brussels in 1989 by 14 Businesses, those that “wanted to
become the power of the sustainable Excellence in
Europe”.
 The network nowadays is spread within thousands of
organizations. The basic principle are Management‐
Models of the EFQM saying that excellent results are build
by one leader group, Policy and Strategies with the help of
co‐workers, partnerships and resources as well as
processes.

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The EFQM – Model of Excellence

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 ISO 14000 Family – Environmental management
 ISO 14001:2015 ‐ Environmental management systems ‐ Requirements
with guidance for use: sets out the criteria for an environmental
management system
 ISO 14004:2015 ‐ Environmental management systems ‐ General
guidelines on principles, systems and support techniques : provides
guidance on the establishment, implementation, maintenance and
improvement of an environmental management system
 ISO 14064‐1:2012 ‐ Greenhouse gases ‐‐ Part 1: Specification with
guidance at the organization level for quantification and reporting of
greenhouse gas emissions and removals: specifies principles and
requirements at the organization level for quantification and reporting
of greenhouse gas (GHG) emissions and removals. It includes
requirements for the design, development, management, reporting
and verification of an organization's GHG inventory.

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 EMAS – The EU Eco‐Management and Audit Schema
 The EU Eco‐Management and Audit Scheme (EMAS) is
a management instrument developed by the European
Commission for companies and other organizations to
evaluate, report, and improve their environmental
performance. EMAS is open to every type of
organization eager to improve its environmental
performance. It spans all economic and service sectors
and is applicable worldwide. Currently, more than
4,600 organizations and more than 7,900 sites are
EMAS registered.

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OHSAS 18000 Series – Occupational Health
and Safety
OHSAS 18001:2007 – Occupational health and
safety management systems. Requirements
 OHSAS 18002:2008 ‐ Occupational health and
safety management systems. Guidelines for the
implementation of OHSAS 18001:2007

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 ISO 50001 – Energy management
 ISO 50001:2011 ‐ Energy management systems ‐ Requirements with
guidance for use
 ISO 50001 is based on the management system model of continual
improvement also used for other well‐known standards such as ISO
9001 or ISO 14001. This makes it easier for organizations to integrate
energy management into their overall efforts to improve quality and
environmental management.
 ISO 50001:2011 provides a framework of requirements for
organizations to:
 Develop a policy for more efficient use of energy
 Fix targets and objectives to meet the policy
 Use data to better understand and make decisions about energy use
 Measure the results
 Review how well the policy works, and
 Continually improve energy management.
20/10/16 24
 ISO 27000 Family – Information security
management
The ISO 27000 family of standards helps organizations
keep information assets secure. Using this family of
standards will help your organization manage the
security of assets such as financial information,
intellectual property, employee details or information
entrusted to you by third parties.
ISO/IEC DIS 27001:2013 + Cor. 1:2014 ‐ Information
technology ‐ Security techniques ‐ Information
security management systems ‐ Requirements

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 ISO 22000 Family‐ Food safety management
 ISO 22000:2005 contains the overall guidelines for food safety
management
 ISO 22004:2014 provides generic advice on the application of
ISO 22000
 ISO 22005:2007 focuses on traceability in the feed and food
chain
 ISO/TS 22002‐1:2009 contains specific prerequisites for food
manufacturing
 ISO/TS 22002‐3:2011 contains specific prerequisites for farming
 ISO/TS 22003:2013 provides guidelines for audit and
certification bodies

20/10/16 26
 ISO 13485 – Medical devices Quality
management
ISO 13485:2016 ‐ Medical devices ‐‐ Quality
management systems ‐‐ Requirements for regulatory
purposes : specifies requirements for a quality
management system where an organization needs to
demonstrate its ability to provide medical devices and
related services that consistently meet customer
requirements and regulatory requirements applicable
to medical devices and related services.

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ISO 31000 – Risk management
ISO 31000:2009 ‐ Risk management ‐‐ Principles
and guidelines :can be applied throughout the life
of an organization, and to a wide range of
activities, including strategies and decisions,
operations, processes, functions, projects,
products, services and assets by any public,
private or community enterprise, association,
group or individual.
20/10/16 28
 ISO 20121 ‐ Event sustainability management
system
 ISO 20121:2012 ‐ Event sustainability management
systems ‐ Requirements with guidance for use
Events take a heavy toll on our resources, society and
the environment. They can generate significant waste,
put a strain on local resources like water or energy, or
even ignite tensions in local communities. Every
action counts, from relying on tap water instead of
plastic bottles to encouraging use of public transport.

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Field specific standards
AQAP Quality assurance of deliveries of
(Allied Quality Assurance Publications ) military commodities
KTA (Kerntechnische Ausschuss ) Pivotal technical rulebook with high
obligation
CECC(CENELEC -Comite Europeen de European commodities seal system for
Normalisation Electrotechnique-Electronic
building pieces in electrical engineering
Components Committee)
GMP (Good Manufacturing Basic principles of world health

Practice) organization (WHO)
GLP (Good Laboratory Practice) Quality management in Laboratory
work area
20/10/16 30
Field specific standards
VDA 6.1 QM‐System audit principles
(Union of automotive industries)
VDA 6.2 QM‐System audit services
VDA 6.3 Process audit
VDA 6.4 QM‐System audit Resources
VDA 6.5 Product audit

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Historical Development
• In the beginning of industrialization of mass
production in the end of the 19th century raised
the need of experts for work preparation,
production and distribution. Workmanship
operating cycle has reached its end by Taylor´s
principle (Frederick W. Taylor 1856‐1915). The
object of the Taylor´s work differentiating was of
course also testing of quality by "control master"
and his quality control division.

20/10/16 32
Historical Development
 quality of products and services take central values
 quality can be found thousand years before Christ
 due to mass production raised the demand on
management advisors
 inefficiency of manufacturers demands resolution for
removal of causes
 Master of production / controlling master
 Reduction of failures costs

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Development of Modern Quality Theory
Quality Management
Total Quality Management
Planning for quality
Management responsibility
Quality Assurance Involving all employees
Europa
Quality is being produced And all business processes
In manufacturing Customers oriented
Quality Control Controls in the Production
Quality is being processes present, prevention
Controlled from start.
End checks
1950 1960 1970 1980 1990 2000 Time
Taylor Deming Juran Crosby Feigenbaum Masing Ishikawa Taguchi
Quality Total Quality

Quality Assurance Total Quality Management Japan
Control Control
Source: SchebestaManegement
20/10/16 34
Development of Quality Management

20/10/16 35
Evolution of QM ‐ Standards
End of the 2. World War
Statistical methods
American Approach Japanese Approach
Military Standards Business specific
Improvement methodology
National and Deming Award

branch specific standards
ISO 9000 Series Usage of the QM Standards
Development of methodology
1987 continuous improvement
Further development of the requirements
Process oriented
Implementing
TQM Aspects

20/10/16 36
Model of a Process Based QM‐System
Model of a process-based quality management system, showing the links to the ISO 9001 37
Schematic representation of the elements of a single process (ISO 9001 : 2015)

20/10/16 38
Taylor Principle
1. Using production resources optimal
2. Production presented in separate steps
3. Control of production quality by „Function
Masters“ (control of a predefined area)
4. Clear differentiating between planning,
manufacturing and control within business
leadership
Source: SchebestaManegement

20/10/16 39
Philip B. Crosby
1. Quality is requirements
2. The basic principle of quality is prevention
3. Zero error
4. For scaling quality, use the costs of bad-quality(costs
of repair and bad-quality corrections)
Do it right the first time!

20/10/16 40
Improve
Quality
Improve Decrease Competitive Capture Stay in

productivity Costs prices market position business
Deming´s Chain Reaction

Provide jobs
and more jobs

20/10/16 41
The Quality Philosophy of Deming
1. Each activity can be understood as process
and can be improved appropriately
2. It is not enough to resolve problems, basis
changes are needed
3. This has to be resolved by the to leadership,

it is not enough to take responsibility.
20/10/16 42
• Deming developed the chain reaction: as quality improves,
costs go down and productivity goes up; this leads to more
jobs, greater market share, and long‐term survival. He
stressed worker pride and satisfaction and considered it
management's job to improve the process, not the worker.
• The GDP in Japan rose steadily from 1960s by more than 10
percent per year. By 1951 the Japanese had named their
quality prize in his honor.
• Deming is known for the fourteen points for management,

Deming Cycle and the Seven Deadly Diseases.
20/10/16 43
• Create a plan; publish the aims and purposes of the organization.
• Learn and adopt the new philosophy of quality.
• Understand the purpose of inspection; stop depending on inspection.
• Stop awarding business based on price alone.
• Improve the system constantly.
• Institute training.
• Teach and institute leadership.
• Drive out fear, create trust, and create a climate for innovation.
• Optimize the efforts of teams, groups and staff areas.
• Eliminate exhortations, and targets for the work force; provide methods of
achievement.
• Eliminate numerical quotas for the work force.
• Remove barriers that rob people of pride for workmanship.
• Encourage education and self improvement for everyone.
• Make action to accomplish the transformation, make it everyone's job.
20/10/16 44
The Seven Deadly Diseases
• Lack of constancy of purpose to plan products and
services.
• Emphasis on short‐term profits.
• Personal review systems for managers and
management by objectives.
• Job hopping by managers.
• Using only visible data in decision making.
• Excessive medial costs.
• Excessive costs of liability driven up by lawyers that
work on contingency.

20/10/16 45
The Quality Circle of Deming
ACT PLAN
Improvements
CHECK DO
Quality
Time
20/10/16 46
Model of a Process Based QM‐System
Schematic representation of a single process within the system 47


20/10/16 Dr. Gökcen Bas ‐ Dipl.‐Ing. Erol Güçlü 48
20/10/16 Fundamentals of personnel certification in the process-oriented integrated management systems 49

The Principles of QM to ISO 9001
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence‐based decision making;
— relationship management.
20/10/16 Fundamentals of personnel certification in the process-oriented integrated management systems 50

ISO 9001:2008 ISO 9001:2015
Products Products and services
Exclusions Not used
Management representative Not used
Documentation, quality manual, Documented information

documented procedures, records
Work environment Environment for the operation of
processes
Monitoring and measuring Monitoring and measuring
equipment resources
Purchased product Externally provided products and
services
Supplier External provider
20/10/16 51
Juran’s Philosophy
• Joseph M. Juran, like Deming, went to Japan in 1954
and assisted the Japanese in their quest to achieve
quality. Like Deming, Juran emphasized planning,
organizing and controlling. However he emphasized
customer satisfaction more than Deming did and
focused on management and technical methods rather
than worker satisfaction. Juran was a prolific author,
publishing over a dozen books. His most influential
book Quality Control Handbook (later called Juran's
Quality Handbook )was published in 1951 and became
a best seller.

20/10/16 52
• By 1960 Japan was using quality control circles and simple statistical
techniques learned and applied by Japanese workers. Juran
developed basic steps that companies must take, however he
believed there was a point of diminishing return, a point at which
quality goes beyond the consumer needs.
• For example, if the consumer trades his car in after 50,000 miles,
the car need to be built to perform trouble‐free for only 60,000
miles. Building a better car would drive up costs without delivering
the expected product. This is called the Pareto Principle, or the
Juran 80/20 rule: 80 percent of the trouble comes from 20 percent
of the problems. The rule is named for Vilfredo Pareto, an
economist, but it was Juran that applied the idea to management. It
can be expressed as: "concentrate on the 'vital few' sources of
problems; don't be distracted by less important problems."

20/10/16 53
Juran's trilogy involves:
• Quality planning (determine customer needs,
develop product in response to needs).
• Quality control (assess performance, compare
performance with goals, act on differences
between performance and goals).
• Quality improvement (develop infrastructure,
identify areas of improvement and implement
projects, establish project team, provide teams
with what they need).
20/10/16 54
Costs of Quality Problems Random
Outliers
40% -- Phase of Quality

Improvement
20% -- New Zone of Quality

Formal Zone of Quality Control
Control
Time
Chronic Lost
20/10/16 55
Armand V. Feigenbaum
Total Quality Control (TQC)
• Main tasks:
 fulfillment of customers requirements and analysis of
potential errors in design
 quality control of suppliers
 production control and product control in compliance with
quality standards requirements
 evaluation of specialized quality assessments to identify
error sources and to enable improvement of products
and processes

20/10/16 56
Kaoru Ishikawa
• Problems with quality locate, analyze and implement improvement
• Quality Circles:
groups from 5 to 12 employees
1 to 2 Hr. during the work time per week
 select work related weak points or problems

 after approval of the responsible lead discussions
and systematical analysis
 responsible implementation of solutions and improvement proposals
 check of attained achievements

20/10/16 57
Humans Maschine Environment
Separate Source
Problem
Supplementary Cause
Material Method Messung
20/10/16
Cause Effect
Fundamentals of personnel certification in the process-oriented integrated management systems 58
The Philosophy of G. Taguchi
Every deviation from the ideal target value is a lost,
either for the manufacturer or customers or society.
- Target values should be kept as accurate as
possible.
- To determine the ideal settings of parameters of a
process has been develop the experimental method
„Design of Experiments“ (variation of parameters of
the signal and noise parameters)

20/10/16 59
Quality lost function defined by Taguchi
Classical Approach Quality lost function
of Taguchi
„non - „non-
conformance“ „conformity“
conformance“
raising raising
lost lost
lower Tolerances Target value

upper lower upper
tolerance- tolerance-
tolerance- tolerance-
limit limit
limit limit

20/10/16 60
Development and Changes within Society
• Market changes
• Structure alterations
• Globalization, Requirements of the WTO
• Diversity within the production line
• Speedy communication
• Lifecycle of products
• Increase of customer requirements
• Values changing within the society
20/10/16 61
Effects on the Management Systems
• Higher flexibility of management systems
– The speed of changes within the Economy demand a quick
reaction within the management, to keep the market
position or even to improve it. Needed is the adaptation of
business structures, stretching of the processes,
implementation of new technologies, etc.
• Justification of processes and streams
– Integration of software‐solutions
– Legal compliance
– Risk analysis
• Integration of various management systems
20/10/16 62
Integration of software‐solutions
• In every business, data shall be collected and
analyzed in electronic form
• In every middle sized and large corporation, the
work shall be defined with processes using a
specialized software
• Decisions have to be based on data and facts and
a control system is absolutely inevitable
• Book keeping, accountancy, tax decelerations etc.
shall be accomplished in electronic form
20/10/16 63
Legal Harmonization
• Product guaranties
• EU Regulations for general product safety
• Conformity declaration procedures
• Sustainability approaches
• Environmental approaches
• Harmonization requirements for job assurance
and health insurance

20/10/16 64
Risk Analysis
• The suitability of the actions has to be provable.
Potential hazard must be estimated.
• EU‐legislation, harmonized with national legislation,
very often asks action plans based on risk analysis
(Seveso Directive – Industrial safety regulations in
Austria after an industrial accident that resulted
exposure of TCDD in a residential population).
• A risk analysis does not release the product from the
responsibility, but is a positive argument for the
general responsibility.
20/10/16 65
Integrated Management Systems
Evaluation of work places
Sanity and Social institutions,
Maintenance Security institutions
Q Prevention
Responsibility, Authority
H&S
Obligations
Contract check Instructing, Training
Design Work steps, jobs, Fire protection
Statistical methods best practice Explosion protection
Customer service Testing, Limit values Keeping of flammable
Documents Inspection, solutions
Inspection appointments
steering Auditing, Documentation,
Liability
Policy
Aims definition
System scheme
Further development
Certification E
Environmental orientation
Environmental programs

20/10/16 66
IMS
11/12/14 Dipl.Ing. Erol Güclü, Dr.techn. Gökcen Bas 67
Case Study 1
• The supplier to the automobile industry:
Federal Mogul Nürnberg GmbH
• Description of business: Supplier to the
automobile industry, development and
production of aluminum alloy pistons for car
engines, owner of foundry and melting house
as well as engine test stands, 1180 employees

20/10/16 68
Case Study 1
• Objective: Integration of occupational health and safety, quality and risk
management, excepting environmental protection as the environmental
management system (EMS)
• In‐house communication
– Kick‐off meeting
– Information on the progress of the project by postings at regular intervals
– Information disseminated in company meetings
– Subject‐related trainings, instructions, brief discussions
– Cross references between procedural instructions from quality management
(QM) and environmental management
– Participation in the environmental initiative “Umweltpaket Bayern”
– Company newsletter
– Educational films on safety at the workplace and environmental protection

20/10/16 69
Cost‐Benefit Synopsis
VDI 4060: 2005 Integrierte Managementsysteme (IMS)

20/10/16 70
Case Study 2
• Plastics‐processing industry: Hellermann Tyton
GmbH
• Description of business : Development,
manufacture and sales of cable‐bundle,
fixture, labelling and cable protection systems
as well as of customer‐specific injection‐
moulded articles, 300 employees

20/10/16 71
Case Study 2
• Objective : Integration of environmental protection and quality
management; continuous improvement of environmental‐
protection performance; transparency of environmental costs,
potentials for cost reduction; use of existing management
instruments
• In‐house communication
– Motivation workshop, formation of environment team plus external
consultancy
– Information events
– Bulletin board
– Interviews with employees at all levels in the context of environmental
impact study and internal audits
– Trainings/meetings/workshops
– Publications in technical literature
20/10/16 72
Cost‐Benefit Synopsis
Literature/sources
Umweltmanagementsysteme – Erfolgreiches Umweltmanagement in der Kunststoffverarbeitenden Industrie. Loseblattwerk, Verlag WEKA Media GmbH, August 2002

20/10/16 73
Fundamentals of personnel
certification in the process‐oriented
integrated management systems
311.158
Prof. Dr. Numan DURAKBASA

Certification of a Management System
• Certification of a management system (such as a
quality or environmental management system of
an organization) according to the ISO/IEC
17021:2015(Conformity assessment ‐
Requirements for bodies providing audit and
certification of management systems), is one
means of providing assurance that the
organization has implemented a system for the
management of the relevant aspects of its
activities, in line with its policy.
• Certification of a management system
provides independent demonstration that the
management system of the organization
a) conforms to specified requirements,
b) is capable of consistently achieving its
stated policy and objectives, and
c) is effectively implemented.

• ISO/IEC 17021:2015 is intended for use by bodies
that carry out audit and certification of
management systems as the International
Standard.
• It gives generic requirements for such
certification bodies performing audit and
certification in the field of quality, environmental
and other forms of management systems. Such
bodies are referred to as Certification Bodies.
• ISO/IEC 17021 includes the existing text of
ISO/IEC 17021:2015 with additional new
requirements for third‐party certification
auditing of management systems and the
competence of personnel involved in the
certification process. It also provides a
framework for the further development of
competence criteria as deemed appropriate
by the relevant ISO TCs.
Certification of a management system provides
independent demonstration that the
management system of the organization:
• conforms to specified requirements;
• is capable of consistently achieving its stated
policy and objectives;
• is effectively implemented

‐ Certification activities involve the audit of an
organization’s management system.
‐ The form of attestation of conformity of an
organization’s management system to a
specific management system standard or
other normative requirements is usually
a certification document or a certificate.

Audit
• What is an Audit?
Audire [lat.]
Definitions:
– be able to hear
– harken, pay attention
– hear, listen
– obey
Audit
What experiences have you had with audits?

Do you know of an audit similar situations?

Types of Audits
• 1. System
• 2. Process
• 3. Procedure
• 4. Product (includes services)

Audit
Audit, systematic, independent and documented

process for obtaining audit evidence (3.3) and
evaluating it objectively to determine the extent
to which the audit criteria (3.2) are fulfilled (ISO
19011: 2011).

Audit criteria
• set of policies, procedures or requirements
used as a reference against which audit
evidence (3.3) is compared (ISO 19011: 2011).

Audit evidence
• records, statements of fact or other
information which are relevant to the audit
criteria (3.2) and verifiable (ISO 19011: 2011).

Auditing Management Systems
• Certification activities involve the audit of an
organization's management system.
• EN ISO 19011:2013 (Guidelines for auditing
management systems) is the international
standard that provides guidelines for auditing
management systems applicable to all
organizations that need to conduct internal or
external audits of management systems or
manage an audit programme.
• Changes from EN ISO 19011:2011
a) the scope has been extended from auditing of quality and
environmental management systems to the audit of any
management systems;
b) the relationship between EN ISO 19011 and ISO / IEC 17021 has
been clarified;
c) remote audit methods (methods that do not require the
physical presence of the auditor on site) as well as the risk concept
was introduced;
d) confidentiality has been added as a new principle;
e) Sections 5 (Managing and audit programme), 6 (Performing an
audit) and 7(Competence and evaluation of auditors) were
reorganized;
Fundamentals of personnel certification in the process‐oriented integrated management systems 15

f) Additional information has been added in a new
Annex B (Additional guidance for auditors for
planning and conducting audits); aid boxes were
removed;
g) determining the competence and the assessment
process has been strengthened;
h) Illustrative examples of discipline‐specific
knowledge and skills have been shown in a new
Annex A (Guidance and illustrative examples of
discipline‐ specific knowledge and skills of auditors )

Process based system audit
• Are the processes defined and adequately
described?
• Are the responsibilities allocated?
• Are the defined processes, procedures and
activities implemented and carried out according
to the documentation?
• Does the process deliver the required results?
• Are the interactions of the processes efficiently
organized?
Audit performance
Examination of the
Arrange the audit
documentation
Audit
On‐site audit
preparation
Creation, approval and Implementation of audit

distribution of the report follow‐up measures

Performing an audit
Typical audit activities (ISO 19011)

20
Principles of auditing
• Integrity: the foundation of professionalism
• Fair presentation: the obligation to report truthfully and accurately
• Due professional care: the application of diligence and judgement
in auditing
• Confidentiality: security of information
• Independence: the basis for the impartiality of the audit and
objectivity of the audit conclu‐ sions
• Evidence‐based approach: the rational method for reaching reliable
and reproducible audit conclusions in a systematic audit process
• Responsibility
• Openness
• Responsiveness to complaints
An organization needing to conduct audits should establish an audit programme
that contributes to the determination of the effectiveness of the audi‐ tee’s
management system.
The audit programme should include information and resources necessary to
organize and conduct its audits effectively and efficiently
• objectives for the audit programme and individual audits;
• extent/number/types/duration/locations/schedule of the audits;
• audit programme procedures;
• audit criteria;
• audit methods;
• selection of audit teams;
• necessary resources, including travel and accommodation;
• processes for handling confidentiality, information security, health and safety,
and other similar matters.
Professional requirements for auditors
• General education
• Auditors Training: Audit Procedures & Techniques?
QM / UM methods and techniques? Standards, laws
and regulations
• Several years' professional experience in the scope
• Auditorium as a trainee
• personal qualities
• independence
Auditor's requirements,
Technical and organizational competence
• QM and auditor training
• Knowledge of the audit basis and objectives
• Quality management standards
• Industry‐specific standards and rules
• QM system documentation
• Empathy in product and process technology
• Planned, systematic and effective procedure
• The common goal: quality improvement
Auditor's requirements,
A responsible task
responsibility towards
• The company management
• Quality management
• The Audit Partner
• All employees
• The customers

Audit Planning
• Audit Programme
An audit programme for the full certification
cycle shall be developed to clearly identify the
audit activities required to demonstrate that the
client's management system fulfills the
requirements for certification to the selected
standards or other normative documents.

Audit Planning
• Audit Programme
The determination of the audit programme and
any subsequent adjustments shall consider the
size of the client organization, the scope and
complexity of its management system, products
and processes as well as demonstrated level of
management system effectiveness and the
results of any previous audits.
Audit Planning
• Audit Programme
The audit programme shall include a two‐stage
initial audit, surveillance audits in the first and
second years, and a recertification audit in the
third year prior to expiration of certification. The
three‐year certification cycle begins with the
certification or re‐certification decision.

Audit Planning
The audit plan shall be appropriate to the objectives and the
scope of the audit.
According ISO 17021 shall include following:
• the audit objectives;
• the audit criteria;
• the audit scope, including identification of the organizational
and functional units or processes to be audited;
• the dates and sites where the on‐site audit activities will be
conducted, including visits to temporary sites and remote
auditing activities, where appropriate;
• the expected duration of on‐site audit activities;
• the roles and responsibilities of the audit team members and
accompanying persons, such as observer or interpreters.
External auditing
Internal auditing
Supplier auditing Third party auditing
For legal, regulatory and similar
purposes
Sometimes called second party
Sometimes called first party audit For certification (see also the
audit
requirements in
ISO/IEC 17021:2011)
*IEN ISO 19011:2011

25/11/16 Dr. Gökcen Bas ‐ Dipl.‐Ing. Erol Güçlü
31
*IEN ISO 19011:2011
Auditor Competence
• Confidence in the audit process and the ability to
achieve its objectives depends on the competence of
those individuals who are involved in planning and
conducting audits, including auditors and audit team
leaders.
• Auditors should possess the knowledge and skills
necessary to achieve the intended results of the audits
they are expected to perform. All auditors should
possess generic knowledge and skills and should also
be expected to possess some discipline and sector‐
specific knowledge and skills.
Desired Personnel Behaviors
• Some examples of personnel behaviors that are important
for personnel involved in certification activities for any type
of management system are described as follows:
– ethical, i.e. fair, truthful. Sincere, honest and discreet
– open‐minded, i.e. willing to consider alternative ideas or points
of view
– collaborative, i.e. effectively interacting with others
– observant, i.e. actively aware of physical surroundings and
activities
– versatile, i.e. adjusts readily to different situations
– morally courageous, i.e. willing to act responsibly and ethically
even though these actions may not always be popular and may
sometimes result in disagreement or confrontation
15/01/15 Dipl.Ing. Erol Güclü, Dr.techn. Gökcen Bas 34
*ISO/IEC DIS 17021‐1:2014‐5
35
*ISO/IEC DIS 17021‐1:2014‐5
Example of a Specific Discipline
• Illustrative example of discipline‐ specific knowledge and
skills of auditors in information security management
guidelines from standards such as ISO 27000 Family – Information security
management, ISO/IEC DIS 27001:2013 + Cor. 1:2014 ‐ Information technology ‐
Security techniques ‐ Information security management systems ‐ Requirements
and ISO/IEC 27002, ISO/IEC 27003, ISO/IEC 27004 and ISO/IEC 27005;
identification and evaluation of customer and interested parties requirements;
the laws and regulations dealing with information security (e.g. intellectual
property; content, protection and retention of organizational records; data
protection and privacy; regulation of cryptographic controls; anti‐terrorism;
electronic commerce; electronic and digital signatures; workplace surveillance;
workplace ergonomics; telecommunications interception and monitoring of data
(e.g. e‐mail), computer abuse, electronic evidence collection, penetration testing,
etc.;

Example of a Specific Discipline
‐ processes, science and technology underlying information security
management;
‐ risk assessment (identification, analysis and evaluation) and trends
in technology, threats and vulnerabilities;
‐ information security risk management;
‐ methods and practices for information security controls (electronic
and physical);
‐ methods and practices for information integrity and sensitivity;
‐ methods and practices for measuring and evaluating effectiveness
of the information security management system and associated
controls;
‐ methods and practices for measuring, monitoring and recording of
performance (including testing, audits and reviews).

Audit Objectives
• Audit objectives shall be specified for each
audit (with reference to the audit plan):
– Conformity with the related Standard and/or
Norms
– Competency of the MS to meet the legal, official
and customer requirements

On‐Site Audit
• Conducting on‐site audits shall include:
– Presentation of the audit team and their
responsibilities
– Clarification of the Audit objectives and open
questions
– Clarification of the Day schedule
– Status of the Audit reports from the previous audits
– Confidentiality Guidelines
– Occupational Health, Safety and Emergency
procedures
– Performance and documentation with an open
meeting
On‐Site Audit
Overview of the process of collecting and

verifying information
On‐Site Audit
• During the audit, information shall be
collected and verified, to be used as audit
evidence:
– Audit transcripts (log, audit report, ...)
– Copies of the audit findings records
• Audit findings shall also include:
– Improvement
– Nonconformities
– Disagreements
On‐Site Audit
• Debriefing and an end meeting shall be
carried out with the management of the
customer and be documented including:
– Presentation of audit findings and Note On
Sampling Procedure
– Further procedure as report and certificate
generation
– Process for the treatment of non‐conformities and
complaints
Audit Report
• The certification body shall provide a written
report for each audit.
• Audit report is the property of the certification
body. The audit team leader shall ensure that the
audit report is prepared and shall be responsible
for its content.
• The audit report shall contain all the information
necessary for a certification decision.
• Audit transcripts (copies of records) are part of
the audit report, in this case, a reference to the
copies of the audit report is necessary.
Audit Report
• The audit report shall include:
a) identification of the certification body;
b) the name and address of the client and the client's management representative;
c) the type of audit (e.g. initial, surveillance or recertification audit);
d) the audit criteria;
e) the audit objectives;
f) the audit scope, particularly identification of the organizational or functional units
or processes audited and the time of the audit;
g) identification of the audit team leader, audit team members and any accompanying
persons;
h) the dates and places where the audit activities (on site or offsite) were conducted;
i) audit findings, evidence and conclusions, consistent with the requirements of the
type of audit;
j) any unresolved issues, if identified.
Certification for Persons
• The international standard ISO/IEC
17024:2012 (Conformity assessment–
General requirements for bodies
operating certification of persons)
contains principles and requirements
for a body certifying persons against
specific requirements, and includes
the development and maintenance of
a certification scheme for persons.
• General requirements for the certification
body of persons include legal matters:
– The certification body shall be a legal
entity, or a defined part of a legal entity,
such that it can be held legally
responsible for its certification activities.
A governmental certification body is
deemed to be a legal entity on the basis
of its governmental status.
• The certification body shall be responsible for,
shall retain authority for, and shall not
delegate, its decisions relating to certification,
including the granting, maintaining,
recertifying, expanding and reducing the
scope of the certification, and suspending or
withdrawing the certification.

Auditor Qualification
• The qualification is based on the principle
requirements of standards and accreditation
bodies, however, each certification body has their
specific needs. The accreditation body shall check
whether the basic requirements are met.
– Vocational Education and Training
– Experience of min. 5 years, 2 of them related with QM
– Any additional qualification as relevant consultant
– QM training and Auditor Training
• Maintaining the auditor qualification is based on the
principle requirements of standards and accreditation
bodies, however, each certification body their specific
needs. Recertification by the certification body shall
consider at least the following:
a) on‐site assessment;
b) professional development;
c) structured interviews;
d) confirmation of continuing satisfactory work and work
experience records;
e) examination;
f) checks on physical capability in relation to the competence
concerned.
• The certification body shall require that a certified person
signs an agreement for the following reasons:
a) to comply with the relevant provisions of the certification
scheme;
b) to make claims regarding certification only with respect to the
scope for which certification has been granted;
c) not to use the certification in such a manner as to bring the
certification body into disrepute, and not to make any statement
regarding the certification which the certification body considers
misleading or unauthorized;
d) to discontinue the use of all claims to certification that contain
any reference to the certification body or certification upon
suspension or withdrawal of certification, and to return any
certificates issued by the certification body;
e) not to use the certificate in a misleading manner.
Dipl.Ing. Erol Güclü, Dr.techn. Gökcen Bas 50
• Transactional Analysis:
How do you react as an auditor?

 
Talking with each other

Interpersonal Relationships
• Interpersonal relationships (Vera
Birkenbihl)
Self Esteem (SWG)
Human wants (Desideratum-Turm)
Motivation
Transactional analysis (TA)
Interpersonal Relationships
• Self Esteem (SWG):
1. We picture ourselves
2. We act according to self-picturing.
3. A self-picturing differs from reality.
4. In the case the inequality of the self-picture and reality is too
separated it influences the communication.
5. Failing communication suppresses the self picture and its
quality.

We create a self-picture
The self-picture is being created by comparison
with others. Consciously or unconsciously we
always answer the question:
Is the other person taller (stronger, more clever,

better, higher educated), shorter or is he equal?

Behave in compliance with
our self-picture
If we believe that the other person has more
value, then we behave different than that of being
equal in the conversation. Self‐picturing is very
important and is the basis for our actions, not
reality.
Our own consideration of reality leads us to
actions, not the objective reality.
Self-picturing can differ from
reality
In selected special cases, the self‐picture and
reality set are equivalent. But not within the
discussion. The faulty self‐picturing made possible
a series of joyful mice and elephant jokes. Ma be
you remember, when they are passing a decrepit
wooden bridge and the mouse says:
»Can you feel shaking the bridge while we are
passing through ?«
As inequality between self-
picture and reality is separated
communication will suffer
Imagine a youngster believes he is extremely
operative in dirty Jeans and having long, untreated
hair ...
According to his self-picturing, he assumes that
ladies will like him as he pretends. If ladies who
are introduced consider him being repulsive, might
the discussion not run well any more.
Failing communication
suppresses self esteem
Within the communication seminars, done by Mrs.
Birkenbihl since the year 1970 in the USA and since
end of the year 1972 also in Germany (for business
as well as private), she has shown repeatedly the
following:
In the case of participants who received help to
better understand communication sentences,
their own reaction has automatically improved.
Who here has in the past spent time to think
consciously and intensively about his fellow men ?
Who asks himself truly why someone shouts upon the
others ? Who would not say: »I have not attacked you
at all !« Nobody has properly learned how to listen.
We are seeking delinquent ones in the case of the
communication mistakes instead of searching for the
reason.
»We learn to drive a car. We take driving lessons and study
the rules and laws. We drive during the first year really
carefully, because we know, that it needs some time to
reach for the needing routine to incorporate the mistakes of
others or to build the right reaction to sudden hazardous
situations.
But how do we do this within interpersonal relationship
preach? We preach out statement, we think negative, we
quarrel and we blame others. Even though a human being is
more complex than a car, lets try, without any training to
understand!«

Eng 311.158 WS2016

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Fundamentals of personnel certification in the process-oriented integrated management systems

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Fundamentals of personnel certification in the process-oriented integrated management systems

Fundamentals of personnel certification in the process-oriented integrated management systems

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Fundamentals of personnel certification in the process-oriented integrated management systems

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1950 1960 1970 1980 1990 2000 Time

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Quality Total Quality

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