Qualitätsmanagement SS2016 ENG

AUSTAUSCHBAU UND MESSTECHNIK - AuM
INTERCHANGEABLE MANUFACTURING AND

INDUSTRIAL METROLOGY
Quality Management
- Seminar and Industrial Applica�ons
311.026

Prof. Dr. Numan M. Durakbasa

Quality Management - Seminar and Industrial Applica�ons

Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü
Management
D  The verb manage comes from the Italian maneggiare
(to handle — especially tools), which in turn derives
from the La�n manus (hand). The French word
mesnagement (later ménagement) influenced the
development in meaning of the English word
management in the 17th and 18th centuries.
D  Management :
(Definition according to ISO 9000:2015; 3.3.3)
coordinated ac�vi�es for direct and control an

organiza�on
2
Managementsystem
D  Management system comprises the
organiza�onal structure, procedures, processes
and resources needed to implement quality
management.
D  Management system :
(Defini�on 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 Quality Management - Seminar and Industrial Applica�ons
3
A management system is a set of
interlinked activities for functioning of
leadership as planning, deciding,
organization, checks, leadership
The famous nowadays applied management

system is the Quality management
according to the:
ISO 9001:2015
4
So a management system defines the play
rules of an organization:
ü  What is the direction of the organization ?
ü  Who is responsible ?
ü  How will be the aims reached ?
ü  In what way are systematic improvements
implemented ?
Quality Management - Seminar and Industrial Applica�ons 5

The most important management standards:
ü Quality management systems:
ISO 9001:2015
EFQM-Modell
ü Environmental management systems:
ISO 14001:2015
ü Management systems for Foods Safety
ISO/TS 22003:2013

6
ü Work safety management systems:
BS OHSAS 18001:2007
ü Informa�on security management systems:
ISO 2700x (ISO 27001:2013)
ü Medical products – Quality management
systems
ISO/DIS 13485:2015
7

Quality management systems
(ISO 9001:20015)
Quality is that the

customer returns,
not the product
8
The scope and the
structure of quality
systems and also of
quality management
standards should be
formed on the basis
of an integrated
system of q u a l i t y
principles.
Figure : Applying the Quality Management Principles to the Execu�ve Management Area of Strategic Planning
Old and new Versions
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
4.1 Verantwortung der Leitung
Management
responsibility
4.2 4.14 S
4.3 Vertragsprüfung C a C
t
u u
Qualitätsmanagementsystem
R i
Measurement ,
4.4 Designlenkung e s
Resource s
Vorbeugungsmaßnahmen s q analysis
,
f
t u management a t
c
i improvement
o r t o
e i
Korrektur- und
m o
m
m
n
e
e
e
n Product/
r t Input Service Output
Product /
r
s
4.19 Kundendienst realization
Service
4.20 Statistische Methoden
ISO 9001:2000
ISO 9001:1994

10
The ISO 9000
international
standards with
its orientation to
processes gave
a useful frame
f o r t h e
development of
q u a l i t y
management
systems.
Figure: Model of a Process-based Quality Management System

Old and new Versions
Prozessmodell der DIN EN ISO 9001:2008 Prozessmodell der DIN EN ISO 9001:2015

12
PLAN-DO-CHECK-ACT Cycle
*ISO 9001:2015, Quality management systems – requirements

13
Representa�on of the elements of a single process

The Schematic representation of the elements of a single process
*ISO 9001:2015, Quality management systems – requirements
14
Notable changes of ISO 9001
D  ISO standards are reviewed every five years and revised if

needed.
D  This helps ensure they remain useful tools for the marketplace.
D  The challenges faced by business and organizations today are

very different from a few decades ago and ISO 9001 has been
updated to take this new environment into account.

15
D  For example, increased globalization has changed the way we do

business and organizations often operate more complex supply
chains than they did in the past.
D  In addition, there are increased expectations from customers and

other interested parties and, with more access to information,
today’s wider society has a stronger voice than ever before.
D  ISO 9001 needs to reflect these changes in order to remain

relevant.

16
ISO 9001 needs to change, to:
D  adapt to a changing world
D  reflect the increasingly complex environments in which
organizations operate
D  provide a consistent foundation for the future
D  reflect the increasingly complex environments in which
organizations operate
D  ensure the new standard reflects the needs of all relevant
interested parties
D  Ensure alignment with other management system
standards Quality Management - Seminar and Industrial Applica�ons
17
D  10-clause structure and core text for all Management System Standards
(MSS)
D  More compa�ble with services and non-manufacturing users
D  Clearer understanding of the organiza�on’s context is required “one size
doesn’t fit all”
D  Process approach strengthened/more explicit
D  Concept of preven�ve ac�on now addressed throughout the standard by risk
iden�fica�on and mi�ga�on
D  The term documented informa�on replaces the terms document and record
D  Control of externally provided products and services replaces purchasing/
outsourcing
D  Increased emphasis on seeking opportuni�es for improvement

18
Prior to the commencement of a revision (or amendment) to a management system
standard, a “Justification Study” is prepared to present a case for the proposed project
which outlines details of the data and inputs used to support its arguments. In relation
to the development of ISO 9001:2015 user needs were identified from the following:
D ISO Annex SL provides a common structure, text, terms and definitions for
management system standards.
D the results of a formal “Systematic Review” on ISO 9001:2008 that was performed by
the members of ISO/TC 176/SC2
D feedback from the ISO/TC 176/SC2 Working Group on Interpretations
D an extensive worldwide “User Feedback Survey” on ISO 9001 was performed by ISO/
TC 176/SC 2
www.iso.org 19
ISO 9001:2015 Cer�fica�on
Transi�on Timeline
2015 2016 2017 2018
September 2015
Published Interna�onal
Standard
September 2015 start of 3 years transi�on period to

September 2018
Cer�fica�ons to ISO 9001:2008 will no longer be valid
a�er September 2018
www.iso.org

Beneficial changes to ISO 9001
D  Enhanced leadership involvement in the
management system
D  Risk-based thinking
D  Simplified language, common structure and terms
D  Aligning QMS policy and objec�ves with the
strategy of the organiza�on
18.04.16 Quality Management - Seminar and Industrial Applica�ons

21
Structure of ISO 9001:2015
(1/3)
1  Scope 2 Norma�ve references 3 Terms and defini�ons
4 Context of the organiza�on

4.1 Understanding the organiza�on and its context
4.2 Understanding the needs and expecta�ons of interested par�es
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Ac�ons to address risks and opportuni�es
6.2 Quality objec�ves and planning to achieve them
6.3 Planning of changes
www.iso.org
(2/3)
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communica�on
7.5 Documented informa�on
8 Opera�on
8.1 Opera�onal planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and
services
8.5 Produc�on and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs www.iso.org
(3/3)
9 Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
www.iso.org
The common structure and ISO 9001:2015 addi�ons
4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Opera�on 10 Improvement
organiza�on Evalua�on
8.1 9.1 Monitoring,

5.1 6.1 7.1
4.1 Understanding Opera�onal planning measurement, 10.1
Leadership and Risks and Resources
context and control analysis and General
commitment opportuni�es
evalua�on
7.2
4.2 6.2 Competence 10.2
5.2 9.2
Interested par�es Planning Nonconformity and
Policy Internal audit
correc�ve ac�on
7.3
5.3 Awareness
4.3 Organiza�onal 9.3 10.3
Scope roles, Management Con�nual
review improvement
responsibili�es and
authori�es
7.4 Communica�on
ISO/TC 176/SC 2/ N1282
4.4
QMS
7.5
Documented
informa�on
25
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance and
Leadership Planning Support Opera�on Improvement
4.1 7.1 9.1

5.1 6.1 8.1 Monitoring, 10.1
Understanding Ac�ons to address Resources General
Leadership and Opera�onal planning measurement,
context risks and
commitment and control analysis and
opportuni�es 7.1.2 evalua�on
4.2 People
Interested par�es 5.2
10.2 Nonconformity
Policy 6.2 See next slide
9.1.2 and correc�ve ac�on
Quality objec�ves 7.1.3
Infrastructure Customer sa�sfac�on
4.3 and planning
Scope 5.3
Organiza�onal roles,
10.3
responsibili�es and 7.1.4 9.1.3
6.3 Con�nual
authori�es Environment for the Analysis and
4.4 Planning of changes improvement
QMS opera�on of processes evalua�on
7.1.5 9.2
Monitoring and Internal audit
measuring resources
9.3
7.1.6 Management review
Organiza�onal
ISO/TC 176/SC 2/ N1282
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
26
4 9
5 6 7 8 10
8.1 Opera�onal planning and 8.3 Design and 8.4 Control of externally 8.6 Release of products and
development of products provided processes, products 8.5 Produc�on and service
control services
and services provision
and services
8.2 Requirements for products 8.5.1 Control of produc�on 8.7 Control of nonconforming
8.3.1 General 8.4.1 General
and services and service provision process outputs
8.2.1 Customer 8.3.2 Design and 8.4.2 Type and extent of 8.5.2 Iden�fica�on and
communica�on development planning control traceability
8.2.2 Determina�on of 8.5.3 Property belonging to

8.3.3 Design and 8.4.3 Informa�on for external
requirements related to customers or external
development Inputs providers
products and services providers
8.2.3 Review of requirements 8.3.4 Design and

ISO/TC 176/SC 2/ N1282
related to products and development controls 8.5.4 Preserva�on

services
8.2.4 Changes to requirements 8.3.5 Design and 8.5.5 Post-delivery ac�vi�es

for products and services development outputs
8.5.6 Control of changes

8.3.6 Design and
development changes
27
4
Context of organiza�on
4.1
Clause 4.1
Understanding context Determine what the relevant external and internal issues
are for your organization, and that are relevant to its
4.2
Interested par�es strategic direction
4.3
Scope
4.4
ISO/TC 176/SC 2/ N1282
QMS
28
4
4.1
Understanding context
Clause 4.2
4.2
Interested par�es Identify the relevant interested parties and their relevant
requirements
4.3
Scope
ISO/TC 176/SC 2/ N1282
4.4
QMS
29
4 Clause 4.3 and 4.4
The requirement for the scope is now better defined, must
4.1 be documented and consider:
Understanding context
§  external and internal issues
4.2
Interested par�es §  requirements of relevant interested parties
4.3
Scope
§  the products and services covered (must also be
stated in scope)
ISO/TC 176/SC 2/ N1282
4.4
QMS
§  allowing applicability of specific requirements
§  justification for any case where a requirement
cannot be applied (exclusion)
30
4 9
5 6 7 8 10
4.1 7.1 9.1

5.1 6.1 8.1 Monitoring, 10.1
context risks and
4.2 People
10.2 Nonconformity
Objec�ves and 7.1.3
4.3 planning
Scope 5.3
Organiza�onal roles, 10.3
6.3 Con�nual
7.1.5 9.2
measuring resources
9.3
Organiza�onal
ISO/TC 176/SC 2/ N1282
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
31

5
Clause 5.1.1
Leadership Leadership is required to ensure:
§  take accountability for the effec�veness of the quality management
5.1 system
Leadership and commitment
§  ensure the quality policy and quality objec�ves are compa�ble with
5.2 the context and strategic direc�on of the organiza�on
Policy
§  ensure the integra�on of the QMS requirements into the
5.3 organiza�on’s business processes
responsibili�es and §  promote the use of the process approach and risk-based thinking
authori�es
§  ensure that the QMS achieves its intended results
§  engage, direct and support persons to contribute to the
effec�veness of the QMS
§  suppor�ng relevant management roles
§  promo�on of improvement
Clause 5.1.2
ISO/TC 176/SC 2/ N1282
Top management needs to ensure customer sa�sfac�on through:

§ customer and applicable statutory and regulatory requirements being
determined and met
§ risk and opportuni�es are being addressed
§ the focus on products and services meeting customers and other
requirements
32
5 Clause 5.2
Leadership
Explicit requirement to apply the policy
5.1
5.2
Policy
5.3
authori�es
ISO/TC 176/SC 2/ N1282
33
5 Clause 5.2
Leadership
§  Explicit requirement to apply the policy
5.1
Clause 5.3
5.2
Policy §  Explicit requirement for relevant roles to be assigned,
5.3
communicated and understood
authori�es §  No requirement for a specific management representa�ve
and the responsibility now resides with top management
to assign and manage
§  Requirement for defining responsibility and authority for
ensuring processes are delivering their intended outputs
ISO/TC 176/SC 2/ N1282
34
4 9
5 6 7 8 10
4.1 7.1 9.1

5.1 6.1 8.1 Monitoring, 10.1
context risks and
4.2 People
10.2 Nonconformity
Quality objec�ves 7.1.3
4.3 and planning
Scope 5.3
10.3
6.3 Con�nual
7.1.5 9.2
measuring resources
9.3
Organiza�onal
ISO/TC 176/SC 2/ N1282
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
35
6 Clause 6.1
Planning
§  Considering the issues raised and relevant interested par�es’

6.1
Ac�ons to address risks and
requirements iden�fied (4.1 and 4.2), this clause requires the
opportuni�es
determina�on of risks and opportuni�es which need to be
addressed, actions to be taken and evaluation of the
6.2
Objec�ves and planning effectiveness of these actions
6.3
Planning of changes

ISO/TC 176/SC 2/ N1282
36
6 Clause 6.2
Planning
Objec�ves should be:

6.1
Ac�ons to address risks and
opportuni�es §  established for processes relevant to the QMS
6.2 §  in line with customer requirements

Objec�ves and planning
§  in line with products and services conformity

6.3
Planning of changes
§  monitored, communicated & updated
ISO/TC 176/SC 2/ N1282
37
6 Clause 6.3
Planning
§ Changes to the QMS should be carried out in a planned
manner
6.1
Ac�ons to address risk and
opportunity § The standard has evolved to enable organizations to
adapt to changing environments or circumstances
6.2
Objec�ves and planning
Note: It is important to know that change is addressed in
6.3
the following clauses:
Planning of changes
§  Clause 6.3 - Planning/implementing changes to the
QMS
§  Clause 7.1.6 - Organizational knowledge - for addressing
changing needs and trends, with respect to knowledge
ISO/TC 176/SC 2/ N1282
§  Clause 8.1 - Controlling operational changes, planned

and unintentional
§  Clause 8.5.6 - Addressing changes affecting products &
services
38
4 9
5 6 7 8 10
4.1 7.1 9.1

5.1 6.1 8.1 Monitoring, 10.1
context risks and
4.2 People
10.2 Nonconformity
4.3 planning
Scope 5.3
10.3
6.3 Con�nual
7.1.5 9.2
measuring resources
9.3
Organiza�onal
ISO/TC 176/SC 2/ N1282
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
39
7
Support Clause 7.1
7.1 There should be adequate resources to ensure effec�veness of
Resources
the QMS. Resource considera�ons now include:
7.1.2
§  internal resources
People
7.1.3
Infrastructure
§  external providers
§  people
7.1.4
Environment for the
opera�on of processes
§  monitoring and measuring resources

7.1.5
Monitoring and measuring
resources §  organiza�onal knowledge required to ensure the processes
provide conforming products and services
7.1.6
Organiza�onal knowledge
§  external communica�on
ISO/TC 176/SC 2/ N1282
7.2
Competence
7.3
Awareness
7.4
Communica�on .
7.5
Documented informa�on
40
7
Support Clause 7.3 and 7.4
7.1 Relevant persons doing work under the organiza�on’s control
Resources
need to have awareness and communica�on (internal and
external) of the QMS and benefits of improving performance
7.1.2
People
7.1.3
Infrastructure
7.1.4
Environment for the
opera�on of processes
7.1.5
resources
7.1.6
ISO/TC 176/SC 2/ N1282
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
41

7
Support Clause 7.5.1
7.1
Resources
Requirements that used to be required for a quality manual
7.1.2
have been enhanced and made more flexible to allow for the
People use of documented informa�on needed for the quality
7.1.3
Infrastructure
management system
7.1.4

Environment for opera�on of
processes
Clause 7.5.2
7.1.5
Enhanced requirement for the crea�on and upda�ng of
resources
documented informa�on, e.g. descrip�on, format & suitability
7.1.6
ISO/TC 176/SC 2/ N1282
7.2
Competence
Clause 7.5.3
7.3
Awareness
Control of documented informa�on – now explicitly includes
7.4
confiden�ality, integrity and access
Communica�on

7.5

42
4 9
5 6 7 8 10
4.1 7.1 9.1

5.1 6.1 8.1 Monitoring, 10.1
context risks and
4.2 People
10.2 Nonconformity
4.3 planning
Scope 5.3
10.3
6.3 Con�nual
authori�es Environment for Analysis and
7.1.5 9.2
measuring resources
9.3
Organiza�onal
ISO/TC 176/SC 2/ N1282
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
43
4 9
5 6 7 8 10
8.1 Opera�onal planning and 8.3 Design and 8.4 Control of externally 8.6 Release of products and
development of products provided processes, products 8.5 Produc�on and service
control services
and services provision
and services
8.2 Requirements for products 8.5.1 Control of produc�on 8.7 Control of nonconforming
8.3.1 General 8.4.1 General
and services and service provision process outputs
8.2.1 Customer 8.3.2 Design and 8.4.2 Type and extent of 8.5.2 Iden�fica�on and
communica�on development planning control traceability
8.2.2 Determina�on of 8.5.3 Property belonging to

8.3.3 Design and 8.4.3 Informa�on for external
requirements related to customers or external
development Inputs providers
products and services providers
8.2.3 Review of requirements 8.3.4 Design and

ISO/TC 176/SC 2/ N1282
related to products and development controls 8.5.4 Preserva�on

services
8.2.4 Changes to requirements 8.3.5 Design and 8.5.5 Post-delivery ac�vi�es

for products and services development outputs

8.3.6 Design and
development changes
44
8 Opera�on
Clause 8.1.b
§  explicit requirement for establishing criteria for processes
8.1 Opera�onal planning and Clause 8.2.1
control
§  explicit considera�ons are now linked to: customer

8.2 Requirements for
products and services communica�ons; customer property, and con�ngency
ac�ons
8.2.1 Customer
communica�on
Clause 8.2.2
8.2.2 Determina�on of
requirements related to
products and services
§  Determina�on of requirements; this requires a process and
8.2.3 Review of requirements
is explicit with regard to substantiating claims for
related to products and
services products and services being offered
ISO/TC 176/SC 2/ N1282
8.2.4 Changes to
requirements for products
and services
45
8 Opera�on
Clause 8.3
This sec�on on design and development of products and
8.3 Design and
services has substan�vely changed and simplified:
development of products
and services
Clause 8.3.2
8.3.1 General
§ Design and development has been restructured to allow for a
8.3.2 Design and
more process orientated approach
development planning
§ Involvement of customers and users as part of design planning
8.3.3 Design and
development inputs
to be considered
8.3.4 Design and

Clause 8.3.3
development controls
§ Design and development inputs – explicit requirements for
ISO/TC 176/SC 2/ N1282
8.3.5 Design and

development outputs
internal and external resource needs, poten�al consequences of
failure, level of control expected by customers
8.3.6 Design and
development changes
Clause 8.3.4
§ Design and development controls – new clause combining
Reviews, Verifica�on & Valida�on
46
8 Opera�on
Clause 8.4
§ The terms which previously referred to purchasing and
8.4 Control of externally
‘outsourcing’ is now ‘Control of externally provided processes,
provided processes
products and services products and services’
8.4.1 General Clause 8.4.1
8.4.2 Type and extent of

§ Condi�ons are applied when controls are required for
control
externally provided processes, products and service
8.4.3 Informa�on for
external providers
§ Terminology has changed from ‘supplier’ to ‘external
provider’
Clause 8.4.2
ISO/TC 176/SC 2/ N1282
§ Type and extent of control of external provision previous

notes in 4.1 (ISO 9001:2008) now turned into requirements
Clause 8.4.3
§ Informa�on for external providers are now more detailed and
explicit
47
8 Opera�on
Clause 8.5.1
This clause specifically considers:
8.5 Produc�on and service §  monitoring and measurement ac�vi�es will ensure the
provision
control of processes and output (clauses 8.2.3 and 8.2.4 of
8.5.1 Control of produc�on
and service provision
ISO 9001:2008 have been moved to 8.5.1)
§  acceptance criteria for products and services are met
8.5.2 Iden�fica�on and
traceability
§  the use, and control of suitable infrastructure and process
8.5.3 Property belonging to
customers or external environment
providers
§  suitable monitoring and measuring resources

8.5.4 Preserva�on
§  Requires competent persons

ISO/TC 176/SC 2/ N1282
8.5.5 Post-delivery ac�vi�es
48
8 Opera�on
Clause 8.5.2
§  The iden�fica�on and traceability now focus on ‘outputs’
8.5 Produc�on and service
provision
rather than on ‘product’ (includes intermediate products
and services) rather than on ‘product’
8.5.1 Control of produc�on
and service provision
Clause 8.5.3
8.5.2 Iden�fica�on and
traceability
§  Customer property has been expanded to include external
providers’ property
8.5.3 Property belonging to
customers or external
providers Clause 8.5.4
8.5.4 Preserva�on §  Preserva�on of product has been changed to preserva�on
of the output
ISO/TC 176/SC 2/ N1282
8.5.5 Post-delivery ac�vi�es
Clause 8.5.5
§  Post-delivery ac�vi�es is a new clause

Clause 8.5.6
§  A new requirement for the control of changes is addressed
in the slide introducing the concept of change 49
Changes in the ISO 9001
4.1
Determine what the relevant external and internal issues are for your
organiza�on, and that are relevant to its strategic direc�on

4.2
Iden�fy the relevant interested par�es and their relevant requirements

6.1
Considering the issues raised and relevant interested par�es’ requirements
iden�fied (4.1 and 4.2), this clause requires the determina�on of risks and
opportuni�es which need to be addressed, ac�ons to be taken and
evalua�on of the effec�veness of these ac�ons

50
7.1
There should be adequate resources to ensure effec�veness of the QMS.
Resource considera�ons now include:
§  internal resources
§  external providers
§  people
§  monitoring and measuring resources
§  organiza�onal knowledge required to ensure the processes provide conforming
products and services
§  external communica�on

51
8.2.1
explicit considera�ons are now linked to: customer communica�ons;
customer property, and con�ngency ac�ons
8.3
This sec�on on design and development of products and services has
substan�vely changed and simplified
8.4
The terms which previously referred to purchasing and ‘outsourcing’ is
now ‘Control of externally provided processes, products and services’

52
8.5.1
monitoring and measurement ac�vi�es will ensure the control of
processes and output (clauses 8.2.3 and 8.2.4 of ISO 9001:2008 have been
moved to 8.5.1)
8.5.2
The iden�fica�on and traceability now focus on ‘outputs’ rather than on
‘product’ (includes intermediate products and services) rather than on
‘product’
8.5.3
Customer property has been expanded to include external providers’
property

53
8.5.4
Preserva�on of product has been changed to preserva�on of the output
8.5.5
Post-delivery ac�vi�es is a new clause
8.5.6
A new requirement for the control of changes is addressed in the slide
introducing the concept of change

54

Summary
§  Determining the organiza�onal context enables a
more effec�ve implementa�on of the quality
management system
§  Greater emphasis on processes being managed to
achieve planned results
§  Alignment with strategic direc�on
§  Integra�on of the QMS into organiza�on’s business
processes
Summary
§  Determining risks and opportuni�es increase the
effec�veness of the organiza�on’s QMS
§  Change management has been expanded to add
emphasis that the QMS should be carried out in a
planned manner
§  The concept of organiza�onal knowledge introduced
to ensure the organiza�on acquires and maintains
the necessary knowledge
§  Communica�on expanded to include external

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AUSTAUSCHBAU UND MESSTECHNIK - AuM

INTERCHANGEABLE MANUFACTURING AND

Quality Management - Seminar and Industrial Applica�ons

coordinated ac�vi�es for direct and control an

Set of interrelated or interacting elements of

The famous nowadays applied management

Quality Management - Seminar and Industrial Applica�ons 5

Quality Management - Seminar and Industrial Applica�ons

Quality is that the

4.20 Statistische Methoden

Quality Management - Seminar and Industrial Applica�ons

Figure: Model of a Process-based Quality Management System

Quality Management - Seminar and Industrial Applica�ons

*ISO 9001:2015, Quality management systems – requirements

D ISO standards are reviewed every five years and revised if

D The challenges faced by business and organizations today are

Quality Management - Seminar and Industrial Applica�ons

D For example, increased globalization has changed the way we do

D In addition, there are increased expectations from customers and

D ISO 9001 needs to reflect these changes in order to remain

Quality Management - Seminar and Industrial Applica�ons

Quality Management - Seminar and Industrial Applica�ons

2015 2016 2017 2018

September 2015 start of 3 years transi�on period to

Quality Management - Seminar and Industrial Applica�ons

18.04.16 Quality Management - Seminar and Industrial Applica�ons

4 Context of the organiza�on

8.1 9.1 Monitoring,

4.1 7.1 9.1

8.2.2 Determina�on of 8.5.3 Property belonging to

8.2.3 Review of requirements 8.3.4 Design and

related to products and development controls 8.5.4 Preserva�on

8.2.4 Changes to requirements 8.3.5 Design and 8.5.5 Post-delivery ac�vi�es

8.5.6 Control of changes

4.1 7.1 9.1

Top management needs to ensure customer sa�sfac�on through:

4.1 7.1 9.1

§ Considering the issues raised and relevant interested par�es’

Objec�ves should be:

6.2 § in line with customer requirements

§ in line with products and services conformity

§ Clause 8.1 - Controlling operational changes, planned

4.1 7.1 9.1

§ monitoring and measuring resources

4.1 7.1 9.1

8.2.2 Determina�on of 8.5.3 Property belonging to

8.2.3 Review of requirements 8.3.4 Design and

related to products and development controls 8.5.4 Preserva�on

8.2.4 Changes to requirements 8.3.5 Design and 8.5.5 Post-delivery ac�vi�es

8.5.6 Control of changes

§ explicit considera�ons are now linked to: customer

8.3.4 Design and

8.3.5 Design and

8.4.2 Type and extent of

§ Type and extent of control of external provision previous

§ suitable monitoring and measuring resources

§ Requires competent persons

8.5.5 Post-delivery ac�vi�es

8.5.6 Control of changes

8.5.5 Post-delivery ac�vi�es

§ Post-delivery ac�vi�es is a new clause

18.04.16 Quality Management - Seminar and Industrial Applica�ons

18.04.16 Quality Management - Seminar and Industrial Applica�ons

D  ISO standards are reviewed every five years and revised if

D  The challenges faced by business and organizations today are

D  For example, increased globalization has changed the way we do

D  In addition, there are increased expectations from customers and

D  ISO 9001 needs to reflect these changes in order to remain

§  Considering the issues raised and relevant interested par�es’

6.2 §  in line with customer requirements

§  in line with products and services conformity

§  Clause 8.1 - Controlling operational changes, planned

§  monitoring and measuring resources

§  explicit considera�ons are now linked to: customer

§ Type and extent of control of external provision previous

§  suitable monitoring and measuring resources

§  Requires competent persons

§  Post-delivery ac�vi�es is a new clause