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AUSTAUSCHBAU UND MESSTECHNIK - AuM INTERCHANGEABLE MANUFACTURING AND INDUSTRIAL METROLOGY Quality Management - Seminar and

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   The verb manage comes from the Italian maneggiare (to handle — especially tools),

Management

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.

Management (Definition according to ISO 9000:2015; 3.3.3) :

coordinated ac�vi�es for direct and control an organiza�on

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

2

Managementsystem   Management system comprises the organiza�onal structure, procedures, processes and resources

Managementsystem

Management system comprises the organiza�onal structure, procedures, processes and resources needed to implement quality management.

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 Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

3

A management system is a set of interlinked activities for functioning of leadership as planning,

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

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

4

So a management system defines the play rules of an organization: ü   What is

So a management system defines the play rules of an organization:

üWhat is the direction of the organization ? üWho is responsible ? üHow will be the aims reached ? üIn what way are systematic improvements implemented ?

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

5

The most important management standards: ü   Quality management systems: ISO 9001:2015 EFQM-Modell ü  

The most important management standards:

üQuality management systems:

ISO 9001:2015

EFQM-Modell

üEnvironmental management systems:

ISO 14001:2015 üManagement systems for Foods Safety ISO/TS 22003:2013

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

6

The most important management standards: ü   Work safety management systems: BS OHSAS 18001:2007 ü

The most important management standards:

üWork safety management systems:

BS OHSAS 18001:2007 üInforma�on security management systems:

ISO 2700x (ISO 27001:2013) üMedical products – Quality management systems ISO/DIS 13485:2015

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

7

The most important management standards: Quality management systems ( ISO 9001:20015 ) Quality is that

The most important management standards:

Quality management systems (ISO 9001:20015)

Quality is that the customer returns, not the product

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

88

The scope and the structure of quality systems and also of quality management standards should

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 quality principles.

on the basis of an integrated system of quality principles. Figure : Applying the Quality Management

Figure : Applying the Quality Management Principles to the Execu�ve Management Area of Strategic Planning

4.1 Verantwortung der Leitung 4.14 4.2 4.3 Vertragsprüfung 4.4 Designlenkung 4.19 Kundendienst 4.20 Statistische
4.1 Verantwortung der Leitung 4.14 4.2 4.3 Vertragsprüfung 4.4 Designlenkung 4.19 Kundendienst 4.20 Statistische
4.1 Verantwortung der Leitung
4.14
4.2
4.3 Vertragsprüfung
4.4 Designlenkung
4.19 Kundendienst
4.20 Statistische Methoden
Qualitätsmanagementsystem
Korrektur- und
Vorbeugungsmaßnahmen

ISO 9001:1994

Old and new Versions

QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT Management responsibility S a C C t u u i
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
Management
responsibility
S
a
C
C
t
u
u
i
R
Measurement
,
s
e
s
s
Resource
analysis
f
q
,
a
u
management
t
t
c
i
improvement
o
o
r
t
i
e
m
m
o
m
n
e
e
e
n
Product/
Input
Service
r
r
t
Output
Product
/
s
Service
realization

ISO 9001:2000

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

10

The ISO 9000 i n t e r n a t i o n a
The
ISO
9000
i n t e r n a t i o n a l
standards
with
its orientation to
processes
gave
a
useful
frame
f
o
r
t
h
e
development
of
a
m a n a g e m e n t
systems.
q
u
l
i
t
y

Figure: Model of a Process-based Quality Management System

Old and new Versions Prozessmodell der DIN EN ISO 9001:2008 P r o z e

Old and new Versions

Old and new Versions Prozessmodell der DIN EN ISO 9001:2008 P r o z e s
Old and new Versions Prozessmodell der DIN EN ISO 9001:2008 P r o z e s

Prozessmodell der DIN EN ISO 9001:2008

Prozessmodell der DIN EN ISO 9001:2015

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

12

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

PLAN-DO-CHECK-ACT Cycle

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

*ISO 9001:2015, Quality management systems – requirements

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

13

Representa�on of the elements of a single process The Schematic representation of the elements of

Representa�on of the elements of a single process

Representa�on of the elements of a single process The Schematic representation of the elements of a

The Schematic representation of the elements of a single process

*ISO 9001:2015, Quality management systems – requirements

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

14

Notable changes of ISO 9001       ISO standards are reviewed every five years

Notable changes of ISO 9001

ISO standards are reviewed every five years and revised if needed.

This helps ensure they remain useful tools for the marketplace.

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.

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

15

Notable changes of ISO 9001       For example, increased globalization has changed the

Notable changes of ISO 9001

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.

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.

ISO 9001 needs to reflect these changes in order to remain relevant.

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

16

Notable changes of ISO 9001 ISO 9001 needs to change, to:   adapt to a

Notable changes of ISO 9001 ISO 9001 needs to change, to:

adapt to a changing world

reflect the increasingly complex environments in which organizations operate

provide a consistent foundation for the future

reflect the increasingly complex environments in which organizations operate

ensure the new standard reflects the needs of all relevant interested parties

Ensure alignment with other management system standards

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

17

Notable changes of ISO 9001   10-clause structure and core text for all Management System

Notable changes of ISO 9001

10-clause structure and core text for all Management System Standards (MSS) More compa�ble with services and non-manufacturing users Clearer understanding of the organiza�on’s context is required “one size doesn’t fit all” Process approach strengthened/more explicit Concept of preven�ve ac�on now addressed throughout the standard by risk iden�fica�on and mi�ga�on The term documented informa�on replaces the terms document and record Control of externally provided products and services replaces purchasing/ outsourcing Increased emphasis on seeking opportuni�es for improvement

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

18

Notable changes of ISO 9001 Prior to the commencement of a revision (or amendment) to

Notable changes of ISO 9001

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:

ISO Annex SL provides a common structure, text, terms and definitions for management system standards. the results of a formal “Systematic Review” on ISO 9001:2008 that was performed by the members of ISO/TC 176/SC2 feedback from the ISO/TC 176/SC2 Working Group on Interpretations an extensive worldwide “User Feedback Survey” on ISO 9001 was performed by ISO/ TC 176/SC 2

  an extensive worldwide “User Feedback Survey” on ISO 9001 was performed by ISO/ TC 176/SC

www.iso.org

19

ISO 9001:2015 Cer�fica�on Transi�on Timeline 2015 2016 2017 2018 September 2015 Published Interna�onal

ISO 9001:2015 Cer�fica�on Transi�on Timeline

2015 2016 2017 2018
2015
2016
2017
2018
September 2015 Published Interna�onal Standard
September 2015
Published Interna�onal
Standard
2018 September 2015 Published Interna�onal Standard September 2015 start of 3 years transi�on period to
September 2015 start of 3 years transi�on period to September 2018 Cer�fica�ons to ISO 9001:2008
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

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

Beneficial changes to ISO 9001   Enhanced leadership involvement in the management system   Risk-based

Beneficial changes to ISO 9001

Enhanced leadership involvement in the management system

Risk-based thinking

Simplified language, common structure and terms

Aligning QMS policy and objec�ves with the strategy of the organiza�on

18.04.16

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

21

Structure of ISO 9001:2015
Structure of ISO 9001:2015

(1/3)

1Scope 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

Structure of ISO 9001:2015
Structure of ISO 9001:2015

(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

Structure of ISO 9001:2015
Structure of ISO 9001:2015

(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

ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282 The common structure and ISO 9001:2015 addi�ons 4 Context of organiza�on 9

The common structure and ISO 9001:2015 addi�ons

4 Context of organiza�on 9 Performance 5 Leadership 6 Planning 7 Support 8 Opera�on 10
4 Context of
organiza�on
9 Performance
5 Leadership
6 Planning
7 Support
8 Opera�on
10 Improvement
Evalua�on
9.1 Monitoring,
5.1
6.1
8.1
7.1
4.1 Understanding
measurement,
10.1
Leadership and
Risks and
Opera�onal planning
Resources
context
analysis and
General
commitment
opportuni�es
and control
evalua�on
7.2
10.2
4.2
6.2
Competence
5.2
9.2
Nonconformity and
Interested par�es
Planning
Policy
Internal audit
correc�ve ac�on
7.3
5.3
Awareness
4.3
9.3
10.3
Organiza�onal
Scope
Management
Con�nual
roles,
review
improvement
responsibili�es and
authori�es
7.4 Communica�on
4.4
QMS
7.5
Documented
informa�on

25

Plan Do Check Act 4 9 5 6 7 8 10 Context of Performance and
Plan
Do
Check
Act
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
9.1
4.1
7.1
5.1
6.1
10.1
8.1
Monitoring,
Understanding
Resources
Leadership and
Ac�ons to address
General
Opera�onal planning
measurement,
context
commitment
risks and
and control
analysis and
opportuni�es
7.1.2
evalua�on
4.2
People
5.2
Interested par�es
10.2 Nonconformity
Policy
See next slide
6.2
and correc�ve ac�on
9.1.2
7.1.3
Quality objec�ves
Customer sa�sfac�on
Infrastructure
4.3
and planning
5.3
Scope
Organiza�onal roles,
10.3
responsibili�es and
7.1.4
9.1.3
6.3
Con�nual
authori�es
4.4
Planning of changes
Environment for the
opera�on of processes
Analysis and
improvement
evalua�on
QMS
9.2
7.1.5
Internal audit
Monitoring and
measuring resources
9.3
7.1.6
Management review
Organiza�onal
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
ISO/TC 176/SC 2/ N1282
4 9 5 6 7 8 10 Context of Performance and Leadership Planning Support Opera�on
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
8.1 Opera�onal planning and
control
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
8.2 Requirements for products
and services
8.5.1
Control of produc�on
8.3.1 General
8.4.1 General
8.7 Control of nonconforming
process outputs
and service provision
8.2.1 Customer
8.3.2
Design and
communica�on
development planning
8.4.2 Type and extent of
control
8.5.2 Iden�fica�on and
traceability
8.2.2 Determina�on of
requirements related to
products and services
8.5.3
Property belonging to
8.3.3 Design and
development Inputs
8.4.3 Informa�on for external
providers
customers or external
providers
8.2.3 Review of requirements
related to products and
services
8.3.4
Design and
8.5.4 Preserva�on
development controls
8.5.5
Post-delivery ac�vi�es
8.2.4 Changes to requirements
for products and services
8.3.5
Design and
development outputs
8.5.6 Control of changes
8.3.6
Design and
development changes
27
ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282 4 Context of organiza�on 4.1 Understanding context 4.2 Interested par�es 4.3 Scope
4 Context of organiza�on 4.1 Understanding context 4.2 Interested par�es 4.3 Scope 4.4 QMS
4
Context of organiza�on
4.1
Understanding context
4.2
Interested par�es
4.3
Scope
4.4
QMS

Clause 4.1 Determine what the relevant external and internal issues are for your organization, and that are relevant to its strategic direction

28

ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282 4 Context of organiza�on 4.1 Understanding context 4.2 Interested par�es 4.3 Scope
4 Context of organiza�on 4.1 Understanding context 4.2 Interested par�es 4.3 Scope 4.4 QMS
4
Context of organiza�on
4.1
Understanding context
4.2
Interested par�es
4.3
Scope
4.4
QMS

Clause 4.2 Identify the relevant interested parties and their relevant requirements

29

ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282 4 Context of organiza�on 4.1 Understanding context 4.2 Interested par�es 4.3 Scope
4 Context of organiza�on 4.1 Understanding context 4.2 Interested par�es 4.3 Scope 4.4 QMS
4
Context of organiza�on
4.1
Understanding context
4.2
Interested par�es
4.3
Scope
4.4
QMS

Clause 4.3 and 4.4

The requirement for the scope is now better defined, must be documented and consider:

§

external and internal issues

§

requirements of relevant interested parties

§

the products and services covered (must also be stated in scope)

§

allowing applicability of specific requirements

§

justification for any case where a requirement cannot be applied (exclusion)

30

4 9 5 6 7 8 10 Context of Performance and Leadership Planning Support Opera�on
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
9.1
4.1
7.1
5.1
6.1
10.1
8.1
Monitoring,
Understanding
Resources
Ac�ons to address
General
Leadership and
Opera�onal planning
measurement,
context
commitment
risks and
and control
analysis and
opportuni�es
7.1.2
evalua�on
4.2
People
5.2
Interested par�es
10.2 Nonconformity
Policy
See next slide
6.2
and correc�ve ac�on
9.1.2
7.1.3
Objec�ves and
Customer sa�sfac�on
Infrastructure
4.3
planning
5.3
Scope
Organiza�onal roles,
10.3
responsibili�es and
7.1.4
9.1.3
6.3
Con�nual
authori�es
4.4
Planning of changes
Environment for the
opera�on of processes
Analysis and
improvement
evalua�on
QMS
9.2
7.1.5
Internal audit
Monitoring and
measuring resources
9.3
7.1.6
Management review
Organiza�onal
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
31
ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282

5 Leadership Clause 5.1.1 Leadership is required to ensure: 5.1 Leadership and commitment 5.2 Policy
5
Leadership
Clause 5.1.1
Leadership is required to ensure:
5.1
Leadership and commitment
5.2
Policy
5.3
Organiza�onal roles,
responsibili�es and
authori�es

§take accountability for the effec�veness of the quality management system §ensure the quality policy and quality objec�ves are compa�ble with the context and strategic direc�on of the organiza�on §ensure the integra�on of the QMS requirements into the organiza�on’s business processes §promote the use of the process approach and risk-based thinking §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 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

ISO/TC 176/SC 2/ N1282

5 Leadership Clause 5.2 Explicit requirement to apply the policy 5.1 Leadership and commitment 5.2
5
Leadership
Clause 5.2
Explicit requirement to apply the policy
5.1
Leadership and commitment
5.2
Policy
5.3
Organiza�onal roles,
responsibili�es and
authori�es

33

ISO/TC 176/SC 2/ N1282

5 Leadership Clause 5.2 §  Explicit requirement to apply the policy 5.1 Leadership and commitment
5
Leadership
Clause 5.2
§  Explicit requirement to apply the policy
5.1
Leadership and commitment
5.2
Policy
5.3
Organiza�onal roles,
responsibili�es and
authori�es

Clause 5.3 §Explicit requirement for relevant roles to be assigned, communicated and understood §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

34

4 9 5 6 7 8 10 Context of Performance and Leadership Planning Support Opera�on
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
9.1
4.1
7.1
6.1
10.1
5.1
8.1
Monitoring,
Understanding
Resources
Ac�ons to address
General
Leadership and
Opera�onal planning
measurement,
context
commitment
risks and
and control
analysis and
opportuni�es
7.1.2
evalua�on
4.2
People
5.2
Interested par�es
10.2 Nonconformity
Policy
See next slide
6.2
and correc�ve ac�on
9.1.2
7.1.3
Quality objec�ves
Customer sa�sfac�on
Infrastructure
4.3
and planning
5.3
Scope
Organiza�onal roles,
10.3
responsibili�es and
7.1.4
9.1.3
6.3
Con�nual
authori�es
Analysis and
4.4
Planning of changes
Environment for the
opera�on of processes
improvement
evalua�on
QMS
9.2
7.1.5
Internal audit
Monitoring and
measuring resources
9.3
7.1.6
Management review
Organiza�onal
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
35
ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282

6 Clause 6.1 Planning 6.1 Ac�ons to address risks and opportuni�es 6.2 §  Considering the
6 Clause 6.1
Planning
6.1
Ac�ons to address risks and
opportuni�es
6.2
§  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, actions to be taken and evaluation of the
effectiveness of these actions
Objec�ves and planning
6.3
Planning of changes

36

ISO/TC 176/SC 2/ N1282

6 Planning Clause 6.2 Objec�ves should be: 6.1 Ac�ons to address risks and opportuni�es 6.2
6
Planning
Clause 6.2
Objec�ves should be:
6.1
Ac�ons to address risks and
opportuni�es
6.2
Objec�ves and planning
6.3
Planning of changes
6.2 Objec�ves and planning 6.3 Planning of changes §   established for processes relevant to the

§established for processes relevant to the QMS §in line with customer requirements §in line with products and services conformity §monitored, communicated & updated

37

ISO/TC 176/SC 2/ N1282

6 Clause 6.3 Planning § Changes to the QMS should be carried out in a planned
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
the following clauses:
6.3
Planning of changes
in the following clauses: 6.3 Planning of changes §   Clause 6.3 - Planning/implementing changes to

§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

§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 Context of Performance and Leadership Planning Support Opera�on
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
9.1
4.1
7.1
10.1
5.1
6.1
8.1
Monitoring,
Understanding
Resources
Ac�ons to address
General
Leadership and
Opera�onal planning
measurement,
context
commitment
risks and
and control
analysis and
opportuni�es
7.1.2
evalua�on
4.2
People
5.2
Interested par�es
10.2 Nonconformity
Policy
See next slide
6.2
and correc�ve ac�on
9.1.2
7.1.3
Objec�ves and
Customer sa�sfac�on
Infrastructure
4.3
planning
5.3
Scope
Organiza�onal roles,
10.3
responsibili�es and
7.1.4
9.1.3
6.3
Con�nual
authori�es
Environment for the
opera�on of processes
Analysis and
4.4
Planning of changes
improvement
evalua�on
QMS
9.2
7.1.5
Internal audit
Monitoring and
measuring resources
9.3
7.1.6
Management review
Organiza�onal
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
39
ISO/TC 176/SC 2/ N1282
7 Clause 7.1 Support 7.1 Resources There should be adequate resources to ensure effec�veness of
7
Clause 7.1
Support
7.1
Resources
There should be adequate resources to ensure effec�veness of
the QMS. Resource considera�ons now include:
7.1.2
People
§  internal resources
7.1.3
Infrastructure
§  external providers
7.1.4
§  people
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
7.2
Competence
7.3
Awareness
7.4
.
Communica�on
7.5
Documented informa�on
40
ISO/TC 176/SC 2/ N1282
7 Clause 7.3 and 7.4 Support 7.1 Resources 7.1.2 Relevant persons doing work under the
7
Clause 7.3 and 7.4
Support
7.1
Resources
7.1.2
Relevant persons doing work under the organiza�on’s control
need to have awareness and communica�on (internal and
external) of the QMS and benefits of improving performance
People
7.1.3
Infrastructure
7.1.4
Environment for the
opera�on of processes
7.1.5
Monitoring and measuring
resources
7.1.6
Organiza�onal knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented informa�on
41
ISO/TC 176/SC 2/ N1282
7 Support Clause 7.5.1 7.1 Resources 7.1.2 People 7.1.3 Requirements that used to be required
7
Support
Clause 7.5.1
7.1
Resources
7.1.2
People
7.1.3
Requirements that used to be required for a quality manual
have been enhanced and made more flexible to allow for the
use of documented informa�on needed for the quality
management system
Infrastructure
7.1.4
Environment for opera�on of
processes
Clause 7.5.2
7.1.5
Monitoring and measuring
resources
Enhanced requirement for the crea�on and upda�ng of
documented informa�on, e.g. descrip�on, format & suitability
7.1.6
Organiza�onal knowledge
7.2
Clause 7.5.3
Competence
7.3
Awareness
Control of documented informa�on – now explicitly includes
confiden�ality, integrity and access
7.4
Communica�on
7.5
Documented informa�on
42
ISO/TC 176/SC 2/ N1282
4 9 5 6 7 8 10 Context of Performance and Leadership Planning Support Opera�on
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
9.1
4.1
7.1
10.1
5.1
6.1
8.1
Monitoring,
Understanding
Resources
Ac�ons to address
General
Leadership and
Opera�onal planning
measurement,
context
commitment
risks and
and control
analysis and
opportuni�es
7.1.2
evalua�on
4.2
People
5.2
Interested par�es
10.2 Nonconformity
Policy
See next slide
6.2
and correc�ve ac�on
9.1.2
7.1.3
Objec�ves and
Customer sa�sfac�on
Infrastructure
4.3
planning
5.3
Scope
Organiza�onal roles,
10.3
responsibili�es and
7.1.4
9.1.3
6.3
Con�nual
authori�es
Analysis and
4.4
Planning of changes
Environment for
opera�on of processes
improvement
evalua�on
QMS
9.2
7.1.5
Internal audit
Monitoring and
measuring resources
9.3
7.1.6
Management review
Organiza�onal
knowledge
7.2
Competence
7.3
Awareness
7.4
Communica�on
7.5
Documented
informa�on
43
ISO/TC 176/SC 2/ N1282
4 9 5 6 7 8 10 Context of Performance and Leadership Planning Support Opera�on
4
9
5
6
7
8
10
Context of
Performance and
Leadership
Planning
Support
Opera�on
Improvement
organiza�on
Evalua�on
8.1 Opera�onal planning and
control
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
8.2 Requirements for products
and services
8.5.1
Control of produc�on
8.3.1 General
8.4.1 General
8.7 Control of nonconforming
process outputs
and service provision
8.2.1 Customer
8.3.2
Design and
communica�on
development planning
8.4.2 Type and extent of
control
8.5.2 Iden�fica�on and
traceability
8.2.2 Determina�on of
requirements related to
products and services
8.5.3
Property belonging to
8.3.3 Design and
development Inputs
8.4.3 Informa�on for external
providers
customers or external
providers
8.2.3 Review of requirements
related to products and
services
8.3.4
Design and
8.5.4 Preserva�on
development controls
8.5.5
Post-delivery ac�vi�es
8.2.4 Changes to requirements
for products and services
8.3.5
Design and
development outputs
8.5.6 Control of changes
8.3.6
Design and
development changes
44
ISO/TC 176/SC 2/ N1282

ISO/TC 176/SC 2/ N1282

Clause 8.1.b 8 Opera�on §  explicit requirement for establishing criteria for processes
Clause 8.1.b
8 Opera�on
§  explicit requirement for establishing criteria for processes
8.1 Opera�onal planning and control 8.2 Requirements for products and services 8.2.1 Customer communica�on 8.2.2
8.1 Opera�onal planning and
control
8.2 Requirements for
products and services
8.2.1 Customer
communica�on
8.2.2 Determina�on of
requirements related to
products and services
8.2.3 Review of requirements
related to products and
services
8.2.4 Changes to
requirements for products
and services

Clause 8.2.1

§explicit considera�ons are now linked to: customer communica�ons; customer property, and con�ngency ac�ons

Clause 8.2.2

§Determina�on of requirements; this requires a process and is explicit with regard to substantiating claims for products and services being offered

45

ISO/TC 176/SC 2/ N1282

Clause 8.3 8 Opera�on This sec�on on design and development of products and services has
Clause 8.3
8 Opera�on
This sec�on on design and development of products and
services has substan�vely changed and simplified:
8.3 Design and
development of products
and services
Clause 8.3.2
8.3.1 General
8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls
8.3.2 Design and
development planning
8.3.3 Design and
development inputs
8.3.4 Design and
development controls
8.3.5 Design and
development outputs
8.3.6 Design and
development changes

§Design and development has been restructured to allow for a more process orientated approach

§Involvement of customers and users as part of design planning to be considered

Clause 8.3.3

§Design and development inputs – explicit requirements for internal and external resource needs, poten�al consequences of failure, level of control expected by customers

Clause 8.3.4

§Design and development controls – new clause combining Reviews, Verifica�on & Valida�on

46

ISO/TC 176/SC 2/ N1282

Clause 8.4 8 Opera�on § The terms which previously referred to purchasing and ‘outsourcing’ is now
Clause 8.4
8 Opera�on
§ The terms which previously referred to purchasing and
‘outsourcing’ is now ‘Control of externally provided processes,
products and services’
Clause 8.4.1
§ Condi�ons are applied when controls are required for
externally provided processes, products and service
8.4 Control of externally provided processes products and services 8.4.1 General 8.4.2 Type and extent
8.4 Control of externally
provided processes
products and services
8.4.1 General
8.4.2 Type and extent of
control
8.4.3 Informa�on for
external providers

§Terminology has changed from ‘supplier’ to ‘external provider’

Clause 8.4.2

§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

ISO/TC 176/SC 2/ N1282

Clause 8.5.1 8 Opera�on This clause specifically considers: 8.5 Produc�on and service provision §  monitoring
Clause 8.5.1
8 Opera�on
This clause specifically considers:
8.5 Produc�on and service
provision
§  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)
8.5.1 Control of produc�on
and service provision
§  acceptance criteria for products and services are met
8.5.2 Iden�fica�on and
traceability
8.5.3 Property belonging to customers or external providers 8.5.4 Preserva�on 8.5.5 Post-delivery ac�vi�es
8.5.3 Property belonging to
customers or external
providers
8.5.4 Preserva�on
8.5.5 Post-delivery ac�vi�es
8.5.6 Control of changes

§the use, and control of suitable infrastructure and process environment

§suitable monitoring and measuring resources

§Requires competent persons

48

ISO/TC 176/SC 2/ N1282

8 Opera�on Clause 8.5.2 8.5 Produc�on and service provision §  The iden�fica�on and traceability now
8 Opera�on
Clause 8.5.2
8.5 Produc�on and service
provision
§  The iden�fica�on and traceability now focus on ‘outputs’
rather than on ‘product’ (includes intermediate products
and services) rather than on ‘product’
8.5.1 Control of produc�on
and service provision
Clause 8.5.3
8.5.2 Iden�fica�on and
traceability
8.5.3 Property belonging to customers or external providers 8.5.4 Preserva�on 8.5.5 Post-delivery ac�vi�es
8.5.3 Property belonging to
customers or external
providers
8.5.4 Preserva�on
8.5.5 Post-delivery ac�vi�es
8.5.6 Control of changes

§Customer property has been expanded to include external providers’ property

Clause 8.5.4

§Preserva�on of product has been changed to preserva�on of the output

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
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

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Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

50

Changes in the ISO 9001
Changes in the ISO 9001

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

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Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

51

Changes in the ISO 9001
Changes in the ISO 9001

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’

18.04.16

Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

52

Changes in the ISO 9001
Changes in the ISO 9001

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

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Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

53

Changes in the ISO 9001
Changes in the ISO 9001

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

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Quality Management - Seminar and Industrial Applica�ons Dr. Gökcen Bas - Dipl.-Ing. Erol Güçlü

54

Summary §   Determining the organiza�onal context enables a more effec�ve implementa�on of the quality

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 §

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