Dr. Anni Koubek, Vice President
Innovation & Business Development Quality, Quality Austria
AdventureQuality
Erfaringer med ISO
9001:2015 org hva kommer
What did we make from the ISO 9001 revision?
What´s up in the future?
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 2
6.-7.juni 2019 Folie Nr. 3Kvalitet & Risikodagene
Was hat es uns gebracht?
Big change Big or small change
Sample
TextSample
Text
Sample
Text
ISO
9001:2000ISO
9001:2008
ISO
9001:2015
?
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 4
P
D
C
A
Overview on Changes
6.-7.juni 2019 Slide Nr. 5
Scope
Context of the organization
LeadershipResponsibility
Risks & Opportunities
Quality objectives and planning
Changes
Organizational knowledgeCompetence
Documented information
Operational planning
Design and Development
External processes, products and services
Production and
service provision
Monitoring and measurement
Performance and Effectiveness
Processes
Interested Parties
Kvalitet & Risikodagene
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Continual Improvement
PLANNING
OPERATIONS
PERFORMANCE
EALUATION
IMPROVE-MENT
Context
Interessierte Parteien
PDCA
Unterstützung
Führung
Kontext der Organisation
6.-7.juni 2019 Kvalitet & Risikodagene 7
P
D
C
A Interessierte
Parteien
Führung
Risiken&Chancen
Betriebliche
Planung
PLANUNG
BETRIEB
BEWERT-UNG DER LEISTUNG
VERBES-SERUNG
Wissen der
Organisation
Dokumentierte
Information
PDCA
Ständige Verbesserung leben
We ensure on all levels:
what gets started, gets done
„Der rote Faden“
System, Processes, Actions
Objectives
RISKS, OPPS
CONTEXT
What is
changing?
What can we
do?
Who needs
what?
Which
opportunities
result?
Related to which
risks? Our Priorities?
Fix Objectives
6.-7.juni 2019 Kvalitet & Risikodagene 8
The red line
„Der rote Faden“
6.-7.juni 2019 Kvalitet & Risikodagene 9
System, Prozesse, Maßnahmen
ZIELE
RISIKEN UND
CHANCE
KONTEXT
Umfeldfaktoren
Interne Themen
Interessierte
Parteien Welche Chancen
ergeben sich?
Welche Risiken
bestehen?
Welche Prioritäten
setzen wir?
Welche Ziele setzen
wir?
Consistent Strategy Work
Systematic Objectives break-down
Clarity on Objectives throughout organisation
What influences the organisation?
Internal / external issues
What requirements we need to fulfill?
Customer satisfaction today and tomorrow?
„Relevant interested parties“
How we deal with stakeholders?
Context of the organisation
6.-7.juni 2019 Kvalitet & Risikodagene 10
Einflussfaktoren auf die Organisation bestimmen
Mit Einfluss auf das QMS
Was beeinflusst unsere „Fähigkeiten“, beabsichtigte Ergebnisse zu erzielen
In Bezug auf Produkte und Dienstleistungen
In Bezug auf die Prozesse
Relevante interessierte Parteien (Stakeholder) bestimmen sowie
deren relevante Anforderungen
Context of the organisation
6.-7.juni 2019 Kvalitet & Risikodagene 11
We systematically adress changes and deal with
stakeholders
Determine risks and opportunities
Plan actions and implement effectively
Risiks and Opportunities
6.-7.juni 2019 Kvalitet & Risikodagene 12
Risiken und Chancen bestimmen
Maßnahmen planen
Risikomanagementsystem ist nicht gefordert
Vorgangsweise für Risiken und Chancen kann unterschiedlich sein
„Vorbeugungsmaßnahmen“ sind nicht mehr erwähnt
Risiks and Opportunities
6.-7.juni 2019 Kvalitet & Risikodagene 13
Our decisions to risks and opportunities are taken
systematically and informed
Less problems
We can take up opportunities, because we are not
busy manageing problems
Determine knowledge
Maintain and share knowledge
Obtain new knowledge when there is change
Organisational knowledge
6.-7.juni 2019 Kvalitet & Risikodagene 14
Wissen bestimmen (zur Durchführung der Prozesse und für Konformität
von Produkten und Dienstleistungen)
Wissen aufrechterhalten und zur Verfügung stellen
Bei Veränderungen momentanes Wissen berücksichtigen notwendiges
Zusatzwissen erlangen
Eng verbunden: Wissen-Kompetenz-Bewusstsein
Unterstützt durch: Kommunikation – Dokumentierte Information
Organisational knowledge
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We are aware of knowledge-singularities
We actvely manage our knowledge for the future
„Accountability“ for the top management
Leadership – new requirements
No „representative of top management“
Leadership
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„Rechenschaftspflicht“ für das QMS ist bei der obersten Leitung
angesiedelt
Neue Anforderungen in Bezug auf Führung, z. B.
Mitarbeiter und andere Führungskräfte unterstützen
Sicherstellen, dass Ergebnisse erzielt werden
Prozessorientierten Ansatz und risikobasiertes Denken fördern
Funktion „Beauftragter der obersten Leitung“ ist nicht mehr gefordert
Leadership
6.-7.juni 2019 Kvalitet & Risikodagene 17
Top Management ensures one integrated
management system
Leadership Culture – not Quality Delegation
Reflecting
Big change
Small or
Sample
TextSample
Text
Sample
Text
ISO
9001:2000ISO
9001:2008
ISO
9001:2015
?
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 18
Big change
1. How are organisations and „quality“ changing?
2. How do we have to change QM Systems and methods in order to be succesful?
2 questions
Blind trust in technology?
Background
Work in project of Johannes-Kepler University
Open Foresight methodology
„Quality 2030“
Funded by Quality Austria and Region of Upper Austria
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 21
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Digitalisation
Quality and Product Life Cycle
Service-Intensification
Agility
Certification
Market requirementInternal Value
Decentral & agilChange ChallengesCentralisedt & standardised
Business Service ModelsMaintenance models
Focus Product Sales
Circular & Green Economy as
Competitive PostiionIMS-ViewCircular & Green Economy as Add-on
Role of MachineHuman--Machine-TeamRole of Human
22
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Quality and Digitalisation
23
Suppliers
Advanced
Supply
Management;
integrated,
automated
supply chain
Planning
Simulations,
virtual models,
digital twins;
realisation of
best solution,
no trail&error
Production
Self-learning
autonomous?,
automated
systems
Cyber physical
systems
Internet of
everything
Data pool (material,
prod-uction, logistics,
service, use)
Data Analytics
Individual, net-worked,
self-controlled, adap-
table; Swarm
intelligencee
Marketing,
Sales
Push-Logic
instead of Pull
Entire customer
journey
Transparent,
multi-channel
Logistics
Predictive
Automated
On demand
modularised
Customer
Services
Improve
service-quality
Shorten
response time
Remote
diagnosis
Remonte
maintenance
Remote repair
Expert systems
Voice of
Customer
Analysis of
demand,
behaviour,
mood, ideas,
Real time dialog
Customer
integration
Re-use
Traceability of
parts
Analysis of
condition
(material,
quantity,
amount)
tracking
Overall process: faster, more transparent, more efficient, more individual, more flexile, networked
people
Supported by
Support Processes:
Digital infrastructure, Automatisiation of (pertial)
processes Digital business
models
Smart
Product
Assistent Systems: Head Gear, Augmented Reality, data
glasses/lentils , exo-skelleton, dataglove, magic shoe, …
Expert systems, translation, speech & human recognition,
Digital knowledge consulting systems, artificial intelligence
Titelmasterformat durch Klicken bearbeitenService-Orientation
24
Performance contracting
Sharing
Produkt + Qualitätskontrolle
Mieten, leasen & pay-per-
use
LebenszyklusAnlagen
Service Energie
Energieeffizienz
IoT
Servitisation
based on Stahel
2010, p.203; Tukker
20046.-7.juni 2019Kvalitet & Risikodagene
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Agilität
Agility
25
Real Production process
Virtual Information and
models
CAX Models
Product
CAX Models
process
Process data
ERP-process control
Data of product use
Real product
Conclusion: digital and real layer
Conclusion 2
Requirements for management systemsneed to be adressed for real and virtualprocesses
Both (Know-how) worlds shoule intractperfectly
Add agile approach/methods to yourportfolio
Don´t compromise conformity, safety and security
Revision waves
Sample
Text
Sample
Text
ISO
9001:2015
ISO
9001:202x
??
5 years + time for development
6.-7.juni 2019 Kvalitet & Risikodagene 29
High Level Structure (Annex SL)
use
Content
Need for change?
Future Concepts
Experiences:
Interpretations
Feedback from users
Future Concepts – topics
Customer experience
People aspects
Change management Agility & Flexibility
Integration of management/business systems
Technologies for information
Knowledge management
Organizational culture
Ethics & integrity
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 30
HLS Revision – topics
Central topic- Risik:
Definition: use of ISO 31000?
Opportunity – decouple? – add hazard?
Other topics:
Change Management – add it?
Emergency preparedness
Incident, non-conformity, non-compliance management
Organisational knowledge
Leadership, governance and culture
Outsourcing
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 31
Annex SL Revision – einige
Themen
Other use?
New name Annex L
How to deal with definitions include them? Compare ISO 9000
Remove details (eg in objectives, communication)
Where to put what (e.g.:ISO 14001 /45001 – compliance obligations
/ legal requirements in section 6, ISO 22301, 50001 in section 4)
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 32
IWA 31
Guidelines on using ISO 31000 in management systems
6.-7.juni 2019 Folie Nr. 33Kvalitet & Risikodagene
Shows that conflict of definition is not so „tragic“
Shows how HLS and ISO 31000 go together
Gives examples of using 31000 in different management systems
(9001, 14001, 45001, 27001)
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 34
Why interesting?
Thank you!
Anni.Koubek@
qualityaustria.com
6.-7.juni 2019 Kvalitet & Risikodagene Folie Nr. 35