Wissensmanagement in der neuen ISO 9001...autonomous?, automated systems Cyber physical systems Internet of everything Data pool (material, prod-uction logistics service , use) Data

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

?


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


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


The red line

„Der rote Faden“


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


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


We systematically adress changes and deal with

stakeholders

Determine risks and opportunities

Plan actions and implement effectively

Risiks and Opportunities


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


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


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



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


„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


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

?


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


Titelmasterformat durch Klicken bearbeiten

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


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


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


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


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


Leadership, governance and culture

Outsourcing


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)


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)


Why interesting?

Thank you!

Anni.Koubek@

qualityaustria.com


Documents

Wissensmanagement in der neuen ISO 9001...autonomous?, automated systems Cyber physical systems Internet of everything Data pool (material, prod-uction logistics service , use) Data