Quality Management System - VCK · v The concept of exclusions will still apply, though the term...

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Niets uit deze uitgave mag worden verveelvoudigd en/of openbaar gemaakt door middel van druk, fotokopie, digitale kopie, scan of op welke wijze dan ook en voor gelijk welke doeleinden, zonder voorafgaande schriftelijke toestemming van Amelior. Het gedeeltelijk of volledig gebruik van de inhoud van deze uitgave is verboden, tenzij met uitdrukkelijke voorafgaande schriftelijke toestemming van Amelior. ISO9001 Quality Management System KWINTA Info Sessie VCK 2015 Quality Plan Leadership PDCA Context Risk Improvement Ivo Demeulenaere Joris De Landtsheer Guido Verrept

Transcript of Quality Management System - VCK · v The concept of exclusions will still apply, though the term...

Page 1: Quality Management System - VCK · v The concept of exclusions will still apply, though the term "exclusions" will not be used. v The terms "document" and "records" are being replaced

Niets uit deze uitgave mag worden verveelvoudigd en/of openbaar gemaakt door middel van druk, fotokopie, digitale kopie, scan of op welke wijze dan ook en voor gelijk welke doeleinden, zonder voorafgaande schriftelijke toestemming van Amelior. Het gedeeltelijk of volledig gebruik van de

inhoud van deze uitgave is verboden, tenzij met uitdrukkelijke voorafgaande schriftelijke toestemming van Amelior.

ISO9001Quality Management System

KW

INTA

Info Sessie

VCK

2015Quality PlanLeadership

PDCA ContextRiskImprovement

Ivo Demeulenaere Joris De LandtsheerGuido Verrept

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1.101.272Gecertificeerde bedrijven eind 2012

ISO9001

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Programma

v Timing

vHigh Level Structure

vHighlights of the Standard (DIS)

vQ&A

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Timing

CDJuni 2013

DISMei 2014

FDISBegin 2015

StandardQ4

2015

2013 2014 2015

Training Certifying bodies

2016

Transition Period (3j)

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Grote en Kleine Veranderingen

19871994

20002008

2015

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A Summaryv "Products and Services" will replace "Products".

v The concept of exclusions will still apply, though the term "exclusions" will not be used.

v The terms "document" and "records" are being replaced by a single term "documented information". Control for documented information will be the same as the 2008 standard.

v An expanded planning section will be titled "Context of the Organization" and will require companies to consider the needs of all interested parties in the design of the QMS.

v There will be more prescriptive requirements for managing the company processes using the process approach and will include process owners, process inputs, process outputs and process measures.

v The title of "management representative" will be dropped, but the requirement for top management to appoint one or more individuals to be responsible for monitoring and reporting on the QMS will still be included.

v A formal "preventive action" process will be dropped, to be replace with the addition of "risk based thinking" in the planning of the QMS and new product design and development. It will still require companies to be forward-looking to avoid possible problems.

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High Level Structuur (HLS)

v Waarom?

ISO 9001 ISO 14001

ISO 22000 OHSAS 18001

Zelfde kernelementen

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High Level Structuur (HLS)

Wordt van toepassing voor alle normen uit de ISO familie

ISO 9001QMS

OHSAS 18001H&SMS

ISO 50001Energy

ISO 22000FSMS

ISO 14001EMS

ISO 27001IT security

ISO 13485Medical

ISO 31000Risk ISO …….

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High Level Structuur (HLS)

ISO 9001:2015

1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10.Improvement

ISO 9001:2008

1. Scope

2. Normative references

3. Terms and definitions

4. Quality management system

5. Management responsibility

6. Resource management

7. Product realization

8. Measurement, analysis and improvement

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HLS - PDCA

4. Contextof the

organisation5. Leadership 6. Planning

Of the QMS 7. Support 8. Operations 9. Performanceevaluation 10. Improvement

Plan Do Check Act

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Niets uit deze uitgave mag worden verveelvoudigd en/of openbaar gemaakt door middel van druk, fotokopie, digitale kopie, scan of op welke wijze dan ook en voor gelijk welke doeleinden, zonder voorafgaande schriftelijke toestemming van Amelior. Het gedeeltelijk of volledig gebruik van de

inhoud van deze uitgave is verboden, tenzij met uitdrukkelijke voorafgaande schriftelijke toestemming van Amelior.

Highlights of the New Standard

ISO / DIS 9001

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Ons Werkterrein …

4. Context of the organizationWat heeft invloed op de uitkomst van het QMS

Noden en verwachtingen van betrokken partijen (klant, eindgebruiker, overheid, leveranciers, eigen medewerkers, buren, …..)

Bepalen van de scope van het QMS

Definiëren van de processen en de interacties

Quality Management System (QMS)Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.

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Context van de organisatie => relevante belanghebbenden(cfr ISO 9004: 2009)

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Aansturen van de OrganisatieDIS 9001:2015

v 4.1 Understanding the organization and itscontext

v 4.2 Understanding the needs and expectations of interested parties

v 4.3 Determining the scope of the quality management system

v 5.1.1 Leadership andcommitment for the qualitymanagement system

v 5.2 Quality policy

ISO 9001:2008

v 0.1 Algemeen

v 5.1 Betrokkenheid van de directie

v 5.3 Kwaliteitsbeleid

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Leiderschap maakt het Verschil

5. LeadershipAantonen van leiderschap en betrokkenheid

⇒ t.o.v. het QMS (beleid, doelstellingen, middelen, communicatie, …)

⇒ t.o.v. noden en verwachtingen van de klanten (risico’s bepalen, klantentevredenheid)

Kwaliteitsbeleid opstellen, communiceren, beschikbaar voor betrokken partijen

Verantwoordelijkheden en bevoegdheden vastgelegd en gecommuniceerd

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‘Planning’ = Voorbereiding

6. Planning for the QMSRisico’s en opportuniteiten definiëren

⇒ om de uitkomst van het QMS te garanderen⇒ om productconformiteit te verzekeren⇒ om ongewenste effecten te voorkomen of te reduceren⇒ om verbetering te bereiken

Doelstellingen vaststellen en opvolgen

Veranderingen moeten gepland worden rekening houdend met de risico’s

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Plannen / beheren innovatie & technologie

DIS 9001:2015v 6 Planning

v 6.1 Actions to address risks and opportunities

v 6.2 Quality objectives and planning to achieve them

v 6.3 Planning of changes

v 8.3 Design and developmentof products and services

ISO 9001:2008v 5.4.1

Kwaliteitsdoelstellingen (meetbaar)

v 5.4.2 Planning van het kwaliteits-managementsysteem

v 7.1 Planning van het realiseren van het product

v 7.3 Ontwerp en ontwikkeling

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NEN-ISO 31000 / Risicomanagement - Principes en richtlijnen

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Gebeurtenis

Sch

ade

Bas

isoo

rzak

en

3 Onderdelen van een Risico

ImpactWaarschijnlijkheid

Oorzaken Gevolgen

FoutenboomFeitenboom

Gevolgenboom

1

2 3

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Basic FMEA Template (Process FMEA)

ProcessStep

Function(s)Potential

FailureMode

PotentialEffect(s)

of Failure Seve

rity Potential

Causesof Failure O

ccur

ence Current

ProcessControls

(Detection) Dete

ctio

n

RPN

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Resources

7. SupportWelke middelen zijn nodig, eventueel externe middelen inschakelen

⇒ Infrastructuur⇒ Procesomgeving⇒ Meetmiddelen⇒ Kennis

Competenties moeten worden bepaald

Bewustmaking van alle medewerkers

Communicatiestructuren moeten worden opgesteld (intern en extern)

Een gedocumenteerd systeem opstellen

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Infrastructuur

DIS 9001:2015

v 7.1.3 Infrastructure

v 7.1.4 Environment for the operation of processes

v 7.1.5 Monitoring andmeasuring resources

ISO 9001:2008

v 6.3 Infrastructuur

v 6.4 Werkomgeving

v 7.6 Beheersing van monitorings- en meetuitrusting

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Vanuit Risico Bekeken

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De Medewerkers

DIS 9001:2015

v 5.3 Organizational roles, responsibilities and authorities

v 7.2 Competence

v 7.3 Awareness

ISO 9001:2008

v 5.5.1 Verantwoordelijkheid en bevoegdheid

v 6.2 Personeel

v 6.2.1 Algemeen

v 6.2.2 Bekwaamheid, training en bewustzijn

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Documentatie, informatie, kennisDIS 9001:2015

v 4.4.QMS & its processes

v 7.1.5 Monitoring & measuring resources

v 7.5 Documentedinformation

v 7.5.1 General

v 7.5.2 Creating andupdating

v 7.5.3 Control of documented Information

ISO 9001:2008v 4.1 Algemene eisen

v 4.2 Documentatie-eisen

v 4.2.2 Kwaliteitshandboek

v 4.2.3 Beheersing van documentatie(*)

v 4.2.4 Beheersing van registraties (*)

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De ‘Core’

8. OperationProcessen moeten gepland worden, met bijhorende criteria

Bepalen van de marktbehoefte en interactie met de klant⇒ Bepalen van de producteisen⇒ Herziening van deze eisen

Communicatie met de klanten

Afspraken met onderaannemers moeten vastliggen (gebaseerd op risicoanalyse)

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Productie en dienstverlening(‘goods & services’)

DIS 9001:2015

v 8.1 Operational planning and control

v 8.2 Determination of requirementsfor products and services

v 8.3 Design and development of products and services

v 8.4 Controle of externally providedproducts and services

v 8.5 Production and service provision

v 8.6 Release of products and services

v 8.7 Control of nonconforming processoutputs, products and services

ISO 9001:2008

v 7.4.3 Verificatie van het ingekochte product

v 7.5.1 Beheersing van productie en het leveren van diensten

v 7.5.2 Validatie van processen voor productie en het leveren van diensten ( => 8.6.1 & 8.6.6)

v 7.5.3 Identificatie en naspeurbaarheid

v 7.5.4 Eigendom van de klant

v 7.5.5 Instandhouding van het product

v 8.2.4 Monitoring en meting van producten

v 8.3 Beheersing van afwijkende producten (*)

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Beheren van Klanten

DIS 9001:2015v 5.1.2 Customer focus

v 8.2.1 Customer communication

v 8.2.2 Determination of requirements related toproducts and services

v 8.2.3 Review of requirementsrelated to products andservices

ISO 9001:2008v 5.2 Klantgerichtheid

v 7.2.1 Bepaling van producteisen

v 7.2.2 Beoordeling van producteisen

v 7.2.3 Communicatie met de klant

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De Vinger aan de Pols

9. Performance evaluationMethoden bepalen om te meten en te evalueren

Analyse van data en gegevens

Klantentevredenheid

Interne audits

Directiebeoordeling

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Bijsturen van de organisatie

DIS 9001:2015v 9.3 Management review

v 10 improvement

v 10.2 Nonconformity andcorrective action

v 10.3 ContinualImprovement

ISO 9001:2008v 5.5.2 Directievertegenwoordiger

v 5.6 Directiebeoordeling

v 8.5.1 Continue verbetering

v 8.5.2 Corrigerende maatregelen (*)

v 8.5.3 Preventieve maatregelen (*) (=> 6.1 risk)

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Any Questions ???

Ivo Demeulenaere

[email protected]

0475 79 05 37

Joris De Landtsheer

[email protected]

0498 52 26 99

Guido Verrept

[email protected]

0496 57 58 15