Webinar: Is your company ready
for the IRIS Certification™ rev.03
transition phase?
January 29th, 2018
Brussels
Stefan Siegler and Bernard Kaufmann
©2018 UNIFE. All rights reserved
©2018 UNIFE. All rights reserved
➢Strategy and evolutions
➢Transition phase
➢Next steps
2
Agenda
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Strategy and evolutions
©2018 UNIFE. All rights reserved
The reason for existence of
Is
the need of Operators and the entire supply chain of railway systems
fora quality
management system which
certificates indicate clearly the quality performance level
of the certified organisation
Main Target:• Ensure that certification
level corresponds to quality performance.
Further Targets:• Worldwide
acknowledgement and application of IRIS Certification™ in entire value chain
• Efficient internal organisaton
IRIS Certification™ with ISO:• Develop ISO / TS to ISO• Create ISO for Certification Methodology • Keep control over certification process in IRIS
Certification ™ at sector level
IRIS Certification™ Promotion and Development:• Create and maintain a worldwide customer panel • Foster position of IRIS Certification™• Establish robust benefit logic for IRIS and promote
IRIS Certification™ Operation:• Professional, transparent, cost efficient• Ensure continuous improvement of the standard• Ensure qualified auditors group to reach goals
Reason for existanceTargetsRoadmap
Strategy
4
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New concept adds performance
dimensions and awards three
certification levels
Audit procedure
• Suitability of the Management
System
• Grade of implementation
Audit procedure
• Evaluation of Quality
Performance / RESULTS
open books policy
• Good RESULTS
IRIS Certificate
+
Performance
meeting
stakeholder
needs
„PROMISE FOR
PRODUCT QUALITY“
Enablers Performance / Results Certificate
Covered topics e.g.
• V Model, PDCA, Risk based
thinking/assessment, APQP
• Project mgmt, product safety
• Knowledge mgmt, RAMS/LCC,
return of experience
5
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Acceptance
„ACCEPTANCE
BY OPERATORS“
OPERATORSTO USE NEW IRIS CERTIFICATION™
AS BASE PREREQUISITE FOR
SUPPLIER SELECTION
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Adherence• in spite of?• in consequence of?
Input Process
Process Supplier
• Description• Regulation
Results
Process Participants
Requirements
Process Targets• consistent?• prioritized?Define
Process Indicators
CIP
PerformanceRequirements
Should
PerformanceData
Is
Performance evaluation
1
Stakeholder• complete?• relevant?
2
3
4
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7
8
Process Owner• Risks & Opps
7
Performance evaluation - meeting
stakeholder expectations
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IRIS Certification™ - system
IRIS Certification™ rev. 03
ISO/TS 22163:2017Railway applications - Quality management system - Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the
rail sector
IRIS Certification™ rules:2017 Rules for achieving and maintaining IRIS Certification™ recognition
REF
EREN
CE
SYST
EM
IRIS Certification™ Technology
Audit-Tool
Portal
Database
TOO
LS
©2018 UNIFE. All rights reserved
ISO/TS 22163:2017
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Translations - status
Published:
➢ English - May 2017
➢ French - May 2017
➢ Russian - August 2017
➢ Italian - December 2017
➢ Hungarian - December 2017
➢ German - January 2018
In preparation:
➢ Spanish
➢ Japanese
IRIS Certification™ rules:2017
Published:
➢ English
➢ French
➢ Russian
In preparation:
➢ Hungarian
➢ German
➢ Italian
➢ Spanish
Published:
➢ English
Assessment sheet in Audit-Tool
In preparation
for Q1/2018:
➢ French
➢ Russian
➢ German
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New Rail specific clause
ISO clause with Rail specific
supplemental
Project
4.Context of the
organization
Understanding
the organization
and its context
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Improvement
9Perform ance
Evaluation
8
Operation
7
Support
6
Planning
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Leadership
Quality
management
system and its
processes
Determining the
scope of the
quality
m anagem ent
system
Understanding
the needs and
expectations of
interested parties
Leadership and
commitment
Organizationalroles,
responsibilities
and authorities
Policy
Actions toaddress risks and
opportunities
Documented
information
Quality objectivesand planing to
achieve them
Resources
Communication
Awarenesss
Competence
Operationalplannlng and
control
Monitoring,m easurem ent,
analysisa and
evaluation
M anagem ent
review
Internal audit
Nonconformityand corrective
action
Continual
im provem ent
Plan Do Check Act
Planning ofchanges
Requirements for
products and
services
Design anddevelopment of
products and
servicesControl of
Externally
Provided
Processes,
Products and
Services Production and
service provision
Business
planning
Process reviews
General
Responsibilities andauthorities of
process owners
Contingency planning
Safety objectives
Audit programme
Auditors management
Management
review
inputs
Management
review
outputs
Planning for the outsourcing or
transfer of processes
Tender management
Management
Integration mgmt.
Scope mgmt.
Time management
Design reviews Design verification
Design validation
Monitoring of ext. provider
performance, re-evaluation and
ranking
Supply chainmanagement
External provider offer selection
Approval of externalprovider
Evaluation of externalprovider EPPPS verification
after release
EPPPS approval ofrelease
Classification of ext. provider and EPPPS
Verification of process for
production and service provision
Special processes
Production equipment
Identification andtraceability
Production scheduling
Cost management
Quality mgmt.
Human resource management
Communication management
Risk and opportunity mgmt
Procurement management
Configuration management
Controlled conditions
Validation of process for production and service provision
RAMS / LCC
First artic le inspection
Obsolescence management
Change management
Release of products and services
Control of nonconforming outputs
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IRIS elements integrated in ISO high level structure
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FOCUS: Leadership
New concept
Major impact on
Standard
Organisations
Responsibility management
....
Structuring element for
development
ISO 9001:2015 – Technical
evolutions
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➢ Obligation of means =>
obligation of results
➢ Pre-requisite for
performance management
➢ Important evolutions for
audits:
❖ Internal
❖ Customer
❖ Certification
©2018 UNIFE. All rights reserved 12
Transition phase
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All organizations currently certified according to
IRIS rev. 02 shall successfully made the transition by
14th September 2018.
The transition phase started on June 1st, 2017.
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By when the transition to the
new ISO/TS shall be done?
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1) All IRIS rev. 02 issued certificates are valid until 14th September
2018 latest.
2) All the IRIS certificates are automatically generated by the system
with a validity of three years.
As a consequence of pt. 1 above, all IRIS certificates having a
validity after September, 14th 2018 will expire at this date,
independent if a later date is stated on the certificate document.
3) No further notice will be given to the organizations or certification
bodies.
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Validity of current IRIS
certificates (acc. IRIS rev.02)
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The transition process includes the following steps:
1. Transition audit composed by
1. readiness review
2. certification audit
2. Nonconformity management
3. Certificate issuance.
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What is the transition process?
(1/3)
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Option 1:
transition process within their current IRIS rev. 02 audit
cycle i.e. at the next planned surveillance or re-certification
audit date.
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What is the transition process?
(2/3)
Next planned re-certification audit
surveillance audit
surveillance audit
re-certification audit
certification audit
Next planned surveillance audit
transition audit
transition audit
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Option 2:
Transition process at anytime i.e. outside the surveillance
and re-certification audit cycle.
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What is the transition process?
(3/3)
surveillance audit
surveillance audit
re-certification audit
certification audit
Outside surveillance audit cycle
Missed surveillance audit:1st surveillance or2nd surveillance
transition audit transition audit
Missed re-certification audit:
Note: The transition phase finishes on September, 14th 2018. All audit cycles started afterwards are considered as certification audits without reduction of time.
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Only during the transition phase, all validly IRIS
Rev.02.1 certified companies can get:
a reduction of the on-site activities time of
max. 20% of the auditor time for certification audit
Certification process
Man day calculation
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➢ Upon successful completion of the transition process the
organization shall be issued a
❖ new IRIS certificate with a three (3) year minus one (1) day validity period and respecting the rules for the reference date.
❖ Quality Performance level statement with a one (1) year minus one (1) day validity period and respecting the rules for the reference date
➢ A new certificate and audit cycle shall then commence.
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Successful completion of the
transition process
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➢ as of 15th March 2018, the IRIS approved certification bodies shall conduct
only IRIS rev. 03 audits (transition, initial certification, surveillance and re-
certification audits).
➢ furthermore, all transition audits shall be conducted until September 14th,
2018.
In both above cases, the closure of potential corrective actions could be over
these dates by respecting the reference date and within ninety (90) days. The
IRIS Certificate rev. 03 validity will start after positive closure of the potential
corrective actions.
➢ Despite this alignment the rules for the validity of the IRIS rev. 02 are still
valid:
All IRIS certificates having a validity after September, 14th 2018 will expire
at this date, independent if a later date is stated on the certificate document
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Alignment of dates with IAF
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Transition timeline
END of transition
phase
START of transition phase
MAY, 24th2017
ISO/TS 22163:2017 launched
IRIS Certification™ rules:2017
launched
Transition phase
31st
DEC2017
15th
MARCH2018
Transition audit acc. ISO/TS 22163:2017
IRIS rev. 03 audits acc. ISO/TS 22163:2017
Certification audit acc. ISO/TS 22163:2017
Certification audit acc. IRIS rev.02
Re-certification and Surveillance audit acc. IRIS rev.02 PERFORMED
STARTJUNE, 1st 2017
ENDSEPT, 14th 2018 (*)
14th
MARCH2018(*)
(*) the closure of potential corrective actions could be over these dates by respecting the reference date and within ninety (90) days.
©2018 UNIFE. All rights reserved 22
Next steps
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➢ ISO/TC 269 WG 5 will work to move to a full ISO
Standard
➢ Start of the WG on November, 24th 2017
➢ Next meeting March, 26th and 27th 2018
➢ UNIFE/IMC will monitor the transition phase to
➢ Ensure that the rules are respected
➢ Assess the maturity of the industry
➢ Stakeholders will prepare their next actions based on
the achievements
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…and now ?
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➢ Take decision for the transition phase
➢ Option 1 or Option 2
➢ Are you ready for the transition phase?
➢ Internal preparation
➢ Contact and agree with your certification body
➢ Planning and scheduling of your transition audit
➢ Scheduling and ensuring the availability of the qualified auditors
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…and YOU ?
Hurry up, time is running
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Schedule your transition audit NOW
Otherwise you may not get it, due to auditors
availability and
Your IRIS Certification™ will EXPIRE!
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Thank you