Webinar: Is your company ready2017 ISO/TS 22163:2017 launched IRIS Certification rules:2017 launched Transition phase 31st DEC 2017 15th MARCH 2018 Transition audit acc. ISO/TS 22163:2017

Webinar: Is your company ready

for the IRIS Certification™ rev.03

transition phase?

January 29th, 2018

Brussels

Stefan Siegler and Bernard Kaufmann

[email protected]

©2018 UNIFE. All rights reserved


➢Strategy and evolutions

➢Transition phase

➢Next steps

2

Agenda

©2018 UNIFE. All rights reserved 3

Strategy and evolutions


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


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


Acceptance

„ACCEPTANCE

BY OPERATORS“

OPERATORSTO USE NEW IRIS CERTIFICATION™

AS BASE PREREQUISITE FOR

SUPPLIER SELECTION

6


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

56

7

8

Process Owner• Risks & Opps

7

Performance evaluation - meeting

stakeholder expectations


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


ISO/TS 22163:2017

9

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


New Rail specific clause

ISO clause with Rail specific

supplemental

Project

4.Context of the

organization

Understanding

the organization

and its context

10

Improvement

9Perform ance

Evaluation

8

Operation

7

Support

6

Planning

5

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

10

IRIS elements integrated in ISO high level structure


FOCUS: Leadership

New concept

Major impact on

Standard

Organisations

Responsibility management

....

Structuring element for

development

ISO 9001:2015 – Technical

evolutions

11

➢ Obligation of means =>

obligation of results

➢ Pre-requisite for

performance management

➢ Important evolutions for

audits:

❖ Internal

❖ Customer

❖ Certification


Transition phase


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.

13

By when the transition to the

new ISO/TS shall be done?


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.

14

Validity of current IRIS

certificates (acc. IRIS rev.02)


The transition process includes the following steps:

1. Transition audit composed by

1. readiness review

2. certification audit

2. Nonconformity management

3. Certificate issuance.

15

What is the transition process?

(1/3)


Option 1:

transition process within their current IRIS rev. 02 audit

cycle i.e. at the next planned surveillance or re-certification

audit date.

16


(2/3)

Next planned re-certification audit

surveillance audit

surveillance audit

re-certification audit

certification audit

Next planned surveillance audit

transition audit

transition audit


Option 2:

Transition process at anytime i.e. outside the surveillance

and re-certification audit cycle.

17


(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.


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


➢ 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.

19

Successful completion of the

transition process


➢ 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

20

Alignment of dates with IAF


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.


Next steps


➢ 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

23

…and now ?


➢ 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

24

…and YOU ?

Hurry up, time is running


Schedule your transition audit NOW

Otherwise you may not get it, due to auditors

availability and

Your IRIS Certification™ will EXPIRE!

25


Thank you

Webinar: Is your company ready2017 ISO/TS 22163:2017 launched IRIS Certification rules:2017 launched Transition phase 31st DEC 2017 15th MARCH 2018 Transition audit acc. ISO/TS 22163:2017

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