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In May 2017, the Association of the European Rail Industry, UNIFE, announced the release of ISO/TS 22163 by the Technical Committee 269 of the International Organization for Standardization (ISO). The ISO/TS 22163 replaces IRIS Rev. 02 as the global standard for quality management systems in the rail industry. Consequently, organisations certified according to IRIS Rev. 02 will have to undergo transition audits to update their certificates to ISO/TS 22163 before 14 September 2018.

ISO/TS 22163 will be based on the structure and requirements of the ISO 9001:2015 standard, which it will adopt in full, but comprises additional requirements for the rail industry.

Transition timelineFollowing the publication of the new standard, organisations are required to implement the changes in their quality management system prior to a transition audit. Certification auditors seeking to carry out audits according to ISO/TS 22163 are required to attend, and successfully complete, training supervised by UNIFE.

As IRIS Rev.02 certificates will expire after 14 September 2018, and all non-conformities need to be closed for all audits before a new ISO/TS 22163 certificate can be issued, the last transition audits should be completed by July 2018.

Information on ISO/TS 22163 (IRIS) transitionAs of July 2017

MAY 2017 SEPTEMBER 2018

Publication of ISO/TS 22163[May 2017]

End of transitionperiod

[14 September 2018]

Transition phase of certification[May 2017 to September 2018]

Publication of ISO/TS 22163 rules[May/June 2017]

Last possible period for transition audit

[July 2018]

Last possible audit for initial certification acc. to

IRIS Rev.02[31 December 2017]

2017 © TÜV SÜD AG

Auditing and auditor daysA transition is conducted as a certifiction audit, including a readiness review and an option to reduce the time required for the audit. According to UNIFE‘s transition strategy, as published in May 2017, organisations certified to IRIS Rev. 02 are eligible for a reduction of the on-site audit time of up to 20 %. For transition audits, customers have two options:

Option 1: The transition audit is carried out at the time of a regular scheduled surveillance or re-certification audit. In this case, the regulations for audit deadlines will apply (-3/+0 months from the reference date). The former reference date will be kept.

Option 2: The transition audit is carried out at any time. However, this option is restricted by the schedule shown in the transition timeline (14 September 2018).

If the reference date for conducting a regular audit is exceeded, this option will inevitably result in a period without certification. In the event of a subsequent transition audit, there will be a new reference date and all future audits will be aligned thereto.

Generally, an audit time reduction for initial certification is not possible for audits carried out after 14 September 2018.

Following a successful transition audit, a new certificate will be issued for a three-year period (minus one day).

Change of certification bodyA change of certification body conducted parallel to a transition audit is acceptable, as ISO/TS 22163 transition audits are certification audits. However, in such circumstances a reduction in the number of auditor days is not possible.

Performance assessmentThe new standard defines five mandatory processes for performance assessment:■■ Project management (clause 8.1.3) ■■ Design and development of products and services

(clause 8.3)■■ Requirements for products and services (clause 8.2)■■ Control of externally provided processes, products

and services (clause 8.4)■■ Control of production and service provision

(clause 8.5.1.1)

Assessments of the five mandatory processes required by the standard must be carried out in each audit on the basis of the process analyses (turtle diagrams) submitted for audit planning.

Management system ratingIn addition to the issuance of the IRIS certificate, UNIFE has introduced a new evaluation approach for the management system, with the ratings of bronze, silver, and gold. The ratings are based on of the evaluation of the “Assessment Sheet,” customer satisfaction, and some of the mandatory processes. They are issued exclusively and automatically by the IRIS platform and do not form part of the certificate.

Scopes of certificationThe 20 IRIS scopes have been changed and aligned to the main product groups in the EN 15380-2 standard.

The following aspects are now required:

■■ Risk management process■■ Annual review of the business plan for the rail

industry, taking into account market and product strategy, management review, budgeting, risk and opportunity assessment, customer expectations, outsourced services, and deferrals

■■ Focus on special processes and their tools, and monitoring and measuring equipment

■■ Skills and knowledge management■■ Expansion of project-management requirements■■ Control of outsourced processes, products and

services, and supplier management■■ Detailing of requirements related to the measurement

of process performance, e.g. submission of the calculations of the relevant data

■■ Establishment of annual process reviews

Transition audit preparationsISO/TS 22163 includes enhanced focus on interested parties, and thus on issues including customer satisfaction and the organisation‘s actual process performance. No later than 60 days before the transition audit, all relevant information is to be submitted to the auditor. This includes:– customer satisfaction/customer perception– customer feedback– customer complaints – process analyses in the form of turtle diagrams for the

five mandatory processes– defined key performance indicators (KPIs)– the process landscape of the organisation– a list of key accounts

If the above deadline is not observed, the auditor will need to verify this information on site prior to the start of the audit.

For the new standard, the period between readiness review and the actual on-site audit has been limited to a maximum of 60 days. Furthermore, all calculation requirements (required minimum number of audit days) have been revised.

Nonconformity with a Knock-Out (KO) requirement will no longer result in termination of the stage two audit, but will be rated as a major nonconformity (insufficient). If the readiness review rates one of the questions of a KO requirement as not fulfilled, the review will have to be repeated.

Regulation for the auditing of remote locations/support functions and extended workbenches/site extensionsAs the quality management system of ISO/TS 22163 takes an integrated approach to the organisations and/or the production site, the transition of the quality management system to ISO/TS 22163 at remote locations/support functions and extended workbenches/site extensions must be completed before the transition audit takes place.

As was the case for former regulations, remote locations/support functions must be audited prior to the associated production site(s). This principle continues to apply, also during the transition phase from IRIS Rev. 02 to ISO/TS 22163.

RecommendationWe recommend completing implementation of the new standard as early as possible in order to enable a transition audit within the scope of the next scheduled regular audit (within the deadlines).

TÜV SÜD will inform its customers about any subsequent changes to the standard.

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Contact

Should you have any questions, please do not hesitate to contact us.Phone: +49 (0)89 5791-0systemcertification@tuv-sud.comwww.tuv-sud.com/systemcertification

TÜV SÜD AG Westendstraße 199, 80686 Munich, Germany Phone: +49 89 5791-0 systemcertification@tuv-sud.com www.tuv-sud.com/systemcertification