ISO/TS 22163:2017 IRIS Certification

What is ISO 22163:2017

The International Organization for Standardization has published guidelines to bring a quality management approach to the rail sector.

ISO/TS 22163, Railway applications – Quality management system – Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector, aims to help system integrators and equipment manufacturers in the rail sector make quality improvements through common best practices.

The technical specification is a sector-specific application of ISO 9001:2015 and was developed in collaboration with the Association of the European Rail Industry to build on its industry standard.

ISO/TS 22163 defines quality management system requirements for the rail sector that can be applied throughout the supply chain—including design and development, manufacturing, and maintenance.

In October 2016, the Association of the European Rail Industry, UNIFE, announced the decision of Technical Committee 269 of the International Organization for Standardization (ISO) to replace the global standard for quality management systems in the rail industry – IRIS Rev. 02 – by a new ISO/TS 22163 version. Consequently, organisations certified according to IRIS Rev. 02 will have to undergo transition audits to update their certificates to ISO/TS 22163. 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. Deadlines and schedule Publication of the ISO/TS 22163 and the associated certification rules is scheduled for May 2017. Following 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. On this background, July/August 2017 is a realistic timeline for the first transition audits. 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. Regulation for the auditing of remote locations/ support functions and extended workbenches/ site extensions Since 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 for the transition phase from IRIS Rev. 02 to ISO/TS 22163.

The new ISO/TS 22163: 2017 standard:

• is published in May 2017 and replaced the existing IRIS Rev.2.01, till September  2018,
  
• covers all requirements of ISO 9001:2015 and has been built according to the High Level Structure, supplemented by existing and new additional mandatory and optional requirements of the rail industry especially also new KPIs,
• continues to be supported by the "IRIS Audit Tool" that is based on the new IRIS Assessment Sheet,composed by around 870 mandatory requirements, which are grouped into about 300 questions,as well as new KO-requirements (plus additional optional requirements),
• requires the appraisal of the customer focus performance level,
•  requires introduction of turtle diagrams and applies the methodology of Process Effectiveness Assessment Reviews (PEAR) for some mandatory processes,
• utilizes a maturity model for business management systems concluding your companies BRONZE-SILVER-GOLD rating.
  
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