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Consultancy: IRIS management systems

IRIS - International Railway Industrie Standard
1. Intention
The representatives of the European Railway Industry have merge into UNIFE and creates on this platform a quality management standard, like other sectoral standards, grounding on ISO 9001 with further sector specific requirements. In addition to the requirements of the quality management system an assessment system was also defined, whose results will be published in the IRIS database.
The aim is to improve the quality in the supply chain significantly and simmultanously reducing efforts in regard of multiple supplier audits carried out so far.
With establishment of the standard in 2006 an introduction phase was defined until 2009, where as a first step the tier 1 suppliers of the leading companies (Alstom Transport, Siemens Transportation Systems, Bombardier Transportation, Knorr-Bremse, Gutehoffnungshütte Radsatz, Voith, Harting and other) were asked to become certified according to IRIS standard.

2. Content
The Iris Standard defines the certification process, the auditing process as well as the single requirements of a quality system under consideration of railway specific requirements.

2.1: Only certification bodies with more than 10.000 certificates in the market and a global approach will be accepted and recognized as partner within the IRIS certification process. Requirements to allow witness audits have to be accepted by certification bodies and clients simillar to the procedures of ISO 17021.
With the beginning of 2009 the auditors have to proof their professional knowledge regarding the IRIS product categories on the bases of a 3 year fulltime employment within the last 10 years. IRIS auditors have to pass a spezific auditor training to whom they will be send on behave of their certification body. Regarding remote sites and functions similar rules are existing compared with the processes of the automotive industry. The realization of so called multi site certification schemes is not possible.

2.2: During the audit a checklist with 259 questions has to be used. Single requirements regarding the product and service relaization processes can be excluded. In addition othe rquestions can be not applicable. Justification of all exclusions and none applications have to be presented. The checklist includes 12 Knock-Out questions, which leads to a complete new begin of the certification process in case they were not met. The other questions will be devided into closed (yes/no) or open questions. The last one are used to achive a higher quality level of maturity. Questions, which were evaluated as insufficient, have to pass an additional on-site audit. Questions, which were partial fulfilled, can be verified with alternative methods concerning the effectiveness of their corrective actions. A company will be certified, if all relevant KO-questions were positive responded, if all corrective actions were closed within 90 days and if All open and closed questions were responded with in minimum 2 points (fulfilled).
The IRIS-audit questionnaire is a helpful tool, as it provides examples of the singles realization levels regarding the open questions.

2.3: The certification according to IRIS is only for such companies possible, who follow their business in the chain of rolling stock or signalling.
Manufacturing of rolling stock is characteriezed by small quantities, long project cycles and much longer product life cycles. Therefore the project management, the knowledge of the employees and the continous improvement have an imprortant status within the system. The mandatory definition of 16 documented procedures (ISO 9001 - 6 procedures), 25 processes with appropriate documentation (ISO 9001 - 3 processes) should not lead to the impression that a system focusing on documents was created. The IRIS system includes advises to gaps in the ISO 9001, where e.g. requirements of production planning is not explicit addressed.

3. Our consultancy approach
The IRIS Standard includes a lot of good ideas, which can be used by ISO 9001 certified companyies, who are looking for further guidelines within the developping process of their system.
Also if a lot of additional documents are requested the IRIS standard is pragmatical defined. A higher maturity level can be achived by the companies following an adapted, time splitting process. Our experience and knowledge can effective implemented within the prioritisation of tasks and the realization of single phases. In addition we provide training lessons for internal auditors and for a better understanding of the IRIS standard in attractive courses.