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Two-minute brief

ISO 22163 (IRIS) requirements explained: video brief

A two-minute brief on how ISO 22163 builds railway requirements around ISO 9001 and how IRIS assesses them.

  • Two-minute brief
  • 2 min

Key takeaways

  • ISO 22163 reproduces ISO 9001:2015 and adds railway requirements.
  • Additions include tender management, business continuity and social responsibility.
  • IRIS Rev. 04 combines ISO 22163 with a performance assessment.
  • Enabling factors, customer perception and process performance are assessed.
  • Distributors and turnkey suppliers have been eligible since Rev. 04.

ISO 9001 in boxes, railway requirements around it

ISO 22163 prints the ISO 9001:2015 text in boxes and adds the railway requirements around it: supplements inside clauses 4 to 10, additional subclauses such as tender management and business continuity, three railway subclauses closing clause 8, and three informative annexes. This short film walks through the additions.

In clause 4, for example, ISO 22163 adds business planning within the context, a subclause on social responsibility, supplements on the scope and the system's processes, and the climate action changes of Amendment 1:2024. In practice that means a business plan feeding the quality objectives, a scope naming the railway activities and products, and a process list with owners. Similar supplements run through leadership, planning, support, operation, performance evaluation and improvement, with the emphasis on preventing and reducing defects and on product quality, including its safety aspects.

How IRIS assesses

IRIS Certification® Rev. 04 combines ISO 22163 with the IRIS Performance Assessment. The assessment looks at three fronts: enabling factors, through an evaluation matrix built on the ISO 22163 requirements; customer perception; and process performance. A certification body under contract with UNIFE carries out the audit, and the results go to the IRIS portal, where the IRIS Management Centre sets the performance level.

The standard applies to rolling stock manufacturers, equipment, component and spare-part suppliers, maintenance companies and, since IRIS Rev. 04, distributors and turnkey suppliers. The current edition is ISO 22163:2023 with Amendment 1:2024, which replaced ISO/TS 22163:2017, and a second edition is in preparation at ISO.

ISO 22163 is the ISO standard, the text of ISO 9001:2015 plus the railway requirements, while IRIS Certification® is UNIFE's scheme built on it, adding the performance assessment, its certification rules and the IRIS portal. No separate ISO 9001 certificate is needed, but the whole ISO 9001 system is. After a successful audit the IRIS Management Centre issues a quality performance level of Bronze, Silver or Gold each year from the organisation's performance results. Small organisations that meet the scheme's criteria can choose a simplified certification with reduced documentation, marked as simplified and without a performance level. The basic data, such as approval status, validity and scope, is published in the IRIS database, while the audit report and score are shared only with those the organisation chooses.

ISO 22163 (IRIS) at a glance

Purpose
Railway quality management across the supply chain: defect prevention and reduction, and product quality including its safety aspects
Relevant to
Rolling stock manufacturers, equipment, component and spare-part suppliers, maintenance companies and, since IRIS Rev. 04, distributors and turnkey suppliers
Edition
ISO 22163:2023 with Amendment 1:2024, which replaced ISO/TS 22163:2017; a second edition is in preparation at ISO
Certification
IRIS Certification® Rev. 04: a certification body under contract with UNIFE audits against ISO 22163 and the IRIS Performance Assessment:2023; results go to the IRIS portal
Sterling's role
Consulting with your team, Effivity, training, internal audits, the IRIS upload pack and readiness for the certification audit, then Sustain™
Cost and timing
Total investment for an ISO 22163 railway QMS depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 6 to 12 months

ISO 22163 (IRIS): the complete guide →

ISO 22163 (IRIS): questions people ask

Is ISO 22163 certification the same as IRIS Certification®?

Not quite. ISO 22163 is the ISO standard: ISO 9001:2015 plus the railway requirements. IRIS Certification® is UNIFE's scheme built on it, adding the Performance Assessment:2023, with its assessment method and certification rules, and the IRIS portal and database, so an IRIS certificate reflects conformity plus an assessment of process maturity and performance. If a customer or tender names ISO 22163, confirm whether it expects IRIS: a certificate citing ISO 22163 but issued outside the scheme has no IRIS assessment and no entry in the IRIS database.

Do we need ISO 9001 certification first?

No separate ISO 9001 certificate is needed, but the whole ISO 9001 system is. ISO 22163 reproduces the ISO 9001:2015 text and adds the railway requirements, and IRIS expects an autonomous railway business management system meeting both, plus the scheme's rules. Your existing ISO 9001 processes are the starting point of the gap analysis.

Is there a simplified route for small companies?

Yes. Small organisations that meet the scheme's criteria can choose a simplified IRIS Certification® with reduced documentation. The certificate is marked as simplified and receives no quality performance level; the route is closed to a small unit belonging to a larger organisation, and a move to full certification happens at a recertification audit after a complete cycle.

Does Sterling issue the ISO 22163 certificate?

No. Sterling's work ends at consulting and preparation. A certification body under contract with UNIFE audits you under IRIS Certification® and makes the certification decision, the IRIS Management Centre sets the performance level, and the result is recorded on the IRIS portal. Anyone offering consulting and certification in a single package is selling paper.

What do Bronze, Silver and Gold mean?

They are the three quality performance levels of IRIS Certification®. After a successful audit the IRIS Management Centre issues the level each year, no later than 30 days after the anniversary of the certification audit, based on your performance results; Gold also requires direct feedback from your customers. Simplified certificates receive no level. Sterling plans the route to the next level with you under Sustain™.

More ISO 22163 (IRIS) questions and answers →

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