Implementation walkthrough
How to implement ISO 22163 (IRIS): video walkthrough
A walkthrough of building an ISO 22163 railway quality management system and preparing for IRIS Certification® Rev. 04.
Key takeaways
- ISO 22163 contains ISO 9001:2015 plus railway sector requirements.
- It is the basis of UNIFE's IRIS Certification® scheme.
- Railway additions include tender management and business continuity.
- IRIS assesses enabling factors, customer perception and process performance.
- Results are uploaded to the IRIS portal.
Railway quality management across the supply chain
ISO 22163 is the international standard for railway quality management systems. It reproduces the full text of ISO 9001:2015 and adds the railway sector's own requirements, for organisations anywhere in the railway supply chain of industrial products and services, placing weight on defect prevention and reduction and on product quality and safety. The requirements began as the industry's own IRIS standard, and the 2023 edition made them a full International Standard.
ISO 22163 is also the basis of IRIS Certification®, the certification scheme of UNIFE, the European rail supply industry association, operated by its IRIS Management Centre. This short film walks through how a railway supplier prepares.
From eligibility to the IRIS audit
Confirm eligibility and register: check the site, its certifiable activities and the certification scope against the scheme's rules, and register on the IRIS portal. A gap analysis then compares the current system with ISO 9001 and every railway addition, from business planning within the context and social responsibility to tender management, business continuity and the railway subclauses that close the operation clause.
Implementation builds the railway quality system and runs it long enough to produce records: a business plan feeding the quality objectives, a scope naming the railway activities and products, processes with owners and measures, and the controls the railway requirements add. Internal audits test the system, and the IRIS upload pack is prepared. A certification body under contract with UNIFE then assesses the site under IRIS Certification® Rev. 04, against ISO 22163 and the IRIS Performance Assessment, which looks at enabling factors, customer perception and process performance. The certificate is the certification body's decision and the performance level the IRIS Management Centre's.
Sterling's expert and experienced consultants support the work with your team under Sterling OS™, with the records held in Effivity. Implementations are built to ISO 22163:2023 and its 2024 amendment.
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): 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™.
Keep exploring
Related to this video
The complete guide
Everything on ISO 22163 (IRIS)
Start with the ISO 22163 (IRIS) page, or go straight to the guide you need.
On the ISO 22163 (IRIS) page
- What are the main ISO 22163 requirements?
- How do you get ISO 22163 certified?
- How much does ISO 22163 certification cost?
- How long does ISO 22163 certification take?
- Who needs ISO 22163 certification?
- How ISO 22163 supports railway delivery and customer confidence
- Frequently asked questions about ISO 22163
Often combined with ISO 22163 (IRIS)
More videos: Automotive, aerospace, rail and defence
- How to implement ISO 26262Implementation walkthrough · 3 min 15 s
- ISO 26262 requirements explainedTwo-minute brief · 2 min
- How to implement ISO/SAE 21434Implementation walkthrough · 3 min 15 s
- ISO/SAE 21434 requirements explainedTwo-minute brief · 2 min
- How to implement IATF 16949Implementation walkthrough · 3 min 14 s
- IATF 16949 requirements explainedTwo-minute brief · 2 min
- How to implement AS9100Implementation walkthrough · 3 min 15 s
- AS9100, AS9110 and AS9120 requirements explainedTwo-minute brief · 2 min
Talk to a consultant
Plan your ISO 22163 certification with confidence.
Tell us your goals, locations and target date. We’ll help you define the scope, timeline and next steps.
hello@sterling-grc.com+1 201 263 4443 (global headquarters) · your nearest office and its number are at the top of this page
What would you like to achieve?
Choose a starting point. The enquiry form takes about a minute.
Book my free discovery callContinue to the enquiry form to share your details. Please do not include passwords, sensitive personal information or confidential files. A Sterling consultant replies within one working day. Privacy notice