Railway & Medical Certification
Certification support for two highly regulated supply chains: ISO/TS 22163 (IRIS) for railway suppliers and ISO 13485 for medical device manufacturers.
Get a Quote for ISO/TS 22163 (IRIS)Our Certification Process
One proven eight-step path, from kick-off to certification award, applied to every standard we support.
- Step 1
Kick-off Meeting
Alignment with management, process owners, and HODs on scope, objectives, and a realistic certification timeline.
- Step 2
Gap Analysis
A review of your current systems, processes, and records against the requirements of the applicable standard(s).
- Step 3
Training & Awareness
Structured training on the standard's requirements, and any sector-specific tools, for management and staff.
- Step 4
Documentation Development
Quality Manual, procedures, work instructions, and supporting formats and records, built around your actual processes.
- Step 5
Implementation Support
Hands-on rollout across every function (production, design, HR, stores, and more) with real records generated along the way.
- Step 6
Internal Audit
Internal auditor training, a full internal audit, and closure of nonconformities ahead of the certification audit.
- Step 7
Management Review
Facilitation of the Management Review Meeting (MRM) and implementation of its outputs.
- Step 8
Certification Audit Support
On-site support through Stage 1 and Stage 2 assessment visits, closure of findings, and certification award.
Standards We Cover
Request a quote for any standard below and we'll follow up with a tailored scope.
Railway
ISO/TS 22163 (IRIS)
International Railway Industry Standard quality management requirements for the rail supply chain.
Medical Devices
ISO 13485
Quality management system requirements for the design, manufacture, and supply of medical devices, with a strong focus on risk management and regulatory compliance.
Frequently Asked Questions
Is IRIS the same as ISO/TS 22163?
ISO/TS 22163 is the international standard that replaced the original IRIS scheme in 2017. Most of the industry still refers to it as IRIS.
What does ISO 13485 cover?
ISO 13485 is the quality management standard for the design, manufacture, and supply of medical devices. It builds on ISO 9001 with stronger requirements for risk management, documentation, traceability, and regulatory compliance.
Ready to get certified?
Tell us where you are today and which standard you're working towards. We'll recommend the right path and a realistic timeline.