Software for UNE 73401

UNE 73401, without folders or surprises

Quality assurance for safety-related activities at nuclear facilities, with exhaustive traceability.

What it is and which edition applies

UNE 73401 is the Spanish quality assurance standard for nuclear facilities. Its logic differs from an ISO management standard: it is organised around a quality assurance programme graded by the safety significance of each item, with formal demands on design control, document control, purchasing from evaluated suppliers, control of special processes, inspection and testing, control of measuring equipment and documented handling of nonconformities.

Content reviewed on 25 August 2026

Scope: Nuclear facilities Quality assurance of structures, systems and components
Approach: Graded by safety significance Not every item receives the same level of control
Regulator in Spain: Consejo de Seguridad Nuclear Sole competent body for nuclear safety and radiation protection
Legal framework: Law 15/1980 creating the CSN Plus the regulation on nuclear and radioactive facilities
International reference: IAEA GSR Part 2 Leadership and management for safety

Document control

Versions, approvals and distribution with read receipts.

Connected to your document cloud

Publish and version documents by connecting to OneDrive, Google Drive or SharePoint, without duplicating folders.

Audits

Annual program, checklists per standard, findings linked to actions.

Non-conformities

Root cause, action, owner, deadline and effectiveness check.

KPIs

Process objectives fed with real operating data.

Legal requirements

A register of legal and other requirements, with validity and compliance evaluation per standard.

Corrective actions

Root cause, action, owner, deadline and effectiveness check, all linked to the nonconformity.

Improvement actions

Improvement opportunities with an owner and tracking, beyond just fixing what already failed.

Management review

A pre-built report with indicators, audits and nonconformities, ready for the meeting.

Component traceability

Safety-critical activities and components linked together.

Historical record

Complete evidence retained for inspection.

Staff qualification

Specific training and qualification of staff in critical activities.

Supplier audits

Critical suppliers audited with their qualification evidence.

Requirements covered

What it solves for UNE 73401

Document control for safety-critical procedures
Traceability of activities and components
Staff qualification and training
Nonconformities and corrective actions
Internal and supplier audits
Complete historical record for inspection

Standards covered

Pick your standard and see what it solves

GMP+ Animal feed safety Food industry · animal feed IATF 16949 Automotive Automotive SQAS2022 Chemical and logistics assessment Quality · chemical and logistics ISO 19600 Compliance management systems Compliance · guidance ISO 37301 Compliance management systems Compliance ISO 22716 Cosmetics manufacturing Quality · cosmetics GDPR Data protection Legal · data protection ISO 14001 Environmental management Environment SGE 21 Ethical and responsible management Social responsibility IFS Food Food safety Food industry FSSC 22000 Food safety management system Food industry BRCGS Global food standard Food industry ISO 14064 Greenhouse gases Environment · carbon footprint HACCP Hazard analysis and critical control points Food industry ISO 27001 Information security Cybersecurity ISO 20000 IT service management Quality · IT services ISO 13485 Medical devices Healthcare ISO 15189 Medical laboratories Quality · healthcare ENS National Security Framework Security · public sector UNE 73401 Nuclear quality assurance Quality · nuclear ISO 45001 Occupational health and safety Health & safety ISO 9001 Quality management Quality · every sector ISO 26000:2010 Social responsibility Social responsibility · guidance Sustainability Sustainability management ESG UNE 19602 Tax compliance Compliance · tax ISO 17025 Testing and calibration laboratories Quality · laboratories

Frequently asked questions

What people ask us before getting started

Which edition of the standard is current?

The edition in force is UNE 73401 (quality assurance for nuclear facilities). When the issuing body publishes a new one, a transition period opens; once it closes, certificates issued against the previous edition stop being valid.

Does this work if we are already certified?

Yes. Your existing system — processes, documents, records, audit history — is loaded in and kept alive from day one. Nothing needs redesigning and the certification cycle does not restart.

Will the auditor accept digital records?

Yes, provided they are traceable, controlled and able to show who did what and when. No standard requires paper; every standard requires reliable evidence, and a properly controlled electronic record provides it better than a folder.

Can it be combined with other standards?

Yes, and that is the sensible route. The common Annex SL structure lets a single integrated system share the process map, document control, internal audits, nonconformities and indicators between UNE 73401 and the rest, leaving only the standard-specific parts separate.

How long does it take to be ready for an audit?

It depends on the starting point. An organisation already working with written procedures is usually ready in two or three months; one starting from scratch needs longer. The bottleneck is rarely the tool — it is the availability of the people who know the processes.

What happens to the documentation we already have?

It is migrated. Existing procedures, forms and records are loaded with their version and approver, so the history is not lost and the system starts with the memory the organisation already had.

Can the auditor look directly at the system?

Yes. They are given read-only access with a defined scope and an expiry date. It is more comfortable for both sides than preparing a folder of screenshots and exports.

What is the difference between a major and a minor nonconformity?

A major one compromises the system's ability to meet a requirement — a required process missing altogether, systematic failure, or a failure affecting the product — and usually blocks certification until it is closed. A minor one is a specific lapse resolved with an action plan.

Are the indicators calculated automatically?

Yes, from the data the processes themselves generate. That is the difference between a dashboard that reflects what is happening and a spreadsheet somebody fills in the week before the management review.

Does it work across several sites or legal entities?

Yes. The model is multi-company and multi-site: what makes sense to share is shared, and what belongs to each location stays separate — including the certificate scope where it differs.

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Sources

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

UNE standards catalogue UNE, Spanish Association for Standardisation · Official catalogue
Consejo de Seguridad Nuclear CSN · Regulatory body
IAEA GSR Part 2 — Leadership and Management for Safety International Atomic Energy Agency · 2016 ed.

Software for UNE 73401 — Nuclear quality assurance

Kimobox is a software for UNE 73401 that digitizes the requirements of the standard: document control for safety-critical procedures, traceability of activities and components, staff qualification and training, nonconformities and corrective actions, with full traceability and evidence ready for the auditor.

The platform lets you run an integrated management system that combines UNE 73401 with other ISO standards and sector protocols, sharing the process map, document control, internal audits, non-conformities and KPIs.