UNE 73401 quality assurance programme manual: contents

In one sentence

The quality assurance programme manual describes the scope of the safety-related activities it covers, the organisation and the independence of the quality assurance function, the grading of controls according to safety significance and the procedures that implement each criterion, and it is the framework document that UNE 73401 and CSN guide GS-10.1 expect in order to establish the programme.

Content reviewed on 17 October 2026

Type of information: Mandatory document Quality assurance programme and organisation criteria; GS-10.1
Who fills it in: Quality assurance manager Approved by management; for the licensee, subject to CSN oversight under its authorisations
When: Before activities start Revised when the organisation, scope or requirements change
How long it is kept: Current version and its revisions Keeping earlier revisions shows which programme was in force when each activity was performed

What the standard requires

What UNE 73401 demands and what it leaves to your judgement

GS-10.1 recommends that the quality assurance programme of Spanish nuclear facilities be based on UNE 73401, with the criteria developed through the CSN’s specific safety guides. The programme covers safety-related activities, structures, systems and components in every phase, as well as the engineering, manufacturing and inspection carried out for them.

Nuclear quality assurance criteria require those who verify to be sufficiently independent of those who perform the work, and to have the authority to stop it. The manual must show that independence in the organisation chart and in the assignment of responsibilities.

For the licensee, the programme is part of the management system required by Instruction IS-19. For a supplier, it is what the licensee audits before adding it to its list of evaluated suppliers.

Read it in context: Organization and quality assurance program, in the UNE 73401 Academy

Structure

Fields the template should include

Scope: safety-related activities, phases and items covered
Basic standard applied and reference guides
Organisation, responsibilities and authority, including quality assurance independence
Criterion for grading controls by safety significance
List of procedures implementing each criterion
Qualification of staff performing safety-related activities
Control of documents and records
Programme audits and management review of its effectiveness
Revision, date and approval

Example

Example: manual of a pipe support manufacturer

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Company	Calderería Irati (fictitious company) · supplier of pipe supports for power plants
Scope	Detailed design, manufacture, welding, non-destructive testing and inspection of safety-class supports
Basic standard	UNE 73401:1995, plus the additional requirements in each licensee’s purchase orders
Organisation	Quality assurance reports to general management, not production, with authority to stop work
Grading	Three levels of control according to the item’s safety class stated in the order
Procedures	22 procedures, one or more per criterion
Revision	Revision 7 approved by general management on 15 January 2026

At the audit

Mistakes auditors commonly flag

An ISO 9001 manual with a new title, lacking the criteria specific to nuclear quality assurance.
Quality assurance reports to production.
No explanation of how controls are graded by safety significance.
Procedures cited in the manual that do not exist or are at a different revision.
The scope leaves out subcontracted activities such as non-destructive testing.

In Kimobox

How this record is kept in Kimobox

1The quality assurance programme is managed as a controlled document.
2The organisation chart is recorded with quality responsibilities clearly separated.
3Programme procedures are versioned, with their revision and approval traceable.
4Staff qualification is managed from each person’s digital file.

Frequently asked questions

What people ask us before getting started

What is the difference between the programme and the manual?

The programme is the set of planned activities that gives confidence that items will perform in service; the manual is the document that describes it and refers to the procedures. In practice the two terms are used almost interchangeably.

Does a supplier need one too?

Yes, if it supplies safety-related items or services. The licensee’s purchase order will require a programme in line with UNE 73401 or, if the supplier is ISO 9001 certified, one supplemented with the additional requirements set out in the standard’s annexed tables.

What does grading mean?

Applying controls with an intensity proportionate to the safety significance of the item or activity. Not every component in a power plant receives the same level of quality assurance.

Keep exploring

Related pages

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 73401:1995 — Garantía de la calidad en instalaciones nucleares (Quality assurance in nuclear facilities) UNE, Spanish Association for Standardisation · Edition of 19 June 1995, confirmed in 2024
Guía de Seguridad GS-10.1 (Rev. 2) — Guía básica de garantía de calidad para instalaciones nucleares (Basic quality assurance guide for nuclear facilities) Consejo de Seguridad Nuclear (Spanish Nuclear Safety Council) · February 1999
Instrucción IS-19, de 22 de octubre de 2008, del Consejo de Seguridad Nuclear, sobre los requisitos del sistema de gestión de las instalaciones nucleares (CSN Instruction IS-19 on management system requirements for nuclear facilities) BOE-A-2008-18062 · 22 October 2008

UNE 73401 quality assurance programme manual