ISO 33401-2024 PDF

Full title and description

ISO 33401:2024 — Reference materials — Contents of certificates, labels and accompanying documentation. This International Standard gives producers of reference materials (RMs) and certified reference materials (CRMs) mandatory, recommended and other categories of information to include on product information sheets, certificates and labels so users can assess suitability and traceability of an RM or CRM.

Abstract

This document helps reference material producers prepare clear, concise documentation accompanying reference materials. It lists and explains the minimum (mandatory) information, recommended items and other useful information to be considered when preparing product information sheets and RM certificates, and specifies minimum labelling requirements for individual RM units. The guidance supports RM users, accreditation bodies and other stakeholders in confirming RM suitability.

General information

• Status: Published.
• Publication date: January 2024 (Edition 1, 2024-01).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 71.040.30 (Reference materials / Metrology).
• Edition / version: Edition 1 (2024).
• Number of pages: 10 pages.

Scope

ISO 33401:2024 specifies the content to be provided in documentation that accompanies reference materials and certified reference materials: product information sheets, certificates and labels attached to RM units. It covers minimum mandatory information (for example, identity and intended use of the RM, metrological traceability and uncertainty statements for CRMs where applicable), recommended information and other helpful details to assist users in determining suitability and proper use. The standard is intended for RM producers and other stakeholders involved in RM distribution and use.

Key topics and requirements

• Minimum required content for RM product information sheets and CRM certificates (identity, intended use, preparation and storage instructions, expiry/retention information, uncertainty and traceability statements where applicable).
• Classification of information into mandatory, recommended and optional categories to support consistent documentation practice.
• Minimum labelling requirements for individual RM units (label contents and format requirements to ensure traceability and safe handling).
• Guidance to ensure documentation is clear, concise and useful for end users, accreditation bodies and purchasers of RMs.

Typical use and users

Primary users are producers of reference materials and certified reference materials, accreditation bodies, testing and calibration laboratories, biobanks and research organisations that purchase or produce RMs, and quality managers responsible for RM selection and documentation. Training providers and conformity assessment bodies will also use the standard when assessing RM documentation practices.

Related standards

ISO 33401:2024 sits alongside and supports ISO/IEC and ISO standards for reference materials and accreditation, notably ISO 17034 (General requirements for the competence of reference material producers). ISO 33401 replaces and updates the role previously covered by ISO Guide 31:2015 regarding the content of RM certificates and information sheets. Users should consult ISO 17034 for production/accreditation requirements and other ISO/TC 334 deliverables for complementary guidance.

Keywords

reference material, certified reference material, RM certificate, product information sheet, labelling, traceability, uncertainty, ISO 33401, ISO/TC 334, accreditation, ISO 17034.

FAQ

Q: What is this standard?

A: ISO 33401:2024 is an International Standard that specifies the content of certificates, labels and accompanying documentation for reference materials and certified reference materials, to ensure users have the minimum information needed to assess suitability and use.

Q: What does it cover?

A: It covers mandatory, recommended and other categories of information to include in RM product information sheets and CRM certificates, plus minimum labelling requirements for individual RM units and guidance on clarity and usability of documentation.

Q: Who typically uses it?

A: Producers of reference materials and certified reference materials, testing and calibration laboratories, accreditation bodies, biobanks, purchasers of RMs, and organisations involved in RM distribution and quality assurance.

Q: Is it current or superseded?

A: ISO 33401:2024 is the current published standard (published January 2024). It supersedes the guidance previously provided in ISO Guide 31:2015 for the content of RM documentation.

Q: Is it part of a series?

A: ISO 33401:2024 is part of the body of work produced by ISO/TC 334 on reference materials and complements ISO 17034 (requirements for RM producers) and other TC 334 publications and guidance documents addressing RM production and use.

Q: What are the key keywords?

A: Reference material, certified reference material, certificate, label, documentation, traceability, uncertainty, product information sheet, RM producer.