GOST ISO Guide 31-2019 PDF

Full title and description

GOST ISO Guide 31-2019 — "Reference materials. Contents of certificates, labels and accompanying documentation". National adoption (GOST) of the ISO guidance that specifies the information to be supplied with reference materials and certified reference materials (CRMs), including contents of certificates, labels and accompanying documentation.

Abstract

This standard defines the recommended content and presentation of documentation supplied with reference materials (RMs) and certified reference materials (CRMs). It covers the minimum information to be provided on certificates and labels (identification of the material, property(ies) of interest, assigned value(s) and uncertainties, traceability statements, homogeneity and stability information, use/storage instructions and validity/expiry), so users and laboratories can correctly apply RMs in calibration, method validation, quality control and measurement traceability.

General information

• Status: Active (national GOST adoption of the ISO Guide).
• Publication date: Approved 9 October 2019; entry/registration and national enactment from early 2020 (introduced 8 January 2020 in national registers).
• Publisher: Federal Agency on Technical Regulation and Metrology (Rosstandart) / published as a GOST national adoption (national publication channels).
• ICS / categories: 71.040.30 (chemical reagents / reference materials).
• Edition / version: GOST ISO Guide 31-2019 — national adoption of ISO Guide 31:2015 (the ISO guidance edition commonly used internationally).
• Number of pages: 17 pages (electronic PDF commercial listings indicate 17 pages for the 2019 national edition).

Scope

The standard applies to reference materials and certified reference materials across chemistry, materials and related measurement fields. It specifies the content and presentation of certificates, labels and any accompanying documentation so that values, uncertainties, traceability, homogeneity and stability information are clearly communicated. The scope is intended to support correct selection and use of RMs for calibration, quality control, method validation and establishing metrological traceability.

Key topics and requirements

• Identification of the material (name, batch/lot, unique identifier) and its intended use.
• Property(ies) of interest explicitly stated (what the assigned value represents).
• Assigned value(s) with measurement uncertainty and statement of coverage interval or confidence level.
• Metrological traceability statement (link to SI or other reference standards, where applicable).
• Information on homogeneity and stability (description of evidence/assessments relevant to intended use).
• Instructions for use, handling, storage conditions and expiry/validity information.
• Statements on limitations, commutability (where relevant, e.g., clinical matrices), and applicable references or normative documents.

Typical use and users

Primary users are producers of reference materials and certified reference materials, testing and calibration laboratories, accreditation bodies, regulators and purchasers of RMs. Laboratories rely on the document to interpret certificates correctly and to ensure valid use of RMs for calibration, method validation, quality control and establishing measurement traceability. RM producers use it to prepare compliant certificates and labels.

Related standards

Closely related international and national documents include ISO Guide 30 (terms and definitions for reference materials), ISO Guide 34 / ISO 17034 (requirements for competence of reference material producers), ISO Guide 33 (good practice for using reference materials), and ISO/IEC 17025 (competence of testing and calibration laboratories). Within the GOST family, national adoptions such as GOST ISO Guide 30-2019 and GOST ISO Guide 33-2019 are directly related.

Keywords

reference material; certified reference material; CRM; certificate of analysis; certificate content; label; traceability; uncertainty; homogeneity; stability; instructions for use; GOST; ISO Guide 31.

FAQ

Q: What is this standard?

A: A national (GOST) adoption of ISO Guide 31 that prescribes the required and recommended content of certificates, labels and accompanying documentation for reference materials and certified reference materials.

Q: What does it cover?

A: It covers what information must appear on certificates and labels (identification, assigned values, uncertainties, traceability, homogeneity/stability data, usage and storage instructions, validity/expiry, limitations and references) to ensure correct and traceable use of RMs.

Q: Who typically uses it?

A: Reference material producers, testing and calibration laboratories, accreditation bodies, and regulators or purchasers who need to verify that certificates and labels provide adequate information for correct RM use.

Q: Is it current or superseded?

A: The GOST ISO Guide 31-2019 edition is listed as the active national adoption (approved in October 2019 and enacted in national registers from early 2020) and replaces the earlier GOST ISO Guide 31-2014 national text. Users should check national registers or the publisher for any later revisions or amendments.

Q: Is it part of a series?

A: Yes — Guide 31 is part of a set of ISO/GOST guidance on reference materials that includes Guide 30 (terms), Guide 33 (use), and Guide 34 / ISO 17034 (production and competence), plus other related metrology and accreditation standards (e.g., ISO/IEC 17025). National GOST adoptions of these guides exist and are commonly used together.

Q: What are the key keywords?

A: Reference material, certified reference material, certificate of analysis, traceability, uncertainty, homogeneity, stability, label, instructions for use, GOST, ISO Guide 31.