GB/T 15000.4-2026Directives for the work of reference materials - Part 4: Contents of certificates, labels and accompanying documentation (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is Part 4 of GB/T 15000, "Guidelines for the Work of Standard Samples". GB/T 15000 has already published the following parts.

---Part 1: General provisions for standard samples in technical standards;

---Part 2: Common Terms and Definitions;

---Part 3: Standard Sample Assignment and Homogeneity and Stability Assessment;

---Part 4: Contents of Certificates, Labels, and Accompanying Documents;

---Part 5: Internal Development of Quality Control Samples;

---Part 6: General Rules for Packaging Standard Samples;

---Part 7: General Requirements for Standard Sample Producer Capabilities;

---Part 8: Use of Standard Samples;

---Part 9: Development of Qualitative Characteristic Standard Samples this document supersedes GB/T 15000.4-2019 "Guidelines for the Work of Standard Samples Part 4: Contents of Certificates, Labels and Accompanying Documents".

Compared with GB/T 15000.4-2019, apart from structural adjustments and editorial changes, the main technical changes are as follows.

---Added the term and definition of "operation-defined measurand" (see 3.7);

---Added terms and definitions for "research and development report" (see 3.8);

---The requirements for a product information table have been added, and the content of Table 1 has been modified accordingly (see 5.1, 2019 version 5.1);

---Added general requirements clauses (see 5.2, 5.3);

---A general clause has been added (see 5.4).

This document is equivalent to ISO 33401:2024, "Content of standard sample certificates, labels and accompanying documents".

The following minimal editorial changes have been made to this document.

---To harmonize with existing standards, the standard title has been changed to "Standard Sample Working Guidelines Part 4: Certificates, Labels and Accompanying Documents".

Contents;

---Translator's note added based on international and domestic standards (see 3.1);

---Added a note to the "Research and Development Report" (see 3.8).

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed and is under the jurisdiction of the National Technical Committee on Standard Samples (SAC/TC118).

Introduction

Standard samples are crucial for quality assurance in various measurement fields, used in a variety of measurement processes, including calibration, quality control, and proficiency testing.

Evidence and method confirmation.

Users of the standard sample obtain the information needed for correct use through the documents accompanying the standard sample. Therefore, the standard sample documents are required.

The content and format should be standardized.

In the technical system of standard samples, GB/T 15000 "Guidelines for Standard Sample Work" is the fundamental and general guideline for standard sample work in my country.

GB/T 15000 aims to establish universally applicable standards for the preparation, determination, packaging, storage, distribution, and application of standard samples by their manufacturers.

The requirements are as follows. It is proposed to consist of 9 parts.

---Part 1: General Provisions for Describing Standard Samples in Technical Standards. The purpose is to specify the requirements for describing standard samples in the development of technical standards.

General requirements for standard samples, the relationship between standard samples and technical standards, and technical criteria for selecting standard samples.

---Part 2: Common Terms and Definitions. The purpose is to define the terms and definitions related to standard samples, particularly those used in standardization.

The terminology used in sample product manuals, certificates, and corresponding development reports.

---Part 3: Standard Sample Assignment and Homogeneity and Stability Assessment. The aim is to provide more specific guidance on technical issues.

It also provides a basic model for evaluating the homogeneity and stability of standard samples and for determining their values.

---Part 4: Contents of Certificates, Labels, and Accompanying Documents. The purpose is to establish the applicable procedures for preparing standard sample certificates, labels, and accompanying documents.

The relevant requirements to be followed when including file content.

---Part 5: Internal Development of Quality Control Samples. The purpose is to standardize and guide the development and use of quality control samples.

---Part 6: General Rules for Standard Sample Packaging. The purpose is to establish basic principles applicable to the packaging, storage, and transportation of standard samples.

rule.

---Part 7: General Requirements for Standard Sample Producer Capabilities. The purpose is to enable standard sample producers to produce samples that meet the required standards.

The organizational management and operational requirements are specified based on the standard samples sought.

---Part 8: Use of Standard Samples. This section aims to provide users of standard samples with proper application guidance.

---Part 9: Development of Qualitative Characteristic Standard Samples. The purpose is to study the assignment, homogeneity, and stability of qualitative characteristic standard samples.

Technical aspects such as the evaluation of interchangeability provide more specific guidance for the production of qualitative characteristic standard samples.

In this document, "development report" is a general term, not limited to the development of standard samples, but also applicable to the development of standard samples.

The copying. In some contexts, "certification report" is also translated as "certification report".

This document largely follows the third edition of ISO Guide 31.This document aims to supplement ISO 17034 and support its implementation.

ISO 17034 Requirements for Standard Sample Documentation.

Standard Sample Working Guide Part 4: Contents of Certificates, Labels, and Accompanying Documents

1 Scope

This document is primarily intended to assist standard sample producers in preparing clear and concise accompanying documentation for their standard samples. It lists and explains the key points for preparing such documentation.

Essential, recommended, and other categories of information to consider when drafting product manuals and standard sample certificates. Standard sample users and other stakeholders.

Only then can this information be used to confirm the suitability of standard samples or certified standard samples.

This document also sets out minimum requirements for the labels affixed to standard sample containers.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 15000.2-2019 Standard Sample Working Guidelines Part 2: Common Terms and Definitions (ISO Guide 30.2015, IDT)

3 Terms and Definitions

The terms and definitions defined in GB/T 15000.2-2019, as well as the following terms and definitions, apply to this document.

The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows.

Standard sample reference material; RM Materials having one or more specified properties that are sufficiently uniform and stable have been determined to be suitable for the intended use in the measurement process.

Note 1.Standard Sample 1) is a general term.

Note 2.Characteristics are quantitative or qualitative (e.g., the identity of a substance or species).

Note 3.Applications include calibration of measurement systems, evaluation of measurement procedures, assignment of values to other materials, and quality control.

Note 4.ISO/IEC Guide 99.2007 (VIM), 5.13 has a similar definition, but limits the term "measurement" to quantitative values only. However, in ISO/IEC...

Note 3 of Guideline 99.2007, 5.13 explicitly includes qualitative characteristics, referred to as "nominal characteristics".

[Source. GB/T 15000.2-2019, 2.1.1, with modifications]

1) Reference material is also translated as reference substance or standard substance.

A standard sample (3.1) having one or more specified characteristics determined using a metrologically valid procedure, accompanied by a standard sample certificate (3.4).

Provide a statement of the specified characteristic value, its uncertainty, and metrological traceability.

Note 1.The concept of value includes nominal characteristics or qualitative attributes, such as identity or sequence, whose uncertainty can be expressed in terms of probability or confidence level.

Note 2.ISO/IEC Guide 99.2007, 5.14 has a similar definition.

[Source. GB/T 15000.2-2019, 2.1.2, with modifications]