ISO Guide 80:2014 PDF
Guidance for the in-house preparation of quality control materials (QCMs)
Guidance for the in-house preparation of quality control materials (QCMs)
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 50
- Дата публикации:
- 24 июля 2014 г.
- Издание:
- ISO GUIDE 80 edition 1 version 1
- ICS:
- 71.040.30
ISO Guide 80 outlines the essential characteristics of reference materials for quality control (QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due to transportation conditions is avoided). The content of this Guide also applies to inherently stable materials, which can be transported to other locations without risk of any significant change in the property values of interest. The primary audience for this Guide is laboratory staff who are required to prepare and use materials for specific in-house quality control applications. Preparation of QCMs, where transportation is a necessary component of the supply chain, such as laboratory sites at different locations or for proficiency testing schemes, should conform to the relevant requirements of ISO Guides 34 and 35. The description of the production of reference materials (RMs), as detailed in ISO Guide 34 and ISO Guide 35 is also applicable to the preparation of quality control materials (QCMs). However, the requirements for "in-house" QCMs are less demanding than those for a certified reference material (CRM). The preparation of QCMs should involve homogeneity and stability assessments, and a limited characterization of the material to provide an indication of its relevant property values and their variation, prior to use. This document provides the quality criteria that a material should fulfil to be considered fit-for-purpose for demonstrating a measurement system is under statistical control. Guidance on uses of such materials is not included in this Guide. The layout and structure of this Guide provides general information on the preparation of QCMs in the main chapters, with specific case studies covering a range of sectors in the annexes. The case studies are not complete "process manuals" but are included to highlight some of the key considerations when preparing QCMs. The case studies vary in complexity and detail, including sector specific terminology, but provide a range of information for laboratory staff to draw from. It is expected that those involved in QCM preparation will have some knowledge of the type of material to be prepared and be aware of any potential problems due to matrix effects, contamination, etc.
Abstract
ISO Guide 80:2014 - Overview
ISO Guide 80:2014 provides practical guidance for the in‑house preparation of quality control materials (QCMs) used by laboratories to monitor day‑to‑day measurement performance. It defines the essential characteristics a QCM should meet to be considered fit‑for‑purpose for demonstrating that a measurement system is under statistical control. The Guide focuses on materials prepared and used within the same facility (avoiding transport‑related instability) but also applies to inherently stable materials that can be moved without altering key property values.
Key topics and technical requirements
ISO Guide 80 covers the full lifecycle of QCM preparation with emphasis on practical, risk‑based steps:
- Material specification: matrix type, matrix matching, commutability, properties and property values, unit size and required bulk amount.
- Sourcing and processing: selection of bulk material, processing, sub‑division and packaging to minimize contamination and matrix effects.
- Homogeneity: design of homogeneity assessments, analytical approaches and statistical treatment of between‑unit variability.
- Characterization and value assignment: limited characterization to provide indicative (informative) property values and their variation prior to use.
- Stability: assessing short‑ and long‑term stability, assigning expiry dates, and monitoring storage conditions.
- Documentation & labelling: essential information to accompany QCMs and records to retain.
- Practical handling: minimum sample size, mixing procedures, dry mass correction, and storing opened containers.
- Annexes include sector case studies illustrating diverse QCM preparations (coal, geological/metallurgical materials, fortified wheat flour, bauxite, pharmaceuticals, bromate in water).
Important note: where transportation or external supply chains are involved, preparation must meet the more stringent requirements of ISO Guides 34 and 35 (production and certification of reference materials).
Practical applications and intended users
ISO Guide 80 is intended primarily for laboratory staff and competent technical personnel who need to prepare QCMs for internal quality control. Typical applications include:
- Day‑to‑day analytical QC where full CRM characteristics (traceability and certified uncertainty) are not required.
- Creating matrix‑matched check samples to complement commercial CRMs or where no suitable CRM exists.
- Sectors illustrated in the Guide: environmental testing, food fortification analysis, coal and mineral testing, pharmaceutical reference standards, and water testing.
Related standards
- ISO Guide 34 - Production of reference materials
- ISO Guide 35 - Characterization and certification of reference materials
- ISO Guide 30 / VIM - Terminology for reference materials
Keywords: ISO Guide 80:2014, quality control materials, QCMs, in‑house preparation, homogeneity, stability, characterization, commutability, ISO Guide 34, ISO Guide 35, certified reference material (CRM).
Технические детали
- Технический комитет
- ISO/TC 334 - Reference materials
- SKU
- ISO Guide 80:2014
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