ISO Guide 80:2014
Guidance for the in-house preparation of quality control materials (QCMs)

Standard No.

ISO Guide 80:2014

Release Date

2014

Published By

International Organization for Standardization (ISO)

Latest

ISO Guide 80:2014

Scope

This Guide 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[1] and 35.[2] The description of the production of reference materials (RMs), as detailed in ISO Guide 34[1] and ISO Guide 35[2] 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, for example setting up a QC chart, is adequately covered elsewhere [3],[4],[5],[6] and 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.

ISO Guide 80:2014 Referenced Document

• ISO 11206:2011 Water quality - Determination of dissolved bromate - Method using ion chromatography (IC) and post column reaction (PCR)
• ISO 13528:2005 Statistical methods for use in proficiency testing by interlaboratory comparisons
• ISO 14488:2007 Particulate materials - Sampling and sample splitting for the determination of particulate properties
• ISO 3534-1:2006 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability
• ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
• ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy values
• ISO 7870-1:2014 Control charts - Part 1: General guidelines
• ISO 7870-2:2013 Control charts - Part 2: Shewhart control charts
• ISO 7870-3:2012 Control charts - Part 3: Acceptance control charts
• ISO 7873:1993 Control charts for arithmetic average with warning limits
• ISO Guide 30:1992 Terms and definitions used in connection with reference materials
• ISO Guide 33:2000 Uses of certified reference materials*， 2024-04-20 Update
• ISO Guide 34:2009 General requirements for the competence of reference material producers
• ISO Guide 35:2006 Reference materials - General and statistical principles for certification
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
• ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

ISO Guide 80:2014 history

• 2014 ISO Guide 80:2014 Guidance for the in-house preparation of quality control materials (QCMs)