ISO Guide 80-2014 PDF

Full title and description

ISO Guide 80:2014 — Guidance for the in-house preparation of quality control materials (QCMs). This Guide describes the essential characteristics that quality control materials should have and provides practical guidance on preparing QCMs within the laboratory or facility where they will be used, with particular attention to homogeneity, stability and limited characterization sufficient to demonstrate that a material is fit-for-purpose for internal quality control.

Abstract

ISO Guide 80:2014 outlines the key attributes of reference materials intended for quality control purposes and describes processes by which competent personnel can prepare those materials in-house (i.e., at the site where they will be used so that transport-related instability is avoided). The Guide also applies to inherently stable materials that can be transported without significant change to the property values of interest. It recommends assessments of homogeneity and stability, provides limited characterization approaches to indicate property values and variability, and includes case studies in annexes to illustrate practical considerations. The Guide is intended to set quality criteria for materials used to show a measurement system is under statistical control; it does not provide detailed procedural manuals for every matrix or test method.

General information

• Status: Withdrawn (replaced by ISO/TR 33402 in 2025).
• Publication date: August 2014 (Edition 1).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 71.040.30 (Reference materials).
• Edition / version: Edition 1, 2014.
• Number of pages: 50 pages.

Scope

The Guide provides guidance for the in-house preparation of quality control materials (QCMs) intended for use within a laboratory or facility. It covers the essential characteristics QCMs should meet to be considered fit-for-purpose for internal quality control: material specification, sampling and sample handling, basic homogeneity and stability assessment approaches, limited characterization to indicate property values and variability, and documentation. The Guide is not intended to replace the more rigorous requirements for certified reference materials; when QCMs must be transported or used across multiple sites, requirements in standards for reference material production should be followed (for example, ISO Guide 34 / ISO 17034 and ISO Guide 35 / successor documents).

Key topics and requirements

• Definition and intended use of quality control materials (QCMs) versus reference and certified reference materials (RMs/CRMs).
• Principles for developing an in-house QCM: material specification, sourcing, and candidate bulk preparation.
• Requirements for assessing homogeneity and short- and long-term stability appropriate to the intended use.
• Guidance on limited characterization (measurement approaches and uncertainty considerations) to establish central tendency and variability for QC use.
• Documentation, labelling and record-keeping needed to demonstrate fitness-for-purpose and traceability within the laboratory context.
• Advice on risk management where transport or external distribution is involved — referral to formal RM/CRM requirements where relevant.
• Practical, sector-specific case studies in annexes illustrating common matrices and preparation challenges.

Typical use and users

Primary users are laboratory staff and quality managers responsible for internal quality control in clinical, environmental, food, industrial and research laboratories. Typical uses include preparation of internal control samples for routine monitoring of analytical methods, method validation support, and ongoing checks of measurement system stability when commercial control materials are unavailable or unsuitable.

Related standards

Relevant related documents include ISO/REMCO and ISO reference-materials guidance (historically ISO Guide 34 and ISO Guide 35), ISO 17034 (general requirements for the competence of reference material producers), ISO/IEC 17025 (competence of testing and calibration laboratories), and the successor technical report ISO/TR 33402 (Good practice in reference material preparation) which replaces Guide 80. Other recent REMCO-derived documents on characterization, homogeneity and stability provide complementary guidance for RM and QCM producers.

Keywords

quality control material, QCM, in-house preparation, reference material, homogeneity, stability, characterization, CRM, ISO Guide 80, ISO/TR 33402, laboratory quality control

FAQ

Q: What is this standard?

A: ISO Guide 80:2014 is a guidance document that described best practices for the in-house preparation of quality control materials (QCMs) used within laboratories to monitor measurement systems and demonstrate statistical control.

Q: What does it cover?

A: It covers planning and preparing QCMs, assessing homogeneity and stability at a level appropriate for internal QC, limited characterization to indicate property values and variability, documentation and labelling, and includes illustrative case studies. It does not provide the full requirements for certified reference materials intended for distribution.

Q: Who typically uses it?

A: Laboratory analysts, quality managers, technical staff preparing internal control samples in clinical, environmental, food, industrial and research laboratories — essentially any facility that needs to produce its own QC materials for method monitoring.

Q: Is it current or superseded?

A: ISO Guide 80:2014 was withdrawn and superseded by ISO/TR 33402 (published in 2025). The Guide is therefore withdrawn and readers should consult ISO/TR 33402 and other current ISO/REMCO documents for up-to-date guidance.

Q: Is it part of a series?

A: Yes. Guide 80 formed part of the collection of ISO/REMCO guidance on reference materials and complements documents on RM terminology, characterization and production. Its subject area has been integrated into the newer ISO/TC 334 reference-materials deliverables (for example ISO/TR 33402 and related ISO 334xx documents).

Q: What are the key keywords?

A: Key keywords are quality control material (QCM), in-house preparation, homogeneity, stability, reference material, characterization, certified reference material (CRM), laboratory quality control.