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[ Policies and Regulations of Chemical Machinery and Equipment Network ] Recently, the national standard plan "Guidelines for the Development of Quality Control Samples in the Laboratory" has been completed and the draft is being solicited for comments
.
This standard is aimed at laboratory personnel who need to develop specific quality control samples (QCM).
condition-induced instability)
.
Chemical Machinery and Equipment Network Policies and Regulations Chemical Machinery and Equipment.
This standard is aimed at laboratory personnel who need to develop specific quality control samples (QCM).
condition-induced instability)
.
A QCM is a reference material (RM), which is mainly used to periodically check the precision of a test procedure, and is a limited and purpose-specific supplement to a certified reference material (CRM)
.
CRM is a standard sample of the highest specification for determining characteristic values and associated uncertainties by metrologically valid procedures, mainly for method validation and for providing metrological calibration traceability
.
However, QCM does not require a standard value with metrological traceability, and can be used instead of CRM within a limited range
.
.
CRM is a standard sample of the highest specification for determining characteristic values and associated uncertainties by metrologically valid procedures, mainly for method validation and for providing metrological calibration traceability
.
However, QCM does not require a standard value with metrological traceability, and can be used instead of CRM within a limited range
.
In measurement laboratories, standard samples are used in huge quantities
.
While standard samples routinely used to assess the precision of measurement procedures do not require their measurements to be determined by a metrologically valid procedure, specific quality control needs can be met using QCMs developed in the laboratory by laboratory personnel familiar with sample characteristics , while reducing the cost of using standard samples
.
.
While standard samples routinely used to assess the precision of measurement procedures do not require their measurements to be determined by a metrologically valid procedure, specific quality control needs can be met using QCMs developed in the laboratory by laboratory personnel familiar with sample characteristics , while reducing the cost of using standard samples
.
In order to ensure that the QCM is sufficiently uniform and stable to meet the requirements of metrological quality control, it is necessary to standardize the development process of the QCM
.
"Guidelines for quality control samples developed in laboratories" is an equivalent transformation of ISO Guide 80:2014 "Guidelines for quality control samples developed in laboratories".
It is under the jurisdiction of the National Standard Sample Technical Committee and drafted by the China Association for Standardization
.
Except for minor editorial treatments, this standard is equivalent to the ISO guideline in terms of framework and technical content
.
The standard outlines the basic characteristics of quality control standard samples, describes preparation, sub-packaging, packaging, information value provision, homogeneity assessment, stability handling, storage, use and precautions, etc.
, and provides some development cases
.
.
"Guidelines for quality control samples developed in laboratories" is an equivalent transformation of ISO Guide 80:2014 "Guidelines for quality control samples developed in laboratories".
It is under the jurisdiction of the National Standard Sample Technical Committee and drafted by the China Association for Standardization
.
Except for minor editorial treatments, this standard is equivalent to the ISO guideline in terms of framework and technical content
.
The standard outlines the basic characteristics of quality control standard samples, describes preparation, sub-packaging, packaging, information value provision, homogeneity assessment, stability handling, storage, use and precautions, etc.
, and provides some development cases
.
This standard enables laboratories to provide material assurance in practice to demonstrate that a particular measurement system is under statistical control, and to minimize the time and effort required to prepare samples as required.
The developers provided normative technical basis and reference information
.
The developers provided normative technical basis and reference information
.
This standard is a part of the 15000 series of national standards "Standard Sample Work Guidelines", which is of great significance to improving China's standard sample management system
.
.
Original title: How to develop quality control samples in the laboratory? Here comes the guide!
