4.1 A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. The basic elements of a laboratory quality assurance program are organization, quality assurance program, training and qualification, procedures, laboratory records, control of records, control of procurement, control of measuring equipment and materials, control of measurements, and deficiencies and corrective actions. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program.

FIG. 1 Quality Assurance of Analytical Laboratory Data

4.2 The fundamental purposes of a measurement control program are to provide the with use assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with use assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address (1) the preparation and verification of standards and reagents, (2) data analysis procedures and documentation, (3) calibration and calibration procedures, (4) measurement method qualification, (5) analyst qualification, and (6) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include (1) chemical analysis procedures and procedure control, (2) records storage and retrieval requirements, (3) internal audit requirements, (4) organizational considerations, and (5) training/qualification requirements. To the extent possible, this standard will deal primarily with quality control requirements rather than overall quality assurance requirements.

4.3 Although this guide uses suggestive rather than prescriptive language (for example, “should” as opposed to “shall”), the elements being addressed should not be interpreted as optional. An effective and comprehensive laboratory quality control program should, at minimum, completely and adequately consider and include all elements listed in Section 1 and in the corresponding referenced sections of this guide.

1.1 This standard provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.

1.2 This guidance is provided in the following sections:

Section

General Quality Control Program Considerations

5

Quality Control Samples

6

Analysis of Quality Control Samples

7

Quality Control Data Analysis

8

Analyst Qualification

9

Measurement System Calibration

10

Measurement Method Qualification

11

Measurement System Maintenance

12

1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.