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Normas ASTM – AENOR
ASTM C1009-13

ASTM C1009-13

Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry

Fecha:
2013-05-13 /Historical
Superseeded by:
Significance and Use:

4.1 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner.

4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses.

4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a product or service will be fulfilled. The quality system is complementary to specific technical requirements. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.

4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in the following sections.

 Quality Assurance of Analytical Laboratory Data
FIG. 1 Quality Assurance of Analytical Laboratory Data

4.5 Although the Standard Guide describes “Recommended Practices” and “Recommendations” and 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 assurance / quality control program should, at minimum, completely and adequately consider and include all elements listed in Sections 5-14 of this guide.

Scope:

1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. Reference to key elements of ASME NQA-1 provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.

1.2 The essential, basic elements of a laboratory QA program appear in the following order:

 

Section

Organization

 5

Quality Assurance Program

 6

Training and Qualification

 7

Procedures

 8

Laboratory Records

 9

Control of Records

10

Control of Procurement

11

Control of Measuring Equipment and Materials

12

Control of Measurements

13

Deficiencies and Corrective Actions

14


Keywords:
equipment; laboratory; measurement; procedure; procurement; quality assurance; record; training
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