1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. References to key elements of ASME NQA-1 and ISO 9001 provide guidance to the functional aspects of analytical laboratory operations. 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
ASTM C1009-13a Referenced Document
ANSI N15.41 Nuclear Facilities - Derivation of Measurement Control Programs - General Principles
ANSI N15.51 Methods of Nuclear Material Control - Measurement Control Program – Nuclear Materials Analytical Chemistry Laboratory (Institute for Nuclear Materials Management (INMM))
ASTM C1068 Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry
ASTM C1128 Standard Guide for Preparation of Working Reference Materials for Use in the Analysis of Nuclear Fuel Cycle Materials
ASTM C1156 Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
ASTM C1210 Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry
ASTM C1215 Standard Guide for Preparing and Interpreting Precision and Bias Statements in Test Method Standards Used in the Nuclear Industry
ASTM C1297 Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
ASTM C859 Standard Terminology Relating to Nuclear Materials
ASTM D1193 Standard Specification for Reagent Water
ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures*, 2018-08-15 Update
ASTM E1578 Standard Guide for Laboratory Information Management Systems (LIMS)
ASTM E178 Standard Practice for Dealing With Outlying Observations
ASTM E29 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
ASTM E542 Standard Practice for Gravimetric Calibration of Laboratory Volumetric Instruments*, 2022-01-01 Update
ASTM E617 Standard Specification for Laboratory Weights And Precision Mass Standards
ASTM E694 Standard Specification for Laboratory Glass Volumetric Apparatus
ISO 1042 Laboratory glassware - One-mark volumetric flasks
ISO 9001 Quality management systems - Requirements [Spanish version]
ISO/IEC 17020 Conformity assessment - Requirements for the operation of various types of bodies performing inspection
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]*, 2017-11-01 Update
ASTM C1009-13a history
2021ASTM C1009-21 Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
2013ASTM C1009-13a Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
2013ASTM C1009-13 Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
2006ASTM C1009-06 Standard Guide for Establishing a Quality Assurance Program for Analytical Chemistry Laboratories Within the Nuclear Industry
1996ASTM C1009-96e1 Standard Guide for Establishing a Quality Assurance Program for Analytical Chemistry Laboratories Within the Nuclear Industry