C1009-21 - Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
Označení normy: | C1009-21 |
Vydáno: | 01.02.2021 |
Status: | Active |
Počet stran: | 12 |
Sekce: | 12.01 |
Označení: | equipment; laboratory; measurement; procedure; procurement; quality assurance; record; training ; |
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/IEC 17025 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 |
Management of Customer Requests and Commitments to Customers | 11 |
Control of Procurement | 12 |
Control of Measuring Equipment and Materials | 13 |
Control of Measurements | 14 |
Control of Nonconforming Work | 15 |
Candidate Actions | 16 |
Preventative Actions | 17 |
1.3 Collection of samples and associated sampling procedures are outside the scope of this guide. The user may refer to sampling practices developed by Subcommittee C26.02.
1.4 Nuclear laboratories are required to handle a variety of hazardous materials, including but not limited to radioactive samples and materials. The need for proper handling of these materials is discussed in 13.2.4. While this guide focuses on the nuclear laboratory QA program, proper handling of nuclear materials is essential for proper function of the QA program.
1.5 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.