Documentation - std11120027

DOE-STD-1112-98

its radiobioassay services. A QA manual or QA plan shall document this program. The QA manual

or plan shall be sent to the PEPA prior to the on-site assessment in order to verify that it meets the

criteria of Appendix A. To qualify for accreditation, a contractor shall demonstrate during the on-

site assessment adherence to the written QA program or plan. The applicable components of DOE

Order 5700.6C should be included in the laboratory' QA Plan. The assessment criteria for the QA

program are contained in Appendix A.

5.5

Documentation

The DOE Contractor and service laboratory shall have thorough, up-to-date documentation

describing all applicable procedures and data recording methods. Written descriptions should cover,

as a minimum:

a. Personnel

1. organizational chart

2. job/position description meeting the qualifications of the personnel

3. procedures for training of personnel

4. methods to assure personnel competency

b. Equipment

1. A description of the measurement systems for which accreditation is requested

2. practices for measurement equipment calibration and maintenance

3. Counting protocol for measurement systems, including instructions for performing system

performance checks

4. protocols for ensuring system stability, including operating limits and failure criteria

c. Calibration

1. calibration data, techniques, and procedures, including source traceability

2. records of system calibration, frequency of calibrations, and verification of calibrations

d. Measurement Protocols

1. operating procedures for routine measurement protocols

2. documentation of non-standard results or special evaluation performance

e. Reporting

1. data handling, storage, retrieval, and reporting

2. actions to be implemented when measurement systems fail to meet the specified criteria.