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§ 71.135 Quality assurance records.
The licensee, certificate holder, and applicant for a CoC shall
maintain sufficient written records to describe the activities
affecting quality. The records must include the instructions,
procedures, and drawings required by § 71.111 to prescribe quality
assurance activities and must include closely related specifications
such as required qualifications of personnel, procedures, and
equipment. The records must include the instructions or procedures
which establish a records retention program that is consistent with
applicable regulations and designates factors such as duration,
location, and assigned responsibility. The licensee, certificate
holder, and applicant for a CoC shall retain these records for 3 years
beyond the date when the licensee, certificate holder, and applicant
for a CoC last engage in the activity for which the quality assurance
program was developed. If any portion of the written procedures or
instructions is superseded, the licensee, certificate holder, and
applicant for a CoC shall retain the superseded material for 3 years
after it is superseded.
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