Title 42 Part 493 → Subpart K → §493.1289

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1289

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1289

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1289

Title 42: Public Health
Subpart K—Quality System for Nonwaived Testing

§493.1289   Standard: Analytic systems quality assessment.

(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in §§493.1251 through 493.1283.

(b) The analytic systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of analytic systems quality assessment reviews with appropriate staff.

(c) The laboratory must document all analytic systems quality assessment activities.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]