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Title 42 Part 493 → Subpart K → §493.1239

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1239

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1239

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

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1239


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart K—Quality System for Nonwaived Testing


§493.1239   Standard: General laboratory 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 general laboratory systems requirements specified at §§493.1231 through 493.1236.

(b) The general laboratory 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 general laboratory systems quality assessment reviews with appropriate staff.

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

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