Okla. Admin. Code § 252:301-9-3

Current through Vol. 42, No. 4, November 1, 2024

Section 252:301-9-3 - Management information required in QA plan

The QA plan and related quality documentation shall state the laboratory's policies established in order to meet the requirements of this rule. The QA plan and related quality documentation shall also contain:

(1) a quality policy statement, including objectives and commitments, by top management;

(2) the organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts;

(3) the relationship between management, technical operations, support services and the quality system;

(4) job descriptions of key staff and reference to the job descriptions of other staff;

(5) identification of the laboratory's approved signatories; at a minimum, the title page of the QA plan must have the signed and dated concurrence, (with appropriate titles) of all responsible parties including the quality manager(s), technical director(s), and the agent who is in charge of all laboratory activities such as the laboratory director or laboratory manager; and

(6) the laboratory management arrangements for exceptional departures from documented policies and procedures or from standard specifications.

Okla. Admin. Code § 252:301-9-3

Added at 25 Ok Reg 2247, eff 7-11-08