§1.1101. What documents are incorporated by reference in this subpart — Inbound Citations

(a) 2017(E) (incorporated by reference, see § 1.1101).

(b) The accreditation body must submit documentation of conformance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) and separate documentation of ILAC membership and ILAC MRA signatory status demonstrating competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025,” in meeting the requirements of § 1.1113(a) through (c). The accreditation body also must submit documentation of its compliance with § 1.1113(d).

(c) If, within the previous 2 years, the recognized accreditation body conducted an onsite assessment of the laboratory in accordance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) to assess whether the laboratory meets the requirements of ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), then the initial assessment under this section:

(1) May be conducted remotely, and

(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).

(a) A recognized accreditation body may require corrective action using the procedures described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 8.7 to address any deficiencies identified while assessing and overseeing a LAAF-accredited laboratory.

(1) The recognized accreditation body must notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to the recognized accreditation body for approval.

(2) The LAAF-accredited laboratory must implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit the results of the corrective action to the recognized accreditation body.

(3) The recognized accreditation body will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.

(2) The recognized accreditation body must handle FDA's notification as a complaint under ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) section 7.12, implement appropriate corrective action under ISO/IEC 17011:2017(E) section 9.5, and submit both the results of the complaint investigation and subsequent corrective action to FDA.

(1) 2017(E) (incorporated by reference, see § 1.1101).

(b) The laboratory may use documentation of conformance with ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), as applicable and supplemented as necessary, in meeting the applicable requirements of this subpart.

(2) The laboratory must become LAAF-accredited by another recognized accreditation body before the laboratory's ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) accreditation lapses or not later than 1 year after the LAAF-accredited laboratory receives the applicable notice under § 1.1115(g), § 1.1116(b), or § 1.1131(d)(2), whichever is sooner.

(3) If the LAAF-accredited laboratory becomes aware that any aspect of the submitted material is inaccurate, the LAAF-accredited laboratory must immediately inform FDA and submit a corrected version. Such corrections must meet the requirements for amendments to reports specified by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.8.8.

(1) 2017(E) (incorporated by reference, see § 1.1101) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d); and

(2) The LAAF-accredited laboratory must handle FDA's notification as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.9, implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of the complaint investigation and subsequent corrective action to FDA.