; (ix) acceptance activities; (x) nonconforming in vitro clinical tests; (xi) corrective and preventive action; (xii) labeling and packaging controls; (xiii) handling, storage, distribution, and installation; (xiv) complaints and records; (xv) servicing; and (xvi) statistical techniques. (2) Exception for laboratory test protocols Developers that are developing test protocols for use as described in subsection (a)(2)(B)(i) are exempt from the requirements under paragraph (1)(C) except for the requirements described in clauses (iv), (ix), (xi), and (xiv) of such paragraph. (3) Quality requirements for certain laboratories distributing laboratory test protocols within organizations or public health networks Quality requirements applicable to the developer who is distributing a laboratory test protocol as described in subsection (a)(2)(B)(ii) shall consist of the following: (A) Clauses (iv), (ix), (xi), (xiv), (xii) of paragraph (1)(B). (B) The requirement to maintain records of the laboratories to which the laboratory test protocol is distributed. (c) Regulations In implementing quality requirements for test developers that participate in international audit programs under this section, the Secretary shall— (1) for purposes of facilitating international harmonization, consider whether the developer participates in an international audit program in which the United States participates and recognizes compliance with, or conformance to, such standards recognized by the Secretary