英文原文:
7.9 Complaints
7.9.1 The laboratory shall have a documented process to receive, evaluate and make decisions on complaints.
7.9.2 A description of the handling process for complaints shall be available to any interested partyon request. Upon receipt of a complaint, the laboratory shall confirm whether the complaint relatesto laboratory activities that it is responsible for and, if so, shall deal with it. The laboratory shall be responsible for all decisions at all levels of the handling process for complaints.
7.9.3 The process for handling complaints shall include at least the following elements and methods:
a) description of the process for receiving, validating, investigating the complaint, and deciding what actions are to be taken in response to it;
b) tracking and recording complaints, including actions undertaken to resolve them;
c) ensuring that any appropriate action is taken.
7.9.4 The laboratory receiving the complaint shall be responsible for gathering and verifying all necessary information to validate the complaint.
7.9.5 Whenever possible, the laboratory shall acknowledge receipt of the complaint, and provide the complainant with progress reports and the outcome.
7.9.6 The outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question.
NOTE This can be performed by external personnel.
7.9.7 Whenever possible, the laboratory shall give formal notice of the end of the complaint handling to the complainant.
翻译中文
7.9 投诉
7.9.1 实验室应有对投诉的接收、评价和做决定的文件化过程。
7.9.2 任何有要求的相关方应可获得对投诉处理过程的描述。在接到投诉后,实验室应该确认该投诉是否与其负责的实验室活动相关,如相关,则应处理。实验室应对投诉处理过程中所有环节负责。
7.9.3处理投诉的过程至少包括以下要素和方法
A)对投诉的接收、确认、调查,以及决定采取何种应对措施的过程描述
B)跟踪并记录投诉,包括为解决投诉所采取的措施
C)确保采取适宜的措施
7.9.4 接到投诉的实验室应负责收集并验证所有必要的信息,以便确认投诉是否有效。
7.9.5 只要可能,实验室应告知投诉人已收到投诉,并向其提供处理进程的报告和处理结果。
7.9.6 需与投诉人沟通的结果应由与所涉及最初实验室活动问题无关的人员作出,或对其审查和批准。
7.9.7 只要可能,实验室应将投诉处理结果正式通知该投诉人