1.The quality plan(s) for all activities for which your facility has requested accreditation
2.Standard operating procedures describing quality assurance activities (e.g. event reporting,conducting internal assessments,proficiency testing,comptency testing,staff training,standardized format for SOPs,process improvement,etc.)
3.Standard operating procedures describing the document control system
4.Schedules and reports of internal assessment performed since the last AABB assessment with records of communication of relevant information to executive managament
5.Summaries of incidents/errors/accidents/events occurring since the last AABB assessment
6.Proficiency testing records for the last two yeas
7.Agreements maintained with supplies of critical goods and services
8.Agreements maintained with facilities to which you supply critical goods and services
9.Protocols in use for softwave,hardwave,and process validation
10.Recent examples of process validation documentation
11.List of critical equipment and materials
12.Minutes of Transfusion Practice Committee(if applicable)
13.Records of donor selection and deferral and information consent
14.Records of component and preparation
15.Records of disposition of components
16.Records of storange temperature of components
17.Standard Operating Procedures describing operational activities
18.Records of staff training and competency assessment
19.Record of quality control of reagents,components,and equipment
20.Records of information system management
21.Records of hardwave and softwave validation
22.Records of lookback and recall activity
感謝大家~~不曉得會不會太多~~而且我的英打不是很好~~應該會有滿多打錯字的吧我想
更新1:
太感謝妳們了~~~~~~~~~