Obsolete controlled documents are dated and marked as obsolete? Is a copy of these obsolete controlled documents retained for a specified time period or in accordance with applicable specified requirements? Service agreements Establishment of service agreements Are procedures established and maintained for review of contracts? Does the agreement include information needed on the request, the examination and the report interpretation? (Each request accepted by the laboratory for examination(s) is considered as an agreement) When the laboratory enters into an agreement to provide medical laboratory services, are the following conditions met? the requirements, including the examination processes to be used are: Defined? Documented? Understood? The laboratory has the capability and resources meet the requirements? Laboratory personnel have the skills and expertise for the performance of the intended examinations? Appropriate examination procedures are selected to meet customers’ needs? The customer (eg clinicians, health care bodies, health
Obsolete controlled documents are dated and marked as obsolete? Is a copy of these obsolete controlled documents retained for a specified time period or in accordance with applicable specified requirements? Service agreements Establishment of service agreements Are procedures established and maintained for review of contracts? Does the agreement include information needed on the request, the examination and the report interpretation? (Each request accepted by the laboratory for examination(s) is considered as an agreement) When the laboratory enters into an agreement to provide medical laboratory services, are the following conditions met? the requirements, including the examination processes to be used are: Defined? Documented? Understood? The laboratory has the capability and resources meet the requirements? Laboratory personnel have the skills and expertise for the performance of the intended examinations? Appropriate examination procedures are selected to meet customers’ needs? The customer (eg clinicians, health care bodies, health
Audit-Checklist-Management.docx