Approaches to quality management and accreditation in a genetic testing laboratory

摘要: Medical laboratories, and specifically genetic testing provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health medical-legal instances, referral laboratories authoritative bodies. All expect results that are accurate obtained in an efficient effective manner, within suitable time frame at acceptable cost. There ways of achieving end results, but compliance with International Organization for Standardization (ISO) 15189, international standard accreditation is becoming progressively accepted as optimal approach assuring quality testing. We present recommendations strategies designed aid implementation management system, including key aspects such document control, external assessment, internal audit, review, validation, well managing human side change. The focus on pragmatic approaches attain levels assurance required according ISO context Attention also given implementing improvement.