Garcia-Hejl Carine, Chianéa Denis, Dedome Emmanuel, Sanmartin Nancy, Bugier Sarah, Linard Cyril, Foissaud Vincent, Vest Philippe
Fédération des laboratoires, Hôpital d'instruction des armées, Clamart, France.
Ann Biol Clin (Paris). 2013 Sep-Oct;71(5):615-24. doi: 10.1684/abc.2013.0881.
To prepare the French Accreditation Committee (COFRAC) visit for initial certification of our medical laboratory, our direction evaluated its quality management system (QMS) and all its technical activities. This evaluation was performed owing an internal audit. This audit was outsourced. Auditors had an expertise in audit, a whole knowledge of biological standards and were independent. Several nonconformities were identified at that time, including a lack of control of several steps of the internal audit process. Hence, necessary corrective actions were taken in order to meet the requirements of standards, in particular, the formalization of all stages, from the audit program, to the implementation, review and follow-up of the corrective actions taken, and also the implementation of the resources needed to carry out audits in a pre-established timing. To ensure an optimum control of each step, the main concepts of risk management were applied: process approach, root cause analysis, effects and criticality analysis (FMECA). After a critical analysis of our practices, this methodology allowed us to define our "internal audit" process, then to formalize it and to follow it up, with a whole documentary system.
为迎接法国认可委员会（COFRAC）对我们医学实验室初次认证的访问，我们的管理层对其质量管理体系（QMS）及其所有技术活动进行了评估。此次评估是通过内部审核进行的。该审核外包给了专业机构。审核员具备审核专业知识，对生物标准有全面了解且保持独立。当时发现了若干不符合项，包括内部审核过程中几个步骤缺乏控制。因此，采取了必要的纠正措施以符合标准要求，特别是将所有阶段形式化，从审核计划到所采取纠正措施的实施、审查和跟进，以及在预先设定的时间内实施开展审核所需的资源。为确保对每个步骤进行最佳控制，应用了风险管理的主要概念：过程方法、根本原因分析、影响和关键性分析（FMECA）。在对我们的实践进行批判性分析后，这种方法使我们能够定义“内部审核”流程，然后将其形式化并进行跟进，同时建立了完整的文件体系。
