实验室质量合规风险管理机制的建立和思考  

Establishment and reflection on laboratory quality compliance risk management mechanism

作　　者：汪湘玲 WANG Xiang-Ling(Centre Testing International Group Co.,Ltd.,Shenzhen 518101,China)

机构地区：[1]华测检测认证集团股份有限公司,深圳518101

出　　处：《实验室检测》2024年第12期61-63,共3页Laboratory Testing

摘　　要：自2021年国家市场监督管理总局《检验检测机构资质认定管理办法》(163号令)修正案和《检验检测机构监督管理办法》(39号令)实施以来,各级监管机构明显提升了双随机监督检查或专项整治的查处力度,检验检测机构被撤销资质、暂停资质、罚款、通报等事屡现报端,引发了行业极高的关注度。作为检验检测机构,需要切实提升质量合规管理水平,认真研读学习各项监管政策和案例,并做好内部质量合规管理以降低行政处罚风险,进而增强社会各方对行业的信心。本文首先介绍了实验室引入质量风险管理机制的必要性和紧迫性,然后对各类风险源进行介绍,最后分别就实验室质量合规风险管理机制策划、实施、绩效评价和改进进行了展开说明,希望帮助读者能够初步理解和掌握实验室实施质量合规风险管理的基本思路。Since the implementation of the State administration for market supervision and administration’s Measures for the Administration of the Qualification of Inspection and Testing Institutions(Order No.163)amendment and Measures for the Supervision and Administration of Inspection and Testing Institutions(Order No.39)in 2021,regulatory authorities at all levels have significantly intensified their efforts in conducting random inspections and targeted rectification campaigns.Cases of inspection and testing agencies being stripped of their qualifications,suspended,fined,or publicly reprimanded have frequently appeared in the media,attracting significant attention from the industry.As inspection and testing agencies,it is imperative to enhance their quality compliance management capabilities,thoroughly study and understand various regulatory policies and cases,and strengthen internal quality compliance management to mitigate the risk of administrative penalties,thereby boosting the confidence of all sectors of society in the industry.This article first introduces the necessity and urgency of introducing a quality risk management mechanism in laboratories.It then describes various sources of risk.Finally,it elaborates on the planning,implementation,performance evaluation,and improvement of the quality compliance risk management mechanism in laboratories,aiming to help readers initially grasp and understand the basic approach to implementing quality compliance risk management in laboratories.

关 键 词：质量合规 风险管理 实验室 质量管理体系 持续改进 

分 类 号：F203[经济管理—国民经济]