GB/T 27423-2019 in English

VALID

Conformity assessment—Guide to risk management for inspection and testing services

Issued on:2019-12-31
Implemented on:2020-07-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $370.00
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Standard No:	GB/T 27423-2019
Document status:	VALID
Title in English:	Conformity assessment—Guide to risk management for inspection and testing services
Title in Chinese:	合格评定检验检测服务风险管理指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2019-12-31
Implemented on:	2020-07-01
ICS Classification:	03.120.20-Product and company certification. Conformity assessment
Chinese Classification:	A01-Technical Management
Professional Classification:	GB-National Standard
Related Keywords:	risk management risk management framework risk management taking risk type example items countermeasures customer trust risk risk management response strategy selection
Related Topics:	check The risk of out-of-scope testing check Testing service bit detection service bit detection service sub-testing service Failed Failed Special inspection management All tests passed Key Risks in Testing Risks when testing Risk Management Guide Animal Inspection Services Qualified at the first level GBT27423 digital PCR testing service Military Software Risk Management Guide Air duct lighting inspection standards

《GB/T 27423-2019合格评定检验检测服务风险管理指南》由TC261（全国认证认可标准化技术委员会）归口，TC261SC1（全国认证认可标准化技术委员会实验室认可分会）执行，主管部门为国家标准化管理委员会。

Introduction

Analysis of the core framework of the standard

Management links	Critical control points	Implementation requirements
Internal environment	Organizational culture/resource allocation	Need to establish an integrity policy and job competency assessment mechanism
Risk assessment	Probability/consequence matrix analysis	Use a combination of qualitative and quantitative methods (refer to GB/T 27921)
Risk management	Response strategy selection	Including 7 processing principles such as risk avoidance, transfer and acceptance

Key points for implementing risk management

Taking medical device testing laboratories as an example, special attention should be paid to:

Technical risk control: Equipment calibration cycle is shortened to 80% of the standard
Compliance objectives: Establish a dynamic tracking mechanism for regulations (at least quarterly updates)
Emergency management: The frequency of biosafety incident drills ≥ 2 times/year

Background of standard evolution

This standard responds to the ISO 31000:2018 risk management framework and forms a supporting requirement with ISO/IEC 17025:2017. Compared with the traditional management method, it highlights the risk priority principle and requires that risk management be integrated into:

Strategic decision-making process
Daily operation monitoring
Personnel performance appraisal

Appendix Application Guide

The list of items provided in Appendix B includes 128 risk points in 6 categories, and typical application scenarios:

Risk type	Example items	Countermeasures
Customer trust risk	Questioning the authenticity of the test report	Establishing a three-level audit + blockchain evidence storage
Technology iteration risk	Verification lag of new detection methods	Setting up a special fund for technical early warning

Supervision and improvement mechanism

The standard requires the establishment of two-dimensional monitoring:

Regular supervision: through internal audit (cycle ≤ 12 months)
Special inspection: stress test on major risk areas

Special attention should be paid to the dynamic adjustment of risk tolerance. Reassessment should be initiated when the following situations occur: