GB/T 27432-2025Technical specification for the remote assessment of laboratories (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part

1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed and coordinated by the National Technical Committee for Certification and Accreditation of Standardization (SAC/TC261). This document was drafted by: China National Accreditation Service for Conformity Assessment, Xi'an Quality and Standardization Research Institute, Liaoning Huace Product Standard Testing Certification Co., Ltd., China Customs Science and Technology Research Center, Huadian Electric Power Research Institute Co., Ltd., Weikai Certification and Testing Co., Ltd., China Certification & Inspection Group Testing Technology Co., Ltd., Shanghai Electrical Equipment Testing Institute Co., Ltd., China Railway Certification & Inspection Center Co., Ltd., Wuhan Institute of Virology, Chinese Academy of Sciences, Ningbo Institute of Metrology and Testing (Ningbo New Materials Inspection and Testing Center), Chaoyang District Disease Prevention and Control, Beijing Prevention and Control Center, Shipu Information Technology (Shanghai) Co., Ltd. The main drafters of this document are. Shi Guanghua, Chen Di, Yang Yaowu, Zhang Yaowu, Chen Xuehui, Zhang Jie, Qin Tao, Ling Honghao, Liu Wenwen, Wang Aiguo, Li Shaolian, Song Rui, Wu Jia, Yan Jianjun, Zhang Xiaoxi, and Li Kang.

Laboratory review generally adopts the on-site review mode, that is, within the specified time, the review experts are concentrated in the laboratory and its laboratory activities. With the continuous advancement of the national "Internet" action and the breakthrough development of information and communication technology, The realization of remote laboratory assessment through information and communication technology has ushered in a new development opportunity. Remote review combined with on-site audit is appropriate and effective. However, there are many differences between the remote laboratory review conducted using information and communication technology and the traditional on-site review model. The implementation of remote laboratory review is very necessary. Technical Specifications for Remote Laboratory Assessment

1 Scope

GB/T 27432-2025 is the Chinese technical specification for assessing a laboratory remotely. Remote assessment began as an emergency measure and stayed because it works for a large part of the job, but an accreditation granted over a video link is only as good as the controls around it: the assessor has to be able to see what they would have seen on site, and to be sure that what they are shown is real and current. This standard sets those controls: when a remote assessment is appropriate and when it is not, the planning and the risk assessment that precede it, the requirements on the technology, the connection, the video and audio quality, the recording and the information security, the conduct of the assessment including the witnessing of testing activities, the examination of records and equipment and the interviewing of staff, the verification of identity and of authenticity, the handling of findings that cannot be resolved remotely, and the reporting and record keeping. For an accreditation body, a laboratory being assessed or an assessor in China, this is the governing procedure.

This document specifies the review principles, scenario selection, implementation conditions and requirements, review process, review report, and materials for laboratory remote review. Requirements for preservation, supervision, inspection, termination of review and subsequent processing. This document applies to laboratory remote assessment activities organized and implemented by management agencies, including on-site assessment and remote assessment of laboratories. It is a review activity that combines remote review and audit. It can be used as a reference for other types of remote review, audit, evaluation and verification activities.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document.

GB/T 27000 Conformity assessment vocabulary and general principles YD/T 1737 Internet Security Protection Testing Requirements

3 Terms and definitions

The terms and definitions defined in GB/T 27000 and the following apply to this document.

3.1 remoteassessment An assessment of the laboratory's physical or virtual location using information and communication technology, conducted wholly or partly outside the laboratory's physical location A systematic, independent and documented process for obtaining objective evidence and developing audit findings at any location to determine whether the audit requirements have been met. process.

Note 1: A virtual location is an online environment used by a laboratory organization to complete work or provide services, allowing personnel in different physical locations to perform processes. environment. Note

2.The technical means adopted include but are not limited to.

a) use of telecommunication facilities, including audio, video and data sharing;

b) review of documents and records by remote access, either synchronously (i.e. in real time) or asynchronously (where applicable);

c) record information and evidence by means of still images, video or audio recordings;

d) Providing video or audio access to remote or potentially hazardous locations. [Source: GB/T 27011-2019, 3.26, modified]

3.2 Information and communication technology information and communication technology; ICT Technology used to collect, store, retrieve, process, analyze, and transmit information.

Note. ICT includes software and hardware, such as smartphones, handheld devices, laptops, desktop computers, drones, cameras, wearable technology, artificial intelligence and others. [Source: APACTEC0-0011.1, 5.3, modified]