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RB/T 029-2019Guidelines for the Construction of Testing Laboratory Information Management System (English PDF)

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Issued by

National Certification and Accreditation Administration

Level / Type

National · Recommended

Issue date

August 26, 2020

Implementation date

December 1, 2020

Scope

RB/T 029-2019 (Guidelines for the Construction of Testing Laboratory Information Management System) is available as an English-translated PDF.

RB/T 029-2019 — This standard proposes the project initiation, demand analysis, system design, system construction, and system implementation in the construction of the information management system for testing laboratories: Guidelines for implementation, system operation and maintenance, and system updates: This standard is applicable to parties involved in the use, construction, and maintenance of laboratory information management systems:

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Document preview — RB/T 029-2019

National Standard of the People's Republic of China

Classification: A 00

Issued by: National Certification and Accreditation Administration

Preface
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Principles of System Construction
4.2 System construction method
4.3 System construction process
4.4 System construction guarantee
5 Project start
5.1 Feasibility analysis
5.2 Determine the project budget
5.3 Establish a project team
5.4 Develop preliminary project plan
6 Demand analysis
6.1 Institutional management requirements
6.2 Resource management requirements
6.2.1 Human Resource Management
6.2.2 Management of facilities and environmental conditions
6.2.3 Device Management
6.2.4 Reference material management
6.2.5 Management of reagents and consumables
6.2.6 Procurement and acceptance management
6.2.7 Supplier Management
6.3 Requirements for testing process management
6.3.1 Contract management
6.3.2 Detection method management
6.3.3 Sampling management
6.3.4 Sample management
6.3.5 Inspection management
6.3.6 Quality control management
6.3.7 Report management
6.3.8 Complaint management
6.3.9 Non-compliance with work management
6.4 System management requirements
6.4.1 System document management
6.4.2 Record control management
6.4.3 Risk and opportunity management
6.4.4 Improve management
6.4.5 Corrective actions
6.4.6 Internal audit
6.4.7 Management review
6.5 Query statistics requirements
6.6 Integrated application requirements
6.6.1 Instrument integration
6.6.2 Internal system integration
6.6.3 External system integration
6.7 System security requirements
6.7.1 System safety performance
6.7.2 Identity Authentication
6.7.3 Access control
6.7.4 Data Security
6.7.5 System Log
7 System Design
7.1 Outline design
7.2 Detailed design
7.3 Prototyping
8 System construction
8.1 Program coding
8.2 Unit and integration testing
9 System implementation
9.1 Preparation for implementation
9.2 System deployment
9.3 System training
9.4 System trial operation
9.5 System acceptance
10 System Operation and Maintenance
11 System update
Reference

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009:

This standard was proposed and managed by the National Certification and Accreditation Administration Committee:

Drafting organizations of this standard: Shenzhen Entry-Exit Inspection and Quarantine Bureau Food Inspection and Quarantine Technology Center, Hangzhou Goss Information Technology Co:, Ltd:, China Food Safety Risk Assessment Center, Shandong Entry-Exit Inspection and Quarantine Bureau Technology Center, Machinery Industry Instrumentation Comprehensive Technology and Economic Research Institute, Beijing Guoshi Testing Technology Research Institute, etc:

1 Scope

This standard proposes the project initiation, demand analysis, system design, system construction, and system implementation in the construction of the information management system for testing laboratories:

Guidelines for implementation, system operation and maintenance, and system updates:

This standard is applicable to parties involved in the use, construction, and maintenance of laboratory information management systems:

2 Normative references

The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article Pieces: For undated references, the latest version (including all amendments) applies to this document:

GB/T 8566 Information Technology Software Life Cycle Process GB/T 8567 Specification for computer software documentation GB/T 9385 Computer Software Requirements Specification Specification GB/T 9386 Computer Software Test Document Preparation Specification GB 17859 Classification criteria for security grade protection of computer information system GB/T 27025 General requirements for the competence of testing and calibration laboratories RB/T 214 General requirements for qualification accreditation of inspection and testing institutions RB/T 028-2020 Laboratory Information Management System Management Specification

3 Terms and definitions

The following terms and definitions apply to this document:

Laboratory information management system; LIMS it is composed of computers and related supporting equipment, facilities (including networks) and software to realize the data and information (including calculation Computer and non-computer system) management, which has the ability to collect, record, report, and store data and information in accordance with laboratory management rules:

Storage, transmission, retrieval, statistics, analysis and other processing functions:

[RB/T 028-2020, definition 3:1]

4 General requirements

4.1 Principles of System Construction

4.1.1 Compliance principle: The construction of laboratory LIMS should comply with GB/T 27025, RB/T 214, RB/T 028-2020 and other countries and industries:

Industry standard requirements:

4.1.2 Principle of applicability: different industries and laboratories of different scales have large differences in testing procedures and management methods:

Business characteristics, management requirements, current status of informatization, and institutional development planning, and build a suitable LIMS:

4.1.3 User participation principle: system users should participate in the LIMS construction process from beginning to end to ensure that the LIMS can be effectively used for the system after it is completed:

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

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