GB/T 27025-2019
General requirements for the competence of testing and calibration laboratories (English Version)

Standard No.

GB/T 27025-2019

Language

Chinese, Available in English version

Release Date

2019

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 27025-2019

Replace

GB/T 27025-2008

Introduction

Core changes in the standard revision

Comparison dimensions	2008 version	2019 version
Structural framework	Management requirements + technical requirements	Five parts: general/structure/resources/process/management system
Risk management	No special chapter	Added 8.5 Measures to address risks and opportunities
Judgment rules	Not clearly defined	Added 3.7 Terminology and 7.1.3 Implementation requirements

---

Key elements implementation points

4.1 Impartiality management

The new version of the standard requires laboratories to establish an impartiality risk identification mechanism, with special emphasis on the assessment of potential impacts such as ownership relationships and financial transactions. Implementation case: A third-party testing agency established a commercial conflict of interest assessment form and updated the list of related parties every quarter.

6.4 Equipment management

Specify the equipment calibration status identification requirements (6.4.8), and recommend the use of a three-color label system: green (valid within the period), yellow (about to expire), red (disabled). Key equipment such as electronic balances need to implement period verification procedures.

---

Process control innovation requirements

7.7 Result validity monitoring

11 new monitoring methods, including the following:

• Use certified reference materials for quality control
• Analyze data trends through control charts
• Requirements for the frequency of retesting retained samples

An environmental testing laboratory uses a moving range control chart to monitor the repeatability of a gas chromatograph.

7.8.6 Declaration of conformity

Requires the application of the judgment rules to be clarified, for example:

When the measured value ±U≤limit value (where U is the expanded uncertainty), it is judged to be in compliance

The basis for the judgment rules used must be stated in the report.

---

Implementation recommendations

Key points during the transition period

1. Carry out a gap analysis of the new version of the standard, paying special attention to the newly added risk identification and determination rules requirements
2. Use a process approach to describe the management system when revising the quality manual
3. Establish a metrological traceability document package for key testing equipment

Document control optimization

It is recommended to establish a two-tier document structure:

First-level document	Policy manual	Covering 8.2 management system requirements
Second-level document	Process flow chart	Visualize 7.1-7.11 processes

GB/T 27025-2019 Referenced Document

• ISO/IEC 17000 Conformity assessment — Vocabulary and general principles*， 2020-05-01 Update
• ISO/IEC GUIDE 99 International vocabulary of metrology — Basic and general concepts and associated terms (VIM)

GB/T 27025-2019 history

• 2019 GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories
• 2008 GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories
• 2000 GB/T 15481-2000 General requirements for the competence of testing and calibration laboratories

Topics on standards and specifications

Standard and Specification