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

Foreword

This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces GB/T 27025-2008 "General requirements for the

competence of testing and calibration laboratories". Compared with GB/T

27025-2008, in addition to editorial changes, the main technical changes are

as follows.

- Structural adjustment. The main clauses of this Standard are. general

requirements, structural requirements, resource requirements, process

requirements and management system requirements;

- Risk-based considerations reduce the requirements of the specification and

replace them with performance-based requirements;

- More flexibility in the requirements of processes, procedures, documented

information and organizational responsibilities;

- ADD the definition of "laboratory" (see 3.6);

- ADD the definition and related content of "decision rule" (see 3.7 and 7.1,

etc.);

- CHANGE the content of informative Annex A to "Metrological traceability";

- CHANGE the content of informative Annex B to "Management system

options";

- Delete "Preventive action" (see 4.12 of GB/T 27025-2008). The content is

included in this Standard "Actions to address risks and opportunities" (see

8.5);

- Delete "Subcontracting of tests and calibrations" (see 4.5 of GB/T 27025-

2008). The content is included in this Standard "Externally provided

products and services" (see 6.6).

This Standard, using translation method, is identical to ISO/IEC 17025.2017

"General requirements for the competence of testing and calibration

laboratories" (English edition).

China's document which has a consistent correspondence with the international

document normatively referenced in this Standard is as follows.

- GB/T 27000-2006 Conformity assessment - Vocabulary and general

principles (ISO/IEC 17000.2004, IDT).

This Standard was proposed by and shall be under the jurisdiction of National

Technical Committee 261 on Certification and Accreditation of Standardization

Administration of China (SAC/TC 261).

Drafting organizations of this Standard. China National Accreditation Service

for Conformity Assessment; National Institute of Metrology, China; China

Certification & Accreditation Association; China Household Electric Appliance

Research Institute; National Research Center for Geoanalysis.

Main drafters of this Standard. Zhang Mingxia, Song Guilan, Fu Wei, Qiao Dong,

Li Xue, Guo Dong, Wang Chunyan, Wang Suming, Rao Hong, Lei Zhiwen, Ji

Haonan, Yang Hui, Cui Fang, An Ziyi, Zhang Bo, Liu Guorong, Li Leqin, Xu

Xiaopeng, Yu Pingwu, Zhong Diyang, Xi Tianpei, Liu Hanxia.

The previous editions of the standard replaced by this Standard were released

as follows.

- GB/T 27025-2008;

- GB/T 15481-2000.

1 Scope

This Standard specifies the general requirements for the competence,

impartiality and consistent operation of laboratories.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are

applicable to this document. For the undated references, the latest edition

(including all the amendments) are applicable to this document.

ISO/IEC Guide 99 International vocabulary of metrology - Basic and general

concepts and associated terms (VIM)1)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC

Guide 99 and ISO/IEC 17000 and the following apply.

4 General requirements

Information about the customer obtained from sources other than the

customer (e.g. complainant, regulators) shall be confidential between the

customer and the laboratory. The provider (source) of this information shall be

confidential to the laboratory and shall not be shared with the customer, unless

agreed by the source.

5 Structural requirements

Laboratory activities shall be carried out in such a way as to meet the

requirements of this Standard, the laboratory's customers, regulatory

authorities and organizations providing recognition. This shall include

laboratory activities performed in all its permanent facilities, at sites away from

its permanent facilities, in associated temporary or mobile facilities or at a

customer's facility.

6 Resource requirements

The laboratory shall have available the personnel, facilities, equipment,

systems and support services necessary to manage and perform its laboratory

activities.

7 Process requirements

The laboratory information management system(s) used for the

collection, processing, recording, reporting, storage or retrieval of data shall be

validated for functionality, including the proper functioning of interfaces within

the laboratory information management system(s) by the laboratory before

introduction.

8 Management system requirements

A laboratory that has established and maintains a management system, in

accordance with the requirements of GB/T 19001, and that is capable of

supporting and demonstrating the consistent fulfilment of the requirements of

Clauses 4 to 7, also fulfils at least the intent of the management system

requirements specified in 8.2 to 8.9.

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