GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories
1 Scope
This standard specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
This standard is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this standard in confirming or recognizing the competence of laboratories.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC International vocabulary of metrology - Basic and general concepts and associated terms (VIM)[) Also known as JCGM 200.
])
ISO/IEC 17000 Conformity assessment-Vocabulary and general principles
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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
- ISO Online browsing platform : available at http://www.iso.org/obp
- IEC Electropedia : available at http://www.electropedia.org/
3.1
impartiality
presence of objectivity
Note 1: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6).
Note 2: Other terms that are useful in conveying the element of impartiality include "freedom from conflict of interests", "freedom from bias", "lack of prejudice", "neutrality", "fairness", “open-mindedness", “even- handedness", "detachment", "balance".
Note 3: GB/T 27021.1-2017, 3.2, modified - The words "the certification body" have been replaced by "the laboratory" in Note 1, and the word "independence" has been deleted from the list in Note 2.
3.2
complaint
expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is expected
Note: GB/T 27000-2006, 6.5, modified - The words "other than appeal "have been deleted, and the words" a conformity assessment body or accreditation body, relating to the activities of that body" have been replaced by "a laboratory, relating to the activities or results of that laboratory".
3.3
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions
[GB/T 27043-2012, 3.4, defined]
3.4
intralaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items within the same laboratory (3.6) in accordance with predetermined conditions
3.5
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons
Note: GB/T 27043-2012, 3.7, modified - Notes have been deleted.
3.6
laboratory
body that performs one or more of the following activities:
- testing;
- calibration;
- sampling, associated with subsequent testing or calibration
In this standard, "laboratory activities" refer three above-mentioned activities.
3.7
decision rule
rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement
3.8
verification
provision of objective evidence that a given item fulfils specified requirements
Example 1: Confirmation that a given reference material as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
Example 2: Confirmation that performance properties or legal requirements of a measuring system are achieved.
Example 3: Confirmation that a target measurement uncertainty can be met.
Contents Foreword I Introduction III 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 4.1 Impartiality 4.2 Confidentiality 5 Structural requirements 5.7 Laboratory management shall ensure that: 6 Resource requirements 6.1 General 6.2 Personnel 6.3 Facilities and environmental conditions 6.4 Equipment 6.5 Metrological traceability 6.6 Externally provided products and services 7 Process requirements 7.1 Review of requests, tenders and contracts 7.2 Selection, verification and validation of methods 7.3 Sampling 7.4 Handling of test or calibration items 7.5 Technical records 7.6 Evaluation of measurement uncertainty 7.7 Ensuring the validity of results 7.8 Reporting of results 7.9 Complaints 7.10 Nonconforming work 7.11 Control of data and information management 8 Management system requirements 8.1 Options 8.2 Management system documentation (Option A) 8.3 Control of management system documents (Option A) 8.4 Control of records (Option A) 8.5 Actions to address risks and opportunities (Option A) 8.6 Improvement (Option A) 8.7 Corrective actions (Option A) 8.8 Internal audits (Option A) 8.9 Management reviews (Option A) Annex A (informative) Metrological traceability Annex B (informative) Management system options Bibliography
GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories
1 Scope
This standard specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
This standard is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this standard in confirming or recognizing the competence of laboratories.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC International vocabulary of metrology - Basic and general concepts and associated terms (VIM)[) Also known as JCGM 200.
])
ISO/IEC 17000 Conformity assessment-Vocabulary and general principles
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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
- ISO Online browsing platform : available at http://www.iso.org/obp
- IEC Electropedia : available at http://www.electropedia.org/
3.1
impartiality
presence of objectivity
Note 1: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6).
Note 2: Other terms that are useful in conveying the element of impartiality include "freedom from conflict of interests", "freedom from bias", "lack of prejudice", "neutrality", "fairness", “open-mindedness", “even- handedness", "detachment", "balance".
Note 3: GB/T 27021.1-2017, 3.2, modified - The words "the certification body" have been replaced by "the laboratory" in Note 1, and the word "independence" has been deleted from the list in Note 2.
3.2
complaint
expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is expected
Note: GB/T 27000-2006, 6.5, modified - The words "other than appeal "have been deleted, and the words" a conformity assessment body or accreditation body, relating to the activities of that body" have been replaced by "a laboratory, relating to the activities or results of that laboratory".
3.3
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions
[GB/T 27043-2012, 3.4, defined]
3.4
intralaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items within the same laboratory (3.6) in accordance with predetermined conditions
3.5
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons
Note: GB/T 27043-2012, 3.7, modified - Notes have been deleted.
3.6
laboratory
body that performs one or more of the following activities:
- testing;
- calibration;
- sampling, associated with subsequent testing or calibration
In this standard, "laboratory activities" refer three above-mentioned activities.
3.7
decision rule
rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement
3.8
verification
provision of objective evidence that a given item fulfils specified requirements
Example 1: Confirmation that a given reference material as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
Example 2: Confirmation that performance properties or legal requirements of a measuring system are achieved.
Example 3: Confirmation that a target measurement uncertainty can be met.
Contents of GB/T 27025-2019
Contents
Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Impartiality
4.2 Confidentiality
5 Structural requirements
5.7 Laboratory management shall ensure that:
6 Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
7 Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
8 Management system requirements
8.1 Options
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective actions (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
Annex A (informative) Metrological traceability
Annex B (informative) Management system options
Bibliography
