GB/T 27404-2008 English PDF (GBT27404-2008)

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GB/T 27404-2008: Criterion on quality control of laboratories -- Chemical testing of food
GB/T 27404-2008
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 03.120.10
A 00
Criterion on quality control of laboratories - Chemical
testing of food
ISSUED ON: MAY 04, 2008
IMPLEMENTED ON: OCTOBER 01, 2008
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword ... 4
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Management requirements ... 8
4.1 Organization and management... 8
4.2 Management system ... 9
4.3 Document control ... 11
4.4 Quality and technical records ... 12
4.5 Customer service ... 13
4.6 Complaint handling ... 14
4.7 Control of non-conformance ... 14
4.8 Measures for correction ... 15
4.9 Precautions ... 15
4.10 Internal audits ... 16
4.11 Management review ... 16
4.12 Continuous improvement ... 17
5 Technical requirements ... 17
5.1 Purchasing services and supplies ... 17
5.2 Personnel ... 18
5.3 Facilities and environmental conditions ... 18
5.4 Equipment ... 21
5.5 Traceability ... 22
6 Process control requirements ... 26
6.1 General ... 26
6.2 Contract review ... 26
6.3 Sampling ... 27
6.4 Handling of samples ... 28
6.5 Method and method validation ... 29
6.6 Testing and subcontracting ... 33
6.7 Data processing and control ... 35
6.8 Results report ... 36
7 Results quality control ... 38
7.1 Internal quality control ... 38
7.2 External quality control... 39
Annex A (informative) Comparison between this Standard and GB/T 27025-2008 on
clauses and subclauses ... 41
Annex B (informative) Commonly used instruments and equipment and measurement
cycles in food physical and chemical testing laboratories ... 43
Annex C (informative) Reference expiration date for standard solution ... 46
Annex D (informative) Workflow control chart of food physical and chemical testing
laboratory ... 47
Annex E (informative) Sampling, preparation and storage methods for food samples
... 48
Annex F (informative) Technical requirements for testing method validation ... 53
Bibliography ... 56
Criterion on quality control of laboratories - Chemical
testing of food
1 Scope
This Standard specifies the management requirements, technical requirements, process
control requirements and quality assurance requirements for the quality control of food
physical and chemical testing laboratories.
This Standard applies to the quality control of food physical and chemical testing
laboratories engaged in the testing of food quality (including sensory, physical and
chemical), chemical substances (including active ingredients, pesticide and veterinary
drug residues, food additives, heavy metals, toxins, environmental pollutants, etc.).
Chemical testing laboratories in other fields can also refer to it.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments (excluding
corrigendum) or revisions do not apply to this Standard, however, parties who reach an
agreement based on this Standard are encouraged to study if the latest versions of these
documents are applicable. For undated references, the latest edition of the referenced
document applies.
GB/T 1.1, Directives for standardization -- Part 1: Rules for the structure and
drafting of standardizing documents (GB/T 1.1-2000, ISO/IEC Directives, Part3,
1997, NEQ)
GB 8170, Rules of rounding off for numerical values and expression and judgement
of limiting values
GB/T 15483.1, Proficiency testing by interlaboratory comparisons -- Part 1:
Development and operation of proficiency testing schemes (GB/T 15483.1-1999, idt
ISO/IEC Guideline 43-1:1997)
GB/T 19000, Quality management systems -- Fundamentals and vocabulary (GB/T
19000-2000, idt ISO 9000:2000)
GB/T 20000.1, Guide for standardization -- Part 1: Standardization and related
activities -- General vocabulary (GB/T 20000.1-2002, ISO/IEC Guide 2:1996,
MOD)
Laboratory quality control work associated with control analysis and subsequent
necessary corrective activities.
4 Management requirements
4.1 Organization and management
4.1.1 The food physical and chemical testing laboratory (hereinafter referred to as the
laboratory) or its organization shall be an entity capable of assuming legal responsibility.
A non-independent legal entity shall have its status in the parent organization, and the
above parent organization has promised not to interfere with its inspection work.
4.1.2 When the laboratory works in its fixed facilities or in other places outside the
fixed facilities it is responsible for, including temporary or mobile facilities, it shall
meet the relevant requirements of this Standard.
4.1.3 If the organization where the laboratory is located is also engaged in activities
other than testing, in order to identify potential conflicts of interest, the responsibilities
of key personnel involved in testing or having an impact on testing activities in the
organization shall be defined.
4.1.4 Management personnel of laboratory shall be responsible for the planning,
establishment, implementation, maintenance and improvement of the management
system, including:
a) Laboratory management and technical personnel shall have the necessary
authority and resources to perform responsibilities including implementing,
maintaining and improving the management system, identifying deviations from
the management system or testing procedures, and taking measures to prevent or
reduce these deviations.
b) Measures are in place to ensure that laboratory management and laboratory
personnel are free from any improper internal and external commercial, financial
and other pressures and influences that adversely affect the quality of work.
c) Establish client information confidentiality policies and procedures to protect
client confidential information and proprietary rights, including procedures for
securing electronic transmission and storage of results.
d) Develop policies and procedures for impartiality education to personnel and avoid
involvement in any activity that may diminish the credibility of their competence,
impartiality, judgment, or operational integrity.
e) Clarify the organization and management of the laboratory, its position in the
parent organization, and the relationship between quality management, technical
operations, and support services.
f) Define the responsibilities, authorities and interrelationships of all management,
operational and verification personnel who have an impact on the quality of
testing.
g) Personnel who are familiar with detection methods, procedures, objectives and
result evaluation shall provide timely training and effective supervision to
laboratory personnel according to their responsibilities, experience and ability.
h) There are technical management personnel who are fully responsible for technical
operations to ensure the resources required for the quality of laboratory operations.
i) Appoint a person in charge of quality, grant him responsibility and authority, and
ensure the operation and implementation of the management system. The quality
manager shall report directly to management personnel of laboratory, who is
responsible for deter...