GB/T 3836.21-2022 PDF English
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GB/T 3836.21-2022: Explosive atmospheres - Part 21: Application of quality management systems for Ex Product manufacture
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GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 29.260.20
CCS K 35
Replacing GB/T 3836.21-2017
Explosive Atmospheres – Part 21.Application of Quality
Management Systems for Ex Product Manufacture
(ISO/IEC 80079-34.2018, Explosive Atmospheres – Part 34.Application of Quality
Management Systems for Ex Product Manufacture, MOD)
Issued on. OCTOBER 12, 2022
Implemented on. MAY 01, 2023
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 4
Introduction... 8
1 Scope... 11
2 Normative References... 11
3 Terms and Definitions... 11
4 Context of the Organization... 14
4.1 Understanding the organization and its context... 14
4.2 Understanding the needs and expectations of interested parties... 14
4.3 Determining the scope of the quality management system... 15
4.4 Quality management system and its processes... 15
5 Leadership... 16
5.1 Leadership and commitment... 16
5.2 Policy... 17
5.3 Organizational roles, responsibilities and authorities... 18
6 Planning... 19
6.1 Actions to address risks and opportunities... 19
6.2 Quality objectives and planning to achieve them... 20
6.3 Planning of changes... 21
7 Support... 21
7.1 Resources... 21
7.2 Competence... 24
7.3 Awareness... 25
7.4 Communication... 25
7.5 Documented information... 26
8 Operation... 29
8.1 Operational planning and control... 29
8.2 Requirements for products and services... 30
8.3 Design and development of products and services... 32
8.4 Control of externally provided processes, products and services... 34
8.5 Production and service provision... 40
8.6 Release of products and services... 43
8.7 Control of nonconforming outputs... 43
9 Performance Evaluation... 45
9.1 Monitoring, measurement, analysis and evaluation... 45
9.2 Internal audit... 46
9.3 Management review... 47
10 Improvement... 48
10.1 General... 48
10.2 Nonconformity and corrective action... 49
10.3 Continual improvement... 50
Annex A (Informative) Correlation Relationship between this Document and GB/T
3836.21-2017... 51
Annex B (informative) Information Relevant to Particular Types of Protection and
Specific Ex Products... 54
Annex C (Informative) Verification Criteria for Elements with Non-Measurable Paths
Used as an Integral Part of a Type of Protection... 76
Annex D (Informative) External Provider's Declaration of Conformity... 80
Bibliography... 84
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This Document is Part 21 of GB/T 3836 Explosive Atmospheres. GB/T 3836 has published the
following parts.
--- Part 1.Equipment – General Requirements;
--- Part 2.Equipment Protection by Flameproof Enclosures “d”;
--- Part 3.Equipment Protection by Increased Safety “e”;
--- Part 4.Equipment Protection by Intrinsic Safety “i”;
--- Part 5.Equipment Protection by Pressurized Enclosure “p”;
--- Part 6.Equipment Protection by Liquid Immersion “o”;
--- Part 7.Equipment Protection by Powder Filling “q”;
--- Part 8.Equipment Protection by Type of Protection “n”;
--- Part 9.Equipment Protection by Encapsulation “m”;
--- Part 11.Material Characteristics for Gas and Vapor Classification – Test Methods and
Data;
--- Part 12.Material Characteristics for Combustible Dusts – Test Methods;
--- Part 13.Equipment Repair, Overhaul, Reclamation and Modification;
--- Part 14.Explosive Gas Atmospheres – Classification of Hazardous Areas;
--- Part 15.Electrical Installations Design, Selection and Erection;
--- Part 16.Electrical Installations Inspection and Maintenance;
--- Part 17.Equipment Protection by Pressurized Room “p” and Artificially Ventilated Room
“v”;
--- Part 18.Intrinsically Safe Electrical Systems;
--- Part 20.Equipment with Equipment Protection Level (EPL) Ga;
--- Part 21.Application of Quality Management Systems for Ex Product Manufacture;
--- Part 22.Protection of Equipment and Transmission System Using Optical Radiation;
--- Part 23.Group I, Category EPL Ma Equipment Intended to Remain Functional in
Atmospheres Endangered by Firedamp and/or Coal Dust;
--- Part 24.Equipment Protection by Special Protection “s”;
--- Part 25.Requirements for Process Sealing between Flammable Process Fluids and
Electrical Systems;
--- Part 26.Electrostatic Hazards – Guidance;
--- Part 27.Electrostatic Hazards – Test;
--- Part 28.Non-Electrical Equipment for Explosive Atmospheres – Basic Method and
Requirements;
--- Part 29.Non-Electrical Equipment for Explosive Atmospheres – Constructional Safety
“c”, Control of Ignition Source “b”, Liquid Immersion “k”;
--- Part 30.Equipment and Components in Explosive Atmospheres in Underground Mines;
--- Part 31.Equipment Dust Ignition Protection by Enclosure “t”;
--- Part 32.Intrinsically Safe Systems with Electronically Controlled Spark Duration
Limitation;
--- Part 33.Equipment in Adverse Service Conditions;
--- Part 34.Equipment Assemblies;
--- Part 35.Classification of Areas for Explosive Dust Atmospheres;
--- Part 36.Electrical Safety Devices for the Control of Potential Ignition Sources from Ex
Equipment.
This Document replaced GB/T 3836.21-2017 Explosive Atmospheres – Part 21.Application of
Quality Systems for Equipment Manufacture. Compared with GB/T 3836.21-2017, the major
technical changes of this Document are as follows besides the structural adjustments and
editorial modifications.
--- Modify the content of each Clause of the full text to coordinate with GB/T 19001-2016;
and list the corresponding content in GB/T 19001-2016;
--- Add the requirements for changing planning (see 6.3 of this Edition);
--- Added the requirements of personnel (see 7.1.2 of this Edition);
--- Add the requirements of personnel consciousness (see 7.3 of this Edition);
--- Add requirements for design and development planning (see 8.3.2 of this Edition).
This Document modified and adopted ISO/IEC 80079-34.2018 Explosive Atmospheres – Part
34.Application of Quality Management Systems for Ex Product Manufacture.
Compared with ISO/IEC 80079-34.2018, this Document made the following structural
adjustments.
--- Annex A corresponds to Annex D of ISO/IEC 80079-34.2018;
--- Annex B corresponds to Annex A of ISO/IEC 80079-34.2018;
--- Annex C corresponds to Annex B of ISO/IEC 80079-34.2018;
--- Annex D corresponds to Annex C of ISO/IEC 80079-34.2018.
The technical differences and their causes between this Document and ISO/IEC 80079-34.2018
are as follows.
--- Use GB/T 2900.35 in the normative references to replace IEC 60050-426 (see Clause 3)
to adapt to China's technical conditions and increase operability;
--- Use GB/T 3836.1 in the normative references to replace IEC 60079-0 (see Clause 3) to
adapt to China's technical conditions and increase operability;
--- Use GB/T 19000 in the normative references to replace ISO 9000 (see Clause 3) to adapt
to China's technical conditions and increase operability.
This Document made the following editorial modifications.
--- In order to be consistent with the existing standard series, change the name of this
Document into Explosive Atmospheres – Part 21.Application of Quality Management
Systems for Ex Product Manufacture;
--- Add NOTE of Annex A to the scope;
--- Delete the NOTE of "Institutions responsible for verification" in 3.12;
--- Adjust the Annex D of ISO/IEC 80079-34.2018 to Annex A, and modify it into "the
corresponding relationship between this Document and GB/T 3836.21-2017";
--- Delete a formula in EXAMPLE 2 of C.4.3;
--- Use Chinese document to replace the informative international documents and modify
the bibliography.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Document was proposed by China Electrical Equipment Industry Association.
This Document shall be under the jurisdiction of National Technical Committee on Explosion
Protected Electrical Apparatus of Standardization Administration of China (SAC/TC 9).
Drafting organizations of this Document. Nanyang Explosion Protected Electrical Apparatus
Research Institute Co., Ltd.; China Mining Products Safety Approval and Certification Center
Co., Ltd.; Shanghai Inspection and Testing Institute of Instruments and Automation Systems
Co., Ltd.; China Coal Science and Industry Group Changzhou Research Institute Co., Ltd.;
Jiamusi Explosion-Proof Electric Machine Institute Co., Ltd.; Warom Technology Incorporated
Company; and Haimo Technologies Group Corp.
Chief drafting staffs of this Document. Wang Jun, Zhang Gang, Xu Jianping, Zhang Yong, Kou
Xiaoguang, Zhong Liyun, Wang Weiyue, Wang Qiaoli, Zhou Jing, and Xi Xiaoyan.
The historical editions replaced by this Document are as follows.
--- GB/T 3836.21-2017 was first-time published in 2017;
--- It is first-time revised hereby.
1 Scope
This Document specifies particular requirements and information for establishing and
maintaining a quality management system to manufacture Ex Products in accordance with the
certificates. While it does not preclude the use of other quality management systems that are
compatible with the objectives of GB/T 19001-2016 and which provide equivalent results, the
minimum requirements are given in this Document.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB/T 2900.35, GB/T
3836.1, GB/T 19000, and the following apply.
4 Context of the Organization
Due to their effect or potential effect on the organization’s ability to consistently provide
products and services that meet customer and applicable statutory and regulatory requirements,
the organization shall determine.
5 Leadership
Top management shall demonstrate leadership and commitment with respect to customer focus
by ensuring that.
6 Planning
When the organization determines the need for changes to the quality management system, the
changes shall be carried out in a planned manner (see 4.4).
The organization shall consider.
7 Support
The organization shall determine, provide and maintain the infrastructure necessary for the
operation of its processes and to achieve conformity of products and services.
When measurement traceability is a requirement, or is considered by the organization to be an
essential part of providing confidence in the validity of measurement results, measuring
equipment shall be.
8 Operation
The information in Annexes B and C for control and acceptance of processes for Ex Products
are one method to ensure compliance with the requirements of the certificate. If other methods
are used, they should be evaluated to ensure full compliance with the requirements of
certification.
9 Performance Evaluation
The organization shall monitor customers’ perceptions of the degree to which their needs and
expectations have been fulfilled. The organization shall determine the methods for obtaining,
monitoring and reviewing this information.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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