GB/T 3836.21-2022Explosive atmospheres - Part 21: Application of quality management systems for Ex Product manufacture (English PDF)

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.

......