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GB/T 3836.21-2022 (GB/T3836.21-2022)

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GB/T 3836.21-2022: PDF in English (GBT 3836.21-2022)

GB/T 3836.21-2022
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.
Explosive Atmospheres – Part 21: Application of Quality
Management Systems for Ex Product Manufacture
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.
This Document is applicable to establishing and maintaining the quality management system
for the manufacture of Ex products.
NOTE: Annex A list the corresponding relationship of each clause between this Document and previous
edition.
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.
GB/T 2900.35 Electrotechnical Terminology - Equipment for Explosive Atmospheres
(GB/T 2900.35-2008, IEC 60050-426:2008, IDT)
GB/T 3836.1 Explosive Atmospheres - Part 1: Equipment - General Requirements (GB/T
3836.1-2021, IEC 60079-0:2017, MOD)
GB/T 19000 Quality Management Systems - Fundamentals and Vocabulary (GB/T 19000-
2016, ISO 9000:2015, IDT)
GB/T 19001-2016 Quality Management Systems – Requirements (ISO 9001:2015, IDT)
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB/T 2900.35, GB/T
3.7 Safety devices
Device intended for use inside or outside explosive atmospheres but required for or contributing
to the safe functioning of equipment and protective systems with respect to the risks of
explosion.
3.8 Schedule drawing
Drawing or document listed in the certificate or test report.
3.9 Related drawing
Drawing or document not listed in the certificate but linked to the schedule drawing, and used
for example, for detailed manufacture or purchase of component parts.
3.10 Technical documentation
Documentation that enables the conformity of the product with the requirements of the
standard(s) to be assessed.
NOTE 1: This includes schedule drawings
NOTE 2: It covers the design, manufacture and operation of the product and can contain:
– a general description;
– design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
– descriptions and explanations necessary for the understanding of drawings and layouts and the
operation of the product;
– a list of the standards referred to in the certificate, applied in full or in part, and descriptions of the
solutions adopted to meet the requirements of the standards;
– results of design calculations made, examinations carried out, risk assessment etc.;
– test reports.
NOTE 3: For Non-electrical equipment, this includes the “Formal Ignition hazard identification and
assessment” referred to in GB/T 3836.28.
3.11 Manufacturer’s documentation
Documents required by a manufacturer but not subject to assessment by body responsible for
verification when making an application for a test report or a certificate.
NOTE 1: For example, manufacturing instructions, related drawings, data sheets and sales literature.
NOTE 2: The manufacturer’s documentation can be either in paper form or electronic form.
......