GB/T 3836.21-2022 English PDF (GBT3836.21-2022)

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GB/T 3836.21-2022: Explosive atmospheres - Part 21: Application of quality management systemsfor Ex Product manufacture
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 Manage...