For the preliminary assessment of IECEx quality management system compliance with ISO/IEC 80079-34, we recommend using the HydITEx checklist. This is one of the auditor's tools used to ensure that the audit covers, at a minimum, the requirements defined in the audit scope. However, the use of checklists does not limit the scope of the audit, which may vary depending on the information collected during the audit.

Using this checklist can be the best way to gain an overall understanding of your business processes and identify areas that need to be brought into compliance with ISO/IEC 80079-34 requirements or simply improved.

HydITEx Quality Checklist for ISO/IEC 80079-34

1. Your Organization has implemented and certified a Quality Management System in accordance with the requirements of ISO 9001? (See Note 1 for details.)

2. Do manufactured Ex products comply with their Ex certificate and technical documentation? (ISO/IEC 80079-34 Clause 4.1)

3. Does the Quality Management System ensure that the finished product complies with the type described in the Ex certificate and technical documentation? (ISO/IEC 80079-34 Clause 4.4)

4. Are there appointed Ex authorized person(s) within the Organization responsible for the effective coordination of activities regarding Ex products? (ISO/IEC 80079-34 Clause 5.3 a) (See Note 2 for details.)

5. Are there appointed Ex authorized person(s) responsible for liaising with Ex products certification bodies (ExCBs) regarding any proposed changes to certified Ex products? (ISO/IEC 80079-34 Clause 5.3 b) (See Note 2 for details.)

6. Are there appointed Ex authorized person(s) responsible for interaction with quality management system certification bodies regarding the planned update of the quality management system? (ISO/IEC 80079-34 Clause 5.3 c) (See Notes 2,3 for details.)

7. Are there appointed Ex authorized person(s) responsible for authorizing the approval process and making changes to the associated drawings? (ISO/IEC 80079-34 Clause 5.3 d) (See Note 2 for details.)

8. Are there appointed Ex authorized person(s) responsible for authorizing deviations from the drawings? (ISO/IEC 80079-34 Clause 5.3 e) (See Note 2 for details.)

9. Are there appointed Ex authorized person(s) responsible for the accuracy of information about Ex products provided to the client in any form (this could be advertising literature, instructions, etc.) (ISO/IEC 80079-34 Clause 5.3 f) (See Note 2 for details.)

10. Are there appointed Ex authorized person(s) responsible for the effective coordination of production processes related to Ex products? (ISO/IEC 80079-34 Clause 5.3 g) (See Note 2,4 for details.)

11. Ensure that the measuring equipment used for compliance testing is calibrated and has a valid calibration certificate. (ISO/IEC 80079-34 Clause 7.1.5)

12. Ensure that your organization has developed, documented, implemented and maintained a process to identify and ensure that all persons who influence the compliance of Ex products are trained and competent. (ISO/IEC 80079-34 Clause 7.2)

13. Ensure that your organization controls internal and external communication regarding Ex products. (ISO/IEC 80079-34 Clause 7.4)

14. Ensure your organization has developed documents that contain the requirements and provisions adopted to ensure and demonstrate compliance of Ex products with their Ex certificates and technical documentation. Ensure such documents are systematized and organized. (ISO/IEC 80079-34 Clause 7.5.1)

15. Ensure that quality management system documentation is clear and does not contain ambiguities. (ISO/IEC 80079-34 Clause 7.5.1)

16. Ensure your organization maintains control over technical documentation related to Ex products. Ensure that such technical documentation is systematized and organized. (ISO/IEC 80079-34 Clause 7.5.3) (See Notes 5,6 for details.)

17. Ensure that your organisation controls all processes relating to Ex products to ensure full compliance with their Ex certificates. (ISO/IEC 80079-34 Clause 8.1) (See Note 7 for details.)

18. Ensure that your organization conducts a Customer Requirements review of Ex products to ensure that their Ex certificate requirements are met. (ISO/IEC 80079-34 Clause 8.2.3)

19. Ensure that Ex authorized person(s) are involved in the process of making and approving changes and modifications to Ex products that may affect the compliance of Ex products with explosion proof requirements. (ISO/IEC 80079-34 Clause 8.2.4, Clause 8.3.6)

20. Ensure your organization conducts a selection process for external suppliers providing products, processes, or services that may impact Ex product compliance with explosion proof requirements. Ensure that external suppliers are selected and provide a product, process or service that meets explosion proof requirements. (ISO/IEC 80079-34 Clause 8.4.1) (See Note 8 for details.)

21. Ensure that your organization controls (verifies) externally provided processes, products, and services that could impact the compliance of Ex products with explosion proof requirements. Ensure that externally provided processes, products, and services do not negatively impact the organization's ability to consistently deliver compliant products and services to its customers. (ISO/IEC 80079-34 Clause 8.4.2) (See Note 8 for details.)

22. Ensure that you inform suppliers providing a product, process or service that may affect the Ex products' compliance with explosion protection requirements what requirements you have for the product, process or service they supply. (ISO/IEC 80079-34 Clause 8.4.3)

23. Ensure that your organization has established and implemented procedures that provide confidence that Ex products comply with their technical documentation. (ISO/IEC 80079-34 Clause 8.5.1) (See Note 9 for details.)

24. Ensure that your organization has developed a system that allows for the identification of Ex products at all stages of the life cycle, from production to distribution. (ISO/IEC 80079-34 Clause 8.5.2)

25. Ensure that your organization verifies that products supplied by the customer or third-party supplier comply with the requirements of the certificate. (ISO/IEC 80079-34 Clause 8.5.3)

26. Ensure that Ex authorized person(s) are involved in the change control process that may affect the compliance of Ex products with explosion protection requirements. (ISO/IEC 80079-34 Clause 8.5.6)

27. Ensure that your organization releases Ex products after satisfactory completion of final inspection and testing. Does your organization provide users with operating instructions for Ex products? (ISO/IEC 80079-34 Clause 8.6) (See Note 10 for details.)

28. Ensure your organization has a system in place to identify the customer to whom the Ex products are delivered that do not meet the Ex certificate requirements. Ensure your organization takes action (responds, informs) when nonconforming Ex products are delivered to the customer. (ISO/IEC 80079-34 Clause 8.7) (See Note 11 for details.)

29. Ensure that the maximum interval between internal audits does not exceed 14 months. (ISO/IEC 80079-34 Clause 9.2)

30. Ensure that your organization's top management and Ex authorized person(s) review the overall effectiveness of the quality management system for Ex products. (ISO/IEC 80079-34 Clause 9.3.1)

Notes

1. 1. Ensure that your ISO 9001 certificate is valid and applicable to the production of Ex products.

2. 2. Ensure that documents appointing Ex authorized persons are available; these may include job descriptions, orders, etc. These documents must be accessible during the audit.

3. 3. Be aware that a change in Ex authorized person(s) is considered a "substantial" change, which must be reported to the quality management system certification body.

4. 4. If your organization has multiple production sites, Ex authorized persons must be appointed for each site.

5. 1. Technical documentation related to Ex products includes not only drawings and test reports, but also various records of Ex product quality and other documented information.

6. 2. Be careful: technical documentation related to Ex products must be retained for at least 10 years.

7. 3. Such processes include, for example, processes that may affect the product's compliance with explosion proof requirements.

8. 4. Ensure that there are documents confirming that external suppliers have been selected and that the external supplier provides a product, process, or service that meets explosion proof requirements.

9. Such procedures include, for example, the use of qualified personnel, specialized technical means, calibrated measuring equipment, etc.

10. Operating instructions for Ex products must contain information on the specific conditions of use of Ex products or information on possible misuse of Ex products.

11. Please note that records regarding Ex products that do not comply with certificate requirements must be retained for at least 10 years.

This checklist does not cover all the requirements and recommendations of ISO 9001 and ISO/IEC 80079-34. To ensure compliance with ISO 9001 and ISO/IEC 80079-34, it is recommended that only the referenced standards be used.