Navigating the New Edition of ISO/IEC 80079-34

Manufacturers with an IECEx Quality Assessment Report (QAR) or an ATEX Production Quality Assurance Notification (PQAN) have noted that a new edition of the associated quality management standard, ISO/IEC 80079-34, has been published. UL is here to help you learn the significant changes between editions, review effective dates as well as important updates related to other relevant IECEx and ATEX quality system topics.

Here are the top seven questions that will help manufacturers and installers navigate the changes to the new edition of ISO/IEC 80079-34.

1. Can the Ex authorized person be the same for the multiple sites but only located at one?

The intent of the standard is that there be a local Ex authorized person at each site to help ensure that the quality system is effective. The responsibilities of the local authorized person may be limited in scope. However, depending on the specific situation, it could be envisioned that the same authorized person could cover multiple locations with properly documented responsibilities and authority. 

2. Are the terms "responsible person" and "authorized person" interchangeable?

Yes, in the context of SIO/IEC 80079-34, these terms are the same. However, the Ex authorized person may be different than the party responsible for e.g. signing a declaration of conformity.

3. What do you recommend to verify that order review was performed at the time of audit?   

Documented records of contract review are preferred. In the case of orders for standard products or for internet orders, auditors may look into the process for ordering and the information available to the customer at the time of order to help ensure the relevant certification details are available and revision controlled. Interviews of sales and order taking staff are also conducted to help ensure those personnel know how to handle questions related to certification. 

4. Could UL’s Yellow Card be used as a Declaration of Conformity (DOC)?

In general, a UL Recognition would not satisfy the requirements for a supplier's Declaration of Conformity. However, it would be considered by UL’s auditors as suitable confirmation of material properties. It would not necessarily be suitable for confirming specific construction attributes of an assembly or component.   

5. Does a contract manufacturer need a QAR?

No, a contract manufacturer is not required to have a QAR, provided that your quality system covers them adequately. First, you would qualify the contract manufacturer as a critical supplier per ISO/IEC 80079-34. This requires that they 1) have a QAR, or 2) have an appropriate quality system such as ISO 9001, or 3) have a site assessment performed by you. Next, you would need to define what tasks you expect the supplier to perform and convey that information to the supplier. This often takes the form of a quality plan. Finally, the delivery requirements are documented so that they are tied to each order, e.g., referencing the quality plan on the purchase order.

6. Can we spread our internal audit schedule over three years and not do it in one year?

No, ISO/IEC 80079-34 states that the maximum period between internal audits shall not exceed 14 months.

7. If we had a PCB assembler stuffing our boards and there are a few critical parts that they provide records for, do they still need a QAR?

No, a PCB assembler is not required to have a QAR, provided that your quality system covers them adequately. First, you would qualify the PCB assembler as a critical supplier per ISO/IEC 80079-34. This requires that they 1) have a QAR, or 2) have an appropriate quality system such as ISO 9001, or 3) have a site assessment performed by you. Next, you would need to define what tasks you expect the supplier to perform and convey that information to the supplier. This often takes the form of a quality plan. Finally, the delivery requirements are documented so that they are tied to each order, e.g., referencing the quality plan on the purchase order.