Configuration verification before testing — confirming the test object is built as planned is standard test management practice.
Class B applicability added by A1:2015. Explicit normative distinction between plan-adherence inspection (5.6.2) and performance testing (5.6.3). [Class B, C]
A distinct integration verification record (not the test report) dated before integration testing, confirming software units are assembled per the integration plan.
Maps to
IEC 62304: §5.6.2 Verify software integration
ISO 13485: §7.3.6 Design and development verification
Pre-QMSR Part 820 (legacy QSR): §820.30(f) Design verification.
Requirement text
The manufacturer shall verify that the software units have been integrated into software items and/or the software system in accordance with the integration plan and retain records of the evidence of such verification. [Class B, C]
Why this clause exists
Clause 5.6.2 fills a gap that would otherwise exist between integration execution (5.6.1) and integration testing (5.6.3): it requires an explicit confirmation that the integration was done as planned before testing begins. Without this verification step, integration testing results could relate to an integration that differs from the plan — software units integrated in the wrong order, missing units, or incorrect versions — making test results uninterpretable as evidence of compliance. The standard explicitly notes this verification is most likely implemented by some form of inspection. IEC 62304 NOTE: this verification is only that the integration has been done according to the plan; it is most likely implemented by some form of inspection.
What changed
Clause 5.6.2 was present in IEC 62304:2006. Amendment 1 (2015) added Class B applicability. The A1:2015 clean text simplifies the requirement to a single verification obligation: confirm that SOFTWARE UNITS have been integrated into SOFTWARE ITEMS and/or the SOFTWARE SYSTEM in accordance with the integration plan, and retain records — removing the prior dual sub-clause (a)/(b) redline structure. The note clarifying this is plan-adherence inspection (not performance testing) is retained.
Common gaps (what we see in audits)
- Integration verification conflated with integration testing — Manufacturers produce integration test reports and treat them as satisfying both 5.6.2 and 5.6.3. Clause 5.6.2 is explicitly a plan-adherence inspection — a separate record confirming the integration was assembled correctly per the plan — not a functional test. The standard's note explicitly distinguishes these.
- Integration verification record not retained — Integration is performed and integration testing proceeds, but no record is retained that confirms the software units were integrated into the software system as specified in the integration plan before testing began.