2 No verification method or no linked verification

Every requirement below the top level is expected to name how it will be verified and to link the test, analysis, inspection or review that does it. The paste shows no method, no linked verification, or neither, so there is nothing for the assessor to sample on this requirement.

the test: a requirement below the top level with a blank verification method, or with no linked test or verification ID in either paste; where every child is verified and passing, or an analysis, inspection, review or simulation carries a recorded justification, it is asked as a question for that justification, never counted as a break
the question: How is this requirement verified, which test or verification record covers it, and where is that link, or the justification for verifying it through its children or by another method, recorded?
asked of: the requirement owner
columns it reads: Verification Method, Verified By and Justification

Not every requirement without a direct verification is a gap. Where every child is verified and passing, the line reads covered through its children; where an analysis, inspection, review or simulation carries a recorded justification, the line reads justification recorded. Either way the finding asks for the justification, and the requirement is never counted as having no passing verification. Where the results carry a method, a verification recorded under a method the requirement does not list is asked about too.

The clauses behind it, by standard

each shown when you tick its standard

ISO 26262: Part 8, 6.4.3, Part 8, 9.4.1, Part 8, 9.4.2, Part 5, 10 (hardware requirements), Part 6, 10.4 (software requirements and high-level requirements) and Part 6, 9.4 (software unit or detailed designs and low-level requirements)
Automotive SPICE: SYS.5.BP4 (system level), SWE.6.BP4 (software requirements), HWE.4.BP5 (hardware requirements) and SWE.4.BP4 (software units and detailed design)
IATF 16949: 8.3.5.1
IEC 62304: 5.1.6 and 5.7.1
ISO 13485: 7.3.6
FDA QMSR: 820.10
DO-178C: A-7.3 (high-level requirements) and A-7.4 (low-level requirements)
AS9100D: 8.3.4

The clause text

ISO 13485 7.3.6Design and development verification

Verification of design and development follows planned, documented arrangements and confirms that the outputs satisfy the input requirements. The organization documents verification plans setting out the methods, the acceptance criteria and, where appropriate, statistical techniques together with the reasoning behind the sample size. If the intended use means the device must connect or interface with other devices, verification must show the outputs meet the inputs in that connected state. Records are kept of verification results, conclusions and any actions needed.

Held text: ISO 13485:2016, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Verification plans with methods, acceptance criteria and sample-size rationale; Verification reports and records of actions; Interface or connected-use verification where applicable; Traceability showing every input verified

where it usually breaks Sample sizes chosen without a documented rationale; Verification of interfaces with other devices omitted; Inputs with no corresponding verification evidence

Every ISO 13485 clause we hold

FDA QMSR 820.10Quality management system requirements: ISO 13485 incorporated by reference

Section 820.10 establishes the substantive QMS requirements by incorporating ISO 13485:2016 SECTIONS 4 THROUGH 8 in full. Manufacturers must implement: ISO 13485:2016 SECTION 4 General QMS requirements + documentation (Quality Manual + Medical Device File + control of documents + records); SECTION 5 Management responsibility + customer focus + quality policy + planning + responsibility / authority / communication + management review; SECTION 6 Resource management (provision of resources + human resources + infrastructure + work environment + contamination control); SECTION 7 Product realization (planning + customer-related + design and development - the medical-device 'design controls' parallel + purchasing + production and service provision + control of monitoring + measuring equipment); SECTION 8 Measurement + analysis + improvement (monitoring + measurement + control of nonconforming product + analysis of data + improvement - including CAPA Sections 8.5.2 + 8.5.3). NB: §820.10 also clarifies that ISO 13485:2016 internal-audit + management-review requirements (Sections 8.2.4 + 5.6) apply to the QMSR.

Held text: 21 CFR Part 820 (QMSR), our statement of the clause, not the instrument verbatim.

what an assessor asks to see ISO 13485 Section 4-8 compliance file; Internal audit programme + records; Management review records + frequency; Cross-reference matrix between QMSR + ISO 13485 + EU MDR/IVDR + FDA Part 11

where it usually breaks ISO 13485 implemented in parts without full Section 4-8 coverage; Internal audit infrequent or scope-limited; Management review absent + meeting minutes incomplete

Every FDA QMSR clause we hold

AS9100D 8.3.4Design and development controls

The design and development process is controlled so that: the intended results are set out; reviews judge whether results can meet requirements; verification confirms that outputs match inputs; validation confirms that the resulting products satisfy the requirements of their intended use; problems are acted on; records are kept; and, under 9100, authorization is given before moving to the next stage, with people from the functions involved in the stage under review taking part in design reviews. 9100 adds that tests needed for verification and validation are planned, controlled, reviewed and documented, so that: test plans name the item tested, the resources, the aims, the conditions, the parameters to be recorded and the acceptance criteria; test procedures explain how the test is run and performed and how results are recorded; the right configuration is presented for test; the plan and procedures are followed; and the acceptance criteria are satisfied. Equipment used to measure tests is controlled under 7.1.5. When design is complete, reports, calculations and test results show that the design satisfies the specification under every operating condition identified.

Held text: AS9100D, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Design review, verification and validation records with stage authorization.; Test plans and procedures meeting a) to e) with configuration of the test item recorded.; Completion evidence covering all identified operational conditions.

where it usually breaks Design reviews without representatives of manufacturing or quality.; Tests run on an undocumented configuration.; Next stage started before authorization.

Every AS9100D clause we hold

IATF 16949 8.3.5.1Design and Development Output - supplemental

Product design output is expressed so that it can be checked (verified and validated) against the design inputs. As applicable it includes: the design risk analysis (FMEA); results of reliability studies; special characteristics of the product; results of design error-proofing, for example DFSS, DFMA and FTA; the product definition, covering technical data packages, 3D models, geometric dimensioning and tolerancing (GD&T) and product manufacturing information; 2D drawings; outcomes of design reviews; guidelines for service diagnosis, together with instructions for repair and for serviceability; requirements for service parts; and requirements for packaging and labelling for shipment. Interim design outputs should include engineering problems being settled through trade-off. As revised: SI 30 (November 2025): item i) becomes requirements for replacement service parts, in line with the Rules 6th edition.

Held text: IATF 16949:2016, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Design output package covering a) to j) as applicable.; Traceability from each output to the design inputs.

where it usually breaks Serviceability instructions and service part requirements missing from the output.; Special characteristics absent from the drawing package.

Every IATF 16949 clause we hold

ISO 26262 Part 8, 6.4.3Management of safety requirements

Safety requirements are managed under configuration and change management with traceability to their source and to their verification, and are verified for correctness, completeness and consistency against the level above. Requirement text not held.