Maps to
QMSR / ISO 13485: §820.80 / 820.86
ISO 13485: §8.2.4 / 7.4.3
Requirement text
Receiving acceptance activities shall be established. In-process acceptance activities shall be established. Finished device acceptance criteria and procedures shall be established. Only devices that have passed all required acceptance activities shall be released for distribution. Records of acceptance activities shall be maintained.
What changed
Part 820 sections 820.80 and 820.86 provided detailed, prescriptive requirements for acceptance activities at three stages: receiving (820.80(a) — incoming components and materials), in-process (820.80(b) — during manufacturing), and finished device (820.80(c)/820.86 — before distribution). Section 820.80 required documented acceptance criteria and acceptance records. Section 820.86 specifically addressed the status of product during acceptance activities, requiring that product be identified as accepted, rejected, or pending throughout the process.
ISO 13485:2016 addresses monitoring and measurement of product in clause 8.2.6 and verification of purchased product in clause 7.4.3, but does not prescribe the three-stage acceptance framework (receiving, in-process, finished) that Part 820 defined. ISO 13485's approach is more general: it requires monitoring and measurement of product characteristics at appropriate stages per planned arrangements, and verification of purchased product. The specificity of a mandatory three-stage acceptance structure is absent.
The QMSR retains the acceptance activities framework as QMSR 820.80. The FDA preamble explained that the three-stage acceptance structure is essential to FDA's manufacturing oversight model and that ISO 13485's general monitoring requirements do not provide sufficient specificity. This is a QMSR-specific requirement: FDA-regulated manufacturers must maintain documented receiving inspection, in-process inspection, and finished device acceptance procedures with defined acceptance criteria at each stage. Acceptance records must identify the acceptance activity, date, results, signature of the person performing the activity, and equipment used where applicable. Products that fail acceptance must be controlled per the nonconforming product procedure.
Atomic constraints
- •Receiving inspection procedures and acceptance criteria must be documented for incoming components and materials.
- •In-process inspection and test procedures must be established at defined production stages.
- •Finished device acceptance procedures and acceptance criteria must be documented.
- •Product shall not be released until all required acceptance activities are satisfactorily completed.
- •Acceptance records must identify the inspector and the acceptance criteria used.
- •Rejected or quarantined items must be identified and controlled per the nonconforming product procedure.
Common gaps
No Formal Receiving Inspection Program
majorIncoming components and materials are accepted into inventory without defined receiving inspection procedures, acceptance criteria, or documented inspection results. Companies may rely on supplier certificates of conformance without performing any incoming verification activities.
Finished Device Release Without Complete Acceptance Review
majorFinished devices are released based on final test results alone without a comprehensive review of all acceptance activities (receiving, in-process, and final). QMSR 820.80 requires that all acceptance activities be satisfactorily completed before distribution.
No final release 'Gate'
majorProduct is shipped without a formal sign-off confirming that *all* required acceptance activities (Incoming/In-process) were completed. ISO 13485 §8.2.6 requires this gate.
In-Process Acceptance Activities Not Defined
moderateManufacturing procedures lack defined in-process inspection points with documented acceptance criteria. Product moves between manufacturing steps without formal verification that intermediate acceptance criteria are met.
Acceptance Records Missing Required Information
moderateAcceptance records exist but lack required information: inspector identification, date, acceptance criteria used, equipment used for measurement, or disposition decision. Incomplete records undermine traceability and auditability of acceptance decisions.
Evidence signals
- •
FILE_EXISTS
(Receiving.*Inspection|Incoming.*Inspection|Acceptance.*Procedure|Final.*Release|Finished.*Device.*Acceptance|In.Process.*Inspection|Release.*Checklist)
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CONTENT_MATCH
Does this document describe acceptance testing, receiving inspection, in-process inspection, finished device release criteria, or product release authorization procedures?
Audit defense
Acceptance activities for [your product] are documented in [your document ID]. Receiving inspection verifies incoming components against specifications before use. In-process inspections at defined production stages verify conformity throughout manufacturing. Finished device release is authorized only after review of all acceptance records per QMSR 820.80.