Receiving inspection, in-process acceptance, and finished device release with documented acceptance criteria — 820.80 and 820.86 acceptance activities structure preserved.
ISO 13485 requires documented acceptance status identification at all stages (7.5.9); supplier verification links to ISO 13485 7.4.3 purchasing controls explicitly.
Finished device release authorization records and in-process acceptance criteria — releasing product without a documented final review against all acceptance records is a primary 483 trigger.
Maps to
QMSR / ISO 13485: §820.80 Receiving, in-process, and finished device acceptance., §820.86 Acceptance status.
ISO 13485: §8.2.6 Monitoring and measurement of product, §7.4.3 Verification of purchased product
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.
Why this clause exists
Acceptance activities are the systematic quality checkpoints built into the manufacturing flow to verify that product conforms to requirements at defined stages — incoming materials, in-process production steps, and finished device release. The requirement that no device be released until all required acceptance activities are satisfactorily completed is the formal prohibition against skipping quality gates under production pressure: conditional or provisional release based on anticipated acceptance rather than demonstrated acceptance is a routinely cited FDA finding. Receiving inspection as an acceptance activity exists because purchased components and materials are inputs to production whose conformance cannot be assumed from a supplier certificate alone; the extent and rigor of receiving inspection is properly scaled to supplier qualification status and the criticality of the input, but the activity must be defined and performed. In-process acceptance activities at defined production stages prevent defects introduced at one stage from propagating into subsequent operations that build upon or conceal them; early detection is both more cost-effective and more reliable than dependence on final inspection. Acceptance records that identify the inspector and the acceptance criteria used create an accountability record: the inspector is identified by name or unique identifier, and the criteria version is captured, so that if acceptance decisions are later questioned, the basis and authority for those decisions can be evaluated objectively.
What changed
§820.80 / §820.86 — Part 820 (legacy)
"General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities. Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented. In-process acceptance activities. Each manufacturer shall establish and maintain procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented. Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until: (1) The activities required in the DMR are completed; (2) the associated data and documentation is reviewed; (3) the release is authorized by the signature of a designated individual(s); and (4) the authorization is dated. Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include: (1) The acceptance activities performed; (2) the dates acceptance activities are performed; (3) the results; (4) the signature of the individual(s) conducting the acceptance activities; and (5) where appropriate the equipment used. These records shall be part of the DHR. Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed."
§8.2.6 / §7.4.3 — ISO 13485:2016 (current)
"8.2.6 Monitoring and measurement of product The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at applicable stages of the product realization process in accordance with the planned and documented arrangements and documented procedures. Evidence of conformity to the acceptance criteria shall be maintained. The identity of the person authorizing release of product shall be recorded (see 4.2.5). As appropriate, records shall identify the test equipment used to perform measurement activities. Product release and service delivery shall not proceed until the planned and documented arrangements have been satisfactorily completed. For implantable medical devices, the organization shall record the identity of personnel performing any inspection or testing. 7.4.3 Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements. The extent of verification activities shall be based on the supplier evaluation results and proportionate to the risks associated with the purchased product. When the organization becomes aware of any changes to the purchased product, the organization shall determine whether these changes affect the product realization process or the medical device. When the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification activities and method of product release in the purchasing information. Records of the verification shall be maintained (see 4.2.5)."
Δ Part 820's receiving/in-process/final device acceptance activities map to monitoring and measurement of product (8.2.6) and verification of purchased product (7.4.3) in ISO 13485; the QMSR restructures product acceptance into risk-proportionate verification rather than prescriptive inspection at each stage.
Common gaps (what we see in audits)
- No Formal Receiving Inspection Program — Incoming 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 — Finished 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' — Product 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 — Manufacturing 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 — Acceptance 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.