Maps to
QMSR / ISO 13485: §820.30(d)
ISO 13485: §7.3.4
Requirement text
Design and development outputs shall be documented, verified against inputs, and include acceptance criteria and essential product characteristics.
What changed
Part 820.30(d) required that design output procedures contain or reference acceptance criteria and ensure outputs are essential for the proper functioning of the device. Outputs had to meet design input requirements, contain or reference acceptance criteria, and identify the characteristics of the design crucial to safe and proper functioning.
ISO 13485:2016 clause 7.3.4 aligns closely but introduces several refinements. Outputs must be in a form suitable for verification against design inputs — a more explicit requirement for traceability than Part 820 stated. ISO 13485 also requires outputs to provide appropriate information for purchasing, production, and servicing, ensuring outputs are not just engineering documents but include downstream operational specifications.
Critically, ISO 13485 7.3.4 requires that design outputs specify the characteristics of the product that are essential for its safe and proper use — using 'essential for safe and proper use' rather than Part 820's 'essential for proper functioning.' This subtle shift expands the scope to include safety-critical characteristics that may not be strictly functional. Additionally, outputs must be approved before release, and this approval must be recorded.
The QMSR alignment also strengthens the expectation that design outputs include or reference risk management outputs, particularly risk control measures that have been implemented as design features. This creates a bidirectional traceability requirement: risk outputs flow into design inputs (7.3.3), and design outputs must demonstrate those risk controls are implemented (7.3.4).
Atomic constraints
- •Outputs must be documented
- •Outputs must be verified against inputs
- •Outputs must include acceptance criteria
- •Essential safety/performance characteristics must be identified
- •Design outputs must be in a form suitable for verification against design and development input requirements.
- •Design outputs must specify the characteristics of the product that are essential for its safe and proper use.
- •Design outputs must provide appropriate information for purchasing, production, and servicing.
- •Design outputs must include or reference risk control measures that have been implemented as design features, establishing traceability from risk management to design output.
- •Design outputs must be approved before release, and the approval must be recorded.
Common gaps
Design outputs not in a form suitable for verification
moderateISO 13485 7.3.4 requires outputs to be 'in a form suitable for verification against design and development input requirements.' Many Part 820-era design output documents are narrative specifications that cannot be directly verified against specific, numbered input requirements without a traceability matrix.
Essential safety characteristics not explicitly identified
moderateISO 13485 7.3.4 requires identification of characteristics essential for safe and proper use. Many legacy design output packages identify key specifications but do not formally tag which characteristics are safety-critical versus performance-related, making it difficult for downstream processes to apply appropriate controls.
Missing service specifications
moderateDesign outputs lack specific requirements for servicing, such as calibration intervals or tool requirements, as required by ISO 13485 §7.3.4.
Undefined essential characteristics
moderateDesign outputs (drawings, specs) don't explicitly identify which characteristics are 'essential for safety' (e.g., critical dimensions).
Missing downstream information for purchasing and production
minorISO 13485 7.3.4 requires that design outputs provide appropriate information for purchasing, production, and servicing. Many Part 820-era design output packages focus on engineering specifications and do not include or reference purchasing specifications, manufacturing work instructions, or service documentation.
Evidence signals
- •
FILE_EXISTS
(Design.*Output|Specification|Drawing|Acceptance.*Criteria)
- •
CONTENT_MATCH
Does this document define design output specifications, acceptance criteria, or essential performance characteristics?
Audit defense
Design outputs for [your product] are documented in [your document ID]. Each output is verified against its corresponding design input and includes acceptance criteria and essential safety/performance characteristics per QMSR 820.30(d).