Maps to
FDA QMSR (Part 820): §820.130 / 820.140 / 820.150
ISO 13485: ISO 13485 §7.5.11
Requirement text
Product conformity must be preserved during internal processing and delivery, including identification, handling, packaging, storage, and protection. Special storage and handling conditions must be documented and controlled.
Atomic constraints
- •Handling procedures must be documented to prevent damage, contamination, or mix-up.
- •Storage conditions (temperature, humidity, light, shelf-life) must be specified and controlled.
- •Storage areas must be controlled and segregated to prevent mix-up and deterioration.
- •Packaging requirements including packaging qualification must be documented.
- •Shelf-life or expiry date controls must be documented and implemented.
- •Special storage condition deviations must be evaluated and documented.
Evidence signals
- •
FILE_EXISTS
(Storage.*Procedure|Handling.*Procedure|Packaging.*Qualification|Shelf.*Life|Storage.*Condition|Distribution.*Qualification)
- •
CONTENT_MATCH
Does this document describe storage conditions, handling requirements, packaging qualification, shelf-life controls, or product preservation requirements?
Audit defense
Product preservation for [your product] is controlled through [your document ID]. Storage conditions are specified and monitored, handling procedures prevent damage and contamination, packaging is qualified to protect device integrity through distribution, and shelf-life controls are implemented per ISO 13485 7.5.11 and QMSR 820.150.