Maps to
QMSR / ISO 13485: §820.130 / 820.140 / 820.150
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.
What changed
Part 820 addressed preservation in three separate sections: 820.130 (Device Packaging) required processes and procedures for packaging to ensure the device met specifications and was not damaged or contaminated during handling, storage, or distribution; 820.140 (Handling) required procedures for handling to prevent mix-ups, damage, deterioration, contamination, or other adverse effects; 820.150 (Storage) required procedures for storage areas and stock rooms with procedures for authorization of receipt into and dispatch from storage areas, and assessment of product condition at defined intervals.
ISO 13485:2016 clause 7.5.11 consolidates all preservation activities into a single clause: the organization shall document procedures for preserving the conformity of product to requirements during processing, storage, handling, and distribution. This includes requirements for identification, handling, packaging, storage, and protection. The standard also requires documented requirements for special storage conditions, which shall be controlled and recorded.
The QMSR adopts ISO 13485 clause 7.5.11 without adding QMSR-specific requirements for preservation. The structural change is the consolidation: where Part 820 had three separate sections that were often addressed by three separate procedures, ISO 13485 expects a unified approach to product preservation. The practical impact is that manufacturers should integrate their handling, packaging, and storage procedures into a cohesive preservation system rather than treating them as independent compliance activities. Packaging validation (which Part 820 implied through 820.130's reference to meeting specifications) is more explicitly addressed in ISO 13485's framework of documented requirements.
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.
Common gaps
No Packaging Qualification/Validation
moderatePackaging has been selected and used without formal qualification demonstrating it protects the device through the defined distribution chain. ISO 13485 clause 7.5.11 requires documented packaging requirements, and industry practice (ASTM D4169, ISTA) expects packaging validation for medical devices.
Missing Shelf-Life Controls and Expiry Date Management
moderateStorage procedures do not define shelf-life limits, expiry date monitoring, or first-in-first-out (FIFO) stock rotation controls. For devices with limited shelf life (especially those with sterile packaging or degradable materials), lack of shelf-life controls risks distributing expired or degraded product.
No environmental monitoring in storage
moderateWarehouse temperature/humidity is not monitored or recorded, even though the device is heat-sensitive. ISO 13485 §7.5.11 requires preservation through storage.
Lack of distribution controls
moderateProcedures don't define how 'first-in, first-out' (FIFO) is enforced to prevent expired product from being shipped. ISO 13485 §7.5.11 requires preservation through distribution.
Storage Condition Monitoring Not Documented
minorStorage areas lack continuous or periodic environmental monitoring (temperature, humidity) with documented records. ISO 13485 requires special storage conditions to be controlled and recorded, meaning monitoring data must be maintained and excursions investigated.
Evidence signals
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FILE_EXISTS
(Storage.*Procedure|Handling.*Procedure|Packaging.*Qualification|Shelf.*Life|Storage.*Condition|Distribution.*Qualification)
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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.