Packaging qualification, handling procedures, storage controls, and shelf-life management — 820.130/140/150 preservation requirements consolidated into 7.5.11.
ISO 13485 explicitly requires preservation through distribution, not just storage; packaging must be validated to maintain device integrity throughout the supply chain.
Packaging validation records and storage condition monitoring logs — expired shelf-life controls and unmonitored environmental conditions in storage are common findings.
Maps to
QMSR / ISO 13485: §820.130 Device packaging., §820.140 Handling., §820.150 Storage.
ISO 13485: §7.5.11 Preservation of product
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.
Why this clause exists
A device that conforms to specification when it leaves the production floor can be degraded to a nonconforming state by inadequate handling, storage outside specified conditions, or packaging that fails to protect the device through the distribution chain. The preservation requirement closes the gap between production conformance and customer receipt: conformance is only meaningful if it is maintained at the point of use. Special storage conditions — temperature, humidity, light exposure, electrostatic sensitivity — represent device-specific vulnerabilities that generic handling cannot address; without explicit documentation of those conditions and controls that enforce them, storage staff and logistics personnel have no basis for making appropriate handling decisions. Shelf-life and expiry date controls address the temporal dimension of product conformance: many device attributes that conform at time of manufacture — sterility barrier integrity, chemical stability of coatings or lubricants, battery charge state — have defined limits on the time over which that conformance can be assumed to be maintained. Storage condition deviations — temperature excursions, humidity excursions, physical damage events — require evaluation and documentation rather than informal disposition, because the effect of the deviation on product quality must be assessed before the affected product can be used or released for distribution.
What changed
§820.130 / §820.140 / §820.150 — Part 820 (legacy)
"Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling. Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate. Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms."
§7.5.11 — ISO 13485:2016 (current)
"The organization shall document procedures for preserving the conformity of product to requirements during processing, storage, handling, and distribution. Preservation shall apply to the constituent parts of a medical device. The organization shall protect product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by: a) designing and constructing suitable packaging and shipping containers; b) documenting requirements for special conditions needed if packaging alone cannot provide preservation. If special conditions are required, they shall be controlled and recorded (see 4.2.5)."
Δ Three separate Part 820 sections are unified into one preservation clause that explicitly extends to constituent parts and requires documented special conditions when packaging alone is insufficient.
Common gaps (what we see in audits)
- No Packaging Qualification/Validation — Packaging 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 — Storage 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 — Warehouse 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 — Procedures 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 — Storage 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.