ISO 13485 2003 is the global standard that concerns itself with quality management for medical devices.
ISO 13485 has a section on how businesses should deal with customer property. ISO 13485 customer property is covered in ISO 13485: 2003 Section 7.5.4. The aim of ISO 13485 customer propertyis to ensure that the property a customer leaves with an organization, which can range from intellectual property or confidential health information, is kept intact. The organization has to exercise utmost care with customer property during the time it is under the organization’s control or being used by the organization.
Sets out reporting rules
It is the duty of the organization to identify, verify, protect and safeguard customer property that comes into its custody. If the actions of an organization results in any loss or damage of customer property or make it unsuitable for use, the organization has to report this to the customer and maintain records of the same.
Extension in the next section
The regulation on customer protection ensured in ISO 13485 customer property finds reinforcement in Section 7.5.5. This section prescribes regulation on how to preserve customer property. This is the essence of this section:
According to this second provision on ISO 13485 customer property; the organization in whose care a customer property has been placed has to not only ensure its upkeep; it should also make sure the conformity of product during the time it is with the organization is kept intact. This has to be maintained till the property reaches its intended destination.The elements included under preservation are identification, handling, packaging, storage and protection.Preservation has to be for the whole product as well as its constituent parts.
Once an organization accepts a customer property; it has to establish documented procedures or documented work instructions for preserving the conformity.
These have to be consistent with the storage conditions of the product unique to it.
Deemed as control of records
The clauses relating to ISO 13485 customer property are bunched under control of records. So, any item covered under ISO 13485 customer property is treated as a record. Accordingly, these customer properties have to be preserved for a period equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by regulatory requirements.
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