ISO 13485 Customer property requirements E-mail

Be careful and do not hide anything from your customers. These are the bottom lines of paragraph 7.5.4 – customer property.  When the organization makes any use of customer's property, it shall exercise it with care. Customer's property may be used for combination or corporation into the product.

When accepting customer's property the organization must refer to the next issues:

ISO 9001
ISO 13485
When accepting customer's property, the organization shall identify and verify and protect all of customer's property. 
When accepting customer's property, the organization shall identify and verify and protect all of customer's property. 
The organization shall define a method how it shall identify and verify and protect all of customer's property.The organization shall define a method how it shall identify and verify and protect all of customer's property.
The organization must define a method to communicate with the customer to notify him when in any case when the property is damaged, lost, or found unsuitable for use. The organization shall record the notification. 
This notification shall be included under the records control procedure as specified in paragraph 4.2.4 – control of records.
The organization must define a method to communicate with the customer to notify him when in any case when the property is damaged, lost, or found unsuitable for use. The organization shall record the notification. 
This notification shall be included under the records control procedure as specified in paragraph 4.2.4 – control of records.
Customer's property includes intellectual property. 
Customer's property includes intellectual property or confidential health information. 

 

The requirement applies for anything that the customers provide: raw materials or components supplied for inclusion in product (including packaging materials), product supplied for repair, maintenance or upgrading, product supplied for further processing (e.g., packaging, sterilization or testing), software, and knowledge, the use of customer's facilities, and information, and customer intellectual property. This requirement applies also to customer's property that has been delivered to the organization for service activities as well.
The only additional requirement here is the reference to confidential health information. Naturally, when dealing with medical devices, sometimes the organization is subjected to highly sensitive health information. This kind of information is considered (by the ISO 13485 Standard) customer's property. Plain as that! In order to support this requirement the organization should define authorities for using this kind of property or information. 
When the organization receives the customer's property, it must verify and record the acceptance of the property. What is required to verify? Approval that everything that was documented is actually what was received.  Fulfilling this requirement would save a lot of debates and headaches later on. Trust me on that. 
The organization must protect the customer's property. Therefore, when there are special customer's requirements for handling his property, they must be available. This is usually crucial when service is provided at the customer's facilities.

When any kind of damage, loss, or the property was found unsuitable for use, the customer should be notified. Records of this notification and approval must be kept and included under the records control procedure. That means that these records are part of your quality management documentation and needed to be documented in the records control procedure as specified in paragraph 4.2.4 – control of records.

After I saved your clients property, allow me to preserve your medical devices according to the ISO 13485 Standard Preservation of property requirements.

 
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