The organization is required to preserve the product and its conformity during all the time that it has responsibility over the product. The organization is required to ensure that no changes will occur during the internal processes that the products are subjected to.

While defining the product's preservation, the organization must refer to the next issues:

Product preservation requires the organization to ensure that no characteristics of the product are to be changed at any cost. How and where changes may appear? Throughout the product realization, transportation, delivery and installation processes. Product preservation is required to avoid damage, deterioration or contamination during handling, storage, and distribution.

The additional requirement of the ISO 13485 Standard here is to maintain a documented procedure describing which activities are required to maintain the product preservation. The ISO 9001 Standard does not require documentation but only a definition. Documentation may appear as procedures or work instruction. In any case, the documentation shall ensure that the product's conformity (to prior requirements – organizational, customer or regulatory) is maintained.

In which cases the product conformity may be harmed?

• Realization processes - The organization must ensure that throughout all the realization processes, the product is preserved.
• Storage activities – Storage conditions must be defined and documented. Parameters such as temperature, humidity, cleanliness, dust (particles count), etc. are defined documented and maintained. Storage activities must refer to identification of products and products' usability status. The main purpose is to prevent from products to mix up, contaminate or any other adverse effects that may harm the products. When defining the requirements, the organization shall define and indicate special areas, identification of products, condition required for every product (condition that would ensure product's preservation), and expiry date.  
• Special reference is given to products that bear limited shelf life or require special conditions. That would be mentioned later on. Packaging – Packaging conditions must be defined and documented. The packaging parameters must compete with the product's requirements. Now, pay attention real good. This is a small paragraph but actually it’s an enormous requirement. That means that the product's container of must be designed to protect and preserve the product. The container must prevent any damage to the product. In some cases this matter shall be required for validation. Then, the organization would have to prove that the container does not harm the product.  When defining packaging activities, a reference for transporting would be given. Packaging requirements must be referred and maintained with consideration to transporting – how shall the organization or the transporter handle the packed medical devices.  Of course, the methods should be defined and documented. 
• Transportation - Transportation conditions must be defined and documented. Transportation shall be performed in order to maintain the characteristics and the quality of the products. Parameters such as air, sea, ground, environmentally defined and controlled.  Transportation includes internal transportation inside the organization and outside the organization. Both shall be referred.  Packaging requirements must be referred and maintained while transporting. Transportation shall be conducted by authorized employees only. 
• Security and protection – Security and protection conditions must be defined and documented. Parameters such as controlled access to products and security measures shall be covered. The security parameters would needed to be referred during definition of storage, packaging and transportation requirements.

Second requirement refers to medical devices that have a lifetime limit.  In other words: expiry date – product that their use or quality deteriorates over time. This requirement refers not only to products that the organization produces and realizes but also to purchased goods stored in the organization facilities (that has a lifetime limit). The organization must define, establish and document procedure describing the preservation activities required for this kind of products. This requirement demands that these products would be indicated and be treated with different (documented) measures. The procedure shall ensure that the organization would identify these products, evaluate their usability according to defined time limits and when the date expired, the product would be disqualified for use or distribution (non conforming product).

Turn to the next "thriling" article about the ISO 13485 Standard control of monitoring and measuring devices requirements