The organization shall define the requirements related to the product. While defining the requirements, the organization shall refer to the next issues:

The organization is required to determine the requirements of the product. The requirements here are the ones defined in the contract with customer or based on a marketing survey.  You may realize the product through different ways or methods, but you are required to define how. It may be that the requirements for the product would be delivered by the customer or that the organization would determine them. It may also be a joint venture.

The organization is required understanding the customers' requirements. Therefore it must obtain a method for understanding our customers' requirements. The definition of the product and its requirements shall be determined according to the intended use of the product. Sometimes the ISO standard enjoys stating the obvious… Another reference shall be to the critical processes of the product's realization process. In other words, when defining the requirements, do not mention your employees' noon break or your annual social gathering as a product's requirement.

Next reference shall be to regulatory requirements. Defining products requirements are a critical stage regarding the regulatory requirements. During definition of your product the 13485, as well as the 9001 (on this matter) requires:

• Determining the required regulatory requirements
• Mentioning the regulatory requirements throughout the product's requirements and defining them as inputs to relevant processes
• Ensuring that the regulatory requirements are available throughout the organization. Availability does not measured only by physical presence but also the employees are required to know the regulatory requirements and their influence and affect on the product and the product's realization.
• Maintaining a method for identifying any changes in the regulatory requirements or identifying new regulatory requirements (relevant to the product, off course) and implementing these changes and amendments throughout the realization processes.
• Maintaining evidences for conforming to the regulatory requirements, when these records are required.

The organization shall define a method (it is not required to document the method) to communicate with the customer; receiving requirements, reviewing them and delivering an answer.  The process of review of customers' requirements includes:

• Accepting a request for an offer from the customer
• Reviewing  the customer's needs
• Delivering an offer according the request
• Accepting approval for the same offer or accepting an order based on that offer.

These definitions would allow you more control over the product and the product realization and would ensure that all requirements are defined. Requirements are the customers' expectation of the product.