In this article we will review the additional requirements for Planning of product realization (chapter 7.1) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard.
The organization is required to plan and develop processes required for the product realization. Planning the realization must compete with other quality management system requirements. When planning the product realization and determining the requirements, the organization must refer to the next issues:

Quality plan means – a list of requirements or activities that the organization would follow in order to supply the product according to the requirements (customer's or regulatory). The purpose of the quality plan is to supply with the means for implementing the quality management system throughout the product realization. The organization can design a document specifying the requirements, processes, resources, verifications and validations activities as a quality plan. The organization shall also define the resources required to maintain the quality plan such as production means, special employees, special training or qualifications, documented instructions, measuring devices, and the required documentation.

A tip: When the organization's product is realized through out designing and developing, the

The organization shall define the required processes for realizing the product according to the quality plan.

The organization shall define the control and measuring activities throughout the realization processes required to validate and verify the product and its competence to the requirements (both regulatory and customers') and the intended use. As a natural result, the organization is required to define the acceptance (or rejection) criteria for the product. The organization is required to define which evidences are to be regarded as a proof for compatibility. Say what?!? Relax, all we said is compatibility. Compatibility is the extent of how much the realized medical device achieved the predefined requirements. It is pretty much crucial with medical devices. Your organization is realizing a product with high significance. This product might require performing activities that maybe people's life would depend on. In order to ensure, beyond any doubt that the product is performing what it is expected to, you would have to prove it: validate the product. And you would have to define the activities. For example, if the organization is manufacturing a medical device that is intended to eliminate one kind of a disease (just for the example), you would have to define, and perform tests and experiments (documented, of course) to prove that this medical device, throughout all possible cases, is appropriate to its intended use.

The main additional requirement for product's realization planning is for risk management during the realization processes. Risk management is a complicated subject. The main idea is to locate specific stages during the realization processes and introduce them to any kind of control, depends on the nature of your organization. The requirements for risk analysis must be documented. It is required to define the process (but it is not required to document it as a procedure). The activities of risk management must be documented. These records are to be delivered later on (according to later requirements of the standard). The documentation must also be referred in your records control procedure where you must mention the risk management records as a quality record. For example, when an organization is developing or manufacturing medical devices, there are various risks:

• The development would fail
• Safety accidents may occur
• Environment accidents may occur
• Risks to the employees during manufacturing
• Risks of hazardous materials

The ISO 13485 Standard requires that any risk during the realization process (whether it is a developing process, manufacturing process or a service provided), would be referred and documented. What shall the organization document? Well, it really depends of the nature of the organization. It varies from one organization to another. The ISO 13485 Standard does not specify exactly what is required but it directs specifically to the 14971 for guidelines for risk management.

View the next articles about the ISO 13485 Customer Related Processes requirements