Iso 13485

CHAPTER VII: Product Realization

An organization must establish the essential processes for product realization such as a risk management system.
Planning of these processes must be consistent with the organization’s requirements for a quality management system.
The organization must determine a list of requirements including requirements mentioned by the customer, applicable legal and regulatory requirements, and necessary organization requirements.
After determining the requirements list, this list must be reviewed by the organization prior to commitment to avoid communication failure with the customer.
This review, the requirements list and other essential documents must be documented accordingly and revised as necessary.
It is the task of the organization to establish and preserve good communication with its clients at the same time preserving regulatory and necessary documents.

Design and Development
It is important for the organization to preserve all documents that is essential for the product design and development. Part of these documents are the stages, their reviews, verifications, methods and resources utilized.
There are necessary inputs that have to be considered by an organization for product design and development such as functional performance, usage, outputs of risk management, and data from previous similar designs.
The organization’s design and development outputs must include accomplishing the input requirements, securing appropriate information, and specifying the product features to the client.
It is important that after a few stages, a review is executed. This is to evaluate the results and the performance of the final product.

After the design and development, the organization must perform design and development verification next.
This is to assure their clients that the specified requirements have been accomplished.
Next to verification is the product’s validation. This is to evaluate if the product satisfies the specified requirements and its intended use.
This activity will be performed on a representative product that best represents the final product. Part of this activity is the necessary clinical and performance evaluations.
The transfer of the design and development outputs must be documented accordingly to ensure that these outputs are suitable and ready for production.
If changes occur in the design and development, the organization must have control over these changes. These changes must be reviewed, verified, validated, and approved.
It is very important for the organization to preserve a design and development file for each medical device.

Purchasing
When purchasing a product, the organization must have a criterion in selecting an appropriate supplier. This criterion should be based on the supplier’s ability and performance.
Purchasing information is necessary and includes product features, quality management system, and product requirements.
The organization must establish the inspection of the purchased products to ensure their compliance with the purchasing requirements.

Production and Service Provision

This activity is essential as it ensures that a product conforms to the specifications promised. The organization must preserve the documents necessary for this activity. Part of this activity is cleaning the product, assuring customers it is sterile and safe to use.
The organization must conduct validation processes to avoid deficiencies when the service or product is delivered to the user.
These processes must be documented and must include important information such as the defined criteria for review, equipment, and methods. The changes employed during these validation processes must be part of the documentation, too.
There are certain requirements for products that need to be extra sterile and safe upon use. These requirements must be noted and part of the organization’s documentation too.
The organization must determine product status requirements throughout product realization.
The product’s status must be preserved throughout the entire process. If possible, each product must have a unique identity.

Traceability
This refers to the ability of a product to be traced either back to its original manufacturer or to the customer. The traceability records must at least include records of components, materials, and environment conditions.
It is the responsibility of the organization to protect customer property if property was utilized by the organization.
The product at all times must conform to the requirements and must be properly documented.

Control of monitoring and measuring equipment
Measuring equipment must conform to the requirements stated in this regulation. The organization must offer documents as evidence to support this conformity.
To ensure valid results, these equipment must be calibrated beforehand, adjusted as necessary, and be protected from all external damage during handling, maintenance, and storage.
The procedures for these validations, adjustments, and protection must be preserved and properly documented.