ISO 13485 Clause 7: Product Realization

ISO 13485:2016 Clause 7 Product Realization has 6 Subclauses, these are:

  • 7.1 Planning of Product Realization
  • 7.2 Customer Related Processes
  • 7.3 Design and Development
  • 7.4 Purchasing
  • 7.5 Production and Service Provision
  • 7.6 Control of Monitoring and Measuring Equipment

7.1 Planning of Product Realization

Production Realization is what the product will be. The organization needs to clearly develop a plan to create a process for product realization. When your organization is developing a plan for product realization, the organization is responsible to be consistent with the QMS. The organization is responsible for documenting the process, and documents of risk management need to be maintained as well.

7.2 Customer- related processes

The requirements of ISO 13485:2016 require organizations to meet customer’s needs, whether they have been specified by customers, or are necessary for intended use, necessary training for use of product or application, and any additional requirements deemed necessary by the organization.

7.3 Design and Development

The organization is required to document all processes for design and development. The organization is required to control all design and development processes for their products, and with the design and development all steps must be well documented. The organization must also maintain a design and development file for each medical device type or medical device family.

7.4 Purchasing

Purchasing process needs to be controlled and meet the needs of ISO 13485. When purchasing products, organizations need to verify that the supplier are able to provide products to meet the needs of the organization and comply with all ISO regulations, along with any other requirements.

Organizations need to keep detailed information on the products they purchase, and verification of anything they purchased, and when they received the material.

7.5 Production and Service Provision

13485:2016 must be in charge of several factors including:

  • Control of production and service provision
  • The cleanliness of all products
  • Installation activities
  • Servicing activities
  • Specific requirements for sterile devices
  • Verifying processes for production and service provision
  • Appropriate requirements for verification of processes for sterilization and sterile barrier systems
  • Identification
  • Traceability
  • Customer property
  • Preservation of product

7.6 Control of monitoring and measuring equipment

The organization is required to not only monitor and measure their products, but also to determine the appropriate equipment that they need to adequately and accurately monitor and measure. As an organization you need to make sure that the equipment is maintained and calibrated correctly.


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