Explained: Planning of product realization in ISO 13485 Part 2

Product realization iso 13485

In the ISO 13485:2016 standard is written what should be included in the planning of product realization in the chapter under this title. The previous article described some of the requirements that are stated in the subclause of standard, such as Processes that are needed for product realization, quality plan, quality objectives, etc.

Here you can find out more about verification, validation, labeling, identifying products, traceability, customer requirements, and records. These are the elements that one medical device company needs to provide as evidence that the realization processes and resulting medical products meet requirements.

Production requirements and resources

The organization shall define the required production resources related to product realization:

  • Required production means – molds, tools, safety equipment
  • Necessary work environment
  • Raw material
  • Storage requirements
  • Human resources
  • Required machinery
  • Production parameters
  • Work instructions

Verification of Product

Verification is a process that proves that product requirement is completed. Those processes can be done through quality tests, calculations, review of the process outputs and records. Also, they are described in the quality plan. In case, it’s not included certain verification, then it refers to related specifications and documentation.

Of course, the whole approach needs to be according to standard.

Validation of Product

As verification proves that certain activities were done, validation supposed to prove that the right product has been validated. Validation can be seen as approval of the requirements for a specific intended use or application that has been fulfilled. Each medical device company has to describe the activities that would evaluate the compatibility of the product and what are the acceptance criteria.

Labeling and Identifying Products

The labeling and identifying requirements for products throughout the realization processes should be defined in the quality plan. The organization with the plan will specify the following:

  • The responsibilities for the labeling activities
  • The data and information to be placed on the labels
  • A reference to the suitable forms and records
  • The parts or components that are to be labeled
  • The stages of the production in which the products are to be labeled

Traceability

The ISO 13485:2016 standard also requires defining a method for handling traceability through the realization process and maintaining documented procedures. Such a quality plan should be made to follow the traceability requirements. Further, it should relate to the status management of material, components, finished goods, and parts. Specific requirements can be found in standard in subclause of Traceability.

Customer requirements

The customer requirements with their functional, technical, and performance specifications should be taken into account when planning product realization. The reference to customer requirements may influence many aspects of the plan, such as additional verifications or validations, labeling, or identification requirements. The medical device company must document all the customer specification requirements. Also, a quality plan is required according to the specific requirements personalized to customer feedback.

Records

The medical device company will determine the records and needed evidence as proof for the compatibility of the product to its specifications as part of the planning and realization of a product. For each activity during the realization of a product must create evidence that:

  • The results of the process meet their predefined requirements
  • The activity was conducted on the appropriate stage and sequence and by the appropriate responsibility

The quality plan will specify or mention to the suitable instructions concerning which documents are expected and where the records are stored. The organizations should refer to the subclause Control of records and standard requires that records should be part of the quality management system and be submitted to the records control process.

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