How to use ISO 13485 for Process Validation in the Medical Device Industry?

If you are into medical device manufacturing industry, you should know how to use ISO 13485 standard to deal with process validation. This article is going to give a detailed account of this utility of ISO 13485.

A medical device goes through two stages during the manufacturing process- the semi-finished goods stage and finished goods stage. In the semi-finished stage, all the raw materials are turned into the semi-finished materials followed by process of making the semi-finished goods out of these materials. In the finished goods stage, the semi-finished goods are turned into the finished goods. The outcomes of these industrial processes are investigated by an inspector or a group of inspectors. The inspection team conducts certain predefined quality tests to ensure that the process has generated the desired in-process or final output. This output must meet the specific requirements. Here pops up a question-what should a medical device manufacturing business do with the processes output of which cannot be investigated due to some valid reasons, such as-

• Destructive Testing
• Unverified product characteristics
• Costly investigation process

How should an organization overcome these barriers? A simple solution to address all of these issues is process validation. ISO 13485:2016 has made it mandatory for the organizations to validate the processes, which cannot be verified. This article is going to discuss how an organization should use ISO 13485 certification for the manufacturing process.

How to Manage the Process Validation using ISO 13485?

Validation demonstrates the capability of industrial processes to gain the desired outcomes consistently. An organization can avoid process validation by performing 100% audit of the product outputs. Even the organization can verify the outcomes of processes based on the rationale of the valid statistics. As per ISO 13485 guidelines, companies are required to validate computer software used in the manufacturing process of medical devices, sterilization, and sterile barrier systems.

You can follow the steps given below to manage the process validation with the help of ISO 13485:

Identify which processes generate unverified outputs

First, an organization should identify the processes, which they can never verify or examine and make a list of such processes.

Document the validation processes

This second step is a lengthy one. The organization should document a procedure to describe the validation as well as the responsibilities. Like the documentation of ISO 9001 Quality Management System, ISO 13485 should include:

• Requirements that define the review and approval process of the validation program
• Equipment qualification as well as installation qualification that shows that the device is conforming in the initial stage
• Personnel qualification that refers to the operators who are going to operate the device
• Use of the testing methods and requirements for the acceptance of the process, for instance, on a heat sealing machine for a finished package, seals strength can be turned into a testing method, etc.
• Identification of a sampling plan required for the validation process. It must contain requirements such as sample size and acceptance requirements
• Records for all activities that have happened in the process validation cycle
• Mention of the requirements from which necessity of revalidation has emerged
• If the validation process is going to be changed, it is important to define the approving authority for the changes

Document the procedures of computer software validation

The organization should create a process that can explain the validation of the computer software used in the manufacturing of the medical devices and the relevant services. Apart from these, the responsibilities should also be defined.

Document sterilization processes and sterile barrier systems

The organization should create a procedure that defines the validation of sterilization and sterile barrier systems, along with defined responsibilities.

Process validation assumes great importance in the medical device manufacturing industry. As per the ISO experts, this process validation is a stand-alone discipline. Guidelines set out for ISO 13485 certification have specified certain requirements for the process validation to identify the processes where verification cannot be executed. Process validation enables an organization to eliminate the uncertainties involved in the manufacturing process of sensitive medical devices and for the critical value-added services.

Process validation ensures that the processes operated by an organization are run effectively, and they do not generate any faulty outputs. Hence, the validated processes require qualified personnel and equipment, process parameter controls, and optional record-keeping protocols. Whenever an organization meets all the requirements of ISO 13485 standard, it gains the confidence in keeping the business cycle running all the time.