Using ISO 13485 To Manage Medical Device Process Validation!

Manufacturing processes in the medical device industry convert raw materials into usable devices. Typically, businesses have a verification method to inspect the outcome of the manufacturing process and ensure they meet the specified requirements.

Still, confusion arises when you have a process you cannot verify. It could be due to destructive testing or unverified product characteristics.

So, how should you address this concern?

The ISO 13485 audit standard might have the perfect answer for you!

Clause 7.5.6 of the standard makes it mandatory for organizations to validate the processes for which verification is challenging or impossible.

It will show the capacity of your industrial processes to attain planned results consistently.

Want to know how the validation of processes for production and service provision works?

Continue reading to find out!

Using ISO 13485 To Manage Medical Device Process Validation

You can avoid validation when your organization has performed a 100% inspection of product outputs and fully verified the results based on statistical rationale.

ISO 13485:2016 certification clarifies that companies shall validate processes where the results or output cannot undergo verification by subsequent measurement or monitoring.

As a result, product deficiencies only become apparent during usage.

Management of process validation

Performing validation on your products can help you ensure you are achieving the planned results consistently. 

The ISO 13485 audit standard encourages organizations to do the following for a proper product validation process.

1. Identify the processes where you are unable to verify the outputs. Make a list of all those processes and take appropriate validation actions.
2. Next, you shall document a procedure explaining the validation of processes, along with specific responsibilities. 

In the documented procedure, you may include:

• The criteria defining the review and approval process of the validation program,
• Equipment qualification or installation qualification demonstrating the conforming of the installation step,
• Personnel qualification refers to the qualification of the operators who will use or test the equipment,
• Testing methods and criteria for acceptance of the process,
• Sampling plan for validating testing,
• Records of all the steps and activities in the process validation cycle, such as testing, review, and approval of records,
• The criteria of revalidation requirements, such as change in machinery or process,
• The approving authority in case changes occur in the process.

3. The ISO 13485 audit standard requests organizations to document their procedures for the validation of computer software. To comply with this clause, you shall establish a procedure explaining the validation of computer software used in medical device production with defined responsibilities.

The procedure can include the frequency of software validation, records of software validation results with conclusions, and a list of actions you may take to address the validation results.

4. Lastly, the ISO 13485 audit standard has a requirement for developing a procedure describing the validation of sterilization and sterile barrier systems. You shall validate the processes before executing them or making any changes. 

Furthermore, the ISO 11607 standard provides guidance on specifications of test methods, sterile barrier systems, and packaging systems. You can refer to it to create a robust validation process for sterile barrier systems.

Final Thoughts

Following the process validation requirements of the ISO 13485 audit standard can help your organization ensure that errors in processes do not affect product outcomes. It will give your stakeholders the confidence to keep running the manufacturing and purchasing cycle.