How to Handle Process Validation Using the ISO 13485 Standard in the Medical Device Manufacturing Se

ISO 13485 allows organizations, specifically medical device manufacturers, to connect their quality management system (QMS) with medical device industry requirements. ISO 13485 offers significant benefits to organizations that manufacture medical equipment and related services. It ensures a commitment to quality and enhances organizational efficiencies.  

Manufacturing facilities for medical devices use industrial processes to transform raw materials into semi-finished products and finished products into semi-finished products. To show that the industrial process has generated an output that satisfies the required specifications, the results are validated by an inspection or some present quality tests. What should we do with processes whose results cannot be verified? is a pertinent question. Process validation is the answer to this issue. Therefore, clause 7.5.6 of ISO 13485:2016 requires organizations to verify those processes for which verification is not feasible.

Validation demonstrates the ability of industrial processes to consistently produce the desired outputs. Processes that are 100% product output inspected by the organization or that fully validate process outcomes using a sound statistical justification can obviate the need for validation. Organizations are required by ISO 13485:2016 to certify processes like sterilization and sterile barrier systems as well as computer software that is utilized in the manufacture or service of medical devices.

Management of process validation by ISO 13485

An organization can ensure that the procedures can consistently generate the desired outputs by undertaking validation. Organizations are helped by ISO 13485 since it requires the following:

Identify processes with unverified outputs: Identifying procedures whose outcomes cannot be confirmed is the first step for organizations to validate their processes. The company must establish a list of these ISO 13485 procedures where verification is difficult.

Document procedures for validation of processes. A procedure explaining the validation of processes should be documented by the organization, along with clear roles and responsibilities. By including a criterion that details the validation program’s evaluation and approval process, an organization can record a procedure. The equipment qualification, also known as installation qualification, verifies that the equipment is in compliance during installation and is accomplished with the aid of certified specifications from the equipment manufacturer. The initial certification of the machinery for the delivery of essential services. Personnel qualification, practical performance evaluations, and other measures ensure that the operators who are responsible for operating the equipment are well-qualified. Any personnel with ISO 13485 training online certification, can manage and fulfil this requirement.

Procedures for validating software should be documented: The organization should develop a procedure with clear roles that outlines the validation of computer software used in the creation of medical devices and associated services. Depending on the level of risk that could have an impact on the product’s capacity to satisfy the required requirements, the procedure may involve the frequency of software validation. All of the procedures must be included in the ISO 13485 documents for future reference. As well as records of the software validation results, along with the conclusion and, if necessary, follow-up activities from the validation, must be kept.

Procedures for validating sterile barrier and sterilization systems should be documented: The organization needs to create a procedure with clear roles and instructions for validating sterilization and sterile barrier systems. A sterile barrier system shields sterilized medical devices from biological agents while they are being packaged, stored, and distributed. Sterilization is the process of eliminating biological agents from medical devices. Before starting the process or making any modifications to it, both of these processes need to be validated. The ISO 11607 standard (Packaging for terminally sterilized medical devices) stipulates test procedures for components, sterile barrier systems, and packaging systems intended to keep medical equipment sterile up to the point of application.  This means that the process must also comply with ISO 11607 to provide reliable validation of sterile barrier systems. Records of validation tests (such as burst tests, dye penetration tests, gross leak detection tests, and seal strength tests) must be kept for both sterilization and sterile barrier systems.

Process validation – Regulation for medical device manufacturers

Process validation is essential for companies that produce medical devices and is regarded as a separate discipline. Process validation, identifying the processes where verification cannot be performed, procedures impacted by computer software in production, and sterilization and sterile barrier systems are all particularly mandated by ISO 13485 standard. Process validation enables businesses to eliminate risk in the creation of delicate goods and essential value-added services like software and sterilization.

Process validation enables organizations to guarantee that processes run efficiently and don’t result in poor outcomes. As a result, validated processes have trained staff, trained equipment, process parameter controls, and enhanced record-keeping procedures. Manufacturers, suppliers, and customers are given the essential assurance to maintain the business cycle by the fulfilment of ISO 13485 process validation standards.


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