IQ OQ PQ qualification of your injection moulding processes
Do you need IQ OQ PQ qualification of your injection moulding process before series production of a medical device?
Cemiplast carries out injection process qualification and plastic part validation in Switzerland. This step is required for medical devices under ISO 13485.
IQ OQ PQ qualification: a step built into product development
Process validation is one of the key steps handled by Cemiplast, after the production of injection-moulded parts and assembly. It demonstrates that the manufacturing process repeatably produces a part that meets specifications.
IQ OQ PQ qualification in the cleanroom: stricter requirements
For parts produced in an ISO 7 cleanroom, process qualification falls within the broader scope of Cemiplast’s ISO 13485 certification, which covers both processes and products.
First, installation qualification (IQ) checks that the equipment is installed according to the supplier’s specifications. Next, operational qualification (OQ) checks that the equipment works as intended across its parameter range. Finally, performance qualification (PQ) demonstrates that the process repeatably produces a compliant part under real production conditions.
IQ OQ PQ qualification: how we work with you
They trust us
Medical device manufacturers entrust Cemiplast with qualifying their injection processes before series production.
Frequently asked questions about IQ OQ PQ qualification
Cemiplast carries out process qualification and validation of medical plastic parts, within the scope of its ISO 13485 certification.
Process qualification demonstrates that the process repeatably produces a part that meets specifications. It therefore limits the risk of non-conformity in series production.
Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ): the three steps in validating a manufacturing process.
Yes. At Cemiplast, process qualification also applies to parts produced in the ISO 7 cleanroom, within the scope of ISO 13485 certification.
It takes place after the production of injection-moulded parts and their assembly, before series production.