For businesses in regulated industries, choosing a manufacturing partner is about more than the finished component. It is also about having confidence that the right processes, controls and quality systems are in place throughout production.
The proof, not just the part
Being able to demonstrate how a product was made is what makes traceability matter. W&S retains quality check records and measurements from production runs, along with first-off and last-off samples, for defined periods, building a production history that can be referred back to. Batch control extends that traceability further, tracing a finished product back through the relevant machines, processes, materials and batch numbers used to make it.
That level of proof exists because it’s what our customers ultimately need. The requirements behind a regulated product are generally set by the customer, whose own obligations are shaped in turn by regulators and applicable standards. W&S’s role is to translate those requirements into manufacturing processes and controls that hold up under that scrutiny.
Where the extra work actually sits
W&S manufactures components across a wide range of applications, from medical devices and healthcare products to safety equipment, industrial parts and electrical products. While established quality processes apply across its manufacturing operations, regulated applications can bring additional requirements at every stage.
Tooling may require additional qualification before approval for use, while manufacturing processes need to be controlled and documented. Testing can also be more extensive and, for some products, repeated at defined intervals. Central to this is validation: a structured way of demonstrating that a manufacturing process can consistently produce components to predetermined requirements.
The company backs this with quality laboratories at both its Australian and Malaysian facilities, covering dimensional checks, specification conformance, capability analysis and mechanical testing. Where the manufacturing environment itself is part of the quality requirement, W&S also operates ISO Class 7 and ISO Class 8 cleanrooms.
The framework, and the people who apply it
This work sits inside a formal quality management framework. W&S’s Australian operation holds ISO 9001:2015 and ISO 13485:2016 certification; its Malaysian operation holds both of these, plus ISO 14001:2015.
ISO 13485 is what allows W&S to take on the moulding of medical components, and it underpins the company’s work in that sector. Products required to meet Australian Standards go through the same established quality process, with the specific requirements of that product built into the manufacturing and quality controls used.
The systems are supported by the people applying them every day. W&S staff are trained to understand the overarching standards that apply across the business, as well as the specific requirements of the products they manufacture. This helps ensure quality is considered throughout the manufacturing process, rather than simply as a final check.
For W&S Plastics, manufacturing to a standard is about more than the finished component. It is the combination of controlled processes, validation, traceability, and people who understand the requirements behind the product that gives customers confidence in how it has been made.
Get in touch with our team to learn more.
