ISO 13485 and AS9100

Case Study:  Takumi Precision Engineering – Medical Devices Quality Management Standard, ISO 13485 & the Aerospace Standard, AS9100

The industry standard

The Aerospace Standard AS9100 includes ISO 9001 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry. AS9100 is recognised by all major Aerospace OEMs.

The aircraft and aerospace industries have recognised AS9100 as a means for continually improving quality and on-time delivery within their supply chain. Most of the major aircraft engine manufacturers, such as General Electric”s Aircraft Engine division (GEAE), Boeing, Rolls-Royce Allison and Pratt & Whitney, are requiring their suppliers to be certified to AS9100.

Gerry Reynolds, company co-founder and Managing Director, Takumi Precision Engineering, commented, “In order to develop our capabilities and to offer a higher level of service to the medical device sector, Takumi has implemented the medical device quality manufacturing standard, ISO13485”.

He continued: “This is a very exacting quality standard in terms of traceability, workmanship and staff training. Considerable preparatory work was required in terms of ensuring that Takumi’s internal procedures complied with this standard.

The most important factor was increased awareness of the requirements of this standard from the least experienced operators through to management and directors.”

“Takumi management are confident that the acquisition of these standards will enable Takumi to seek out work internationally.”

Gerry Reynolds, Managing Director

The aerospace and medical sectors have been identified by management as growth areas that are not as exposed to the global downturn as other manufacturing areas. We can provide solutions from component manufacture, through to supply chain management, taking care of all validation and regulatory requirements. With Takumi, as the manufacturing partner, our customers leave supply chain issues with us and can focus on growing their market share.”

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