Takumi Precision Engineering, with consultancy support and guidance from Almir Business Ltd, has successfully achieved certification to the Medical Devices Quality Management Standard, ISO 13485 and the Aerospace Standard, AS9100 Certification to both these standards enables Takumi Precision Engineering to expand into the overseas aerospace and medical markets. Takumi is now the only company in Ireland to hold both AS9100 and ISO13485 standards.
The Tánaiste and Enterprise Minister Mary Coughlan T.D. officially awarded on Wednesday, July 29, 2009 two international standards to a Limerick sub-contract precision engineering company enabling it to expand into the overseas aerospace and medical markets.
[intlink type=”p” slug=”medical-devices-iso-13485″ text=”ISO 13485″] is the international gold standard for companies involved in the manufacture of medical devices. Recognised throughout the world, ISO 13485 certification is evidence of a company’s commitment to its customers through the high quality of its products and services. It demonstrates the existence of a highly effective quality management system which meets international regulatory, safety and quality concerns specific to the medical device industry.
[intlink type=”p” slug=”aerospace-as9100″ text=”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.”
According to Mr Reynolds: “Takumi management are confident that the acquisition of these standards will enable Takumi to seek out work internationally. 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.”
This article was prepared by Des Butler of Almir Business Ltd. for any further information please [intlink type=”p” slug=”contact-management-consultancy-company” text=”Contact Us“]