ISO 13485 Medical Devices
Case Study: Homecare Medical Supplies
Ballyhaunis-based Homecare Medical Supplies, one of Ireland’s leading distributors of medical equipment and daily consumables, has had its Quality Management System achieve ISO 13485 certification.
Internationally recognized standard
An internationally recognized standard for medical device companies, Homecare’s ISO 13485 certification is applicable specifically to the sales and distribution of medical equipment and consumables, including the decontamination and service of medical equipment.
Established in 1988 by Peter, Mary and Noel McGuinness, Homecare Medical Supplies is a fully Irish-owned company employing 70 employees in Co Mayo.
The company distributes both own-brand (private label) and supplier branded products to nursing homes, the retail sector, HSE, General Practitioners and pharmacies throughout Ireland. It also services and decontaminates medical equipment for nursing homes and the HSE.
“Critical to growing and developing our business”
In January 2010 Homecare Medical Supplies made the decision to pursue certification to ISO 13485. This was achieved in November 2010 following a detailed process review by INTERTEK, the industry leader in quality and safety auditing.
The certification process was coordinated internally by Andrew Llewellyn, Homecare’s Operations Manager under the auspices of Desmond Butler of Almir Business Consultants.
“We are pleased to receive the ISO13485 certification which is critical to growing and developing our business”.
John Doyle, General Manager
Strong third party external accreditation
General Manager John Doyle continues: “This standard is vital to our business as it enables us to CE mark our own products and continue our efforts in developing our own branded medical consumables and equipment. It also provides strong third party external accreditation to our service and decontamination processes.
“ISO 13485 demonstrates our ongoing commitment to providing the highest level of product quality and excellent service to our customers”.
A progressive company Homecare Medical Supplies is actively sourcing new and innovative product lines for distribution at competitive prices under its’ own brand name to customers throughout Ireland.
The international gold standard
ISO 13485 is the international “gold standard” for companies involved in the manufacture and distribution of own brand Almir Business Client Homecare Medical achieves ISO certification 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.
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