ISO 13485 Certification in the Staffing Industry

463291219Those in the medical device manufacturing field are very familiar with the importance of ISO 13485 certification. Here’s how it can provide value to those in the staffing world.

ISO 13485 applies to organizations that design, develop, produce, install and service medical devices as well as those that provide related services. Certification is typically only attained by the healthcare product manufacturers themselves.  Till date, Operon, is the only known staffing firm in the country to attain this certification.  The certification, officially titled ISO 13485:2003Quality Management Systems Standard for Medical Devices Manufacturers and Related Services, was awarded by BSI Inc., a global independent business conformity assessment organization.

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The process of attaining this kind of certification for any business is challenging because of the work required to establish a compliant quality management system. And it was especially difficult in this case to find a business conformity assessment organization open to recognizing a staffing firm as a related supplier to the medical device industry. We had to prove that it offered a value proposition that reached a significant threshold for preparing workers for the manufacturing floor.

The key motive for a staffing organization to obtain the certification is to guarantee medical device and healthcare product manufacturing clients that their temporary workforce is screened and trained in compliance with the stringent quality requirements established by the ISO 13485 Standard.

By obtaining this certification, staffing firms like Operonare able to mitigate a customer’s risk of compliance. For manufacturers, ISO 13485 certification provides proof to customers and consumers that an organization is providing safe and effective medical devices.  In order to ensure the safety and efficacy of products, an increased emphasis has been placed on requiring the same level of quality management systems and practices in those companies that supply parts and services to medical device manufacturers.  Many ISO certified companies now require all suppliers to hold the same level of certifications that they do. As a key input into the manufacturing process, companies are now looking for a staffing partner that can ensure their production workforce is fully compliant with the standard.

Quality is key when providing staffing for healthcare product manufacturers—ensuring a quality management system, training quality workers and helping clients manufacture high quality products.Having an ISO 13485 certified staffing firm ensures quality on all fronts.

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Whitney Andrews

Whitney Andrews
Whitney Andrews is a quality manager at Operon Resource Management.

Whitney Andrews

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