To become ISO 9001 certified a company must fulfill requirements outlined by the ISO (International Standardisation Organization). Specifically, ISO 9001 requires an organisation to demonstrate a quality management system with the ability to consistently provide product and services that meets customer
as well as statutory and regulatory requirements.

ISO 9001 certification also means the organisation has demonstrated its commitment to enhancing customer satisfaction through the application of the management system, with processes for continual improvement and the assurance of conformity to customer, statutory and regulatory requirements.
The ISO 13485 certification relates specifically to the design and manufacture of medical devices and is tailored to the industry’s quality system expectations and regulatory requirements.

Ian Morgan, General Manager of Sharp Clinical Services UK, attributes the company’s successful completion of this important certification to his employees. "Everyone at Sharp Clinical Services put in a great deal of effort and has been critical to our success in achieving certification. We are all excited about what this means for our customer relationships. ISO 9001 & 13485 certification is further evidence to them, and to new prospects, that we manufacture and supply quality products and services that meet the unique demands of the clinical supply industry," he said.