Sharp Clinical Services ISO certification
Sharp Clinical Services UK is proud to announce its recent ISO 9001 and ISO 13485 certification following
a successful audit by BSI.
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.
About Sharp Clinical Services
Sharp Clinical Services is a leading provider of specialist clinical supply services; from drug product
development and manufacturing through to increasingly complex clinical supplies labelling, packaging
and global distribution. We also offer EU QP services including audits of non-EU manufactures and QP
importation and final release.
Our experienced project management and operational teams bring together years of experience in
managing your clinical supply chain project across the globe. All activities are compliant with current
Good Manufacturing and Distribution practices and international regulatory authorities. Learn more
about Sharp Clinical Services at www.sharpservices.com
About ISO
ISO (International Organization for Standardization) is the world’s largest developer and publisher of
International Standards. ISO International Standards ensure that products and services are safe, reliable
and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and
errors and increasing productivity. They help companies to access new markets, level the playing field
for developing countries and facilitate free and fair global trade. Learn more about ISO at iso.org.
ISO certificate MD
602264.pdf