Quality Assurance

Pennine Healthcare - Quality Assurance.

Pennine Healthcare have invested significantly in a purpose-built manufacturing facility at its headquarters in Derby. The plant covers almost 100,000 sq ft, incorporating an area for storage and loading, capable of handling over 2,500 pallets. The site houses some of the most sophisticated technology in the industry, including two state-of-the-art clean rooms, operating to BS EN ISO 9001-2008 standards.

  • In 1995 the company was accredited to the ISO 9001 and EN 46001 standard.
  • Our quality system is accredited to IS0 9001:2008 and ISO 13485:2012.
  • Clean room classification BS EN ISO 14644-1 ISO Class 8.
  • United States Food and Drug Administration (FDA) approval.
  • Pennine Healthcare was one of the first companies in Europe to be given the right to CE Mark our products.
  • Pennine Healthcare sterilisation processes are re-validated annually to deliver a Sterility Assurance Level of 10-6
  • Pennine Healthcare sterile products are presented in packaging that cannot be re-used, and which has the necessary seal strengths to maintain seal integrity during sterilisation, transport and storage.


© 2024 Whelehan Surgical,
  • Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Dublin 15, D15XC64, Republic of Ireland.
  • Phone: +353 1 574 2410
  • Fax: +353 1 834 2340
  • Email: info@tpwhelehan.ie


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