Swann-Morton Limited, Services and Laboratory Quality and Environmental Accreditations

Swann-Morton Accreditations & Certificates Download

The indicated certificates are available to download in Adobe Acrobat (pdf) file format. All divisions Current Quality System Third Party Accreditations :

Swann-Morton Limited

BSI Certificate of Registration ISO 13485:2003

Certificate number FM 73368

Scope of Registration: The design and manufacture of surgical blades, disposable scalpels, handles and blade removers.

EC - Certificate

Council Directive 93/42/EEC Annex II, Section 3.2 Certificate number 00482, in respect of:

The design and manufacture of sterile and non-sterile stainless steel and carbon steel surgical blades, scalpels and skin graft blades.

Council Directive 93/42/EEC Annex V, Section 3.2

Certificate number 59550, in respect of:

Those aspects of Annex V related to securing and maintaining the sterility in the manufacture of sterile stitch cutters.

FDA: Registration Number: 9611194 Operator Number: 9003320

Product Standards BS EN 27740:1992 / ISO 7740:1985

Instruments for surgery, scalpels with detachable blades, fitting dimensions

Specification for Materials and packaging of Surgical Scalpels with detachable blades BS 2982:1992

Swann-Morton (Services) Limited

BSI Certificate of Registration ISO 13485:2003

Certificate number MD 75859

Scope: The irradiation of medical equipment and ancillary products such as surgical blades, implants and clean room clothing in accordance with EN 11137-1:2006.

FDA: Registration Number: 3008812251 Operator Number: 9003320

Swann-Morton (Microbiological Laboratory Services) Limited

BSI Certificate of Registration ISO 13485:2016 Certificate number MD 75864

Scope: The provision of a service for sub-contract microbiological analysis of medical devices, their accessories and the related work environment.

All divisions

Current Environmental Management System Third Party Accreditation's :

W.R. Swann Group

(Consisting of: Swann-Morton Limited; Swann-Morton (Services) Limited; Swann-Morton (Microbiological Laboratory Services) Limited and Jewel Blade Limited)

BSI Certificate of Registration ISO 14001:2015 Certificate number EMS633531

Scope: 'The design and manufacture of surgical, craft and industrial blades & handles. The irradiation of medical equipment and ancillary products and the microbiological analysis of medical devices, their accessories and the environment.'

Current Energy Management System Third Party Accreditation's :

W.R. Swann Group

BSI Certificate of Registration ISO 50001:2011 Certificate number ENMS633525

Scope: 'The design and manufacture of surgical, craft and industrial blades and handles, including company transportation. The irradiation of medical equipment and ancillary products and the microbiological analysis of medical devices, their accessories and the environment. Principal energy uses are electricity for heating, lighting, cooling, process equipment and compressed air; hydrogen and nitrogen for hardening and tempering; natural gas for heating; and diesel for transportation, at all locations of the W.R. Swann Group.'