Swann-Morton 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 Accreditation's :

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 manufacture related to securing and maintaining the sterility of 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, incontinence pads, clean room clothing, drainage tanks and containers in accordance with EN 552.

Swann-Morton (Microbiological Laboratory Services) Limited

BSI Certificate of Registration ISO 13485:2003
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 :

Swann-Morton Group

(Consisting of: Swann-Morton Limited; Swann-Morton (Services) Limited & Swann-Morton (Microbiological Laboratory Services) Limited

SGS Certificate of Registration ISO 14001:2004)
Certificate number GB03/58532

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.'