Since the initial contact with the company in January 1999 we have use the services of B.S. Partnership to attain first ISO 9002, and later ISO 9001:2000 accreditation. The company structured our Quality Management System (QMS) in such a way that it has become a natural part of our business routines. B.S. Partnership is now assisting our company in implementing ISO 9001:2000 and ISO 13485 standards at our new production facility in Sweden.-Biotech-IgG

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Vigilance and Product Recall

New Guidance for Manufacturer's and European Representatives of Medical Device and In-Vitro Diagnostic Medical Devices

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ISO 9001:2008

Changes required for the New Quality Standard

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Life Assays Receives ISO 9001:2008 Certification

Swedish CRP Disgnostic Test Manufacturer Awarded ISO 9001:2008 Certification

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Flow Cytometry

Link to advice on Flow Cytometry

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Alliance Planning ISO 9001:2008 Certification

Planning Consultancy 'Alliance Planning' receive ISO 9001:2008 Certification for four Offices

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Transgenomic Inc CE Mark K-RAS IVD Kit

BS Partnership helps Transgnenomic Inc obtain the CE Mark for their Surveyor Scan K-RAS In Vitro Diagnostic Test Kit.

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Risk Management for Medical Devices and In-Vitro Diagnostic Medical Devices

Important Information for any Organisation with CE Marked Products in the Medical Device and In-Vitro Diagnostic Medical Device Industries.

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ISO 9001:2008 Updates

Changes required to move from ISO 9001:2000 to ISO 9001:2008

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