ISO13485
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Quality Control Manager for a UK reuseable and sterile single use medical device manufacturer.
Responsible for:
Quality Assurance and Quality Control of clean room manufacture of sterile single use renal dialysis kits and endotracheal tubes and red rubber endotracheal and endobronchial tubes and a wide range of catheters and related products.
Regulatory Affairs responsibility registering with the FDA all LMI products and the heart lung set manufactured by our subsidiary Cimid on the south coast of the UK.
An early succesful FDA GMP inspection of a subsidiary manufacturing heart-lung sets.
Implementing a Quality Management System to the then recent requirements of the UK Department of Health.
Representing the company on the BSI Anaesthesiology Products committed and then representing the UK BSI committee at the ISO TC committee.
Coordinating Medical and Legal support in response to significant medical device complaints.
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ISO 9001
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Contract Employment with the UK branch of a major international institute of Quality Management.
Implementing ISO 9002 and then Total Quality Management with 17 establisments throughout Scotland and Northern England.
Taking them from awareness training, through system design, implementation, audit and management review to successful certification.
Further steps then introduct Business Process Design and 5 Tools for Quality.
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ISO17025
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A Plant and Water Treatment laboratory of a major chemicals complex in Scotland required ISO 17025 accreditation.
The project contract achieved this successfully within time and budget and entailed:
A GAP analysis and report;
Assistance in delivering the measurement uncertainties with a validated management system for the uncertainties.
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ISO13485
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A Medical Device Manufacturing Company needed audit and certification assistance prior to seeking to obtain a CE mark for a class 2A device using rule ( of the Medical Device Directive. An audit training awareness exercise was conducted and the company successfully obtained their ISO 13485 certification.
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ISO17025
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A major renewables testing facility up and recruited a General Manager full time and a Quality Manager and H&S and Environment Specialists to design an Integrated Management System.
As Quality Manager I was responsible for designing those parts to do with the testing of renewables conversion systems. We gained accrediation to ISO 17025 for for the first class of systems in 2005 and for the other class of conversion systems in 2008.
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PS9000 Pharmaceutical standard
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The pre-qualification of five Bio-pharmaceutical establishments across the UK, Beligium and the US for a large Bio-pharmaceutical manufacturer against PS 9000 for excipients provided invaluable experience and understanding of this application of Good Manufacturing Practice to a specific sector of Bio Pharmaceutical manufacturing.
The sites included a contract research laboratory, a temperature controlled specialist courier company, a repackaging company, manufacturer of water for injection and an aseptic filling company.
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