Henry Sibun BSc (Tech) Hons, MSB CBiol, MCQI CQP has over 24 years' experience in the medical device industry having worked on three sides of the camp – (1) as a Quality Manager implementing the Medical Devices Directive (MDD), ISO 9001 and EN 46001/ISO 13485, (2) as a Senior Manager, Lead Notified Body Auditor & Technical Expert for the largest Notified Body – TÜV SÜD Product Service, and (3) as a Consultant & Trainer.
Henry is an IRCA registered Lead Auditor and Chartered Member of both the Royal Society of Biology and the Chartered Quality Institute.
After graduating with a 2.1 degree in Applied Biology from the UWIST in Cardiff Henry worked for the Water Board in Sydney completing a large project on microbiological beach pollution as a result of storm-water run-off. On returning to the UK he managed a small QC microbiology laboratory for a food company before moving on to a medical device manufacturer in 1993.
As the Quality Control Manager and Microbiologist, responsibilities included the implementation, the quality system to ISO 9001, EN 46001 and the Medical Devices Directive 93/42/EEC as well as the validation and control of an on-site ethylene oxide steriliser.
In 1998 Henry joined TÜV SÜD Product Service Ltd to train as a medical device auditor and progressed to become part of the Senior Management Team and Manager of the Medical & Health Services Team for the UK and Ireland. In addition to the usual business management responsibilities, Henry continued auditing companies and reviewing medical devices against the requirements of ISO 9001, ISO 13485 and the European Directives. Throughout this time he was actively involved in speaking at international conferences, conducting public training courses, and in training of other auditors world-wide within TÜV SÜD (ISO 13485, MDD, biocompatibility, risk management, clinical data, sterilisation). He was also a Technical Expert for sterilisation technologies.
In addition to running his own business Henry is still an auditor for TÜV SÜD Product Service GmbH (as a subcontractor) and holds the European Accreditation Codes for – 12 (chemistry), 13 (pharmaceuticals), 14 (rubber & plastics), 35 (services), 38 (healthcare) which are used to audit against ISO 13485/ISO 9001. For the Medical Devices Directives he holds these additional specialisms: Technical expert for sterilisation (irradiation, moist heat, dry heat, ethylene oxide, aseptic processing and novel technologies); specialist auditor for disposable devices including extracorporeal circulation, blood processing devices, infusion/transfusion, catheters, absorbable implants, solutions (including irrigation, disinfectants and haemodialysis concentrates), microbiology & chemistry activities, cleanrooms & hygiene and plastics.
In addition to the above roles, Henry's earlier work experience included working for Anglia Water as a biologist/chemist and Addenbrooke's Hospital's Public Health laboratory as a microbiologist.
Regulatory compliance can be a challenge with complex requirements constantly evolving in different markets.Read more
Quality Management Systems are the foundation of all good businesses, whether certified or not.Read more
Auditing is more than just gaining information on compliance.Read more
Making the best use of your key assets - your employees - is vital for a successful business.Read more
Sterilisation is a "special process" requiring careful validation and control to ensure the safety of devices.Read more
However good your systems, problems can always pop up unexpectedly.