Founded Hallmark in June 1989. An established and professional consultant operating in a number of management consultancy and training disciplines:Regulatory (CE Marking):93/42/EEC & ISO13485:2003 (Medical Devices Directive)97/23/EEC (Pressure Equipment Directive)94/9/EC (Atex – Explosive Atmospheres Directive)Quality Assurance:ISO13485:2003 (medical devices QMS), ISO9001:2008, TQM, Statistical Process Control (SPC), also Internal Audit & QA training, including specific training for QA Managers.Phil is also IRCA Lead Auditor certificated to ISO13485, ISO9001, ISO14001 and OHSAS18001.Manufacturing:Production planning, inventory control, operations efficiency and process improvementStrategy:Strategy Formation/Formulation, Change Management, Vision/Mission/Goal setting, business health-checks and business rescue plansManagement Training and Development:Leadership, facilitation and communication skills, team work, problem solving, process analysis & mapping, decision making, customer service teams/complaints management, thinking skills development (application of ‘Effective Intelligence’ thinking tools)Phil is also a registered consultant with the DTi Manufacturing Advisory Service.Specialities: Since 1995 Phil has been at the forefront of CE Marking of Medical Devices, including Article 12 compliance for Sterile Services. He has a 100% track record in getting medical companies through ISO13485:2003 certification and the Medical Devices Directive regulations 100% first time, guaranteed.For the last 6 years Phil has been involved with the healthcare sector working at a strategic level with hospital top management and the 'shop floor' with strategy and process improvement.
Listed skills include Quality Assurance, Quality System, Change Management, Strategy, and 46 others.