James QA

With over twelve years' experience in setting up, implementing and maintaining ISO 9001 Good Clinical Laboratory Practice, ISO 17025 and ISO 15189 Quality Management Systems James QA can cover all aspects of Laboratory Quality Management.Extensive experience from start-up implementation through to refinement of established procedures.Services include:Quality Management System Development (ISO 9001, ISO 17025, ISO 15189 and GCLP)Auditing (creation of audit calendars, audit checklists and documentation, risk assessments, conducting audits of facilities, processes, studies, SOPs, protocols and reports) conducted both onsite and remotelyAssistance with setting up laboratories and facilities to GCLP, 17025 and 15189 standardsDocumentation development and review (ISO 9001, ISO 17025, ISO 15189 and GCLP)Gap AnalysisVendor audits/quality assessmentsAssessment PreparationQ-Pulse configuration and implementationEquipment validationData Integrity mappingWhether you are looking for a one-off audit or continued support to ensure compliance to your chosen standard then James QA can help.