James QA - Quality Management Consultancy

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.

• Quality Management System Development (ISO 9001, ISO 17025, ISO 15189 and GCLP)

• Auditing (creation of audit calendars, audit checklists and documentation 

• Risk management systems,

• Conducting audits of facilities, processes, studies, SOPs, protocols and reports, both onsite and remotely

• Assistance with setting up laboratories and facilities to GCLP, 17025 and 15189 standards Documentation development and review (ISO 9001, ISO 17025, ISO 15189 and GCLP)

• Gap Analysis

• Vendor audits/quality assessments

• Assessment Preparation

• Q-Pulse configuration and implementation Equipment validation

• Data Integrity mapping

• ISO 13485 and IVDR