- Experienced and well qualified trainers
- Complete Study material along with a training kit
- Free Re-training for those who have doubts or missed any sessions
- After Training Services
- Convenient Weekend batch
- Course Completion certificate
ISO 15189:2013 Medical Laboratories
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. (ISO.org)
Course Contents
• Quality and Quality Management concepts
• Commonly used quality management system standards
• Overview and requirements of ISO 15189:2013
• Design, control, and implement documents and information.
• Use corrective and preventive action processes, internal audits, management reviews for continual improvement;
• Additional requirements of ISO 15189 over CPA (2010)
• Differences between ISO 15189:2012 & 2003
• Structure of Quality System Documentation
• Identify, manage, monitor, and learn from complaints and non-conformances.
• Effectively implement the key process inputs to the critical laboratory systems of pre-analytic, analytic, post-analytic and reporting phases
Target Audience
• Laboratory Quality/Technical managers
• Laboratory Technicians/Supervisors
• Assessors of Laboratory management systems
• Personnel responsible for procurement and evaluation of Laboratory Services
• Users of clinical test services
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