ISO 15189: 2012- Medical Laboratories
Details
ISO 15189 specifies the quality management system requirements particular to medical laboratories, stressing the importance of evidence, document control, and control of records and clinical material. ISO 15189 standards are based on the details of ISO/IEC
17025:1999 General requirements for the competence of testing and calibration laboratories. ISO 15189 advises the users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing
is to be provided in a medical emergency and the lab's role in the education and training of health care staff.
- Organization and management responsibilities
- Quality management system
- Document control
- Service agreements
- Corrective and preventive action
- Continual improvement
- Control of records
TECHNICAL REQUIREMENT
- Personnel
- Accommodation and environmental conditions
- Chemical equipment
- Pre and Post Examination process
- Reporting of results
- Release of results
- Laboratory information management
WHY WE NEED MEDICAL LABORATORIES?
- Recognition of testing competence
- Marketing advantage
- Benchmark for performance
- International recognition
Integrated Management Consultancy (IMC) is one of the leading process management and improvement consultants in UAE and India.IMC consultants are experienced to help the process owners to identify, analyze and improve existing process of an organization to achieve the organization’s objectives.
We provide accredited ISO 9001, ISO 14001, OHSAS 18001 Certification, ISO 27001, ISO 22000, ISO 15189 Certification Services.
Our Process Improvement solutions are
- ISO Consulting and Implementation
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Our consultants are having vast experience in construction, hospitality, healthcare, steel, water, perfumes, Bank, Insurance, and Financial Institutions.
ISO Standards
- ISO 9001:2008
- ISO 14001 :2004
- ISO 18001:2007
- ISO 22000:2005
- ISO 27001:2005
- ISO 15189:2003
ISO Certification Services
- Process Study
- Gap Analysis
- Documentation
- Implementation
- Training
- Certification
