ISO 15189 - 2003

Quality Management in Medical Laboratories

ISO 15189
ISO 15189 is a global initiative that aims at creating a standard measure of quality in medical laboratories. Promotes competence and responsibility in medical laboratory processes, equipments and outcomes.

ISO 15189 Cont..

Effective Quality Management System (QMS) that has strong elements of Quality Assurance, Quality Control and Quality Improvement.

ASSESSED FACTORS
Technical competence of staff Validity and appropriateness of test methods Traceability of measurements Calibrations to national standards Suitability, calibration, & maintenance of equipment Testing environment Sampling, handling & transport of test items Quality assurance of test & calibration data

The benefits of ISO 15189

An ISO 15189 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems. Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective. Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery. The certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs. Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing.

1.0 Management Requirements

1.1 Organization and Management

1. 2. 3. Policy Director Managers Responsibilities

1.2 Quality Management System

Doesnt need to be complex Factors 1. Size of the laboratory 2. Staff numbers 3. Range, volume and complexity of the work Quality manual

1.3 Document control

All documents are to be reviewed and approved by authorized personnel before use All documents must carry identifying information,

Document register or master index Changes to documents are identified. Documents are readable. Obsolete documents are retired and marked as such.

1.4 External services and supplies

Purchase of consumables or perishables Purchase of equipment

1.5 Resolution of complaints

Mechanism should be in place to cater for resolutions. Normally not more than 60 days

1.6 Identification and Control of nonconformities

Proper identification Resolution and avoid future occurrence

1.7 Corrective action

Corrective actions may be identified thru internal audits, analysis of QC data, performances in PT, incide nce of nonconforming work and external assessment,

1.8 Preventive actions

This highlights the need to identify potential problems and opportunities for improvements. (Proactive actions)

1.9 Continual Improvements

This highlights the need to identify potential problems and opportunities for improvements. (Proactive actions)