This module focuses on the Quality Management Systems used in the Healthcare Sector.
Good Laboratory Practice:
Applying Good Laboratory Practice. The Quality Assurance Unit. Standard Operating ProceduresAccreditation of Laboratory facility.
Good Manufacturing Practice:
Definition of manufacturing process. Provision of necessary facilities e.g. suitable equipment and services. Writing of procedures. Training. Documentation e.g. records of manufacture. Recall system.
Quality Systems:
ISO 9000 series of standards. ILAB requirements. Gaining Accreditation. Setting up a quality system. Auditing the system. Certification Registration. TQM. ISO 11134. ISO11135. ISO11136. ISO 11607, ISO 13683, ISO14160.
Process Validation:
Design qualification. Installation Qualification. Performance qualification. Documentation hierarchy. Writing procedures.
Appropriate Standards:
Department of Health guidelines/regulations. European directives. FDA guidelines. ISO standards. ILAB requirements. NSAI standards.
Audit requirements:
Preparing for the audit. Error or defect investigation and follow up. Internal and external auditing. Towards a TQM standard for self assessment.
Tailored case studies:
Quality improvement tools. HACCP analysis. TQM implementation. HIQA audits
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |