Management Requirements (cont.):
1. Corrective Actions
Problems must be investigated to determine the source of error (TT LABS, 2004)1*.
2. Preventive actions
Any necessary improvements and non-conformities concerning technical or management system should be identified, followed by the development of plans and procedures to reduce chances for recurrence (TT LABS, 2004)1*.
3. Continual Improvements
All procedures must be reviewed at regular intervals to observe for traces of non-conformances (TT LABS, 2004)1*.
4. Quality and Technical records
Records should include definitions and terminology, organization scheme, internal problems etc (To The Point, 2008)3***, complemented by procedures establishment for identification, maintenance etc (TT LABS, 2004)1*.
5. Internal Audits
Various auditing task include performing root cause analysis, documentation of findings, and continuation of corrective and auditing procedures (College of American Pathologists, 2008)2**.
6. Management Review
Quality Management Systems must be periodically reviewed by the laboratory management to maintain and enhance the system (TT LABS, 2004)1*, (CAREC, 2004)****.
(117 words excluding in-text citations and references)
References:
1. Trinidad and Tobago Laboratory Accreditation Service.(2008).Summary of Requirements in ISO 15189 for Medical Laboratories.Retrieved 16th June, 2008.from
http://www.ttbs.org.tt/brochures/Brochure_ISO_15189.pdf
2. College of American Pathologists.(2008). ISO 15189:2007 Fact Sheet.Retrieved 15th June, 2008.from
http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7bactionForm.contentReference%7d=laboratory_accreditation%2Fiso%2Fiso_fact_sheet.html&_state=maximized&_pageLabel=cntvwr
3. To The Point.(2008).15189 Quality Records.Retrieved 15th June, 2008.from
http://www.iso9000plus.com/15189_quality_records.html
4. Caribbean Laboratory Accreditation Service.(2004).A Guideline Documentation for Application of ISO 15189:2003 to Medical Laboratories.Retrieved 15th June, 2008.from
http://www.carec.org/pdf/accreditation_guidelines_april_2004.pdf
Done by: Albert Chan
0604524I
TG01
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