ISO 15189:2003, Medical Laboratories – Particular requirements for quality and competence is an international standard specific for medical (clinical) laboratories that accredits their competence in technical operations and service and staff quality management1. It has two categories - Management and Technical Requirements1 – which contain 23 quality system elements2 that allow the laboratories to produce credible results3 and improve their quality management systems4. It also enables them to ‘organize their operational procedures efficiently, meet the expectations of their clients and improve their service’1.
Management requirements: generic requirements for quality management systems1.
Technical requirements: specific requirements for activities carried out by clinical laboratories1.
(100 words)
References
1 Périgo, D. M., & Rabelo, R. (2004). ISO-3: The New ISO 15189:2003 as a Quality Management Standard. Retrieved June 15, 2008 from http://www.westgard.com/iso3.htm
2 Cooper, G. (n.d.). ISO 15189 Quality System Elements. In
Preparations and Considerations When Seeking Laboratory Accreditation Under ISO 15189. Retrieved June 15, 2008 from http://www.sacb.org.sg/documents/PreparinglabforISO15189-GCooper.pdf
3 Colby Group International, Inc. (2003). Lab Accreditation Support. Retrieved June 15, 2008 from
http://www.colbygroup.com/en/iso.html
4 International Organization for Standardization. (2003). New ISO standard promotes quality and competence of medical laboratories. Retrieved June 15, 2008 from http://www.iso.org/iso/pressrelease.htm?refid=Ref857
Done By: Nor Liyana (0607927A) TG02
Management requirements
1. Organization and Management
· States identity1 of laboratory
· Describes personnel responsibilities2
· Organization structure2
· Ensures no financial or political1 issues would affect testing
2. Quality Management System
· Implementation of quality policy1
· Documentation and update of policies and protocols through a quality manual1
· Educating personnel regarding quality management to meet objectives2
3. Document Control
· Approved1 documentation
· Constant1 updating of documents
· Reviewed often1
4. Review of Contracts
· Regular review of personnel’s skills to meet customer’s needs2
5. Examination by Referral Laboratories
· Monitored for accreditation and through proficiency testing1
· Evaluation of results by other labs2
6. External Services and Supply
· Evaluate quality of purchased products2
(95 words)
References
1. Cooper, G. (2004). Preparing Your Laboratory to Certify or Accredit Under ISO 15189. Retrieved June 13, 2008 from,
http://www.sacb.org.sg/documents/PreparinglabforISO15189-GCooper.pdf
2. Périgo, D. M., R.Ph. and Rabelo M.D., Ph.D. (2008). ISO-3: The New ISO 15189:2003 as a Quality Management Standard. www.westgard.com. Retrieved June 13, 2008 from,
http://www.westgard.com/iso3.htm
Done By: Nur Azeimah (0607060A) TG 02
7. Advisory services
· Advice and assistance1 given on selection of examinations and services.2
· Meetings conducted regularly.2
· Eg. Advice on specimen collection
8. Resolutions of complaints
· Steps managing complaints and investigation records in place.1
· Measures rectifying complaints: taken and documented.1
· Eg. Supplier’s complaints
9. Identification and control of nonconformities
· Measures taken to rectify diversions.1
· Diversions investigated, recorded, evaluated by personnel.2
· Eg. QC results1
10. Corrective action
· Implemented to eliminate recurrence following investigation.1
· Results reviewed for effectiveness.1
· Audits done when deviations.3
11. Preventive action
· Reduce probability of non-conformance.3
· Can implement improvement3
· Eg QC data reviewed regularly4
12. Continual Improvement
· Improve process by reviewing regularly.2
· Identify opportunities for improvement.1
(100 words)-Not inclusive of numberings and bullets
References
1. Périgo, D. M., R.Ph. and Rabelo M.D., Ph.D. (2008). ISO-3: The New ISO 15189:2003 as a Quality Management Standard. www.westgard.com. Retrieved June 13, 2008 from
http://www.westgard.com/iso3.htm
2. Charles-Diamond, Keisha (2007). Brochure ISO 15189. Trinidad and Tobagao Laboratory and Accreditation Service, Retrieved June 13, 2008, from
http://www.ttbs.org.tt/brochures/Brochure_ISO_15189.pdf
3. Chris (2005). Amendments to 15189: Annex D (Normative) – Point-of-Care Testing (POCT). Retrieved June 13, 2008, from
http://www.cdhb.govt.nz/ch_labs/POCT/ISOWD22870.pdf
4. Cooper, G. (2004). Preparing Your Laboratory to Certify or Accredit Under ISO 15189. Retrieved June 13, 2008 from,
http://www.sacb.org.sg/documents/PreparinglabforISO15189-GCooper.pdf
Done by: Nur Liyanah Bte Md Zaffre (0607718D) TG02
13. Quality and Technical Records
· Maintenance, safe disposal and retrieval of quality records1
· States results achieved2
· Provides evidences of activities performed2
14. Internal Audits
· Checks compliance of processes to ISO 15189 and internal procedures1
· Conducted regularly by trained laboratory staff2 from other departments
15. Management Review
· Evaluates the effectiveness2 of quality system and the need for resources1
· Review occurrences and activities since last review2
Technical Requirements
1. Accommodation and Environment Conditions
· Adequate space2
· Safe environment2
· Clean workspace2
· Good structural organisation
· Controlled environmental conditions1
2. Laboratory Equipment
· Selection and monitoring1 of all lab equipments
· Includes monitoring, calibration and maintenance procedures1
· Requirements for computer software and automated equipment1
(99 words)
References
1. Cooper, G. (2008). Preparations and Considerations When Seeking Laboratory Accreditation Under ISO 15189. Retrieved June 14, 2008, from
http://www.sacb.org.sg/documents/PreparinglabforISO15189-GCooper.pdf
2. Périgo, D. M., and Rabelo, R., (2004). ISO-3: The New ISO 15189:2003 as a Quality Management Standard. Westgard QC. Retrieved June 14, 2008, from
http://www.westgard.com/iso3.htm
Done By: Liong Ka Hang (0606688J) TG02
3. Personnel
· The director of a medical laboratory must have sufficient education, experience and training. (NATA, 2005)
4. Pre-examination procedures
· Pre-analytical SOP must be clearly defined for smooth operation and validation. (NATA, 2005 and Westgard QC, 2004)
5. Examination procedures
· Involves analytical processes (validation, reference and critical intervals) control and documentation as it was implemented. (NATA, 2005 and Westgard QC, 2004)
6. Post-examination procedures
· Detailed document must specifics the storage or disposal of used samples and result evaluation before release. (Westgard QC, 2004)
7. Quality assurance of examination procedures
· Quality control implementation to provide confidence in results through documentation and traceability. (NATA, 2005 and Westgard QC, 2004)
8. Results reporting
· Evidence must be provided to support the accuracy and reliability of results for compliance to national legal requirements. (NATA, 2005 and Westgard QC, 2004)
(99 words, not counting the bullet points and in-text citations)
References:
1. University of Maryland University College (UMUC). (2007). APA Citation Examples – Information & Library Services -UMUC-. Retrieved June 15, 2008, from
http://www.umuc.edu/library/guides/apa.shtml
2. National Association of Testing Authorities (NATA), Australia. (2005). ISO 15189 – The New Standard for Medical Testing Laboratories. Retrieved June 15, 2008, from
www.nata.asn.au/index.cfm?objectid=0870E6A5-A8D1-2553-F3DBF59E30C60829
3. Westgard QC. (2004). ISO-3: The New ISO 15189:2003 as a Quality Management Standard. Retrieved June 15, 2008, from
http://www.westgard.com/iso3.htm
4. ISO 15189 Blogspot. (2006). ISO 15189: Section 5 – Technical Requirements. Retrieved June 15, 2008, from http://iso-15189.blogspot.com/2006/07/section-5-technical-requirements.html
5. Ontario Medical Association. (2004). PARTNERING TO PROMOTE AN UNDERSTANDING OF ISO 15189:2003. Retrieved June 15, 2008, from
http://wwwn.cdc.gov/dls/iqlm/2005Posters/Crawford-9-Partnering%20to%20promote%20understanding%20of%20ISO%2015189-2003.pdf
Done By: Low Quan Jun (0607243C) TG 02
ISO 15189
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