KENYA ACCREDITATION SERVICE Doris Mueni - Msc. Med. Microbiology

PT and Accreditation to ISO 15189     PT and Accreditation to ISO 15189

ACCREDITATION Formal ISO 17000 definition: “Third party attestation that a Conformity Assessment Body fulfils specified requirements and is competent to carry out specific conformity assessment tasks” Accreditation (by an Accreditation body) is the formal recognition that an organization is competent to perform specific processes, activities, or tasks, in a reliable, credible and accurate manner.

Difference between Accreditation and Certification Means compliance with a std. or specification (system or product std.) Uses management system auditors who are certified by an independent body as meeting international agreed criteria May be general in the scope of recognition Considers the total business

Accreditation: Is the recognition of specific competence and its scope is normally highly specific, Evaluates people, skills, and knowledge Uses assessors who are recognized specialists in their field Evaluates the supporting management system for a specific activities Involves practical tests as appropriate (PT & measurement audits).

Current situation Accreditation has a much broader application than the current, definition in ISO/IEC 17000 would suggest. Several types of organizations that are subject to accreditation are not strictly conformity assessment bodies: Medical laboratories Veterinary laboratories

LABORATORY ACCREDITATION It is a formal recognition that a laboratory is competent to perform specific tests or measurements This (cost effective) recognition is undertaken by an independent, authoritative 3rd party bodies (i.e. KENAS) When a laboratory is accredited its demonstrated capability is defined in a schedule of specific tests and calibrations granted by the accreditation body Occurs only after an accreditation body is satisfied that the laboratory seeking accreditation has access to all necessary resources to undertake these particular tests correctly and is managed in such a way that it is likely to do this consistently.

ISO 15189 ISO 15189: Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories The standard was developed by the International Organization for Standardization's Technical Committee 212 (ISO/TC 212) While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Guiding principle To provide patients users with high level of health care

Proficiency Testing (PT) PT is the term applied to comparing test results from different laboratories. Current std. in use is (ISO/IEC Guide 43:1997) -(ISO/IEC 17043) PT is a valuable tool in quality improvement process PT provides objective evidence of laboratory competence for customers, accrediting bodies, and regulatory agencies Current accreditation requirements include integration of PT schemes into laboratory quality improvement program (ISO 15189:2007 &ISO/IEC 17025:2005 require accredited laboratories participation in appropriate P.T schemes)

Getting the most out of your PT participation PT fulfills regulatory requirements (ISO 15189 & 17025) Improves the quality of testing Serves as a marketing tool Potentially reduce overall cost, and improve cost effectiveness by identifying testing problems Can reduce adverse health outcome Prevent unnecessary tests, and avoid litigation PT data can be used to document personnel competency and to identify competency problems that may be resolved with additional training and monitoring.

The uses of PT Assessing a laboratory's analytical performance Monitoring technical problems within laboratories Correcting laboratory problems Improving analytical performance, testing methods and inter-laboratory comparability Educating and training lab staff Assessing competency of testing personnel.

Do’s and Don’ts of Proficiency Testing handle PT samples in the same manner as patient samples:  PT samples are tested along with regular patient workload PT samples are tested by personnel who routinely perform the analysis PT  samples are rotated among the staff who perform the tests Don’t give PT samples preferential treatment:  PT samples are not analyzed by a special person PT  samples are not analyzed in replicate when patient samples are not run in replicate

Requirements for the competence of providers of P.T. All areas of conduct of PT schemes, including: Planning of PT schemes, Selection and preparation of materials, Assessment of homogeneity and stability, Identification, labeling, packaging and distribution of materials Statistical and technical evaluation of participants’ performance Content of PT scheme reports

Need for local PT providers Reduce cost of PT Freight and handling Logistics during transportation Time

KENAS Kenya Accreditation Service (KENAS), the sole National Accreditation Body for Kenya, was formally established in March 2005 via a legal notice 26/2005 Its establishment was a result of the need to accommodate the gaps that were not addressed by the previous Quality Systems Assessment Committee (QSAC) and the National Calibration Services (NCS) both of which became defunct, since KENAS took over their functions It is currently an affiliate member of the International Laboratory Accreditation Cooperation (ILAC). KENAS has made an application for membership to the International Accreditation Forum (IAF) and, It is a key player in the East African Community Accreditation System (EACAS) KENAS operates in line within the requirements of ISO/IEC 17011:2004 and ILAC/IAF key performance indicators (KPI’s).

As a regulator, KENAS is recognized by the Kenyan Government as the sole National Accreditation Body that provides accreditation services to Conformity Assessment Bodies (CAB’S): Test and Calibration Laboratories (ISO/IEC 17025:2005) Medical Laboratories (ISO 15189:2007) Veterinary Laboratories (ISO/IEC 17025 & OIE 2008 Quality standard and Guidelines for Veterinary laboratories) Certification Bodies (ISO/IEC 17021: 2006) Inspection Bodies (ISO/IEC 17020:1998) Proficiency Test providers (ISO/IEC Guide 43:1997) - (ISO/IEC 17043) .

Vision & Mission Vision Mission To be a global leader in the provision of internationally recognized accreditation services Mission To provide accreditation services that promote fair trade to all our customers.

Currently, KENAS is in the process of building capacity: Assessors- training on ISO 15189 is on going, Technical experts KENAS recognizes HuQAS and its role in quality.

PT SITES EURACHEM www.eurachem.ul.pt CITAC www.citac.cc EPTIS www.eptis.bam.de

Conclusion The use of accredited PT providers will help us achieve our primary objective of “Tested once, recognized and accepted everywhere)” This will facilitate increased trade, creation of wealth and hence improvement of the country’s economic status and therefore realization of the G.O.K Vision 2030.

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