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Ho to Apply for Accreditation of Medical Laboratory in Kenya
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|Ho to Apply for Accreditation of Medical Laboratory in Kenya by Kenyans247(1): Sun Jan 2020 08:04am|
Step one Enquiry through telephone, email or contact with KENAS staff.
Step two - Formal response by responsible KENAS officer on the terms and conditions applicable to provision of accreditation service by KENAS including training where necessary.
Step three - Formal application for accreditation by the client.
Step four - Review of application including support documentation provided by applicant client (Desk Assessment)
Step five - Formal response by KENAS to the applicant/client regarding the outcome of the review of application and the conformity assessment bodys documentation.
Cross reference matrix of internal documents against the normative standard
Operating Procedures/ Methods
Evidence of PT / ILC
Application Fee paid
Step six - On site assessment
Step seven - Follow up assessment of the applicant/client for determination of effective implementation of the corrective action requests(CARs) raised
Step eight - Decision by the KENAS accreditation committee as regards outcome and/or report of the assessment.
Step nine - Formal communication of the decision to the client/applicant.
Step ten - Formal issuance of an accreditation certificate to the client/applicant.
Step eleven - Periodical surveillance
Office Locations & Contacts
Kenya Accreditation Service (KENAS)
Embankment Plaza, 2nd floor, Longonot Road, Upper Hill
P. O. Box 47400 - 00100 Nairobi
Telephone: +254 725 227 640
Fax: +254 787 395679
View Map http://kenas.go.ke/contact-us/
Currently KENAS is offering accreditation to the following medical laboratories:
General medical/clinical laboratory accreditation
Research medical laboratory accreditation
Forensic medical laboratory accreditation
Blood transfusion laboratories
X-ray laboratory accreditation
Gazetted Fees http://kenas.go.ke/our-services/gazetted-fees/
Application - KShs. 40,000
Document Review - KShs.95, 000
Assessment (initial) - KShs. 250,000
Pre-assessment - KShs.50,000
Additional Assessor per day - KShs.60,000
Application for Extension (all inclusive, except for VAT) - KShs. 250,000
Review of re-submitted Documents - KShs. 45,000
Annual Accreditation Fee - KShs.192,500
Any fee charged shall be subject to value added tax.
The assessment fee has taken into account one assessor unit for two days.
The assessor unit consists of one lead assessor, a technical expert/assessor and Kenya Accreditation Service support required to facilitate the assessment. For complex assessment or wider scopes, the additional assessor/expert shall be charged based on the rate indicated on other charges.
These fees do not cover the cost of travel and accommodation outside Nairobi. The fees shall be borne by the client in the event that there are no established assessors within the region or location.
The Kenya Accreditation Service shall retain as penalty ten percent in value of accreditation assessments that are cancelled less than five days to the assessment date.
Documents to Use
Application Form for Accreditation http://kenas.go.ke/wp-content/uploads/2014/04/KENAS-TS-F-022-03-Application-for-Accreditation.doc
KENAS ISO 15189 checklist http://kenas.go.ke/wp-content/uploads/2013/03/KENAS-ISO-15189-checklist.pdf
The general criteria for accreditation of medical laboratories are contained within the ISO 15189:2012 Medical Laboratories- Particular Requirements for quality and competence.
A laboratory interested in the KENAS MLA should first seek to become familiar with the requirements of ISO 15189: Medical Laboratory-Particular Requirements for Quality and Competence, KENAS ISO 15189 checklist, criteria for Conformity (ies) to which the laboratory is seeking accreditation and regulations. These documents can be downloaded from the KENAS website www.kenyaaccreditation.org except for the ISO 15189 standard which can be purchased from the National Standards body (Kenya Bureau of Standards) and the regulations which would be specific to the laboratory based on its establishment.
Position within the organization
Type and Nature of business
If organization operate on several sites
The Legal Status of your organization
Total Number of Staff
List the conformity Assessment Services offered
If your conformity Assessment activities are part of a larger organization
Other organization activities
Scope of accreditation
Need for the Document
Accreditation is a formal third party confirmation that Conformity Assessment Bodies (CABs) are competent to carry out specific conformity assessment activities. Conformity Assessment Bodies are those bodies that assess the compliance and or conformance of products, services and suppliers to guided specifications and requirements e.g. Testing and Calibration Laboratories, Proficiency testing Laboratories, Inspection and verification bodies, Medical Laboratories, Certification bodies etc.
Accreditation is distinct from certification because certification focuses on an organization overall compliance with systems and products standards rather than the technical competence which is what accreditation focuses on. Therefore accreditation becomes a formal recognition to the CABs that they are competent to carry out conformity assessment tasks.
Kenya Accreditation Service (KENAS) is the only national accreditation body for Kenya that gives formal recognition that Certification Bodies (CBs), Inspection Bodies (IBs) and Laboratories (testing and calibration, medical, veterinary, pharmaceuticals, proficiency testing scheme providers) are competent to carry out specific conformity assessment tasks.
Medical laboratory accreditation is a means of determining the technical competence of a medical laboratory to perform specific types of testing, measurement and calibration of equipment. Medical laboratory accreditation also provides a formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing and measurement services able to meet the customers needs.
Information which might help
Responsibility and Obligation of the Medical Laboratory The principal function of accreditation is for laboratories to deliver quality, efficient laboratory services and reliable test results. Accreditation assessment ensures that laboratories meet explicit quality management criteria and recognizes the laboratorys technical competence
Laboratories are required to provide objective evidence, management commitment, and communication within and outside the laboratory, client satisfaction, and continual improvement through effective IQC/EQA/PT reporting practices.
Laboratories can only claim accreditation with respect to the scope for which they have been granted accreditation by KENAS.
Significant changes in their statutes or operations in respect to legal, commercial, ownership and organizational or other such matters that may affect the ability of the laboratory to fulfill its accreditation requirements are required to be communicated within thirty days to KENAS.
Responsibility and Obligations of KENAS MLAS
Information about the current accreditation status of medical laboratories granted accreditation will be made publicly available on the KENAS website as well as the Kenya gazette;
Notice on changes to accreditation requirement shall be given on time and expressed views of interested parties taken into account with regard to the precise form and effective date of changes before effecting the changes;
Information about all international arrangement shall be available to interested parties;
Information shall be available on suitable ways of obtaining traceability of measurements and participating in proficiency testing and or interlaboratory comparison;
Changes in accreditation fees shall be communicated to the laboratories.
Other uses of the Document/Certificate
Benefits of accreditation
Sound management system
Access to global marketplace
Ministry of Industrialization and Enterprise Development http://www.industrialization.go.ke/
Kenya Accreditation Service (KENAS) http://kenas.go.ke/
Process and Flow Map http://kenas.go.ke/technical-information/accreditation-process/process-and-flow-map/
Procedure for granting accreditation http://kenas.go.ke/wp-content/uploads/procedures/KENAS-TS-OP-019-01-Procedure-for-granting-accreditation.pdf
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