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

Procedure

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.

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 surveillanceAds by Google

Required Documents

  • Application form
  • Cross reference matrix of internal documents against the normative standard
  • Quality Manual
  • Operating Procedures/ Methods
  • Evidence of PT / ILC
  • Application Fee paid

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
Email: info@kenyaaccreditation.org
Website: http://kenas.go.ke/
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Eligibility

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

Fees

Gazetted Fees

Assessment fees

  • Application – KShs. 40,000
  • Document Review – KShs.95, 000
  • Assessment (initial) – KShs. 250,000


Second Schedule

Other Charges

  • 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


Third Schedule

Annual fees

  • Annual Accreditation Fee – KShs.192,500


NOTE:

  • 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

KENAS ISO 15189 checklist

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

  • International recognition
  • Sound management system
  • Prevents defects
  • Increased accuracy
  • Cost savings
  • Reduced waste
  • Access to global marketplace

External Links

Ministry of Industrialization and Enterprise Development

Kenya Accreditation Service (KENAS)

Guidelines

Process and Flow Map

Procedure for granting accreditation

[http://www.ke

About the Author

Sande Kennedy is the founder and Editor in Chief of SandeKennedy.co.ke & Kenyans247.co.ke He is a Kenyan-based Internetprenuer,blogger Political Activist & informer who has an interest in politics, governance, corporate-fraud and human-interest. Kindly drop me a note if you feel aggrieved on any matter that you would want to be highlighted  Twitter: @nyosake , Instagram: @itssandekennedy WhatsApp: +254791890826 Read More about me here