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How to Apply for Accreditation of Reference Medical Laboratory in Kenya

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How to Apply for Accreditation of Reference Medical Laboratory in Kenya by Kenyans247(m): Sun Jan 2020 08:45am
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 surveillance assessment of the accredited Conformity Assessment Body.

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/
View Map http://kenas.go.ke/contact-us/

Eligibility
Reference measurement laboratories

Fees
Gazetted Fees http://kenas.go.ke/our-services/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 http://kenas.go.ke/wp-content/uploads/2014/04/KENAS-TS-F-022-03-Application-for-Accreditation.doc

Instructions
The general requirements for accreditation of medical reference laboratories are laid down in ISO 15195: Laboratory medicine: Requirement for Reference Measurement Laboratories. ISO 15195:2003 is not applicable to routine medical laboratories.

ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such calibration laboratories are usually denoted as reference measurement laboratories. ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure



Required Information
Contact details
Organization
Address (Physical)
Address (Postal)
Telephone
Email
Website
Contact person
Position within the organization
Type and Nature of business
If organization operate on several sites
Organization details
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
Declaration
Signature

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.

KENAS accreditation of medical reference measurement laboratories enables these organizations that are interested to demonstrate a level of competence and global recognition

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 http://www.industrialization.go.ke/

Kenya Accreditation Service (KENAS) http://kenas.go.ke/

Guidelines http://kenas.go.ke/technical-information/accreditation-process/guidelines/

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

State Corporations (Cap. 446) http://www.kenyalaw.org:8181/exist/kenyalex/actview.xql?actid=CAP.%20446

Others
Kenya Accreditation Service (KENAS) is the Sole National Accreditation Body (NAB) mandated to offer accreditation services in Kenya. It is established under the States Corporations Act, Cap 446; vide Legal Notice No. 55 of May 2009. It gives formal attestation that Conformity Assessment Bodies (CABs) are competent to carry out specific conformity assessment activities.

KENAS is a member of the International Accreditation Forum (IAF) and an associate member at the International Laboratory Accreditation Cooperation (ILAC) which are apex organizations that oversee accreditation activities at a global level. KENAS carries out accreditation based on the following: regional directives; relevant statutes and government regulations; requirements for health, safety, and protection of the environment; and the market and needs of clients.

KENAS is mandated to:

Provide accreditation to conformity assessment bodies. These conformity assessment bodies are:-
Certification Bodies
Management Systems ISO/IEC 17021
Personnel ISO/IEC 17024
Products, processes and services ISO/IEC 17065
Testing and Calibration Laboratories ISO/IEC 17025
Medical laboratories ISO 15189
Inspection and Verification bodies ISO/IEC 17020
Proficiency Test providers ISO/IEC 17043
Reference Medical Laboratories ISO/IEC 15195
Veterinary Laboratories ISO/ IEC 17025 & OIE
Develop, regulate and review the criteria or requirements for accreditation of Conformity Assessment Bodies;
Open, maintain and update the register of accredited Conformity Assessment Bodies;
Design and issue identification numbers and certificates to all accredited Conformity Assessment Bodies;
Publish in the Kenya Gazette all Conformity Assessment Bodies that have been accredited within a particular year;
Promote the use of accreditation marks and certificates issued to accredited Conformity Assessment Bodies;
Promote competence and equivalence of accredited bodies;
Establish and nurture relations and co-operation with regional and international accreditation bodies, persons, associations and organizations that KENAS may consider desirable or appropriate, in furtherance of the objectives and purposes for which KENAS is established;
Promote accreditation as a means of facilitating regional and interna

Source https://www.wikiprocedure.com/index.php?title=Kenya_-_Apply_for_Accreditation_of_Reference_Medical_Laboratory

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