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How to Apply for Accreditation of Veterinary Laboratory in Kenya

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How to Apply for Accreditation of Veterinary Laboratory in Kenya by Kenyans247(1): Sun Jan 2020 09:22am
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
Clinical veterinary laboratories that conduct commercial, government, academic, and international veterinary testing in the following areas: infectious disease diagnostics, disease surveillance, virology, pathology, microbiology, immunology, screening for growth promoters and drug/chemical residue that includes antibiotics, antihelmethetics, pesticides, metals, organics, DNA/RNA, and GMO.


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 criteria for accreditation of Veterinary Laboratories are contained within ISO/IEC 17025:2005.

Specific criteria are used to augment the general criteria applicable to a certain field of testing, testing technology, or specific test. The specific criteria for accreditation of veterinary laboratories are stated in the OIE Quality Standard and Guidelines for Veterinary: Laboratories: Infectious Diseases, 2008.

Additional requirements supplement ISO/IEC 17025:2005 to evaluate diagnostic and clinical veterinary laboratories that conduct commercial, government, academic, and international veterinary testing in the following areas: infectious disease diagnostics, disease surveillance, virology, pathology, microbiology, immunology, screening for growth promoters and drug/chemical residue that includes antibiotics, antihelmethetics, pesticides, metals, organics, DNA/RNA, and GMO.

These specific requirements also are designed to complement any applicable regulatory requirements that may affect government veterinary laboratories (state, regional, national, and international.)



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.

Veterinary Laboratory accreditation covers facilities that test animals and animal products for the diagnosis, monitoring and treatment of disease. The scheme accommodates government and private facilities, veterinary practices and university veterinary schools

Information which might help
The Health and Safety pillar of the Kenya Accreditation Service was formed to offer accreditation to conformity assessment bodies (laboratories) that offer services that pertain to;

Human health
Animal Health

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

Veterinary Laboratory Accreditation http://kenas.go.ke/health-and-safety/veterinary-laboratory-accreditation/

Accreditation Standards http://kenas.go.ke/technical-information/accreditation-standard/

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

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