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How to Apply for Accreditation of Proficiency Test Provider in Kenya

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How to Apply for Accreditation of Proficiency Test Provider in Kenya by Kenyans247(1): Sun Jan 2020 08:14am
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
KENAS accreditation of proficiency testing scheme providers enables organizers that are interested in planning, providing and evaluating proficiency testing schemes to achieve and demonstrate a level of competence. The program provides testing, calibration, and medical laboratories providers with a fully functional and operational system of accredited providers of proficiency testing schemes conforming to international criteria.

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
KENAS, ISO 15189, and ISO/IEC 17025 require that accredited laboratories participate in Proficiency Testing activities supporting their scope of accreditation. Proficiency Testing providers, and specifically ISO/IEC 17043.

Accredited PT providers that operate a quality system in accordance with ISO/IEC 17043 are required to be utilized per KENAS Policy to support their scope activities. KENAS has collected a listing of PT providers that have been known to operate PT programs in accordance with ISO/IEC Guide 43 (outdated) or ISO/IEC 17043.

It is the responsibility of the accredited laboratory to determine if the particular PT program they are interested in is operated in accordance with ISO/IEC 17043. It is also the responsibility of the lab to assure the PT program they are subscribing conforms to the requirements of ISO/IEC 17043.



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.

Proficiency testing involves a group of laboratories or analysts performing the same analyses on the same samples and comparing results. The key requirements of such comparisons are that the samples are homogenous and stable, and also that the set of samples analyzed are appropriate to test and display similarities and differences in results.

Proficiency Testing (comparative testing) is an important way of meeting the requirements of ISO 15189, ISO/IEC 17025 in the area of quality assurance of laboratory results. It is also mandated by accreditation bodies that laboratories participate in proficiency testing programs for all types of analyses undertaken in that laboratory, when suitable programs exist.

Information which might help
The general criteria for accreditation of medical laboratories are contained within the ISO 17043:2010 conformity assessment- general requirements for proficiency testing. ISO/IEC 17043:2010 provides a consistent basis for all interested parties to determine the competence of organizations that provide proficiency testing.

Benefits of Proficiency Tests to Individual Laboratories

The participating laboratory is provided with a regular, independent and external assessment of its performance
The laboratory can use PT results to identify problems in operations, and initiate remedial actions if necessary
The laboratory has a means of demonstrating its data quality to third parties, e.g. customers, regulatory agencies or organizations providing recognition.
The laboratory is able to regularly compare its performance with that of peer laboratories.
If the test method is specified, the study can provide information on the performance characteristics of analytical methods.
The laboratory can have, in the coordinating organization, a source of technical advice and guidance on analytical problem.
PT schemes can be used to assign values to reference materials
PT scheme results can be used as a traceability link.

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

http://www.kenyalaw.org:8181/exist/kenyalex/actview.xql?actid=CAP.%20446 State Corporation

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

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