Kenya - Apply for Accreditation of Reference Medical Laboratory

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Procedure

• The accreditation of Medical Reference Measurement laboratories by KENAS enables the labs to demonstrate a level of competence and global recognition.
• The Medical Reference Measurement Laboratories in done in accordance with ISO 15195

Apply In-Person

1. The applicant has to submit his/her accreditation enquiry to a Kenya Accreditation Service (KENAS) Staff. This can be either through telephone, email or visiting KENAS offices. Contact information of KENAS can be obtained in our “office and contact “ information section of this page or through the following link
2. This is followed by a formal response by KENAS Officer on the terms and conditions applicable to provision of accreditation services.
3. The applicant should submit the duly filled and signed formal application. The application from can be obtained from KENAS Offices or downloaded from their website through the following link. You submit the application form with all the required documents.
4. This is followed by review of the application including support documents provided by the applicant.( desk assessment /document review)
5. After review, there is a formal response to the applicant regarding the outcome of the review of the application and documentation.
6. This is followed by an on-site assessment visit. Corrective Action Requests will be made to the applicant for review.
7. Follow up assessment of the client is done to determine effective implementation of the corrective action requires (CAR’s) raised.
8. An independent accreditation commitee will then make a formal accreditation decision as outcome and/or report of the assessment.
9. After this a formal communication will be made to the applicant on the decision made.
10. Upon a successful assessment. The applicant will be issued with an accreditation certificate.
11. Periodical surveillance assessments are done of the accredited conformity assessment body.

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Required Documents

1. Application form
2. Cross reference matrix of internal documents against the normative standard
3. Quality Manual
4. Operating Procedures/ Methods
5. Evidence of PT / ILC
6. Application Fee paid

Office Locations & Contacts

Kenya Accreditation Service (KENAS) - Head Office
Embankment Plaza, 2nd floor,
Longonot Road, Upper Hill
P. O. Box 47400 - 00100 Nairobi
Telephone: +254 725 227 640
Fax: +254 787 395679
Email: [email protected]
Contact details.

Eligibility

• Reference measurement laboratories

Fees

• Gazetted Fees

FIRST SCHEDULE 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.

Validity

• Accreditation is valid for a period of one year.

Documents to Use

• Application Form for Accreditation

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• Feedback on receipt of an application is within 5 working days.
• Processing of application is done within Sixty (60 days)
• Refer to the service charter through this link

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since january 1908.

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

• 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

Information which might help

• 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.

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

• Accreditation Process
• Step by step Process
• Service Delivery Charter

Others

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;

1. Human health
2. Animal Health
   

The pillar offers accreditation to the following schemes:

Medical Laboratory Accreditation in accordance with ISO 15189 :2012

• The medical laboratory accreditation to ISO 15189 is available to laboratories performing tests in various fields of human pathology including anatomical pathology (histology and cytology), chemical pathology, microbiology, hematology, immunohematology, cytogenetics, molecular biology and immunology, blood transfusion services and assisted reproductive technologies.
  

Veterinary Laboratory accreditation in accordance with ISO 17025 + OIE- Quality standard and guidelines for Veterinary Laboratories : Infectious Diseases

• 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.
  

Proficiency Testing Providers in accordance with ISO/IEC 17043

• 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.
  

Medical Reference Measurement Laboratories in accordance with ISO 15195

• The accreditation of Medical Reference Measurement laboratories by KENAS enables the labs to demonstrate a level of competence and global recognition.
  

Pharmaceutical Laboratories in accordance with ISO/IEC 17025

• KENAS accreditation of pharmaceutical laboratories enables pharmaceutical laboratories that are interested in accreditation by demonstrating a level of competence and global recognition.