Kenya Accreditation Service
Accreditation and it’s Impact in County
Development
by
Michael K Talam
Assistant Director- Certification
Overview
2
1
• Who we are….
2
• What is accreditation and it’s
benefits?
3
• Impacts at County Level
INACCURATE RESULTS
INSPECTION FAILURES
Professional bodies
Bogus certifications…
Eye sore.
KENYA ACCREDITATION SERVICE
 KENAS is the sole national accreditation body
 It is set up under legal notice No. 55 of 2009 whose
mandate is accreditation of CABs.
 KENAS Carries out accreditation based on:




Government regulations
Regional directives
Requirements for health, safety and protection of the
environment
The market and the needs of clients
KENYA ACCREDITATION SERVICE
8
 Vision
To be a global leader in the provision of accreditation
services.
 Mission
Provision of accreditation services that promote fair
trade, health and safety as well as protection of the
environment.
 Motto
Competence in conformity assessment.
KENAS- MANDATE








Develop, regulate & review the criteria & requirements for
accreditation.
Open, maintain & update the register of accredited CAB’s.
Publish in the Gazette all CAB’s that have been accredited
within a particular year.
Promote use of accreditation mark(s) & certificates issued
to accredited CAB’s
Promote competence &equivalence of results of accredited
bodies.
Establish & nurture relations and co-operation with
regional &international accreditation bodies
Promote accreditation as a means of facilitating regional &
international trade.
Raise awareness on the importance & purpose of
accreditation.
ACCREDITATION SCHEMES
 KENAS provides accreditation in the following areas:
 Medical Laboratories ISO 15189:2007 / 2012
 Inspection bodies ISO/IEC; 17020:1998 / 2012
 Certification Bodies for
MS ISO/IEC 17021:2011
 Persons ISO/IEC 17024:2012
 Products ISO/IEC 17065:2012



Testing & Calibration laboratories ISO/IEC 17025:2005
Proficiency Test providers ISO/IEC 17043: 2010
The Structure (National)
MINISTRY OF INDUSTRIALISATION
BOARD OF DIRECTORS
ACCREDITATION
COMMITEE
KENAS MANAGEMENT
TESTING &
CALIBRATION
INSPECTION &
VERIFICATION
HEALTH &
SAFETY
CERTIFICATION
ASSESSORS &
EXPERTS
CONFORMITY
ASSESSMENT
BODIES
11
The Structure (International)
International
IAF
ILAC
Regional
AFRAC
EAAB
National
KENAS
CABs
CB’s, T&C, IB’s
Products / Services
12
KENAS HOUSE
white
Work not yet started
yellow
Work in progress
green
Work nearly finished
05 2012
KENAS
Ix - Implementation
0%
Sx - Sustainability
0%
KENAS
Milestone
Percentage
05 2012
Milestone
Vx - Velocity (p.a.)
13%
Mean Value
92%
MS 01
80%
MS 16
SI = ####
MS 02
90%
ILAC - IAF MRA / MLA
MS 03
Pre Peer Evaluation
Internationally recognized
Accreditation Body
National
Key Parameter
Quality
Percentage
S
96%
80%
P
91%
MS 17
100%
O
84%
100%
MS 18
100%
MS 04
100%
MS 19
90%
I
93%
MS 05
100%
MS 20
90%
N
93%
MS 06
100%
MS 21
80%
G
81%
MS 07
100%
MS 22
100%
MS 08
100%
MS 23
95%
F
94%
MS 09
100%
MS 24
100%
C
85%
MS 10
90%
MS 25
80%
H
95%
MS 11
100%
MS 26
90%
P
90%
MS 12
90%
MS 27
90%
MS 13
80%
MS 28
80%
G
94%
MS 14
90%
MS 29
100%
A
92%
MS 15
90%
MS 30
65%
I
92%
PE =
91%
TA =
91%
S
90%
30
Scope
28
14
26
Public Relations
Monopole
27
Special Courses
12
Client Organisat.
24
Working Groups
Quality Doc.
11
21
2nd Floor =
29
25
10
Joint Accredit.
20
Personnel
91%
Profic. Testing
First Scope
Pre-Assessments
BSC
13
Independency
5
9
19
Equipment
8
18
Man. Structure
4
Techn. Comm.
7
Legal Status
17
Location
2
Training System
6
16
3
Control Board
15
Legal Entity
Player
22
Techn Assessor
Lead Assessor
96%
Director
Nat. Coordination
Internat. Assoc.
1st Floor =
Financial Policy
23
Metrology
1
National Policy
P = 91%
11%
A = 96%
17%
T = 92%
11%
E = 83%
12%
13
WHAT IS ACCREDITATION?
 Accreditation is a third party attestation related to a
conformity assessment body conveying formal
demonstration of its competence to carry out specific
conformity assessment tasks.

“Procedure by which an authoritative body gives
formal recognition that a body or person is
competent to carry out specific tasks” (Definition from
ISO/IEC Guide 2:1996)
 KENAS is the sole National Accreditation body that
provides such formal recognition.
DIFFERENCE BETWEEN ACCREDITATION AND
CERTIFICATION
 In certification, the emphasis is to assess
compliance/conformance to a documented system,
which could be a management system on quality,
environment, health and safety, etc.
 In accreditation, the primary emphasis is to establish
and recognise the specific technical competence of
the conformity assessment bodies and their staff in
either testing, certification and inspection.
 Technical Competence w.r.t.


Infrastructure: Methods, procedures, equipment, environment
Personnel: Skills and Knowledge.
THE ACCOUNTABILITY MATRIX
ISO/IEC 17011
ILAC/ IAF
The process is carried out by trained Assessors and SME if need be.
APPLICATION
RECEIPT AND
PROCESSING
STAGE 1:
DOCUMENT
REVIEW
Accreditation
Body REVIEW OF
STAGE 2:
WITNESSING
Ongoing Surveillance
ISO/IEC 17020
FINDINGS AND
CAPAs
Inspection
Body
DISPOSITION
M-System
I-System
Peer Evaluator
Re-assessment after
3 years
17020 Assessor
It’s impact at County Level
 Provides confidence in the conformity assessment
activity.
Test results
 Inspection
 Certificates

 Help business to compete- Acceptance .
 Reduces duplication of effort
 Removes technical barriers to trade- Facilitates
Trade
It’s impact at County Level
 Supports competitiveness & productivity.
 Improves turn around time- No re-test
 Reduces expenditure/ costs
 Provides for County, Regional / International
recognition.
So what?
 Need to have at least one Accredited lab in the
County
 Have budgetary allocation for Accreditation
 Seek Accreditation
 Be the Champion
ACCREDITATION ACTIVITIES
 Testing and Calibrations: ISO/IEC 17025
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There are 16 labs accredited.
Four under assessment.
Many requests under review.
 Inspection: ISO/IEC 17020
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Two accredited inspection bodies One cross Frontier, one local.
Two under review.
 Certification (MS): ISO/IEC 17021
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One accredited.
One under assessment.
Two under review
ACCREDITATION ACTIVITIES
 Medical:
 One Laboratory accredited.
 End term assessment for the 1st Cohort Labs (5) under ASCP

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Varied levels of implementation of ISO 15189:2007.
End term assessment for the 2nd Cohort Labs under AGHFP
(8) – March 2012.
Comparisons between Mid term and End term.
 Level of preparedness for accreditation in some labs evident
 Drop in others.

Michael Kibet Talam
Kenya Accreditation Service (KENAS)
Assistant Director- Certification
email:[email protected]
Tel:+254710413451