Kenya Accreditation Service Accreditation and it’s Impact in County Development by Michael K Talam Assistant Director- Certification

1 2 Overview Who we are…. What is accreditation and it’s benefits? 3 Impacts at County Level This is another option for an Overview slide.

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 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 KENAS MANAGEMENT ACCREDITATION COMMITEE TESTING & CALIBRATION INSPECTION & VERIFICATION HEALTH & SAFETY CERTIFICATION ASSESSORS & EXPERTS CONFORMITY ASSESSMENT BODIES

The Structure (International) IAF ILAC Regional AFRAC EAAB National KENAS CB’s, T&C, IB’s CABs Products / Services

Internationally recognized National Accreditation Body KENAS HOUSE white Work not yet started   Ix - Implementation 0% KENAS 05 2012 Key Parameter yellow Work in progress Sx - Sustainability Mile-stone Percen-tage Quality green Work nearly finished Vx - Velocity (p.a.) 13% S 96% Internationally recognized National Accreditation Body Mean Value 92% MS 01 80% MS 16 P 91% SI = #### MS 02 90% MS 17 100% O 84% 30 ILAC - IAF MRA / MLA MS 03 MS 18 Scope 28 Pre Peer Evaluation MS 04 MS 19 I 93% 29 Monopole 14 Public Relations 26 Special Courses 27 Client Organisat. 2nd Floor = MS 05 MS 20 N 12 Quality Doc. 24 Working Groups MS 06 MS 21 G 81% 11 First Scope 21 Profic. Testing 25 Joint Accredit. MS 07 MS 22 BSC 10 Personnel 20 Pre-Assessments MS 08 MS 23 95% F 94% 13 Independency MS 09 MS 24 C 85% 5 Financial Policy 9 Equipment 19 Metrology 23 Internat. Assoc. 1st Floor = MS 10 MS 25 H 8 Man. Structure 18 Techn. Comm. MS 11 MS 26 4 Legal Status 7 Location 17 Training System MS 12 MS 27 Player 2 Nat. Coordination 6 Director 16 Techn Assessor 22 Control Board MS 13 MS 28 3 Legal Entity 15 Lead Assessor MS 14 MS 29 A 1 National Policy MS 15 MS 30 65% P = 91% 11% A = 96% 17% T = 92% E = 83% 12% PE = TA =

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 APPLICATION RECEIPT AND PROCESSING STAGE 1: DOCUMENT REVIEW STAGE 2: WITNESSING REVIEW OF FINDINGS AND CAPAs DISPOSITION ILAC/ IAF The process is carried out by trained Assessors and SME if need be. Accreditation Body ISO/IEC 17020 Ongoing Surveillance Inspection Body 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 There are 16 labs accredited. Four under assessment. Many requests under review. Inspection: ISO/IEC 17020 Two accredited inspection bodies One cross Frontier, one local. Two under review. Certification (MS): ISO/IEC 17021 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 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:talam@kenyaaccreditation.org Tel:+254710413451