KENYA

Accreditation of Laboratories & Proficiency Testing Schemes

ELDORET
KISUMU NAIROBI

John M. Rukaria Labs. Accreditation Kenya Accreditation Service Email: rukariaj@kebs.org

KENYA
MOMBASA

ELDORET

Outline

KISUMU NAIROBI

MOMBASA

Introduction Terms Accreditation & Trade KENAS and its role Benefits of accreditation of medical labs. The need and operation for P.T. schemes Way forward

ELDORET

1.0 Introduction

KISUMU NAIROBI

MOMBASA

The aim of this presentation is two fold :Give an overview of KENAS mandate in providing regulatory and or accreditation services to its customers in the field of accreditation of laboratories (CABs). Highlight its role in the operation of proficiency testing schemes, a tool used in demonstrating the competence of a laboratory to carry out the task of testing

ELDORET

2. (a)Terms-Quality infrastructure

KISUMU

NAIROBI

MOMBASA

ELDORET

(b)What is Accreditation?

KISUMU NAIROBI

MOMBASA

The word accreditation comes from Latin credere (to give believe, to be confident in) therefore means to give confidence Essentially, accreditation is a procedure by which an authoritative body (NAB) gives formal recognition to a person or organization for their competence to carryout specific tasks. This recognition can be awarded to: certification bodies; laboratories (Calibration & testing); and inspection bodies Therefore it relates to the assessment of competence

ELDORET

Definition

KISUMU NAIROBI

MOMBASA

ISO 17011: 2004-conformity assessment general requirements for accreditation bodies accrediting conformity assessment bodies. (NABs e.g. KENAS to meet these Requirements to attain international recognition ) Third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks.

ELDORET

(c) What about Certification?

KISUMU NAIROBI

MOMBASA

Certification is a procedure by which a certification body confirms that a product, process or service conforms to a specific standard or specification- Compliance Certification is a commercial activity where several certification bodies compete with each other for business Therefore it relates to the assessment of conformity
Examples:
ISO 9001:2000 (QMS) ISO 14001:1996 (EMS) Codex Principles 1997/ISO 22000: 2005 (HACCP) Product Certification (Diamond Mark of Quality) EUREPGAP ISO 18001:1999(OHASS)

ELDORET

Then Conformity assessment?

KISUMU NAIROBI

MOMBASA

Conformity as defined in ISO 9000:2005 Fulfilment of a requirement Conformity Assessment: demonstration that specified requirements relating to a product, process, system, person or body are fulfilled
Conformity assessment include activities such as testing, inspection and certification

ELDORET KISUMU

(LAB) Proficiency testing

Determination of Lab testing by means of inter-laboratory comparison Incl. Qualitative schemes Data transformation exercises Single item testing One off exercises Continuous schemes Sampling

NAIROBI

MOMBASA

ELDORET

Inter-laboratory comparisons

KISUMU NAIROBI

MOMBASA

Organization, Performance & Evaluation of tests on the same or similar test items by two or more laboratories in accordance with pre-determined conditions. N/B One of the labs involved may be the lab which provided the assigned value for the test item.

ELDORET

3.0 Accreditation & Trade

KISUMU NAIROBI

MOMBASA

WTO/TBT agreement Article 15.2 Each member shall inform WTO on measures in existence or those taken to ensure implementation and administration of the agreement Includes article 6 on conformity assessment activities which include:certification, quality assurance, testing, inspection & Accreditation

ELDORET KISUMU

Accreditation & trade

cont..

NAIROBI

MOMBASA

6.1& 6.1.1 acceptance of results of conformity assessment of other member states so long as such results are generated by competent CAB 6.3 provisions of recognition of results through signing of Mutual Recognition Agreements (MRAs) & Multilateral arrangements (MLAs)

ELDORET KISUMU

The Technical Barrier to trade (TBT)

Barriers t o Trade

NAIROBI

MOMBASA

Tariff t rade Barriers

Non-Tariff t rade Barriers

Non-Technical

Technical

Physical Unit s Product Specificat ion Conformit y Assessment Test Cert ificat e

ELDORET

Accreditation of CABs e.g. Lab

KISUMU NAIROBI

MOMBASA

Done on the basis of compliance to:International Stds. & Guides e.g ISO 17025 (LABS),17020 (IBs),15189 (clinical labs) etc. ISO guide 43:1997 pt 1 & 2 Laws and Regulations Support Org. documentation on Mgt. Of activities I.e. Manuals, Procedures, records ( QMS )etc. Other market requirement docs. e.g. Contracts etc.

ELDORET

4.0 Present situation -National

KISUMU NAIROBI

MOMBASA

A number of accreditation programmes have been undertaken I.e Accreditation of Certification Bodies through Quality assessment Committee(QSAC) from 1995 vide L.N.90/95 Accreditation of calibration by KEBS under the National Calibration Scheme(NCS) from 1984 vide L.N. 80/84(Assumed by KENAS under Sec.of KENAS L.N. 14)

ELDORET

Present situation National

cont..

KISUMU NAIROBI

MOMBASA

A number of KEBS laboratories have been assessed by external Accreditation bodies UKAS (U.K.) & DKD (Germany). 2 metrology labs. (AC/DC & Volume ) by DKD of Germany and three testing labs by UKAS of the United Kingdom(Chemistry,Micro &Food & Agric. Labs) are waiting accreditation Other accredited labs include :- SGS lab, KEPHIS labs, Pathway Medical Lab. by SANAS of South Africa. QSAC undertook registration of assessors under the provisions of L.N. 90/95 (Assumed by KENAS Sec. 14 of KENAS L.N.).

ELDORET

Present situation - National

KISUMU NAIROBI

Certification bodies - ISO/IEC 17021:2006 4 Active bodies SGS, BVQI, KEBS & CVA international Calibration Laboratories - ISO/IEC 17025:2005 7 - various fields of measurement ( 12 requests ) Personnel - ISO/IEC 17024:2003 114 - Assessors (43 new applicants)

MOMBASA

Present situation - National cont.

Inspection bodies - ISO/IEC 17020:1998 New area being developed 1 request Public health, plant health, local authority, motor vehicle, seed, buildings, lifts & escalators etc

ELDORET

KISUMU NAIROBI

MOMBASA

Testing Laboratories - ISO/IEC 17025:2005 New area 15 Request 2 from medical labs(ISO 15189:2003)

ELDORET KISUMU

Present situation- National

cont.

NAIROBI

MOMBASA

Laboratories Proficiency Testing Programmes by the EAC Bureaux

KENAS scheme on Mineral water

Private schemes by HuQAS ( Human Quality Assessment Scheme for medical Diagnostic Labs.

ELDORET

5.0 KENAS - Objectives

KISUMU NAIROBI

MOMBASA

Provision of accreditation and regulatory services to conformity assessment bodies (CABs) Registration of assessors, inspectors & Management Systems training course providers

Creation of order in trade and service

Elimination of incompetent practices

Provision of level playing ground to CABs

Realize local accreditation services that are of lower cost than those being provided by external accreditation bodies.

red blue yellow green

Political Support Administration Technical Support External Relations

ELDORET KISUMU

KENAS Internationally recognized Regional Accreditation System

30 MRA / MLA Pre-Evaluation 14 Public Relations 26 Special courses 24 Working groups Quality documentation 21 Proficiency Testing 20 Personnel Pre-Assessments Independency 9 Equipment 19 Metrology 18 Management structure Technical committees 17 Location 6 Director 16 Technical assessors 15 Legal entity Lead assessors National policy Control board Training system 22 Associations 23 25 Joint accreditations Client organisations 27

NAIROBI

MOMBASA

28 29 Monopole

12

11 First scope 10

13 5 Financial policy

8 7

4 Legal status 2 National coordination

ELDORET

KENAS & its Role

cont.

KISUMU NAIROBI

MOMBASA

KENAS established in March 2005 under L.N. 26/2005 KENAS is Affiliate member of ILAC w.e.f.July 2005 TC Membership will represent all stakeholders CBs, C&T labs, IBs, TPs etc

ELDORET

KENAS & its Role cont.

KISUMU NAIROBI

MOMBASA

Mandate of KENAS Registration of assessors, auditors, conformity assessment inspectors & training providers (TPs) Accreditation of CABs ie CBs, IBs,C&T labs.(incl.medical &diagnostic labs. ISO 15189:2003) Cooperation with Regional & international accreditation bodies e.g EACAB (East African Community Accreditation Board), IAF (Int. Accreditation Forum), ILAC ( Int. Laboratory Accreditation Cooperation). Accounts auditable by the Controller & Auditor general

ELDORET

KENAS & its Role cont.

KISUMU NAIROBI

MOMBASA

Accreditation awareness sessions done for:Policy makers & stake holders (Nairobi) AKMLSO (Assoc . of Kenya Medical Lab. scientific officers) (Eldoret. ) Vet Lab officers (Machakos)

ELDORET

Stakeholders-31st

March 2005

KISUMU NAIROBI

MOMBASA

Study visit to Germany Jan. 2006

ELDORET KISUMU NAIROBI

MOMBASA

ELDORET KISUMU

Accreditation seminar

2nd

Nov.2006

NAIROBI

MOMBASA

ELDORET

6.0 Current situation EAC level

KISUMU NAIROBI

MOMBASA

A draft SQMT(Standardisation, Quality assurance, metrology & testing) bill has been formulated through joint efforts of the three states . UG, KEN, TZ This will also address Conformity assessment issues It is in the process of being finalised Awaiting ascent by country CEOs of Kenya ,Uganda, Tanzania to become Law

ELDORET

Current situation EAC level

KISUMU NAIROBI

MOMBASA

Sub-commitees on Metrology, testing standardisation & accreditation to discuss and chart way forward on appropriate conformity assessment issues Regular meetings of the CEOs of the three NSBs to articulate these issues Training and or awareness on conformity assessment activities undertaken under various support programmes e.g. By PTB of Germany , USDA(US), SIDA(Sweden)

ELDORET

East Africa Region

E. A. Community Experts Accre.Committee
N

KISUMU NAIROBI

MOMBASA

Experts Committee
Tech.Committee

EACAS BOARD

TC

A
T I O

TC
TANAS Industries Tanzania KENAS Industries Kenya UNAS Industries Uganda

A
T I O

N
A L

N
A L

ELDORET

Accreditation-International level
ILAC EA APLAC

KISUMU NAIROBI

MOMBASA

SADCA
EA APLAC IAAC SADCA EACAS

IAAC
European co-operation for Accreditation Asia Pacific Laboratory Accreditation Cooperation Inter-American Accreditation Cooperation Southern African Accreditation Cooperation East Africa Community Accreditation System

Cooperation ILAC MRA

Mutual recog.
EA/APLAC/IAAC/SADCA

Govt.&Industry recognition

Cooperation IAF MRA

KISUMU

ELDORET

Accreditation bodies
Accredit labs&Insp. bodies
ISO/IEC 17011&17010

Conformity Assessment Accreditation Hierarchy

Personnel ISO/IEC 17024 personnel examined
Per spec.

Mutual recog.

NAIROBI

EA,APLAC/IAAC/ SADCA

MOMBASA

Accreditation bodies
Accredit certification bodies
ISO/IEC GUIDE61

Labs. Medical/Test
specimen/Materi 15189 / 17025

Insp. bodies inspect

Products/items ISO/IEC 17020

Cert. bodies
Certify pdts.

Cert. bodies
Certify systems

Guide 65
Products marked
Per spec.

17O21 QMS/EMS certified

Per req.

Products Tested
Per spec.

Products inspected
Per spec.

Products Tested
Per spec.

Confidence regarding compliance regulations

2nd parties

ELDORET KISUMU

7.0 Accreditation of Medical Labs- Benefits

Recognition and trust Improved confidence on the part of users of the lab Reduced risks of wrong diagnosis Reduced risks of litigations Reduced complaints Improved productivity Improved trade and or business Improved efficiency & effectiveness hence productivity Reduced cost of doing business

NAIROBI

MOMBASA

ELDORET

8.0 The Need for P.T scheme

KISUMU NAIROBI

MOMBASA

Gauging of the technical competence of a Lab. Used in self evaluation of performance A vehicle for establishing mutual confidence between users of different labs Currently a condition for accreditation by e.g. KENAS Enable continual improvement of the lab. QMS Identification of interlab. Differences Assigning Values to reference Materials (RMs) & assessment

ELDORET

KENAS & P.T. schemes

KISUMU NAIROBI

MOMBASA

As Per Requirements of ISO 17011:2004 KENAS shall establish procedure governing the assessment & decision making as labs participation & performance in P.T. Cl 7.15.1 KENAS may organize P.T. schemes -Cl. 7.15.2 One on mineral water is running Participants include KEBS, UNBS, TBS, SABS,BOBS, one lab. In Germany

ELDORET

KENAS & P.T. schemes

cont..

KISUMU

NAIROBI

MOMBASA

KENAS may involve another body judged to be competent e.g. HuQas? Cl 7.15.2 KENAS shall maintain a list of appropriate P.T. and other lab comparison programmes- Cl. 7.15.2 KENAS shall ensure its accredited labs participate in P.T. where available & appropriate -Cl.7.15.3 KENAS shall ensure that Corrective actions(CAs) are carried out when necessary -Cl.7.15.3 KENAS shall specify minimum amount of P.T. testing, frequency of participation in liaison with interested parties e.g Labs.- Cl.7.15.3

ELDORET

9.0 Operation of a P.T scheme

KISUMU NAIROBI

MOMBASA

Consider:- ISO/IEC Guide 43-1:1997 Selection of P.T. scheme (cl.4) Organization & design (cl.5) Operation & reporting (cl.6) Confidentiality/ethical considerations (cl.7) (Aim at having an operating accredited P.T scheme)- HuQas?

ELDORET

10.0 Way Forward

KISUMU NAIROBI

MOMBASA

Aim at :One test accepted every where Also, Use of ILAC/IAF Cross frontier accreditation Policy Hence need:For labs (medical) to carry out conformity assessment activities (testing) competently in line with the requirements of National/International standards e.g. ISO 15189/15195/ Guide 43 pt 1& 2 To verify or assess the said competence to facilitate trade at National and international arena I.e. Accreditation services by e.g.KENAS

ELDORET

Way Forward

cont

KISUMU NAIROBI

MOMBASA

Reduction/elimination of multiple inspections/certifications, testing of goods as they transcend borders safeguarding credibility of results of conformity assessment activities by entering into ILAC/IAF MRAs/MLAs Evolution of KENAS in Line with the 30 milestones Need for provision of appropriate support from Government, stakeholders,donors to realise WTO/TBT agreements, that include areas of conformity assessment KENAS Pursuit of full recognition by IAF & ILAC

ELDORET KISUMU NAIROBI

Company S.A.

Quality Manual

MOMBASA

Internal Auditor

ELDORET KISUMU

Certification Body

NAIROBI

ISO 9001 ISO 9000

MOMBASA

Company

QM

ISO 9000 Auditor

Internal Auditor

ELDORET KISUMU

Accreditation Body

NAIROBI

ISO 17021

MOMBASA

Certification Body

ISO 9000 ISO 9000

Company

QM

ISO 17021 Auditor

ISO 9000 Auditor
Internal Auditor

ELDORET KISUMU NAIROBI

ISO 17011 ILAC IAF

MOMBASA

Accreditation Body

ISO 17021

Certification Body

ISO 9000 ISO 9000

Peer Evaluator
ISO 17021 Auditor
ISO 9000 Auditor
Internal Auditor

Company

QM

ELDORET

End

KISUMU NAIROBI

MOMBASA

THANK YOU