KENAS
Competence in Conformity Assessment
ABOUT KENAS
KENAS is the sole National Accreditation Body (NAB)
recognized by the Government of Kenya to offer
accreditation services. KENAS operations are
monitored by the International Accreditation Forum
(IAF), International Laboratory Accreditation
Corporation (ILAC), the industry, government and
professional bodies, some of whose representatives
make up the KENAS Board. KENAS’s accreditation
programs use internationally recognized standards.
Kenya Accreditation Service (KENAS) is a member of
IAF and an associate member at ILAC which are
umbrella organizations that oversee accreditation
activities at a global level.
OUR VISION:
Our vision is to be a global leader in the provision
of accreditation services.
OUR MISSION:
Provision of accreditation services that
promote fair trade, health and safety as well as
protection of the environment.
OUR MOTTO:
Competence in Conformity Assessment.
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www.kenas.go.ke
Accreditation is third-party attestation related to a conformity
assessment body conveying formal demonstration of its
competence to carry out specific conformity assessment tasks.
WHAT CAN ACCREDITATION DO FOR YOU?

For the Conformity Assessment Bodies (CABs), it is a
benchmark of performance.

Build confidence in your quality and environmental
systems, personnel and product certification systems,
inspection and verification systems, as well as
measurements and tests that your business conducts.

Accreditation improves acceptance of laboratory test
results worldwide.

As a consumer note that accreditation gives you assurance
and confidence on the quality and safety of products and
services that you purchase and consume.

Tests conducted by accredited food and water testing
laboratories on food and water supplies will minimize the
risk of outbreaks of food and water born diseases such as
typhoid, cholera and dysentery.
The Need for Accreditation
Accreditation is a benchmark for performance that assures high standards in operational systems by
Conformity Assessment Bodies (CABs). It is a means of reducing technical barriers to trade hence leading to
increase in trade and thus creation of wealth. Consequently, much needed growth in our economy is realized
through industrialization, enhanced proper procedures and improved quality of manufactured goods and
services.
A Conformity Assessment Body (CAB) is a testing laboratory, a calibration laboratory, certification body or an
inspection body that provides inspection, testing and certification services in all fields both in the public and
private sectors.
What is Accreditation?
Accreditation is an independent evaluation of conformity assessment bodies against recognized conformity
assessment standards to competently carry out specific conformity assessment activities to ensure
integrity, impartiality and objectivity.
Accreditation bodies have been established in many countries with the primary purpose of ensuring that
conformity assessment bodies are subject to oversight by an authoritative national accreditation body.
Accreditation is performed against requirements set out in internationally recognized conformity
assessment standards taking into account local regulations and government directives.
Accreditation is distinct from certification as certification focuses on an organization's overall
compliance with requirements, systems and products, standards whilst accreditation focuses on technical
competence. Therefore, accreditation is a formal recognition to the CABs that they are competent to carry
out specific conformity assessment tasks.
Kenya Accreditation Service (KENAS) as the sole National Accreditation Body (NAB) for Kenya accredits CABs
therefore giving them formal recognition and providing evidence that they are competent to carry out
specific conformity assessment tasks.
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Accreditation Services
The listed accreditation services are offered by KENAS. Training for the implementation of the Standards is
available as well as assessor training for all standards, uncertainty of measurements, validation and verification
of methods and internal auditing as per the specific standards. For further enquiries contact:
info@kenyaaccreditation.org or visit our website www.kenas.go.ke
Scopes of Accreditation
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Accreditation
Standard
Voluntary or
Regulatory Domain
Validity Period of
Accreditation
Certificate
Reference Medical Laboratories
ISO/IEC 15195
Voluntary
3 years
Medical Laboratories
ISO 15189
Voluntary
3 years
Veterinary Laboratories
ISO/IEC 17025 & OIE
Voluntary
3 years
Pharmaceutical Laboratories
ISO/IEC 17025
Voluntary
3 years
Calibration Laboratories
ISO/IEC 17025
Voluntary
3 years
Testing Laboratories
ISO/IEC 17025
Voluntary
3 years
Management Systems
Certification Bodies
ISO/IEC 17021
Voluntary
3 years
Products, Processes and Services
Certification
ISO/IEC 17065
Voluntary
3 years
Personnel Certification Bodies
ISO/IEC 17024
Voluntary
3 years
Proficiency Test (PT) Providers
ISO/IEC 17043
Voluntary
3years
Inspection Bodies
ISO/IEC 17020
Voluntary
3 years
HEALTH AND SAFETY
SCHEME
The Health & Safety Scheme in KENAS provides accreditation for the recognition of
technical competence in areas of medical laboratories, veterinary laboratories,
pharmaceutical laboratories, proficiency testing laboratories, reference medical
laboratories to specific ISO standards.
1. Medical Laboratory Accreditation - ISO 15189
Government directives and private initiatives demanding
and supporting laboratory accreditation have ensured
quality assurance implementation as a culture in
laboratory practice. In the system of accreditation, the
standards do not just indicate the minimum
requirements but give higher targets that attempt to
bring all the medical laboratories to a higher level of
quality.
Medical laboratory accreditation is a means of
determining the technical competence of a medical
laboratory to perform specific types of testing,
measurement and calibration of equipment. It also
provides a formal recognition to competent laboratories,
thus providing a ready means for customers to identify
and select reliable testing and measurement services that meet their needs. Medical laboratory services are
essential to patient care and therefore have to be availed in a manner that meets the needs of all patients
and the clinical personnel responsible for the care of these patients. These services include: arrangements
for requisition, patient preparation, patient identification, collection of samples, transportation, storage,
processing and examination of clinical samples together with subsequent validation, interpretation,
reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Currently, KENAS is offering accreditation to the following medical laboratories: -
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
General medical/clinical laboratories

Research medical laboratories

Forensic medical laboratories

Blood transfusion laboratories

X-ray laboratories.
The general criteria for accreditation of medical
laboratories are contained within the ISO 15189Medical Laboratories- Particular requirements for
quality and competence.
KENAS recommends that all accredited
medical, veterinary, pharmaceutical and
testing & calibration laboratories use
accredited Proficiency Testing providers
2. Accreditation of Veterinary Laboratories - ISO / IEC 17025 & OIE
The general criteria for accreditation of Veterinary Laboratories are
contained within ISO/IEC 17025. Specific criteria are used to augment the
general criteria applicable to a certain field of testing, testing technology, or
specific test. The specific criteria for accreditation of veterinary
laboratories are stated in the OIE Quality Standard and Guidelines for
Veterinary Laboratories.
Additional requirements supplement ISO/IEC 17025 to evaluate diagnostic
and clinical veterinary laboratories that conduct commercial, government,
academic, and international
veterinary testing in the following areas:
infectious disease diagnostics, disease surveillance, virology, pathology,
microbiology, immunology, screening for growth promoters and drug/chemical residue that includes antibiotics,
antihelmethetics, pesticides, metals, organics, DNA/RNA, and Genetically Modified Organisms (GMO).
These specific requirements also are designed to complement any applicable regulatory requirements that may
affect government veterinary laboratories (state, regional, national, and international) and private
veterinary laboratories.
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3. Accreditation of Medical Reference Laboratories - ISO/ IEC 15195
The general requirements for accreditation of medical reference
laboratories are laid down in ISO 15195: Laboratory medicine:
Requirement for Reference Measurement Laboratories.
ISO 15195 refers to the specific aspects of calibration laboratories in
the field of laboratory medicine where such "calibration laboratories"
are usually denoted as "reference measurement laboratories". ISO
15195 may form a basis for the
accreditation of a reference
measurement laboratory that require official recognition of the
performance of a reference measurement procedure.
ISO 15195 is not applicable to routine medical laboratories.
4. Accreditation of Pharmaceutical Laboratories - ISO/ IEC 17025
The need for Kenyan pharmaceutical laboratories to achieve national and global recognition through
demonstration of conformance to international standards led to the establishment of an accreditation
programme for pharmaceutical laboratories under the auspices of KENAS. The general criteria for accreditation
of pharmaceutical laboratories are contained within ISO/IEC 17025. Pharmaceutical laboratories seeking
accreditation need to comply with the following requirements: -
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
The quality management, scientific and technical aspects of pharmaceutical laboratories as required by ISO/
IEC 17025 regulatory documents which are developed by the KENAS Pharmaceutical Technical
Committee.

Participation in Proficiency Testing (PT) or Inter-Laboratory Comparisons (ILC), where possible.
5. Accreditation of Proficiency Testing Providers - ISO/ IEC 17043
ISO/IEC 17043—Conformity Assessment—General requirements for proficiency testing is the general criteria for
accreditation of proficiency test providers. The Standard provides a consistent basis for all interested parties to
determine the competence of organizations that provide proficiency testing. Inter-laboratory comparisons are
widely used for a number of purposes and their use is increasing internationally. Purposes for inter-laboratory
comparisons include: 
Evaluation of performance of laboratories for specific tests or measurements and monitoring laboratory’s
continuing performance;

Identification of challenges in laboratories and limitation of actions for improvement which, for example,
may be related to inadequate test or measurement procedures, effectiveness of staff training and
supervision as well as the quality of the environment where the tests are carried out;

Establishment of the effectiveness and comparability of test or measurement methods;

Provision of additional confidence to laboratory customers;

Identification of inter-laboratory differences;

Education of participating laboratories based on the outcomes of such comparisons;

Validation of uncertainty claims;

Evaluation of the performance characteristics of a method;

Assignment of values to reference materials and assessment of their suitability for use in specific test or
measurement procedures;

Support for statements of the equivalence of measurements of national metrology institutes through “key
comparisons” and supplementary comparisons conducted on behalf of the internationally bureau of weights
and measurement (BIPM) and associated regional metrology organizations.
The need for ongoing confidence in laboratory performance is not only essential for laboratories and their
customers but also for other interested parties such as regulators, laboratory accreditation bodies, support
partners and other organizations that specify requirements for laboratories.
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TESTING AND
CALIBRATION
SCHEME
The Testing and Calibration Scheme in KENAS provides accreditation for the
recognition of the technical competence of a testing and calibration laboratory for a
specific task following ISO/IEC 17025 international standard.
Accreditation of Testing & Calibration Laboratories - ISO/ IEC 17025
The Testing and Calibration Scheme in KENAS provides accreditation for the recognition of the technical
competence of a testing and calibration laboratory for a specific task following ISO/IEC 17025 international
standard. The KENAS testing and calibration scheme has been established with the objective to provide
Government, Industry and Private laboratories in general with a scheme for third-party assessment of the quality
and technical competence of their laboratories to carry out specific testing, measurements and calibrations.
The Government of Kenya has authorized and recognized KENAS as the sole National Accreditation body for
provision of accreditation services to testing and calibration laboratories.
The concept of Laboratory Accreditation was developed to provide a means for third-party attestation of the
competence of laboratories to perform specific type (s) of testing and calibration. The competence takes into
account the caliber of personnel; infrastructure that include equipment; test methods and procedures; the
testing environment etc.
Laboratory Accreditation
provides formal recognition
of competent laboratories,
thus providing a ready
means for customers to find
reliable testing and
calibration services in order
to meet their demands and
facilitate trade.
Laboratory Accreditation
enhances customer confidence
in accepting testing or
calibration reports issued by
accredited laboratories. This is
anchored in the ILAC/IAF
principle of “one inspection
report / test report /
certificate accepted
everywhere.”
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The globalization of the Kenyan economy and the liberalization policies initiated by the Government in eliminating
barriers to trade hence providing greater thrust to exports makes it imperative for Accredited Laboratories
to demonstrate competence and hence entrench requisite confidence, trust and reliability with respect to conformity
assessment results that accompany traded goods and services. For accreditation, the laboratories should be legally
identifiable and appropriately registered. They can be a part of a big organization or an independent entity.
KENAS provides accreditation to:
Laboratories undertaking any sort of testing or calibration in the specified fields.

Private or government laboratories.

Small, medium and large laboratories.

Site facilities, temporary field operations and mobile laboratories.
KENAS scope for accreditation extends to:A) Testing Laboratories: Biological, Chemical, Electrical,
Electronics, Fluid-Flow, Mechanical, Non-Destructive, Photometry,
Radiological and Thermal.
B) Calibration Laboratories: Electro-Technical, Mechanical, Fluid
Flow, Thermal & Optical, Radiological, Time and Frequency, Mass
and Pressure.
For accreditation, the laboratories should be legally
identifiable and appropriately registered. They can
be part of a big organization or an independent
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identity.
CERTIFICATION
SCHEME
The Certification Scheme in KENAS offers accreditation to Certification Bodies offering
Management Systems Certification, Process, Product and Service certification, and Personnel
certification. Accreditation is based on the assessment of performance of a certification body
including (as appropriate) procedures, staff competence, inspection, review of product
acceptability, and reporting. Certifying bodies are accredited according to their scopes of work,
under the following standards:
ISO/IEC 17021: Requirements for bodies providing audit and certification of management
systems

ISO/IEC 17024: General requirements for bodies operating certification of persons.

ISO/IEC 17065: Requirements for bodies certifying products, processes and services.
1. Accreditation of Management Systems Certification Bodies
- ISO/IEC 17021
Accreditation by KENAS for bodies offering Management System certification
demonstrates that an organization has met the requirements of the International
Standard (ISO/IEC 17021-Conformity Assessment-Requirements for bodies
providing audit and certification of management systems ) for management
system certification bodies and is able to competently audit and certify
management systems. A management system is the framework of processes and
procedures used to ensure that an organization can fulfill all tasks required to
achieve its objectives. A certification body’s scope of accreditation indicates the
management systems for which it is accredited to audit and certify.
For example;ISO 9001-Quality Management Systems (QMS);
ISO 22000– Food Safety Management System (FSMS);
ISO 140001– Environmental Management System (EMS) and
ISO 18001–Occupation Safety and Health Management System ( OHSAS) e.t.c
KENAS accredits conformity assessment bodies for the following management
system certification schemes: 
Quality management system scheme (ISO 9001)

Environmental management system scheme (ISO 14001)

Food safety management system scheme (ISO 22000)

Food safety system certification (FSSC 22000)
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
Occupational health and safety system scheme (ISO 18001).
2. Accreditation of Personnel Certification Bodies - ISO/ IEC 17024
Accreditation of a personnel certification body is the
process of assessing and publicly recognizing the
credibility, impartiality and technical competence of an
organization’s personnel certification or registration
services.
Personnel certification or registration bodies provide
services for many professional personnel.
This is a requirement for bodies that certify or register
persons e.g. auditors, inspectors, drivers, electricians,
doctors, nurses, etc.
The certification body should be able to demonstrate
that it has fulfilled the requirements for certifying or
registering persons including the development and
maintenance of a certification scheme for persons.
Accreditation is based on their professional competency as prescribed by ISO/IEC 17024 - Conformity
Assessment - General requirements for bodies operating certification of persons.
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3. Accreditation of Product Certification Bodies - ISO/ IEC 17065
Product certification is a means of demonstrating that a product, process, or service satisfies specified
requirements. This is a scheme that evaluates the technical competence, integrity and independence of
product certification bodies, based on the general requirements of ISO/IEC 17065– Conformity AssessmentRequirements for bodies certifying products, processes and services.
Implementation of ISO/IEC 17065 ensures that the product certification bodies operate certification schemes in a
competent, consistent, objective and impartial manner; thereby facilitating the recognition of such bodies.
The overall aim of certifying processes, products or services is to give confidence to all interested parties that a
process, product or service fulfills specified requirements. The value of certification is the degree of confidence and
trust that is established by an impartial and competent demonstration of fulfillment of specified requirements by a
third-party.
KENAS accreditation attests that a product certification body has demonstrated: -
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
It is competence to perform specific product certifications or specific types of product certifications;

Its quality system is documented, is fully operational, and addresses and conforms to all elements of ISO/IEC
17065;

It is operating in accordance with the required quality system and

It is fulfilling or meeting the requirements of customers.
INSPECTION & VERIFICATION
SCHEME
The KENAS Inspection and Verification accreditation program, provides inspection bodies
with a means of demonstrating to their customers their competence and professional skills in
executing inspection and verification mandates in conformance to ISO/IEC 17020
(Conformity assessment - Requirements for the operation of various types of bodies performing inspection) International Standard.
Accreditation of Inspection & Verification Bodies ISO / IEC 17020
This accreditation service is
available to all bodies that
conduct in-house and
independent services, from one
person operations to large-scale
inspection and verification bodies
e.g. inspection of speedometers,
motor vehicles, buildings, axleload, chemicals, agricultural
produce, imported and local
products, oil, gas, plant and
machinery, etc.
Inspection and verification
accreditation is the formal
recognition of the competence of
an organization and its
inspectors. Accreditation,
confirms the capability to perform
defined inspection and
verification mandates.
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This allows customers to readily
identify organisations which are
able to meet their needs.
Inspection and verification
accreditation allows an
organization to benchmark itself
against the relevant industries’
best practices.
Manufacturers may also use it to
offer clients assurance of their own
in-house inspection and
verification practices.
KENAS has systems that balance
the needs for transparency with
those of confidentiality and
provides impartial and technicallyfocused evaluation of
competence.
STEPS TOWARD ACCREDITATION
Kenya Accreditation Service (KENAS) | Embankment
Plaza, 2nd Floor | Longonot Road, Upper Hill,
Nairobi
P. O. Box 47400—00100 GPO, Nairobi.
Tel: +254 725 227640/ 787 395679
Email: info@kenyaaccreditation.org
Website: www.kenas.go.ke
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