Big 4 Agenda

Accreditation is an enabler and a driver for quality in universal health care, affordable housing, food security and manufacturing which are the components of the Big 4 agenda.

Accreditation provides a framework for Conformity Assessment Bodies (CABs) to improve their processes and outcomes, which stimulates continuous quality improvement in service delivery for every Kenyan. Conformity assessment activities include laboratories that carry out general testing, medical testing, calibration; inspection bodies and certification bodies.

Accreditation of such bodies will provide an independent confirmation that they can consistently provide high-quality services and products to Kenyans. This will, in turn, provide the desired credibility, reliability and trust that will enable trade in goods and services on the global market, thereby reducing technical barriers to trade, a principle embraced by the World Trade Organisation (WTO).

In simple terms, Accreditation is a process that allows a business to be seen as a knowledgeable body that can carry out a specific task.

KENAS accredits conformity assessment activities as follows: –

1) Testing, calibration and sampling laboratories to ISO/IEC 17025

2) Medical laboratories & diagnostic imaging facilities to ISO 15189

3) Point of care testing to ISO 22870 & ISO 15189

4) Proficiency testing providers to ISO/IEC 17043

5) Inspection bodies to ISO/IEC 17020

6) Certification bodies for

i. Management Systems to ISO/IEC 17021-1

ii. Personnel to ISO/IEC 17024

iii. Product, process and services to ISO/ IEC 17065

Accreditation: Delivering Confidence in the Manufacturing Sector

The Government of Kenya seeks to raise manufacturing sector GDP contribution from 8.5% to 15%.

Accreditation assures confidence to businesses, consumers, suppliers, purchasers and regulators that products placed on the market are safe, of quality and that they meet the manufacturers’claims made about them.

The manufacturing sector is crucial for the achievement of Vision 2030 and is arguably the most important for job creation because of its strong forward and backward linkages with other sectors of the economy. So as to achieve the above target, the government intends to improve on the ease of doing business, increase industrial parks, market access, and uptake of standards.

Manufacturers need confidence that raw materials and component parts used in the manufacturing process meet standards for quality and performance requirements.

Testing and inspection of manufactured products for consistency of quality and compliance with market specifications reduce the risk of product failures and recalls.

Regulators, business communities and consumers need confidence through certification that a manufacturer conforms to safety and environmental regulations and standards.

In the manufacturing sector, accreditation is provided based on the following standards:-

1. Testing of raw material and component used in manufacturing e.g. agri-products, finished food products, plastics, oil and gas, detergents, paints and coatings, toys and consumer goods, textiles, apparels and leather, glass, cosmetics, construction products, electronic goods to ISO/IEC 17025.

2. Calibration of measurement equipment in manufacturing to ISO/IEC 17025.

3. Inspection of design and items of equipment e.g. sub-assemblies and assemblies, production capability assessment, construction of pipework, pipelines, valves, pressure systems, storage vessels and tanks, process plant and systems, carriage of dangerous goods by rail or road work place and facilities, inputs and finished products prior to dispatch accredited to ISO/IEC 17020.

4. Management system certification to ISO/IEC 17021-1 e.g.

• ISO 9001 Quality Management Systems (QMS),
• ISO 14001 Environmental Management Systems certification (EMS)
• ISO 50001 Energy Management Systems (EnMS)
• ISO 22301 Business Continuity Management Systems (BCM),
• ISO 27001 Information Security Management
• ISO 45001 Occupational health and safety
• ISO 55001 Asset Management Systems
• ISO 28000 Supply Chain Security Management Systems (SCSMS)

5. Product certification of manufactured products to ISO/IEC 17065.

6. Certification of persons working in the manufacturing sector e.g. welders, electricians, and food handlers, to ISO/IEC 17024.

Accreditation: Delivering confidence in the building sector

The demand for decent homes far outstrips supply, particularly in the low-cost and affordable segment, making it an important area of action. Accredited conformity assessments and Standards are market-based tools that are used in the construction sector to deliver confidence and safety in the buildings and homes.

Kenya is facing a shortage of affordable housing which directly and indirectly contributes to the development of slums and poorly serviced informal settlements near the urban areas.

To address the shortage of affordable housing, the government has undertaken to facilitate the provision of 500,000 housing units by 2022.

Accreditation comes into perspective by focusing on the ways and means of supporting professionalism in the construction industry by ensuring that standards and regulations in the construction and built environment are implemented.

Accreditation supports the construction sector to meet its need for smarter, cleaner and safer construction by providing assurance into the safety of the workforce on-site, the quality and origin of construction production and raw materials, energy efficiency of buildings, the quality of design and architecture, the safe installation of electrical and gas networks, and the long-term sustainability of buildings.

Standards and accredited conformity assessment are market-based tools that are important in the construction sector to cover construction products and materials, building techniques and practices, on-site health & safety, environmental impact, and even the use of digital technology for housing.

In the housing sector, accreditation is provided based on the following standards;

1. Material testing e.g. testing of steel, concrete, timber etc. to ISO/IEC 17025

2. Products certification for building material to ISO/IEC 17024

3. Green buildings certification to ISO/ IEC 17065

4. Inspections for compliance to building code to ISO/IEC 17020

5. Certification of persons in the housing sector e.g. energy auditors, welders, personnel in non-destructive testing, plumbers, electrical technologists and technicians to ISO/IEC 17024

6. Calibration of equipment to ISO/IEC 17025

Accreditation: Delivering confidence in patient care

The health sector plays a pivotal role in economic growth and poverty reduction. Universal healthcare is supported by accredited medical laboratories that carry out diagnostic tests and produce accurate and reliable results leading to correct diagnosis and treatment thus better health outcomes.

A healthy nation means a more productive nation and therefore the reason why the government is investing in Universal Health Coverage (UHC) is to ensure access to quality and affordable health care for all Kenyans.

KENAS recognizes the importance of quality healthcare to patients across Kenya. KENAS accredits medical laboratories, Point of Care Testing (POCT) providers, diagnostic imaging facilities, pharmaceutical laboratories, healthcare professional certification bodies in the public and private sector and non-governmental organizations.

Accreditation of healthcare providers forms the technical foundation for supporting healthcare services through ensuring the quality of medical tests results, that support attainment of the highest standard of health as envisioned in Article 43 (1) (a) of the Constitution of Kenya 2010 and as articulated in the government’s Big 4 Agenda.

Medical laboratory accreditation supports affordable healthcare by promoting efficiency and reducing costs resulting from repeat testing and the effects of misdiagnosis.

Medical test reports should be accurate, reliable and trusted thereby providing patients with confidence in laboratory services.

The provision of Point of Care Testing (POCT) in the community is on the increase, whereby vital signs and tests are monitored and performed at the patient’s bedside, doctors’ offices, triage, ambulatory care and by on-site paramedics. POCT and medical laboratories are accredited to assure quality.

The primary goal of accreditation is to ensure that healthcare facilities not only perform evidence-based practices but also give importance to access, affordability, efficiency, quality and effectiveness of healthcare.

In the healthcare sector, accreditation is provided based on the following standards: –

1. Medical laboratories & diagnostic imaging facilities to ISO 15189

2. Point of Care Testing to ISO 22870 & ISO 15189

3. Pharmaceutical laboratories to ISO/IEC 17025

4. Proficiency testing providers to medical laboratories to ISO/IEC 17043

5. Inspection bodies that inspect medical facilities and devices to ISO/IEC 17020

6.Certification of health facilities to ISO/IEC 17021-1 & KQMH (Kenya Quality Model for Health)

7.Certification of persons for healthcare professionals’ certification and licencing bodies to ISO/IEC 17024

Accreditation: Supporting the delivery of sufficient, safe and nutritious food

The productivity and health of citizens can only be assured if they have access to enough quantities of food to meet their nutritional needs and also safe food so that their health and safety is guaranteed.

Accreditation supports access to safe food, clean drinking water and quality agricultural products.

The Government of Kenya (GoK) has continued to give agriculture a high priority as an important tool for promoting national development and ensuring 100% food and nutritional security for its people. Food security is defined as existing “when all people at all times have physical, social and economic access to sufficient, safe, nutritious food that meets their preferences and dietary needs to maintain a healthy and active life”.

Food security can only be assured if food production is increased and enhanced through quality inputs, good agricultural practices and good post-harvest practices. In order to achieve food security, the government intends to increase arable land under cultivation, increase irrigated agriculture, use locally blended fertilizers and avail initiatives for post-harvesting handling practice. Food security is guaranteed through accredited conformity assessment activities including testing, inspection and certification to food safety management systems which ensures accessibility to safe food and reduction in waste through post-harvesting losses.

It is critical that consumers access nutritious, safe food and are confident in the quality and safety of food that they consume. This confidence is gained through the application of common food safety management systems supported by credible testing and inspection regimes that are accredited.

In the food and agricultural sector, accreditation is provided based on the following standards: –

1. Veterinary laboratories, verifying phyto-sanitary requirements to ISO/IEC 17025 & OIE

2. General testing in the areas of food products, agricultural inputs e.g. fertilizers, water, soil, heavy metals, agricultural produce, microbiological requirements to ISO/IEC 17025.

3.Pharmaceutical laboratories, testing vaccines and toxicological agents (pesticides and herbicides) to ISO/IEC 17025

4. Calibration of measuring equipment used in testing and inspection to ISO/IEC 17025

5. Proficiency testing providers to testing and calibration laboratories to ISO/IEC 17043.

6. Inspection bodies that inspect agricultural inputs, produce and products to ISO/IEC 17020

7. Product certification e.g. seed certification and food fortification to ISO/IEC 17065

8. Management systems certification to ISO/IEC 17021-1 (FSMS/HACCP)