Quality Assurance Agreement (Kenya)

A Quality Assurance Agreement in Kenya governs the relationship between the parties by fixing what each must do.

The Kenya Bureau of Standards (KEBS) is the primary statutory body governing product and service quality standards in Kenya, established under the Standards Act Cap. 496 — now the Standards Act No. 29 of 2016 — administered by the State Department for Industry. KEBS develops, promotes, and enforces Kenya Standards (KS) across all product and service categories, from building materials and food products to electrical equipment, motor vehicles, and healthcare devices. For regulated product categories subject to Compulsory Standards under Section 21 of the Standards Act, compliance with the applicable KS is not optional — products that do not conform to a compulsory standard cannot lawfully be sold in Kenya, and KEBS inspectors have power to seize and destroy non-compliant goods under Section 25 of the Act. The KEBS standardisation mark — the Diamond Mark of Quality for superior products and the Standardisation Mark for conforming products — is issued after KEBS product testing and certification.

The Quality Assurance Agreement in Kenya operates within a broader international and regional quality framework. ISO 9001:2015, published by the International Organization for Standardization (ISO), is the globally recognised standard for quality management systems (QMS) and is the basis for most commercial QA agreements in Kenya. ISO 9001:2015 certification — granted by an ISO-accredited certification body — is increasingly required by government procurement entities under the Public Procurement and Asset Disposal Act No. 33 of 2015 and by multinational buyers operating supply chains in Kenya. The Kenya National Accreditation Service (KENAS), established under the Accreditation Act No. 18 of 2012, accredits testing laboratories, inspection bodies, and certification bodies in Kenya against ISO/IEC standards — KENAS accreditation provides assurance that the QA service provider's testing and inspection outputs are internationally recognised.

In the food and agriculture sector, Quality Assurance Agreements frequently incorporate Hazard Analysis and Critical Control Points (HACCP) requirements under the Kenya Food, Drugs and Chemical Substances Act Cap. 254 (now the Food Safety Act No. 2 of 2019) administered by the Kenya Bureau of Standards (KEBS) and the Kenya Plant Health Inspectorate Service (KEPHIS) under the Kenya Plant Health Inspectorate Service Act No. 54 of 2012. For export-oriented companies, QA Agreements must address the requirements of destination market regulators — the European Union Food Safety Authority (EFSA) for exports to the EU, the US Food and Drug Administration (FDA) for exports to the United States, and the Gulf Cooperation Council (GCC) Gulf Standardisation Organisation (GSO) for exports to GCC countries.

In the construction sector, Quality Assurance Agreements are integral to large infrastructure and building projects, incorporating the requirements of the National Construction Authority (NCA) under the National Construction Authority Act No. 41 of 2011, the KEBS standards for construction materials, and the engineer's quality oversight obligations under FIDIC Conditions of Contract (Red Book, Yellow Book, or Silver Book) commonly used for public and private construction in Kenya. The Quality Assurance Agreement enables the project owner to engage an independent QA consultant — typically a registered engineer under the Engineers Act No. 43 of 2011 — to audit the contractor's quality management system and inspect works throughout the construction programme.

A Quality Assurance Agreement in Kenya is distinct from a quality control (QC) agreement. Quality assurance is a proactive, process-oriented discipline focused on preventing defects through systematic planning, training, documentation, and audit — aligned with ISO 9001:2015 quality management system principles. Quality control, by contrast, is reactive — it involves inspection and testing of finished products or completed activities to detect defects after they have occurred. A thorough QA Agreement may cover both QA and QC activities and should clearly delineate the responsibilities of the QA service provider, the client, and any regulatory body such as KEBS or KENAS.

A Quality Assurance Agreement in Kenya under the Kenya Bureau of Standards Act Cap. 496 and the Law of Contract Act Cap. 23 is required in a wide range of commercial and regulatory situations, and several circumstances make a formal written QA agreement immediately necessary.

A Quality Assurance Agreement is needed when a manufacturer in Kenya — of food products, beverages, pharmaceuticals, cosmetics, building materials, electrical equipment, or motor vehicle parts — engages a KENAS-accredited testing laboratory or KEBS-approved inspection body to audit its production processes and certify that its products comply with applicable Kenya Standards (KS) or Compulsory Standards under the Standards Act No. 29 of 2016. Without a written QA agreement, there is no legally binding basis for specifying the testing protocols, turnaround times, reporting standards, or remediation obligations if non-conformances are detected.

A Quality Assurance Agreement is required when an exporting company engages a KEBS-appointed Pre-Export Verification of Conformity (PVoC) agent in the destination country to inspect goods before shipment. The KEBS PVoC programme covers over 150 product categories and requires exporters of goods destined for Kenya to obtain a Certificate of Conformity (CoC) before shipment. The agreement between the exporter and the PVoC agent must specify the inspection procedures, the applicable Kenya Standards, and the process for handling non-conformances that would prevent issuance of the CoC.

A Quality Assurance Agreement is needed when a construction project owner under the National Construction Authority Act No. 41 of 2011 engages an independent QA consultant — a registered engineer or architect — to audit the contractor's quality management system, inspect materials on delivery, and certify the quality of completed works. Large government infrastructure projects funded by the World Bank, the African Development Bank (AfDB), or bilateral donors typically require a formal QA agreement as a condition of project financing.

A Quality Assurance Agreement is required when a multinational company operating supply chains in Kenya — sourcing agricultural produce, cut flowers, apparel, or handicrafts — engages a third-party QA firm to audit its Kenyan supplier's facilities, labour practices, and product quality against international buyer standards such as GlobalG.A.P., Fair Trade, SA8000, or custom buyer specifications. The QA agreement protects the buyer from liability for supply chain non-compliance and supports the buyer's ESG (environmental, social, and governance) reporting obligations.

A Quality Assurance Agreement is needed when a pharmaceutical company, medical device manufacturer, or healthcare facility in Kenya engages a QA consultant to audit its compliance with Good Manufacturing Practice (GMP) standards under the Pharmacy and Poisons Board (PPB) regulations under the Pharmacy and Poisons Act Cap. 244. QA audits for pharmaceutical manufacturers seeking PPB product registration or WHO-prequalification status must be conducted by qualified QA professionals under a formal agreement specifying the audit scope, methodology, and reporting format.

A valid and enforceable Quality Assurance Agreement in Kenya under the Law of Contract Act Cap. 23 and the Kenya Bureau of Standards Act Cap. 496 must contain the following essential elements.

Parties and Scope of Appointment: Full legal name, Business Registration Service (BRS) registration number, registered address, and contact details of the client and the QA service provider. The QA service provider should state its relevant accreditations and certifications — KENAS accreditation number under the Accreditation Act No. 18 of 2012, ISO 9001:2015 certification, KEBS approval status, or registration as a professional engineer under the Engineers Act No. 43 of 2011. The scope of appointment must precisely describe the products, processes, facilities, or systems subject to QA activities, and the geographic locations where QA activities are to be conducted.

Applicable Standards and Regulatory Requirements: The specific quality standards, Kenya Standards (KS), international standards (ISO, ASTM, BS, IEC), sector-specific regulations (HACCP, GMP, GlobalG.A.P.), and contractual specifications against which the client's products or processes will be assessed. For products subject to KEBS Compulsory Standards under Section 21 of the Standards Act No. 29 of 2016, the relevant compulsory standard number must be identified. For export products, the destination market regulatory requirements must be incorporated, including EU Regulation 2017/625 on official controls, FDA 21 CFR requirements, or GCC/GSO standards as applicable.

QA Programme and Inspection Protocols: A detailed description of the QA activities to be performed — including document review, process audits, in-process inspections, final product testing, sampling plans (statistical or 100% inspection), and laboratory testing methodologies. The sampling plan should specify the lot size, sample size, acceptance quality limit (AQL), and rejection criteria in accordance with ISO 2859-1 or other applicable sampling standard. Laboratory testing methods must comply with the relevant ISO/IEC 17025:2017 standard for testing and calibration laboratories, which is the basis for KENAS accreditation of testing laboratories in Kenya.

Reporting Obligations: The format, content, and timing of QA reports — including inspection certificates, test reports, non-conformance reports (NCRs), corrective action requests (CARs), and audit reports. Reports must be delivered within a specified period after each inspection or audit activity. The QA service provider's reports must state clearly the standard against which the assessment was conducted, the findings, the severity classification of any non-conformances (critical, major, minor), and the recommended corrective actions. Test reports issued by KENAS-accredited laboratories carry international recognition under mutual recognition arrangements between KENAS and accreditation bodies affiliated with the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF).

Non-Conformance and Remediation Procedures: The procedure for handling non-conformances — products or processes that fail to meet the specified standards. The agreement should specify: the timeframe within which the client must respond to a non-conformance report; the corrective action and preventive action (CAPA) process; the re-inspection or re-testing requirements after corrective action; and the escalation procedure if the client repeatedly fails to achieve conformance. For products subject to KEBS Compulsory Standards, the QA service provider's obligation to report persistent non-conformances to KEBS under Section 23 of the Standards Act should be addressed.

Confidentiality: Mutual confidentiality obligations protecting the client's trade secrets, production processes, formulations, and proprietary specifications from disclosure by the QA service provider to third parties, subject to mandatory disclosures to KEBS, KENAS, or other regulatory authorities. The confidentiality obligation should extend to all personnel of the QA service provider who access the client's facilities or documents.

Fees and Payment Terms: The QA service provider's fees — whether per inspection, per day, per audit, or on a retainer basis — expressed in Kenya Shillings (KES); the payment schedule; VAT obligations under the Value Added Tax Act No. 35 of 2013; and withholding tax obligations for professional fees under the Income Tax Act (Cap. 470) administered by the Kenya Revenue Authority (KRA). The withholding tax rate for professional fees paid to resident QA service providers is 5%.

Liability and Professional Indemnity: The QA service provider's liability for negligent inspection or incorrect test results that cause loss to the client — for example, where a QA certificate of conformance is issued for non-conforming goods that are subsequently rejected by the client's customer or seized by KEBS. The liability should be capped at a multiple of the fees paid, with carve-outs for gross negligence and wilful misconduct. The QA service provider should maintain professional indemnity insurance with an IRA-licensed insurer.

Term and Termination: The duration of the QA engagement — project-specific, annual with renewal, or rolling — and the conditions under which either party may terminate, including termination for breach, termination for convenience with notice, and termination in the event of loss of KENAS accreditation or KEBS approval by the QA service provider.

Dispute Resolution and Governing Law: Disputes under the Quality Assurance Agreement are governed by the laws of Kenya and should be referred to mediation under the Nairobi Centre for International Arbitration (NCIA) or to arbitration under the NCIA Rules 2015 before recourse to the High Court of Kenya under the Civil Procedure Act Cap. 21.

Forms-legal.com provides this Kenya Quality Assurance Agreement template for businesses seeking to formalise their quality management arrangements. Companies in regulated sectors — food, pharmaceuticals, construction, and manufacturing — should obtain specialist advice from an advocate admitted to the Roll of Advocates maintained by the Law Society of Kenya (LSK) and from KEBS or KENAS on the applicable mandatory standards and accreditation requirements.

Under the Companies Act No. 17 of 2015, the Registrar of Companies at the Office of the Attorney General maintains the register of Kenyan companies. Section 3 of the Law of Contract Act (Cap. 23) governs contractual obligations. The Competition Authority of Kenya (CAK) enforces the Competition Act No. 12 of 2010. The Kenya Revenue Authority (KRA) administers corporate tax under the Income Tax Act (Cap. 470). The High Court of Kenya has unlimited original jurisdiction under Article 165 of the Constitution of Kenya 2010.