SCHEME DEVELOPMENT

Background

KENAS develops new accreditation schemes or extends scopes under existing operational accreditation schemes in response to emerging market, industry and business needs that may be initiated by, but not limited to Accreditation Scheme Managers (KENAS), Regulators, Government agencies (MDAs), Trade associations, Conformity Assessment Bodies or Professional Bodies.

This process involves the engagement of technical expertise drawn from Conformity Assessment Bodies, users of the accredited conformity assessment services, business & industry, research & academia, government & regulators who form the Technical Working Groups.

Recently Developed

1. Accreditation of Medical Devices Certification Bodies based on ISO 13485

The ISO 13485 accreditation framework is an essential component of the global conformity assessment system for the medical devices industry. It offers a well-structured and internationally accepted approach that enables organizations to prove their ability to consistently meet regulatory requirements and maintain effective quality management systems in the design, production, and distribution of medical devices. Unlike broad quality management standards, ISO 13485 is specifically focused on the unique safety, performance, and regulatory demands associated with medical devices throughout their entire lifecycle. This covers all stages, including design and development, manufacturing, storage, distribution, installation, servicing, and eventual disposal. The importance of accredited ISO 13485 certification can be viewed from several dimensions:

a. Patient safety and public health

Medical devices directly impact diagnosis, treatment, and patient outcomes. ISO 13485 ensures that manufacturers consistently produce devices that meet safety and performance requirements. The standard places strong emphasis on risk management and lifecycle control, reducing the likelihood of device failures.

b. Regulatory Compliance and Market Access

ISO 13485 aligns closely with global regulatory frameworks (e.g., EU MDR, FDA requirements), making it a gateway standard for accessing international markets. Accredited certification demonstrates that an organization meets harmonized regulatory expectations, facilitating trade and reducing technical barriers.

c. Confidence in Conformity Assessment

Accredited certification ensures that assessments are conducted by competent bodies, enhancing trust among regulators, healthcare providers, and consumers. This is particularly important in high-risk sectors like healthcare where failures can have severe consequences.

d. Operational Efficiency and Continuous Improvement

The standard drives structured processes, documentation, and performance monitoring. This leads to improved efficiency, reduced waste, and better decision-making within organizations.

2. Accreditation of Survey Equipment Calibration Laboratories

Surveying underpins nearly every aspect of modern infrastructure—roads, buildings, land boundaries, utilities, mining, and environmental management. At the heart of accurate surveying lies the reliability of the instruments used, such as total stations, GNSS receivers, levels, drones, and distance meters. The survey equipment calibration accreditation scope, aligned with ISO/IEC 17025, provides a formal framework for ensuring that laboratories performing calibration of such instruments are technically competent, consistent, and traceable to international measurement standards. Accreditation in this scope involves the assessment of calibration laboratories that verify and adjust survey instruments to ensure their measurements are accurate within specified uncertainties. The accreditation process evaluates key elements including ut not limited to technical competence of personnel, suitability and traceability of reference standards, measurement uncertainty estimation, environmental controls, equipment maintenance and calibration intervals.
Through accreditation, calibration results issued by laboratories are internationally recognized under mutual recognition arrangements, ensuring confidence in measurement results across borders.

3. Accreditation of Inspection of Passenger vehicles Body Construction

The inspection of passenger vehicle body construction is a specialized conformity assessment activity that ensures vehicles, especially public service vehicles (PSVs) such as buses, minibuses, and coaches, are designed and manufactured in line with applicable safety, structural, and regulatory requirements. In Kenya, the implementation of KS 372 is supported and enforced by the National Transport and Safety Authority (NTSA), which plays a key role in ensuring compliance within the transport sector.

Accreditation of inspection bodies under ISO/IEC 17020 and KS 372 provides formal recognition that these bodies are competent, impartial, and consistently capable of carrying out vehicle body inspections in a reliable manner.

This ISO/IEC 17020 accreditation scope generally includes inspection activities covering:

  1. Structural integrity of the vehicle body, including the frame, joints, and welding quality
  2. Passenger safety features, such as seat anchorage, emergency exits, and fire safety provisions
  3. Compliance with approved design specifications and body layouts
  4. Roadworthiness aspects linked to body construction standards
  5. Assessment of modifications and conversions, such as transforming vans into PSVs

Inspection may be conducted at various stages, including during fabrication, upon completion of body construction, or periodically throughout the vehicle’s service life. With accreditation in place, these inspections are performed using standardized methods, competent personnel, and properly calibrated equipment, ensuring that findings are consistent, credible, and legally defensible.

In this system, NTSA provides regulatory oversight and enforcement of KS 372, while accredited inspection bodies support compliance verification, helping to improve passenger safety and ensure uniform application of standards across the transport sector.

4. Accreditation of Gas Detectors and Breathalysers Calibration Laboratories

Calibration of gas detectors and breathalysers sits at the intersection of public safety, occupational health, and law enforcement. These instruments are used to detect hazardous gases in workplaces and to measure blood alcohol concentration (BAC) in drivers. Because their readings directly influence safety decisions—and, in the case of breathalysers, legal outcomes—their accuracy must be beyond question.

Accreditation of calibration laboratories in this scope, typically against ISO/IEC 17025, provides formal assurance that laboratories are technically competent to calibrate these instruments and produce reliable, traceable results. Within this accreditation scope, laboratories perform calibration of:

  1. Gas detectors (fixed and portable) for gases such as carbon monoxide, methane, hydrogen sulfide, and oxygen
  2. Breathalysers used by traffic enforcement agencies
  3. • Supporting equipment such as gas flow controllers and calibration gas delivery systems

The calibration process involves exposing instruments to certified reference gas mixtures of known concentration and verifying that the instrument readings fall within acceptable limits. Through accreditation, the results issued by these laboratories are recognized as credible, consistent, and internationally acceptable.

Importance of Accreditation in this Scope
a. Protection of Human Life and Safety

Gas detectors are critical in industries such as oil and gas, mining, manufacturing, and confined space operations. Inaccurate readings can lead to undetected gas leaks, explosions, or toxic exposure. Accredited calibration ensures that these instruments function correctly, safeguarding workers and the public.

b. Integrity of Law Enforcement

Breathalysers are widely used in enforcing drunk-driving laws. Calibration accuracy is essential because results may be used as legal evidence. Accreditation ensures that measurements are reliable and defensible in court, reducing disputes and wrongful penalties.

c. Regulatory Compliance

Many safety and environmental regulations require regular calibration of gas detection equipment. Accredited laboratories provide assurance that organizations comply with these requirements using recognized and competent services.

d. Confidence in Measurement Results

Accreditation builds trust among regulators, industries, and the public by ensuring that calibration results are technically valid and traceable. This is especially important where measurement results have safety or legal implications.

e. Risk Management and Operational Continuity

Accurate gas detection supports early warning systems, allowing organizations to respond promptly to hazardous situations. This minimizes downtime, accidents, and financial losses.

Newly developed accreditation schemes

1. Validation & Verification scheme based on ISO/IEC 17029

ISO/IEC 17029 accreditation provides for competent and independent third-parties to evaluate the validity of claims relating to Green House Gas emissions and to ensure that claims are not empty or exaggerated, but factual. Validation and verification as conformity assessment are understood to be a confirmation of reliability of information declared in claims. Validation is applied to claims regarding an intended future use or projected outcome (confirmation of plausibility), while verification is applied to claims regarding events that have already occurred or results that have already been obtained (confirmation of truthfulness).

KENAS in the month of September 2023 completed the development and has operationalized the Validation and Verification accreditation scheme for environmental information with a focus on the aviation industry for the Carbon Offsetting and Reduction Scheme for International Aviation (CORSIA) scope initiated by the International Civil Aviation Organization (ICAO). It is an industry requirement for ICAO that Validation and verification Bodies, validating and/or verifying claims for carbon emissions in the aviation industry are accredited to ISO/IEC 17029 and ISO 14065.

2. Forensic Testing Based on ISO/IEC 17025

Forensic testing is the scientific analysis of evidence used in criminal investigations, legal proceedings, and regulatory compliance. Forensic testing laboratories play a critical role in the justice system by ensuring that evidence is examined with precision and impartiality, contributing to public safety and the fair administration of justice.

Accreditation is essential to maintaining the integrity of forensic evidence and the justice system. By adhering to internationally recognized standards such as ISO/IEC 17025, accredited forensic laboratories demonstrate their commitment to competency, impartiality, and quality management. Accreditation ensures that forensic results are accurate, reliable, and scientifically valid. These accredited results enhance legal integrity by reducing the risk of wrongful convictions and strengthening the justice system.

Periodic assessments provide confidence that forensic testing laboratories employ qualified personnel who conduct tests using validated methods; utilize calibrated and well-maintained equipment to ensure precision; uphold transparency, ethical practices, and impartiality always.

3. Non-Destructive Testing Based on ISO/IEC 17020 & ISO/IEC 17025

Non-Destructive Testing (NDT) encompasses to a range of techniques used to evaluate the properties and structural integrity of materials, components, and systems without causing damage. NDT is vital across industries such as aerospace, construction, manufacturing, and energy, ensuring safety, compliance, and quality control.

Accreditation of NDT inspection bodies and laboratories is crucial for ensuring the reliability and accuracy of inspection reports and test results. Facilities performing NDT services adhere to internationally recognized standards such as ISO/IEC 17020 for and for inspection bodies ISO/IEC 17025 testing laboratories. Compliance with these standards assures that personnel, procedures, and equipment meet stringent quality and technical requirements.

Accreditation provides assurance that NDT laboratories and inspection bodies operate at the highest standards of accuracy and professionalism. Additionally, accredited Non-Destructive Testing services promote regulatory compliance, international recognition, continuous improvement, and contribute to public safety, economic growth, and environmental sustainability.

4. Anti-Doping Testing Based on ISO/IEC 17025 & WADA guidelines

Anti-doping testing is a scientific process used to detect prohibited substances and methods in athletes, ensuring a fair and drug-free sporting environment. These tests are conducted in compliance with the World Anti-Doping Agency (WADA) standards and national anti-doping regulations to uphold integrity in sports and protect athletes' health. Anti-doping testing plays a crucial role in promoting fair competition, protecting athlete well-being, and maintaining public confidence in sports. Accreditation ensures that anti-doping laboratories operate at the highest standards, providing accurate, impartial, and reliable test results.

With the growing concerns over performance-enhancing drugs and doping scandals, ensuring the accuracy, reliability, and credibility of Anti-Doping testing is essential. Accrediting Anti-Doping laboratories based on internationally recognized standards, such as ISO/IEC 17025 and the World Anti-Doping Agency (WADA) guidelines, strengthens trust in sports, ensures compliance with global regulations, and safeguards the future of clean competition.

Accreditation of anti-doping laboratories is essential to ensure the accuracy, reliability, and credibility of test results. This guarantees that testing methods, personnel, and equipment adhere to the highest levels of scientific rigor and impartiality. By enforcing strict quality standards, fostering public trust, and supporting international regulatory frameworks, accreditation plays a fundamental role in the fight against doping.

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