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.

Accreditation schemes and scopes under development

1. Diagnostic Imaging based on ISO 15189

In recent decades, medical imaging has experienced a technological revolution. Accredited radiography/fluoroscopy, mammography, and ultrasound services processes involve peer review evaluations of imaging and processing equipment, physician and technologist staff qualifications, quality control and quality assurance programs, and image quality and, where applicable, radiation dose.

The benefits of accredited Diagnostic Imaging include: Provision of high quality care to patients; Provision of objective, independent attestation that the imaging practice is competent to carry out examinations; Building confidence for patients and referrers that the practice can produce reliable data on which to make patient management decisions; Provision of improved patient outcomes through independent assessments against professionally recognized standards.

2. Bio banking based on ISO 20387

Accreditation to ISO 20387 increases confidence in a biobank’s output and assures customers that crucial requirements are consistently being met. This promotes greater cooperation and harmonization between biobanks to ensure reliable biological material and data is available for use in research and other applications. The ISO 20387 covers the banking of biological materials from multicellular organisms, e.g. Human samples, animal samples, fungal samples, plant samples, microorganisms. Requirements regarding the preparation and long-term preservation of samples and long-term sample traceability, biobank-specific collection and transportation procedures are also considered.

This accreditation scheme will incorporate a review of the activities performed by biobanks to ensure proper collection/ possession of material, authentication of the material, data management, distribution, the appropriate preservation, testing, quality control, distribution and storage of the material.

3. Good Clinical Practice based on the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

GCP is the agreed international standard for conducting clinical research. Good Clinical Practice is recommended for researchers conducting Clinical Trials of Investigational Medicinal Products. Accredited Good Clinical Practice Certification aligned to ISO/IEC 17065 is designed to give the researcher a basic understanding of the regulations and requirements for research using investigational drugs or devices.

Accredited GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Further this aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.

4. GLOBAL G.A.P based on ISO/IEC 17065

GLOBALG.A.P. is the internationally recognized voluntary standard for the certification of agricultural products worldwide for safe and sustainable agriculture practices. This internationally recognized process certification scheme allows farms and farm groups of all size and in all regions to demonstrate compliance with good agricultural practices.

Accredited GLOBAL G.A.P certification gives assurance that farm produce is safe and reliable for consumption. It is a benchmark for product quality through which there is a demonstration of commitment to quality and safety.

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.

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