Health and Safety
The Health and Safety Pillar of KENAS has five accreditation schemes:
(a) Medical Laboratory Accreditation
The general criteria for accreditation of medical laboratories are contained within the ISO 15189:2007 Medical Laboratories- Particular Requirements for quality and competence.
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. Medical laboratory accreditation also provides a formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing and measurement services able to meet the customers’ needs.
Medical laboratory services are essential to patient care and therefore have to be available to meet 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:
- General medical/clinical laboratory accreditation
- Research medical laboratory accreditation
- Forensic medical laboratory accreditation
- Blood transfusion laboratories
- X-ray laboratory accreditation
(b) Medical Reference Laboratories
The general requirements for accreditation of medical reference laboratories are laid down in ISO 15195: Laboratory medicine: Requirement for Reference Measurement Laboratories.
ISO 15195:2003 is not applicable to routine medical laboratories.
ISO 15195:2003 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 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure.
(c)Proficiency Test Accreditation
The general criteria for accreditation of medical laboratories are contained within the ISO 17043:2010 conformity assessment- general requirements for proficiency testing. ISO/IEC 17043:2010 provides a consistent basis for all interested parties to determine the competence of organizations that provide proficiency testing.
(d) Inter Laboratory Comparisons
Inter laboratory comparisons are widely used for a number of purposes and their use is increasingly 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 problems in laboratories and imitation of actions for improvement which, for example, may be related to inadequate test or measurement procedures, effectiveness of staff training and supervision;
- 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, and other organizations that specify requirements for laboratories.
All Medical, Veterinary, Pharmaceutical and General testing & calibration laboratory are required to participate in recognized/ accredited proficiency testing where applicable or possible.
(e) Veterinary Laboratory Accreditation
The general criteria for accreditation of Veterinary Laboratories are contained within ISO/IEC 17025:2005.
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: Infectious Diseases, 2008.
Additional requirements supplement ISO/IEC 17025:2005 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 GMO.
These specific requirements also are designed to complement any applicable regulatory requirements that may affect government veterinary laboratories (state, regional, national, and international.)
(f) Pharmaceutical Laboratory Accreditation
The general criteria for accreditation of pharmaceutical laboratories are contained within ISO/IEC 17025:2005. There is a need for global acceptance of this form of accreditation in Kenyan pharmaceutical laboratories to achieve national and global recognition, as well as conformity against international standard led to the establishment of an accreditation programme for pharmaceutical laboratories under the auspices of Kenya Accreditation service (KENAS).
Requirements for accreditation
Pharmaceutical laboratories seeking accreditation need to comply with the following requirements:
- The quality management, scientific and technical aspects of pharmaceutical laboratories as determined by ISO/IEC 17025 regulatory documents which may have been developed by the KENAS Pharmaceutical Technical Committee (KPTC).
- Participation in proficiency testing or inter-laboratory comparisons, where possible.
- What is Accreditation?
- Testing Laboratories
- Health and Safety
- Inspection and Verification
- Proficiency Testing Providers
- Directory of Accredited CABS
- Gazetted Fees
- ISO/IEC 17021-1:2015 Conformity assessment – Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
- ISO/IEC 17024:2012 Personnel Certification
- ISO/IEC 17065:2012 for Products,Processes and Services