Product Certification & Medical Laboratory

Product Certification

Product certification demonstrates that a product, process, or service meets set requirements of established international schemes. Accreditation requirements are specified in ISO/IEC 17065 — Conformity assessment — Requirements for bodies certifying products, processes and services.

Owners of product certification schemes include industry associations, regulatory authorities and conformity assessment bodies. These owners can apply to IACAB for either public or private schemes.

Medical Laboratory

ISO 15189:2022 defines particular requirements for the quality and competence of medical laboratories. It may be noted that medical laboratories accredited to ISO 15189 (a sector-specific technical competence and management system standard) are recognized as meeting the management system principles of ISO 9001.

Medical laboratory services are essential to patient care and 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 the laboratory.

Accreditation is available primarily for the following classifications:

• Pathology
• Chemistry
• Cytogenetics
• Hematology
• Histocompatibility
• Immunology
• Microbiology
• Point of Care Testing
• Immunohaematology
• Imaging