ISO 15189:2012 Is the international standard for Medical Laboratories – Requirements for Quality and Competence.
Within the healthcare sector as in most other areas of industry and commerce, the need for organisations to operate formal Quality Management Systems is fast becoming a Commissioner, Service User, and/or Regulatory Authority prerequisite.
Some of the other common healthcare standards currently in place include external certifications such as ISO 22870, ISO 17043, ISO 13485, MHRA, HTA, QSI (Quality Standard for Imaging) and many others. Jim Keegan, FCQI. CQP. has worked in certification, accreditation and compliance for over thirty years, utilising standards generally and internal audits as essential process quality improvement and strategic management tools in all areas of business, commerce and government.
Keegan Consulting Services ('KCS') has been set up to provide clients with professional yet bespoke solutions designed to meet every aspect of their needs as they seek to meet or exceed their chosen Management System requirements. Since early 2007, KCS has worked almost exclusively with Medical Laboratories where they have provided Consultancy and Training primarily to assist Pathology Laboratories and Proficiency Testing Schemes to meet ISO standards such as ISO 17043, ISO 15189 and others. KCS ensures its advisory work is founded upon available guidelines such as those from the Royal College of Pathologists (‘RCPath’), Institute of Biomedical Scientists (‘IBMS’) and United Kingdom Accreditation Service (‘UKAS’).
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