ISO 15189 : Genial Genetics

iPassport QMS can support work towards multiple sets of standards, including ISO 15189, Standards for Medical laboratories. The ISO 15189 standards are particular requirements for quality and competence. Accreditation to these standards is done through implementation and maintenance of the quality system which is accomplished through management of laboratory policies and procedures.

iPassport QMS can manages all document types needed to work towards ISO standards including SOPs, Policies and MSDS sheets. QOPs, WDIs, product inserts, research papers and journal articles can be linked to SOPs and policies and managed as external documents. iPassport QMS also enables you to comply with ISO 15189 Document Control standards. iPassport QMS records when documents became approved and controlled. Any amendments can be logged when a new version of the document is created. It also sets review dates to ensure that documents are reviewed at regular intervals for relevancy. There are system audits to provide a master list of documents on the iPassport QMS database. Obsolete documents can be made inactive and appear inactive on document enquiries and searches. iPassport QMS also manages training records to demonstrate compliance with staff competency standards.

If policies and procedures are documented and managed via iPassport QMS, the laboratory can implement a quality system meeting requirements of ISO 9000.

Demonstrating compliance with the ISO 15189 sets a basis for medical laboratories, who can also simultaneously manage work towards accreditation to particular disciplines. iPassport QMS can manage requirements for quality so that medical professionals can spend their time on patient care.