Some clinics advertise the fact that they have ISO certification. This certification is over and above the regulations that their countries regulatory body insist on. The International Organization for Standardization (www.iso.org) is based in Geneva. Quoting from their website: A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.
ISO 9001:2008: One of the most popular ISO certifications and a standard for a quality management system. This standard enables an organisation to demonstrate that its products and services always meet customer’s requirements, and that quality is consistently improved. It is the only standard in the ISO 9000 family that is certifiable. A minor correction led to ISO 9001: 2009 being published
ISO 15189:2007: For medical laboratories, this ISO standard is most relevant. This is used by medical laboratories to develop a quality management system and to assess their ability and competence in running a medical laboratory. This standard is also certifiable.
ISO 14001:2004: Environmental Management Systems. This is another ISO standard sometimes advertised by IVF clinics. This standard specifies requirements for an organisation to implement a policy which respects legal obligations and other conditions relating to environmental aspects.
Certainly, an ISO certification is a good thing to possess as it demonstrates a responsible and professional approach to the field of reproductive medicine. This is very important within the laboratory. It is also beneficial for the whole clinic to be actively operating quality management principles thereby demonstrating a commitment to continual improvement. Whilst some clinics are not yet ISO certified, all clinics must adhere to the regulations which their country lay down before being granted a license. Therefore, you can be confident that even without ISO, the clinics all operate within a strictly defined set of regulations.
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