So how do we go about using the principles, techniques and tools described in the preceding chapters to set up quality management and/or risk management systems in an IVF lab? As we have already said, in truth these goals cannot be limited to the IVF lab, they must involve the entire IVF Center, all its operations and all its personnel. However, for the purposes of this book, we can consider some specific areas that are pertinent to the lab that will illustrate how they are inherent to proper lab management.

Methods design and selection

The same principles apply whether we are designing a new (or revised) method ourselves, or selecting one of several variant methods that exist in the literature. When someone in Industry wants to have someone make or build something, or perform a task, or provide a service for them, they establish a comprehensive set of criteria specifying all aspects of what is to be done or provided. These specifications are often described as the “user requirement specification” or URS, and establish the detailed framework within which the work will be done. Creating such specifications is, in reality, a universal principle that can – and should – be applied whenever one individual or organization is supplied a product or service by another.

Particular matters relating to the provision of services by another organization, e.g. estradiol assays by an external endocrine assay lab, are discussed in the following section on “Third-Party Services.”