Again written and supported by the Canadian delegation to ISO TC 212 Working Group 1, it still contains the content of the standard, interpretation and guidance and tips on implementing the requirements. The guides and tips are designed for use in laboratories with a range of size and complexity. It will be helpful and useful for medical laboratories in many countries
Most or all of the editing issues that needed addressing in the first edition have been much improved. The book contains both table of contents, and an index, and contains all the annexes.
It is available through the Canadian Standards Association web-site (www.ShopCSA.ca) at a fair and reasonable cost.
One of the themes that I have raised before is that in many countries, medical laboratory accreditation is NOT a requirement, and in some places where it is a requirement, there are allowable options for accreditation to requirements other than ISO15189:2007. But in many countries, medical laboratorians recognize the value of implementing this standard on a voluntary basis because of its superior quality management and its international application.
Some who go through voluntary implementation go further by applying for voluntary accreditation.
Both these steps provide great value to the laboratory that makes the commitment because ISO quality implementation and accreditation can be the basis of international recognition, business opportunity and all the benefits that accrue: higher satisfaction, lower costs, improved patient safety.
PS: A third iteration of 15189:XXXX is underway and may be available in 2013.