ISO 15189 Resource Centre
Important Note to Users of this Site: Although this site is intended to be a useful information resource for those seeking to implement and maintain effective laboratory quality management systems, www.iso15189.com is not affiliated with and does not act on behalf of the International Organization for Standardization (ISO), which is the organization that develops and issues international standards, including the ISO 15189 standard. The URL of the official web site for ISO is located atwww.iso.org.
The most notable differences between ISO 15189:2007 and ISO 15189:2012 include:
1. Improved layout and listing of subclauses to make it easier to identify specific subclauses within the document;
2. A more logical ordering of subclauses under each clause, wherever possible, to reflect the normal
flow of activities in a laboratory setting.
3. Additional normative sections (5.9 and 5.10);
4. Clause 5.8 of ISO 15189:2007 has been split into the requirements for reporting (5.8) and release of results (5.9);
5. Clause 5.10 is a new section in relation to Laboratory Information Management which has been taken from Annex B - this was previously informative.
A complete analysis of the updates can be found at the following link: UPDATES