Please Review the following statements or questions carefully and determine what ISO 15189:2012 Clause/Sub-clause would apply to the topic identified in the statement or question: i.e where would you find the relevant guidance and/or information in the ISO 15189:2012 Standard about that topic.

Tip: You may find reference to a topic in one or more sub-clauses.

 

Example:  

Statement: An assessor has asked to see the lab’s procedure for disposal of human samples or tissues

Answer: Clause: 4.1.1.3d (Requirement: Laboratory management shall have arrangements in place to ensure that there are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements)