ISO 15189 – MEDICAL LABORATORIES-REQUIREMENTS FOR QUALITY AND COMPETENCE

MODULE 5. Requirements and Procedures for Records

MODULE V. Procedures and records requirements from all parts of 15189

Course Objectives 

This Module examines ISO 15189 records requirements, from all relevant Clauses including 4.13.

The clinical laboratory is required to exercise good control of the records it generates, and this module examines this concept as described throughout the standard. Examples of record control processes are discussed.

Control of records is explicitly or implicitly stated throughout all parts of 15189 and there are no requirements that do not imply sufficient control of the records that demonstrate fulfillment of requirements.

Module 5 is divided into the following Parts:

Part 1: Understanding of the requirements contained in 15189

Part 2: Samples of requisite laboratory control of records.