Workshop - Fulfilling the requirements of ISO 15189

Aims

During this workshop the ISO 15189 standard will the point of departure for all activities. The main objective is that for the topics involved you will attain an in depth understanding of what the standard requires and how you can translate this into practical measures in your laboratory. More specifically, after the workshop you should be able to:

Perform a management review in your laboratory

-You can explain what the added value of a management review is;
-You can describe the different elements that constitute the process of a management review according to ISO 15189;
-You know which persons need to be involved in a management review for your laboratory and together with them you can prepare the review both on the level of content (what are you going to review) as on the level of process (what methodology are you going to use);
-You develop an efficient report of the management review.

Use participation in External Quality Assessment schemes as an integral part of the Quality Management System in your laboratory

-You can explain what is required for ISO 15189 when participating in interlaboratory comparison;
-You know how to find and select the appropriate EQA scheme for your laboratory (and if no existing schemes are available you can choose the equivalent alternatives);
-You can define the added value for your laboratory of the participation in an EQA scheme and link it to the other elements in your QMS;
-You can describe the process of an EQA schema and the roles and responsibilities of the different parties involved;
-You know how to follow up the results of an EQA scheme (report + comments), you are able to develop an action plan that is understood and driven by the different people in your laboratory.

Perform Internal quality control in your laboratory

-You can define the concept of ‘internal quality control' and you can link it to the various elements of the QMS in your laboratory;
-You have developed an action plan on how to build in various control checks to verify whether the QMS in your laboratory is attaining its goals.

Last changed: 2008-12-15