Event - Workshop - Fulfilling the requirements of ISO 15189 for management review, internal quality control and external quality assessment (WP1.8)

OBJECTIVES

During this workshop the ISO 15 189 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.

FOR WHO?
For those who would like to learn more on management review, internal quality control and external quality assessment.
The participants of this workshop should have a basic knowledge of accreditation and ISO 15189.
These workshops are of equal value to accredited and non-accredited genetic testing labs.
Participants include lab directors, scientists, technicians and quality managers.
The workshops are in English.

REGISTRATION
The registration fee for this workshop is 400 euros per person (500 euros for industrial partners).
The fee covers documentation, restaurant dinner together on Thursday evening, plus two lunches and morning and afternoon refreshments.
Travel and hotel are at the expense of your laboratory.
Registration starts January 2009

CANCELLATION POLICY
For cancellation within 6 weeks of the workshop, 50% of the registration fee is due to cover our costs.
For cancellation within 3 weeks or no-show, registration will be billed in full. There is no penalty if you send someone else in your place.

ACCOMMODATION
Registration fee does not include hotel accommodation. Participants should arrange their own accommodation.

AGENDA
Friday, May 22, 2009

08.30h - 09.00h Registration desk open and welcome coffee
09.00h - 09.30h Introduction and agenda
09.30h - 10.30h IQC and EQA and the requirements of the standard - Case work
10.30h - 10.45h Break
10.45h - 11.45h IQC and EQA and the requirements of the standard - Interactive presentation
11.45h - 12.30h Positive and negative controls - Group discussion

12.30h - 13.30h Lunch

13.30h - 14.45h Follow up of IQC and EQA - Sub group discussion and whole group agreement
14.45h - 15.00h Management review - Presentation and lessons learned
15.00h - 15.15h Break
15.15h - 16.15h Preparation of a management review - Case work
16.15h - 17.15h Management review - Meeting rules
17.15h - 17.45h End of first day

20.00h Dinner with the whole group 

Saturday, May 23, 2009

08.30h - 10.30h Execution of a management review meeting - Role play
10.30h - 10.45h Break
10.45h - 11.00h Management review, report writing and action plan - Presentation
11.00h - 12.00h Management review, quality indicators - Sub group work and discussions
12.00h - 12.30h Q&A
12.30h - 12.45h Summary presentation
12.45h - 13.00h Wrap up and evaluation

13.00h - 14.00h Lunch