wfhss conf20070503 lecture09 en

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Procurement of Medical
Products in the „AEMP“*

Renate Zierler
ÖGSV

* Processing Unit for Medical Devices

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ÖGSV R. Zierler Mai 2007

„Introduction“

Procurement

Definition of the term „logistics“

The correct Goods

In the correct Quantity

In the correct Quality

At the right Time

Iin the right Place

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ÖGSV R. Zierler Mai 2007

„Legal basis“

Austria: Purchase Contract Awards Act

2006

Purchase contract awards act

Pharmacy Law

Medical Products Law

Standards

Guidelines

Purchase Contract Awards Act

/

Award of

Contract

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ÖGSV R. Zierler Mai 2007

„Legal basis“

Contract placing

Conformity / Medical Device Act

Testing of Products

Direct Awards of Contract

Purpose

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ÖGSV R. Zierler Mai 2007

„Procurement types“

Operational Procurement

Strategic Procurement

Inventory Procurement

Individual Procurement in case of Need

Disposal- or fabrication synchronal
Procurement „just in time“

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ÖGSV R. Zierler Mai 2007

„Quality Management“

Procurement Processes

Forms, Checklists, Clearing of Complaints

Minimum Stock / Maximum Stock

Prozess Description of the Controls

Ecological View / Waste Management

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ÖGSV R. Zierler Mai 2007

„ Procurement Process“

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ÖGSV R. Zierler Mai 2007

„ Analysis of Needs “

Procurement

of Equipment

Laws and Standards

Communication

Team of the Processing Unit for Medical

Products

Hygiene team

Technician etc.

Reprocessable MP

Instruments

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ÖGSV R. Zierler Mai 2007

„ Analysis of Needs “

Packing Material

EN ISO 11607

Cleaners, Disinfectants

ÖGHMP

VAH (formerly DGHM)

Agents for Instrument Care

Provided for Steam Sterilisation

Penetrable for Steam

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ÖGSV R. Zierler Mai 2007

„ Analysis of Needs “

Textiles

Chemical- proof

Heat- proof

Documentation

Analysis of Training Requirements

Austria: Medical Products Law § 94

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ÖGSV R. Zierler Mai 2007

„Budget“

Investments – Budget planning

Planned Strategic Changings

Effects

Analysis of Needs in Time

Specific Equipment

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ÖGSV R. Zierler Mai 2007

„Choice/Evaluation of Suppliers“

Accurate Analysis of Needs

Detailed Specification

Which Criteria

Strategic choices

Professional consultation

Service

Handling of complaints

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ÖGSV R. Zierler Mai 2007

„Order“

Article, Amount, Date, Location

Frame contract

Handling of Complaints

Which Form

Which Way

Authority to sign

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ÖGSV R. Zierler Mai 2007

„Stock Receipt“

Definition of the Authorized Person for the
Receipt

Receiving Controls

Completeness / Damage

Accordance with the Order

Goods which must be stored cool

Delivery of Machines

Control of Documents

Acceptance by an Independent Testing Laboratory

Training of Eployees etc.

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ÖGSV R. Zierler Mai 2007

„Payment execution“

Goal should be:

In Time

Accurate Execution

Definition of Further Treatment

Accompanying Papers

Procedure in case of damages

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ÖGSV R. Zierler Mai 2007

Danke für Ihre Aufmerksamkeit!

Thanks for your attention!

Merci pour votre attention!

Grazie per la vostra attenzione!


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