3.5 Procurement

Provision of external products and services

The management must define in procedural instructions how equipment, medicines, medical products (medical supplies), food and services are procured, how suppliers are assessed and selected, how the products and services are accepted and incorporated into the processes.

The quality requirements of the hospital with regard to the intended purpose must be fulfilled by the suppliers and their subcontractors. The type and scope of the measures with which the management ensures compliance with the requirements (QM presentation) must be defined. This also applies to the procurement of services such as laboratory, X-ray or therapy services or the awarding of major building services.

If necessary, products or services of subcontractors must be tested. The hospital management must be aware that the responsibility for the quality of the procured products always remains with the hospital itself. Environmental protection and disposal issues should be taken into account from the outset.

Meaningful documents must be created about the procurement process. As far as applicable, it must be possible to state the exact designation of the product or service, whether instructions were given to the personnel and how the products are handled.

Documents on operation, test instructions, relevant technical information, handling authorizations and staff qualification requirements should be formally implemented. Consideration should be given to the control of defective products in procurement in order to protect patients from harm, avoid unjustified costs and sustainably support the contractual relationship between suppliers and hospitals.

The management should take environmental protection into account in all regulations for hospital operations, in particular in procurement, the economical use of disposable products, energy and water, hygiene, cleaning, occupational safety and waste disposal.

The regulations can make use of the system developed in the standards (DIN EN ISO 14000). Appropriate proof of compliance with environmental protection requirements should be provided.