Quality Management Systems
Throughout the validity period of a certificate, a client is obliged to inform HTCert accurately, honestly, timely and in detail regarding any plan for substantial changes to the quality system or the covered product-range.
Notification is made by submission of Substantial Change Notifications Form.
Medical Devices Certified according to MDD 93/42/EEC
The manufacturer must inform HTCert of any plan for substantial changes to the quality system or the covered product-range.
Changes to the approved design must receive further approval from HTCert whenever the change could affect conformity with the essential requirements of the 93/42/EEC Directive or with the conditions prescribed for use of the product.
Notification is made by submission of Substantial Change Notifications Form.
Note
Substantial changes might include but are not limited to:
- legal / commercial / organizational status or ownership;
- critical (e.g. key managerial or decision-making or technical) staff;
- contact address and sites;
- scope of operations under the certified management system;
- major changes to the management system and processes
- significant increase or decrease of employees
HTCert recommends clients to directly communicate any question related to the characterization of a change in order to get a common understanding.
