This International Standard specifies requirements for a quality management system to be used by an organisation involved in one or more stages of the life cycle of manufacture, supply and operation of a medical device.
In relation to ISO 13485, we offer the following services:
- Implementation of the requirements of the standard and preparation for the certification audit.
- Implementation of internal audits according to the requirements of the standard.
- Maintaining the established quality management system from the position of quality manager.
- Provision of documentation manager or metrologist services as required by the standard.
- Reviewing your organization's internal documents in accordance with ISO 13485 requirements.
- Revision of the existing quality management system according to ISO 13485, simplification of the system or integration with the requirements of other ISO standards.
- Training of your employees in the requirements of ISO 13485.
- Training of key positions for the quality management system, i.e.
- Quality manager,
- Documentation manager,
- Internal auditor.
- An overview of scheduled training dates can be found in the Training section, or we can arrange individual training sessions just for your employees.