A Quality Management System ensures that all activities are under control and all activities together are leading to a safe, effective and efficient product or service. This will help you to deliver a high-quality product or service.
Groots In Vitro Diagnostic Expert is your excellence partner for developing, implementing, and maintaining quality management systems that comply with Quality Management System standards as described below.
ISO 13485
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
ISO 9001
This International Standard specifies requirements for a quality management system where an organization:
- Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Do you need support with setting up or maintaining your quality management sytem?
Contact our senior consultant Lizette