Quality Oversight Visits
ISO Quality Management
We offer ISO consulting programs to assist you in developing and implementing an effective Quality Management System (QMS) that meets the requirements of ISO 13485, Council Directive 93/42/EEC for CE marking of medical devices, the FDA QSR and Medica Device Single Audit Program (MDSAP). We provide a full range of services such as:
- Development and implementation of new QMS
- Upgrade or optimization of your existing QMS to establish compliance with additional standards
- Conduct second party audits, including pre-certification audits
- Development and implementation of documentation systems
- Assistance in certification audits
ISO 13485 Internal Audits
QA INSIGHT assists in internal auditing of the client ISO 13485 quality management systems.
We focus on compliance of your Quality Management System with applicable standards and regulations and on effectiveness of its implementation. Our goal is to help you to optimize your documentation, increase repeatability of your processes and identify opportunities for improvement.
Our contract internal auditing service will help you to stay on schedule and get a professional and impartial assessment of your ISO 13485 quality management system.
Subcontractors / Suppliers Audits
Taking care of maintenance and improvement of your Quality System you cannot neglect control and management of your suppliers.
Supplier quality management has emerged as one of the leading business practices.
Supplier Audits are one of the best ways to ensure that supplier is following the processes and procedures that you agreed to during the selection processes.
The supplier audit identifies non-conformances in manufacturing process, shipment process, engineering change process, invoicing process and quality process at the supplier.
- +972 52 6134368
- P.O.Box 7746 Haifa, 3107701, Israel
- info@qa-insight.com