Quality

Medius’s consultative arm, the Medius Control Quality and Compliance Consulting Team, offers quality consulting services and on-site quality management workshops for users of Medius Control software and non-users alike on core quality processes (CAPA, audit management, risk management, supplier management, and document management) to help regulated companies not only comply with international regulatory standards, but also gain a competitive edge in the marketplace. The workshops, which are based on industry best practices, and are not software specific, are delivered at the customer’s facility and can be customized to focus on GxP, ISO, or other compliance considerations. The quality consulting services are ideal for any company that needs hands-on help identifying the strengths and weaknesses in its quality management system (QMS), or developing a system from scratch if one is not in place. Quality coaches are available to work on-site to guide a quality team throughout the QMS implementation process.

We work with only the most reputable registrars to ensure your certification has the proper national and international recognition for your industry. We also ensure your registrar “partner” is well suited to work with you to continually improve your quality management system and organizational effectiveness.

Quality Consulting Services Offered

• Quality Management System (QMS) Consulting.
• Audit (Internal and for your suppliers).
• Training.
• Supplier Management.

Quality Standards

• Medius Quality Consulting works with all of these quality standards:
• Quality Management Systems Requirements – ANSI/ISO/ASQ Q9001-2000
• The International Aerospace Quality System Standard, Revision B – SAE AS9100 Revision B
• Environmental management systems – Requirements with guidance for use – ANSI/ISO/ASQ E14001-2004
• Quality Systems – Automotive Suppliers – Particular Requirements for the Application of ISO 9001:2000 – ISO/TS 16949:2002
• Medical devices – Quality management systems – Requirements for regulatory purposes (e-standard) – ISO 13485:2003
• General requirements for the competence of testing and calibration laboratories – ANSI/ISO/IEC 17025-2005