Bespoke Quality Management Systems
Your priority is providing patients with the highest standard of care and we are here to support you. To complement our comprehensive range of services, we provide the expertise of our registered healthcare professionals to assist with all your Quality Management System (QMS) needs, ensuring full compliance with ISO 9001, ISO 13485, and South African regulations.
WHO WE ARE
Qualiphy QMS Consulting
QUALITY – more than just a check box , it’s your pathway to success.
Qualiphy, is a premier consulting firm dedicated to serving the medical device and pharmaceutical sectors. Our primary focus is on assisting companies in establishing and maintaining robust Quality Management Systems (QMS) that are meticulously tailored to their unique operational needs. With a focus on ISO 13485 and ISO 9001 compliance, we offer a comprehensive suite of services.
Quality management consulting
Comprehensive support for the planning, integration, and establishment of QMS
Regulatory compliance services
Guidance through the process of regulatory license applications and amendments
Training and development
Training for staff on implementing and sustaining a QMS, covering all core aspects
Documentation
Creation and enhancement of critical QMS documentation
Providing our clients with the confidence that their QMS meets the highest standards.
OUR SERVICES
With a focus on ISO 13485 and ISO 9001 compliance, we offer a comprehensive suite of services
Documentation
Creation and refinement of critical QMS documentation such as Site Master Files, Quality Manuals, SOPs, and other essential working documents to ensure regulatory alignment.
QMS Implementation
Comprehensive support for the planning, integration, and establishment of a Quality Management System tailored to meet ISO 9001 and ISO 13485 standards.
Training Programs
Training for staff on implementing and sustaining a QMS, covering all core aspects of quality management to build confidence and competence within the team.
License Applications & Amendments
Guidance through the process of regulatory license applications and amendments, ensuring accuracy and adherence to regulatory standards.
Regulatory & Client Audit Support
Assistance in preparing for regulatory audits and client inspections, from initial preparation through response planning and corrective action support.
Quick Contact
Need help or have questions? Our team is ready to assist—contact us below.
©2024 Qualiphy QMS Consulting, All Rights Reserved