Qualiphy QMS Consulting
Your Partner in Quality Management Solutions
Qualiphy QMS Consulting
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Are you ready to take your quality management system to the next level? Contact us today for a consultation or explore our services to learn more about how we can support your compliance journey.

    Our services stand out in the industry due to their unique alignment with the specific regulatory requirements of the South African medical device and pharmaceutical markets.

    We ensure compliance with both local and international standards, providing our clients with the assurance that their operations meet the highest quality benchmarks.

    Furthermore, we offer ongoing support and training to keep our clients' Quality Management Systems effective and up-to-date with evolving industry standards.

    Our scalable consulting services are designed to cater to both small start-ups and large established companies, ensuring that each client receives the personalised attention and resources they require.

    FAQs

    Conduct a gap analysis to compare current practices with SAHPRA, ISO, and other regulatory requirements.

    Develop a project plan that includes resource allocation, timelines, and objectives.

    Draft and approve policies, procedures, and work instructions.

    Train staff on QMS principles and specific procedures.

    Implement document control and record-keeping systems.
    It typically takes 6 to 12 months depending on the organization's size, complexity, and current level of compliance.
    Suppliers should be classified (e.g., critical, major, minor) and monitored based on key performance indicators (KPIs) such as on-time delivery, regulatory compliance, and quality of goods. Regular audits and reviews are essential.
    Regulatory compliance
    Improved operational efficiency
    Enhanced product quality and safety
    Better customer satisfaction