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QMS Development

We develop quality management systems which are tailored to meet the requirements of ISO 13485:2016 and ISO 9001:2015 systems…

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QMS Implementation

Implementing and maintaining ISO 13485:2016 and 9001:2015 quality management systems can be daunting. But fear not, we are here to assist…

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QMS Internal Audit

We conduct Quality Management System internal audit as a means of meeting the requirements outlined in ISO 13485:2016 and ISO 9001:2015…

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We are an authorized training partner of the Professional Evaluation and Certification Board (PECB), a certification body that provides internationally recognised standards training, examination and certification services…

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Building a Culture of Quality: The Role of Leadership in QMS Implementation

| ISO 13485:2016, ISO 9001:2015 | No Comments
In the pursuit of excellence, organizations across industries recognize the critical importance of implementing effective Quality Management Systems (QMS). However, beyond the procedures and protocols lies a fundamental element that…

Demystifying ISO 9001:2015: A Guide to Navigate Quality Management

| ISO 9001:2015 | No Comments
In today's competitive landscape, ensuring the quality of products and services is paramount for businesses to thrive. Among the myriad of quality management standards available, ISO 9001:2015 stands out as…

Securing South Africa’s Medical Future: SAHPRA Mandates ISO 13485 for Medical Devices

| ISO 13485:2016 | No Comments
South Africa's healthcare landscape is in for a significant shift come January 2025. The South African Health Products Regulatory Authority (SAHPRA) is raising the bar for medical device quality by…

Medical Device Safety Matters: Understanding ISO 13485:2016

| ISO 13485:2016 | No Comments
When it comes to medical devices, trust is paramount. We rely on them for accurate diagnoses, effective treatments, and improved health outcomes. Enter ISO 13485:2016, the international standard for achieving…