Journey to Excellence: Unpacking the World of ISO 9001 and ISO 13485
Welcome to our Blog archive where we will give insights and information that can help you to a better Quality Management Solution.
ISO 13485 Consultants in South Africa
A Game Changer for Medical Device Manufacturers in South Africa In the dynamic and highly regulated medical device industry, quality assurance and patient safety are paramount. This is where ISO 13485 certification comes into play. As an international symbol of quality, it is no surprise that obtaining ISO 13485 certification is crucial for medical device…
Is ISO Certification Compulsory?
When it comes to quality management systems, one question often arises: Is ISO certification compulsory? The short answer is no, but there's more to this than meets the eye. Let's dive into the details. What is ISO Certification? ISO certification of a Quality Management System means you comply with all the requirements of the applicable…
The Impact Of The International Standards Organization Quality Management System
Accreditations Dr J. C. Stoltz Introduction Quality management is a challenging topic with an abundance of different views on what to do and how to do it (Knowles, 2011), and in order for companies to make sense of it all, impartial guidance is required, since Knowles (2011) warns that quality standards are for guidance purposes…
A Conceptual Model to Assess the Impact of Quality Management
Accreditations Dr J. C. Stoltz INTRODUCTION Quality management is a challenging topic with different views on what to do and how to do it (Knowles, 2011), and in order for companies to make sense of it all, impartial guidance is required, since Knowles (2011) warns that quality standards are for guidance purposes and not a…
EXPLORING THE IMPACT OF A QUALITY MANAGEMENT SYSTEM ON THE
Introduction The updated medical device Regulations introduced mandatory certification to ISO 13485:2016 - a Medical Device (MD) and In Vitro Diagnostic (IVD) industry-specific standard. The study was undertaken to access the impact of mandatory ISO certification within the IVD industry and to develop a theoretical framework for practical relevance. Methods A concurrent mixed method research…
What is ISO 13485?
ISO 13485:2016 defines quality management system (QMS) requirements for organizations producing medical devices. Based on ISO 9001, the ISO 13485 standard is a stand-alone document with specific requirements for medical device manufacturers, including a greater focus on risk management and additional documentation requirements. Note that this standard is based on ISO 9001:2008, not the more…
ISO 13485 Quality Management System Consulting
Unlocking Certification Excellence: ISO 13485 Quality Management System Consulting In today's competitive healthcare industry, ensuring the safety and effectiveness of medical devices is paramount. This is where ISO 13485, the internationally recognised standard for quality management systems in the medical device industry, comes into play. Implementing ISO 13485 is not only a SAHPRA requirement but…
What Does Being ISO Certified Mean
If you've ever worked in a company, you may have come across the term "ISO certified." But what is ISO and why is it important? Does it have an impact on your business? In this blog post, we will explore the meaning and benefits of ISO certification of a Quality Management System What does it…
Choosing the Right ISO Consultant: Your Comprehensive Guide
Selecting the right ISO consultant is a critical decision that can significantly impact your organisation's path to ISO certification. An experienced, competent consultant will not only streamline your certification process but also help you leverage ISO standards to enhance your business operations and efficiency. Here's a checklist of factors to consider when choosing an ISO…
