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ISO 9001 vs ISO 13485. What's the Difference, and Which One Does Your Business Need?
If you work with quality systems in South Africa, you have probably heard of both ISO 9001 and ISO 13485 . They sound similar, and they do share some common principles. But they are designed for different purposes, and choosing the right standard for your business matters. So, what is the difference? Here is a plain-English guide. ISO 9001 is for almost any business ISO 9001 is a general quality management standard that can be applied to organisations of almost any size or sector. It is used by manufacturers, service providers, construction companies, schools, professional services firms and many other types of organisations. At its heart, ISO 9001 is about having a consistent, controlled way of working so that you can meet customer and applicable requirements and continually improve your organisation's performance. In simple terms: Understand what your customers and organisation need → control your processes → deliver consistently → monitor what is happening → impr...
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