ISO 19011:2018 Changes: How They Impact Medical Device QMS Auditors
Management system standards such as ISO 13485:2016 define the requirements that auditors are reviewing for conformance – the what – but they don’t get into the details of how to audit against them. ISO 19011, on the other hand, does just that – it provides a methodology to guide auditors in doing their work by adding further context and guidance. ISO 19011 was previously updated in 2011. Since then, the practice of auditing has evolved in the ways that audits […]
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