<h1 class="entry-title">Category: ISO 13485</h1>

ISO 13485 QMS Planning vs. Quality Plans

July 19, 2021 ISO 13485 QMS Planning vs. Quality Plans   I think it’s important to remember that the general quality management system planning and set-up called for by ISO 13485 clause 5.4.2(a) is fundamentally distinct from clause 7.1’s product/project/object/output-oriented planning.  If they were the same, then ISO TC/210 would not have separated and distinguished […]