July 29, 2021 FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation My experience has been that FDA views a test method as a process that produces an output. And if such output can’t be fully verified, then it must be validated. Since FDA’s 21 CFR §820.72 is not generally related […]
<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 […]
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