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ISO 13485 INTERNAL AUDIT CHECKLIST ISO
This would result in failing to get certified or losing your ISO 13485 certification. Your organization can only really fail if you ignore the auditor’s suggestions for fixing non-conformances. ISO 13485 audits don’t technically result in a “pass” or “fail” grade. The auditor may produce a list of non-conformances which have to be corrected before you can be certified or receive recertification. The auditor will review documentation, controls, internal audits and management review, and all relevant processes. This is a comprehensive evaluation of your organization’s compliance with ISO 13485:2016 standards. Stage 2 audits typically last several days. An ISO auditor from your certifying body will provide a report of positive and negative findings to determine whether your company is ready to proceed to stage 2. Stage 1 and Stage 2 audits differ in duration, depth, and scope. The best ISO 13485 audit checklists can help you prepare for both stages or an internal audit prior to certification or recertification. ISO 13485: 2016 requires Stage 1 and Stage 2 audits. The Best ISO 13485 Audit Checklists to Ensure Readiness With a solid ISO 13485 audit checklist, you’ll sleep well at night knowing your quality systems are up to standard. Nevertheless, you don’t need to live in constant fear of an audit. The company wasn’t following protocol for CAPA, complaint handling, acceptance activity, or purchasing controls. Recently, a Kentucky-based company made headlines for a failed audit. Too many organizations fail their ISO 13485 audits because the quality team wasn’t careful to prepare with assessments. Medical device manufacturers aren’t guaranteed recertification, either. The standard includes 77 clauses, so there are a lot of opportunities to fall short.
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An ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails.