The standard includes 77 clauses, so there are a lot of opportunities to fall short.Īn ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails. Medical device manufacturers aren’t guaranteed recertification, either. Too many organizations fail their ISO 13485 audits because the quality team wasn’t careful to prepare with assessments. The format of the checklist encourages the auditor to document objective evidence of compliance based on the organization’s. The audit plan includes an ISO 13485 audit checklist of required tasks. Recently, a Kentucky-based company made headlines for a failed audit. Clause 8 of the ISO 13485 addresses the importance of audits, citing that a manufacturer must plan and perform internal audits on a regular basis. The company wasn’t following protocol for CAPA, complaint handling, acceptance activity, or purchasing controls. Nevertheless, you don’t need to live in constant fear of an audit. 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. ISO 13485: 2016 requires Stage 1 and Stage 2 audits.

The best ISO 13485 audit checklists can help you prepare for both stages or an internal audit prior to certification or recertification. Stage 1 and Stage 2 audits differ in duration, depth, and scope. 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 2 audits typically last several days. This is a comprehensive evaluation of your organization’s compliance with ISO 13485:2016 standards.

The auditor will review documentation, controls, internal audits and management review, and all relevant processes. The auditor may produce a list of non-conformances which have to be corrected before you can be certified or receive recertification. ISO 13485 audits don’t technically result in a “pass” or “fail” grade.

Your organization can only really fail if you ignore the auditor’s suggestions for fixing non-conformances. This would result in failing to get certified or losing your ISO 13485 certification.

Free iso 13485 internal audit checklist