![]() ![]() Length of a Pro QC Internal Audit Assessment This third-party Internal Audit Assessment may come before a recertification audit that establishes continued compliance. Thus, a medical device manufacturer with an existing ISO 13485 certification may hire a third-party audit company to verify continued compliance. And it is always difficult for an organization to examine itself with the same objectivity and detachment an outsider can apply. A third-party audit expert such as Pro QC conducts this intermediate audit or series of audits. A medical device manufacturer that has prepared for ISO 13485 certification by building its quality management system will want to comprehensively assess for gaps before proceeding with a second-party audit that could lead to certification. This is considered a high-stakes audit because the auditor serves as a registrar (or accredited certification body) that determines ISO certification status. It is recommended that buyers should regularly perform monitoring audits on their critical suppliers.Ī second-party organization audits for compliance to ISO standards and awards the certification (or “registration” in ISO’s terminology). This requires the organization and its employees/operators to follow procedures and continuously improve their own system. It is merely a framework that guides the organization in deploying best practices. The ISO 13485 QMS is not a one-time event. Many factories initially seem to have a high quality capability but over time their performance declines. Monitoring the effectiveness of your supplier’s quality best practices. ![]() The results of the analysis can help buyers decide whether to do business with the supplier, work with them to resolve issues, or disqualify the supplier outright. An internal audit assessment conducted at a supplier will detail where the supplier meets the ISO 13485 standard and where it does not. Medical device manufacturers increasingly rely on suppliers for specialized materials, software, packaging, and labeling.
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