Qualitas can help with your compliance auditing needs.
We have ASQ, Certified Quality Lead Auditors that can conduct audits for compliance to FDA 21 CFR Part 820, Good Manufacturing Practices (GMP) and ISO 13485:2016.
Internal audit – Are you in compliance with your internal procedures / requirements as well as the medical device industry specific Quality and regulatory compliance? Qualitas can come onsite to conduct an internal audit.
Supplier audit – Make sure your critical suppliers are meeting your quality requirements and regulatory requirements. We can conduct onsite supplier audits to review compliance with your quality agreements and to help mitigate risk product / process risk.
External Audit – We can represent you in an external audit for ISO certification. Qualitas can come alongside your team to provide representation for your company during the ISO 13485:2016 certification audit. We can come in prior to a third-party audit to review your quality management system and answer questions asked by the auditor during the certification stage 1 or stage 2 audits.
Qualitas is available to represent your company and sit alongside your team during your continuing assessment audits and can help with post-audit wrap-up.
Qualitas utilizes a process approach to auditing, which provides a comprehensive way to review an area of the company by looking at inputs / outputs and the interactions between them for objective evidence. At the completion of an audit, we will provide comprehensive, detailed audit reports to the client for their review and inclusion within their QMS.
If you have already had an audit and were issued nonconformities / findings, Qualitas can help you address the findings and mitigate the risk to maintain compliance with the standards.
Helpful Links: FDA and Medical Device Industry