FDA QSR (GMP) & ISO 13485 Quality System Auditing and Supplier Audits
Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards. Failure to do so can result in poor product quality, loss of certification or lack of process improvement. Medical device companies often ask us to conduct FDA compliance audits and/or audits of their system to ensure compliance with the FDA Quality System Regulation, European Device Directives, Japan's PAL and Canadian Medical Device Regulations (CMDR). Typically, we perform audits for companies because they do not have the resources or expertise to conduct the audit, or they prefer having an independent company conduct the audit.
Emergo Group offers several quality management system auditing services:
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Gap analysis audits - This is an audit in which we will determine your current level of compliance with the appropriate quality regulations including FDA QSR, ISO 13485, Japan PAL and/or CMDR. The gap analysis is typically conducted before a system is implemented to identify areas of deficiency.
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Pre-assessment audits - We highly recommend that a pre-assessment audit be conducted 2-4 weeks prior to a certification audit. Our consultants will ensure that you are aware of all non-compliances and how to properly address them before your certification audit.
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Full or partial internal audits - ISO and FDA QSR (GMP) require that manufacturers conduct regular internal audits of their quality management systems. Emergo Group provides internal auditing services which allow for an independent review of your full quality system. We can also be contracted to conduct partial audits where we focus on specific areas of the quality system where you suspect non compliances occur or have occurred, or focus on areas where audits cannot be conducted by your in-house internal auditor due to possible conflict of interest.
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Subcontractor or supplier audits - Critical suppliers must be "controlled." This is not only a good business practice, but often also a regulatory requirement. For example, if your device is manufactured by a subcontractor, it is your responsibility to ensure their manufacturing processes meet the appropriate standards and regulations. Emergo Group can conduct on-site supplier audits on your behalf to ensure that the activities you contracted them for are being executed according to your specifications and applicable regulations.
Please contact us for more information or a free proposal on ISO or FDA QSR quality system audits.
