ISO 13485:2003 Audits and Gap Analysis

Medical device companies must perform internal audits as part of their quality management system on a regular basis to ensure compliance with the ISO 13485:2003 standard. Internal audits are designed to assist companies in assessing the quality system. Failure to conduct these audits can result in poor product quality, loss of certification or lack of process improvement. Emergo Group can help you conduct ISO 13485 internal audits to ensure compliance with European, Canadian, Japanese and other international regulations such as the FDA QSR. Typically, we conduct ISO 13485 and FDA audits for companies that prefer having an independent company conduct these audits, or do not have the resources or expertise to conduct them in-house.

The internal and supplier ISO 13485 audits we conduct for manufacturers should not be confused with ISO 13485:2003 certification audits which are conducted by Notified Bodies, Registrars, Conformity Assessment Bodies and Registered Certification Bodies.

Emergo offers several Quality Management System auditing services for ISO 13485 and FDA QSR (cGMP)

Gap analysis audit – This audit is intended to determine your current level of compliance with ISO 13485:2003 and appropriate quality regulations including Japan Pharmaceutical Affairs Law (PAL), the Canadian Medical Devices Regulations (CMDR) and US FDA Quality System Regulation. The gap analysis is typically conducted before a quality management system is implemented to identify areas of deficiency.

Full or partial internal ISO 13485 audit – Emergo Group provides internal auditing services which allow for an independent review of your full quality system. This audit is customized to your needs and can include the following: MDD/IVDD/ISO 13485, FDA QSR, JPAL, and/or CMDR/CMDCAS regulatory requirements. We can also conduct partial audits focused on specific areas of the quality system where you suspect non-compliances occur or focus on areas where audits cannot be conducted by your in-house internal auditor due to a possible conflict of interest.

Subcontractor or supplier audit – 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.

ISO 13485:2003 pre-certification audit – We highly recommend that a pre-assessment be conducted 4-6 weeks prior to your ISO 13485 certification audit. Our consultants will ensure that you are aware of all non-compliances and how to properly address them before the audit by your certification body.

Please contact us for more information or a free proposal on our ISO 13485 auditing and/or global requirements.