Each of the standards requires an internal audit to be performed on the entire Quality Management System at least once during the audit cycle (3 years). Reduce the risk of 3rd party and customer audit findings by performing your internal audit program annually. The internal audit program includes an audit plan & schedule, comprehensive audit of the full QMS with reference to clauses, and audit report of findings, including recommendations to correct nonconformances and listed opportunities for improvement.

Maintaining the supply chain can be a daunting task. Using methods of surveillance and auditing will help keep your supply chain in line. Setting up a supply chain audit includes determination of your and your customer's requirements, applicable standard and regulatory requirements, and develops an audit appropriate to your organization and supply chain flow-down needs. The audit is then carried out on a specified frequency (at least once in the 3rd party audit cycle of 3 years) and results are shared with the organization for analysis and retention.

Once your Quality Management System is complete and you are ready to become certified to your preferred standard, the organization will need to register with an accredited registrar who will send one of their certified auditors to your location to audit and determine if your QMS can be certified under the organization's scope of product and service offerings. 

Is your system ready to become certified or in a need of changing registrars? Melissa Biggin is a Lead Auditor (9001 & 13485) and Team Auditor (9100) for Amtivo, PRI, TUV-SUD, and PRG. All of these registrars are ANAB accredited and accepting new clients. 

Melissa also offers technical review and CB internal auditing services. 

A Gap Analysis provides a comparison of an existing Quality Management System to the Requirements of a current or new standard. If your QMS has fallen behind due to COVID, changes in personnel, or other factors, this option helps to identify areas of major concern which would need to be corrected prior to certification or re-certification. If you are looking to upgrade your system from ISO9001 to ISO13485 or AS9100, a Gap Analysis will determine areas that are acceptable and those that need editions or implementations. The Gap Analysis Report will provide the identification of issues as well as recommendations to correct them.