Program Overview
The OBA Internal Auditor Exchange Program (IAEP) is designed for Oregon Bio members who are in a regulated GxP industry and maintain a Quality Management System. This includes companies associated with medical devices, diagnostics, biologics, pharmaceuticals, or analytical laboratories. These industries typically require that companies monitor the effectiveness of their Quality Management System by performing routine internal audits to ensure overall compliance.
Since many Oregon Bio member companies are small to medium in size, they often find themselves resource limited. Depending on the nature of the business and location of sales, the governing regulations and standards may vary and may include more than one regulation or standard. Examples may include ISO 13485, ISO 9001, 21CFR Part 820, 21CFR Part 211, and directives such as EU MDD, IVDD, AIMDD, and/or Canadian Medical Device Regulation.
Over the past five years, three Oregon Bio member companies have developed a successful program to exchange auditors between their companies to conduct internal audits and maintain compliance. Oregon Bio is now expanding it to all Oregon Bio members as a member-only benefit.
The primary objectives of this program are to:
- Connect two companies that want or need external help for their internal audits.
- Offer training through BioPro and audit shadowing or mentoring opportunities to help "qualify" people to become internal auditors.
- Match volunteer auditors to companies that don't yet have qualified internal auditors.
Companies or auditors interested in participating in the program should review the IAEP Recommendations, a guidance document that was developed to assist the host companies and internal auditors in conducting a successful and valuable exchange audit.
If you or your company are interested in participating in the IAEP program, please complete the Statement of Interest and submit it to iaep@oregonbio.org. The IAEP Review Committee will make recommendations based on your specific needs.
Roles and Responsibility of Committee
The IAEP steering committee is responsible for the overall program requirements of the IAEP:
- implementation of a short application process
- general IAEP guidelines
- training and mentoring programs applicable to internal audits
- an evaluation process to monitor the program success and effectiveness
Internal Auditor Exchange Program Committee Secure Area (requires login)