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.