Internal Auditor Exchange Program (IAEP) Gives a Qualifying Boost to Medical Device Companies
By Seamus Kennedy

Developing, implementing, and maintaining a quality management system is an all-important concern for every medical device company. Qualifying for ISO 13485 (medical device standards) can be a centerpiece for manufacturing companies’ operations. The focus of ISO 13485 is that regulatory requirements are a management responsibility.

The standard also scopes such concerns as work environment, risk management, inspection, traceability, documentation, and verification of correct and preventive actions. Moreover, this standard is seen as the first step towards compliance with regulations of the European Union, Canada, and Japan, as well as the regulatory requirements of the FDA. One significant concern to ISO 13485 qualification is the need for a second auditor. Most OBA medical device companies do not have two internal auditors, and many are without a certified auditor.

The OBA Internal Audit Exchange Committee (IAEC) has recently addressed these needs, and has developed the Internal Auditor Exchange Program (IAEP). This program provides for an exchange of internal auditors, plus a job shadowing program as well as volunteer opportunities for maintaining internal auditor certifications. In conjunction with this exchange, OBA’s BioPro will offer internal auditor training classes.

Exchanging talent can lead to best practices

The IAEP supplies internal auditors by identifying needs and scope, and databasing auditing competencies from each of the participating companies. The committee also reviews host companies’ policies and procedures, to match qualifications for an external auditor. In this way, the exchange program arranges for experienced auditors who can quickly begin addressing specific quality management systems issues.

The outcome is understanding and implementing best practices for ISO 13485 certification. By nature, IAEP fosters independence and objectivity, and does so without any exchange of money. Committee member Jack McCutcheon of SAM Medical notes that this exchange helps companies avoid outside vendor costs by utilizing talent from within the association’s membership.

Mentor/shadow program assists internal auditors in training

The IAEP Review committee provides opportunity for training in a Mentor/shadow program. Using its database, the program can join trainees with seasoned professionals to increase understanding of internal audits.

Volunteer opportunities help internal auditors maintain certification

IAEP offers external volunteer opportunities for auditors who are seeking to maintain their certification. Both shadowing and volunteering bolster the preparation and quality of internal audits of OBA participating companies.

BioPro soon to offer internal audit training

Keeping pace with compliance needs, BioPro will be announcing training in conjunction with IAEP. Heather Deibele, IAEC chair, notes that these classes will provide elements of audit, worksheet examples, open-ended questions, and basic tools to develop understanding of industry needs.

To sell products globally, companies need to start with ISO 13485 certification. OBA member companies are poised to increase their qualifications by increasing their internal audit savvy. This in turn supports certifications, and furnishes access to enter the world market. As Dan Hill, BioPro workforce training director, points out: “Training is our great starting point.”

Seamus Kennedy is a business communicator, who deals with effective packaging of verbal, nonverbal, written and visual communication. What we say and how we say it can add strength to even our clearest message, and Seamus helps individuals and organizations to bolster their ability to get their message across. His public speaking and presentation classes, for example, have garnered the attention of local press. skennedy@imagina.com