certified internal auditor for medical device companies

Five criteria for a certified internal auditor program of medical device lead auditors for ISO 13485 quality systems auditing and supplier auditing.  Five criteria are essential to a certified internal auditor program:

1. formal training by a qualified trainer
2. an exam to demonstrate the effectiveness of training
3. practical experience
4. observation of actual audits by an experienced lead auditor
5. documentation

Internal auditors do not need a certificate from a third party (i.e., someone other than your company or customers), and training programs do not need to be accredited. Your company can save money and develop an in-house certification program. The only reason why third-party certification and accreditation are needed is 1) if your internal auditor procedure requires it or 2) if you are training to become a third-party auditor working for a certification body or registrar. Therefore, I don’t recommend writing a procedure that requires a certificate from a third party or an accredited program. Write your internal auditor training requirements to allow flexibility, but ensure you include each of the five elements listed above.

1. Formal training by a qualified trainer

Formal training is planned and has a documented curriculum. The curriculum can consist of one long course over several days, or you can limit the duration of each class to an hour over several months, and you can develop a schedule to fit individual needs. Training should be customized to a certain extent for each internal auditor, but most programs have at least one primary lead auditor course that everyone must complete. A qualified trainer must also deliver formal training.

2. An exam to demonstrate the effectiveness of training

I have written about the use of exams to document training effectiveness. You can use a combination of multiple-choice questions, fill-in-the-blank, short answer, and essay questions for an exam. However, to demonstrate the effectiveness of auditor training, one evaluation method is superior to all others: writing nonconformities. If you provide a hypothetical scenario to an auditor, the auditor should be able to write a complete nonconformity. This exercise tests the auditor’s ability to identify the applicable regulatory requirements, assess conformity, grade nonconformities, and select the appropriate wording of the nonconformity and associated objective evidence. The only downsides to writing nonconformities are: 1) they are more challenging for instructors to grade, and 2) the grading is subjective.

3. Practical experience

The most common way to document the previous experience of internal auditors is to include a copy of the person’s resume in their training record. However, I recommend using a tracking log for all audits to identify which auditors conducted which audit. Ideally, you want to use an electronic database that allows you to search the database using the auditor’s name as a search field. Your database should also indicate which role the auditor was fulfilling: 1) lead auditor, 2) team member, 3) trainee, or 4) observer. Sometimes, the person may have multiple roles (e.g., team member and trainee or lead auditor and observer).

4. Observation of actual audits by an experienced lead auditor

It doesn’t matter if training is remote and recorded or live and in-person, but remote and recorded training needs to be balanced with an observation of actual audits by an experienced medical device quality system auditor. “Observation” needs to be defined, but I recommend using a controlled form to document observations. Attached to this form is a completed observation form, a copy of the audit notes, and a copy of the audit report, which creates a complete record to demonstrate the trainee’s observation of each audit. Just don’t make your controlled form overly burdensome. A single page is fine–as long as it consists of more than yes/no checkboxes. “Experienced” also needs to be defined, but I recommend the following combination of qualitative and quantitative experience. First, an experienced lead auditor must have documented formal training, but formal training does not need to be third-party training. Second, an experienced lead auditor should have completed at least 100 audits. One hundred is an arbitrary number, but that number represents more than 1,000 hours of audit preparation, auditing, and report writing. Anything less than 1,000 hours is inadequate to be qualified to begin training others.

5. Documentation

Documentation must include all of the above elements. You need to document the training plan for each internal auditor, and it must meet minimum training requirements–which should be documented in your internal auditing procedure. Your documentation should include the minimum criteria for qualification of a trainer–often a resume, and adding the person to your approved supplier list is sufficient. You should document the results of any formal quizzes and exams for training effectiveness. Auditing experience for each person should be documented. Specifically, you should have a form listing a description of the scope and dates for each audit during the certification process. Auditors’ Observations need to be documented, and any corrections or recommendations for improvement should include documented follow-up. If an auditor already has extensive experience before joining your company, your procedures should allow for a written justification instead of repeating the training. If your company uses a software tool to manage training, I recommend creating a separate training group for internal auditors rather than incorporating internal auditing into another job description and/or training curriculum.

What Really Matters

Whether your internal auditor training is effective and internal auditors are competent matters. Certificates make pretty training records to post on the wall of your cubicle. Competent internal auditors identify quality issues before you receive an FDA 483 or a nonconformity from your certification body. Competent auditors also add value by identifying ways to make processes more efficient and opportunities to save money. If you are looking for a qualified trainer to provide formal training in a public venue or in-house, please visit the following webpage: http://bit.ly/Lead-Auditor-Course.