Good auditors are always in demand regardless of if the QMS being evaluated is premised on 21 CFR, Part 820 (FDA’s QSR); ISO 13485: 2003; EN ISO 13485:2012; ISO 9001:2008; or AS 9100. Auditors are a unique group of individuals capable of blending intellect, integrity, tenaciousness, humility, a sense of humor, and auditing demeanor (in Dr. D’s opinion, Da meaner, Da better; just kidding).

Additionally, the doctor strongly believes that there is some value in having a certified lead auditor to ride herd over an organization’s internal audit program; however, having a lead-auditor certification in every conceivable regulation and standard, not so much. Folks – Dr. D is sorry if his tone is borderline quality sacrilegious when talking about paying for external training; however, there is more value in being out there in the field and actually auditing versus spending an eternity in classrooms. If an organization feels that formal auditor training, formal auditor training, and more formal auditor training will have an overwhelming impact and “redound” (look-it-up) on the organization’s approach to quality, it is the doctor’s belief the money can be better spent elsewhere, like buying a bridge. Did Dr. D mention he is selling the Bay Bridge? Auditors should be adequately trained, and possess the appropriate level of experience and education, period! That being said, Dr. D hopes you enjoy this week’s brief guidance. 

For those of you familiar with ISO 19011:2011, I am sure you are aware that there is no formal requirement for auditors to be certified. If a registrar or notified body states that your auditors must be certified, PUSH BACK! If they continue to insist their interpretation of ISO 19011 is correct, ask for a new auditor that actually comprehends applicable standards and regulations. The doctor also strongly suggests that you recommend having the auditor that fails to interpret the certification requirement correctly to read ISO 19011:2011, Clause 7, all of it! Did the doctor mention your organizations actually pay registrars and notified bodies for their abuse; excuse me – audit support? ISO 19011 contains some excellent points associated with ensuring auditors have the appropriate level of training and experience.  

The following list should not be construed as all inclusive. Dr. D recommends reading ISO 19011 for an all-inclusive list of auditor attributes. However, some of the more important skills, knowledge, and personal attributes associated with a good auditor (the doctor’s opinion) are:

• Integrity;
• A good sense of humor;
• Open mindedness;
• A good sense of humor;
• Tactfulness when dealing with people;
• A good sense of humor;
• Observant;
• A good sense of humor;
• Perceptive and capable of comprehending complex systems and processes;
• A good sense of humor;
• Tenacious;
• A good sense of humor;
• Ability to make decisions;
• A good sense of humor;
• Ability to be fair and objective;
• A good sense of humor;
• Able to act independently of others;
• A good sense of humor;
• Interact appropriately and constructively with others;
• A good sense of humor;
• Sensitive to cultural differences;
• A good sense of humor;
• In depth knowledge of quality management systems;
• A good sense of humor;
• Understanding potential statutory requirements impacting an audit;
• A good sense of humor;
• Knowledge of special processes (when deem necessary);
• A good sense of humor;
• Ability to collect and organize evidence of compliance and non-compliance;
• A good sense of humor;
• Appropriate level of education;
• A good sense of humor;
• Good written composition skills;
• A good sense of humor;
• Ability to accurately formulate non-conformances when noted;
• A good sense of humor;
• Applicable audit training;
• A good sense of humor
• Practical experience (most important in Dr. D’s humble opinion); and
• A good sense of humor.

Did Dr. D mention that auditors really do need to possess a good sense of humor? Levity is great way to break the ice and lower the stress and tension typically associated with an audit.

As previously stated, there is no formal requirement to have auditors and lead auditors certified; however, it would be considered prudent to have at least on certified lead auditor to manage an organization’s audit program and to assist with auditor selection and training program. If resources are limited, you can always employ a 3rd-party firm such as Devine Guidance International, Inc. Dr. D would love to have the opportunity to help your organization improve their QMS.

For this edition of DG, the doctor will lead the readers with two takeaways. One – there is no better way to gain the appropriate level of audit experience than actually performing audits. Two – although there is no formal requirement for auditors to be certified, it would be considered prudent to have at least one lead auditor with a current RAB certification (regardless of standard). In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided.

Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success. 

References: 

1. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. ISO 9001:2008 (2008, November). Quality management system- requirements (ISO 9001:2008).
4. ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
5. ISO 19011:2011. (2011, November). Guidelines for quality and/or environmental management systems auditing (ISO 19011:2011).