This topic was submitted to my suggestion box from a colleague in Australia. For brevity sake, I’ll limit my comments here to ISO certification body auditors and exclude FDA inspectors. The basic approach is the same, but there are some important nuances. Maybe FDA inspectors will be a future blog…http://medicaldeviceacademy.com/blog/.

Auditor Personality
100% of auditors are a little weird (yep, takes one to know one). You travel for a living and tell people what’s wrong with their quality system. If you don’t start out drinking scotch, you probably will eventually. However, a little patience, understanding and over communication helps. For example, provide directions (that are accurate). Recommend a hotel (middle of the road, not the Ritz or a flea bag). Tell them about the corporate discount. Ask them in advance if they have food allergies (I’m gluten-free, and not by choice), and then try to remember not to serve only the things they are allergic to (yes, Panera Bread is a crappy choice but a gluten-free pizza is heaven). If Uber makes sense recommend it, because nobody wants to negotiate with Payless Rent-A-Car at 11:59pm.

Ego
Everyone has one. Auditors typically have a big one. I’m not shy, I’m smart and I love a good debate. If I’m you’re auditor, you’re lucky because I’ll admit when I’m wrong or make a mistake. Most auditors will not admit mistakes. In fact, the stronger they argue a point the more likely that they are insecure on the topic or that they have a personal preference that is a result of a bad experience.

Don’t ask them to prove it to you. Don’t ask them to show you in the standard. Instead, try reading Habit 5 by Covey (7 Habits of Highly Effective People). You need to be an empathic listener. The auditor doesn’t hate you. They might even be trying to help you. They also might be wrong, but try restating what the auditor is saying in your own words and try explaining why it’s important. This shows them that you were listening, you understand what they said and you understand how they feel about the issue. Pause. Then tell them how you were trying to address this issue.

Incompetencies
You don’t have time during the audit to retrain your auditor. Don’t even try. I do this for a living and we’re a stubborn bunch of orifices. Instead, try the empathic listening first. 99% of the time one or both of you is not communicating clearly. Either they can’t find what they are looking for, or they misunderstood what you were telling them. It could be a difference of interpretation, but it’s probably not. If it is, then say “We were interpreting that requirement as…”. Say this once. If they argue, let it drop for now.

Resolution
You shouldn’t just take incorrect findings lying down. Do your homework. Send me an email. Get help. If you’re right, then contest it at the closing meeting in a factual and persuasive way. If the auditor holds their ground, ask what the policy is for resolving disputes. This is supposed to be covered as part of the closing meeting of every audit. If your auditor is just lazy, sloppy and incompetent–request a new auditor. You might even disagree in writing, address the finding anyway and then request the new auditor. That shows the management of the certification body that you’re not lazy, sloppy or incompetent.

Caution
If you make a habit of disputing everything, your auditor will come prepared for war. You also will have little credibility with the managers at the certification body. Dispute only things that are justified and provide a written, factual justification that is devoid of all emotion.

PS – I just announced a CE Marking and 510(k) submission workshop to be hosted at University of Oxford on February 9, 2016:

http://medicaldeviceacademy.com/ce-marking-workshop-and-510k-submissions-workshop/

source: https://www.linkedin.com/groups/2070960/2070960-6077845574726537219