An ISO quality management or environmental management system audit can be an uneasy and stressful time for many people in companies today. This article gives 16 common sense tips for a successful audit are based on real world experiences consulting with dozens of companies and auditors over the past two decades. These tips apply to ISO 9001; ISO 13485; ISO 17025; ISO 14001; RC 14001; AS 9100 or TS 16949 audits.
In my consulting practice I have observed people at all levels in an organization getting “uptight” or having “audit anxiety” about an ISO registration or continuing effectiveness (surveillance) audit by their registrar. Proper preparation can help lower the anxiety level. These tips can help you and everyone in your organization be better prepared for the audit.
- Know your job, roles and responsibilities.
- Know where to find the appropriate procedures, forms and documents; It is o.k. to refer to them to answer questions, do not guess. Be sure all forms and records are up to date and completed properly.
- Be sure your work area is clean and clutter free; have files, records and information readily accessible.
- Know your quality policy and how it applies to your job.
- If you don’t understand a question, ask the auditor to clarify or repeat the question. If a question is still not clear, then ask someone to help you understand it. It could be a question that should be asked of someone else, if so tell the auditor it is not a part of your job and ask him/her to talk to ask else. Do not guess at an answer.
- Answer questions honestly, clearly and concisely. Do not keep on talking after you answer the question. Be aware that whatever you tell the auditor may have to be supported by the appropriate documents or records.
- Know what is done with a customer complaint (if it applies to your job).
- Know what to do with any non-conforming material (if it applies to your job).
- Know that we have a corrective action process and who is responsible for it.
- If there are regulatory or special requirements for your job, process or product know and be able to explain them (i.e. FDA, FAA, special handling requirements; soldering; sterilization).
- Know the quality objective and/or goals that apply to you.
- If there are areas of which you are unsure, do not guess, defer to someone else!
- DO NOT ARGUE with the auditor. Questions of the auditor are fine, but don’t argue.
- Remember, this is not an adversarial situation. Your company is paying the auditor to be there to do his/her job and the auditor is actually a customer. The auditor cannot fine you, send you to jail or get you fired. The auditor is there simply to insure the QMS meets the requirements of the standard.
- The auditor will not tell you how to do something, but may say something like “I have seen…..” Listen and learn.
- Be positive. We have an effective quality system and are a good company. Talk about our successes as appropriate…just be aware that anything said could require documented evidence.