An ISO top quality administration or environmental administration program audit can be an uneasy and stress filled time for quite a few people in corporations currently. This write-up presents 16 popular perception suggestions for a profitable audit are based mostly on serious earth ordeals consulting with dozens of corporations and auditors above the previous two decades. These suggestions utilize to ISO 9001 ISO 13485 ISO 17025 ISO 14001 RC 14001 AS 9100 or TS 16949 audits.
In my consulting observe I have noticed people at all ranges in an organization receiving “uptight” or having “audit anxiousness” about an ISO registration or continuing success (surveillance) audit by their registrar. Good preparing can help decreased the anxiousness stage. These suggestions can help you and every person in your organization be far better organized for the audit.
- Know your position, roles and duties.
- Know wherever to obtain the ideal procedures, kinds and files It is o.k. to refer to them to reply concerns, do not guess. Be absolutely sure all kinds and information are up to date and finished thoroughly.
- Be absolutely sure your perform space is clean and litter free have documents, information and data readily accessible.
- Know your top quality coverage and how it applies to your position.
- If you you should not recognize a dilemma, question the auditor to make clear or repeat the dilemma. If a dilemma is still not obvious, then question a person to help you recognize it. It could be a dilemma that need to be requested of a person else, if so notify the auditor it is not a part of your position and question him/her to discuss to question else. Do not guess at an reply.
- Reply concerns actually, plainly and concisely. Do not maintain on speaking after you reply the dilemma. Be aware that whichever you notify the auditor may well have to be supported by the ideal files or information.
- Know what is accomplished with a customer criticism (if it applies to your position).
- Know what to do with any non-conforming substance (if it applies to your position).
- Know that we have a corrective action approach and who is liable for it.
- If there are regulatory or particular specifications for your position, approach or products know and be able to clarify them (i.e. Fda, FAA, particular managing specifications soldering sterilization).
- Know the top quality aim and/or ambitions that utilize to you.
- If there are spots of which you are uncertain, do not guess, defer to a person else!
- DO NOT ARGUE with the auditor. Issues of the auditor are fine, but you should not argue.
- Remember, this is not an adversarial condition. Your business is shelling out the auditor to be there to do his/her position and the auditor is actually a customer. The auditor simply cannot fine you, send you to jail or get you fired. The auditor is there just to insure the QMS satisfies the specifications of the regular.
- The auditor will not notify you how to do something, but may well say something like “I have found…..” Pay attention and find out.
- Be positive. We have an efficient top quality program and are a great business. Communicate about our successes as ideal…just be aware that something said could need documented proof.