TABLE OF CONTENTS The following is a list of some of the most important questions that an external auditor would be likely to ask when assessing an organisation's QMS for conformance to ISO 9001:2000.
| Typical auditor's questions (quality management system) | Remarks |
|---|---|
| Who is responsible for ensuring that the company's Quality Manual meets the requirements of the specified standard for the QMS and does it? | |
| Do the procedures generated as part of the QMS meet the requirements of the Quality Manual? | |
| Are written procedures in all areas of the QMS unambiguous, understandable (simple enough so that the intended user has sufficient guidance to assure that quality is maintained) and do they specify methods and criteria? | |
| How does the documented QMS ensure that a product conforms to specified requirements? | |
| How does the QMS identify and ensure that new ideas and techniques that affect quality are verified before being introduced? | |
| How does the QMS ensure that adequate resources are available to attain and maintain the level of quality detailed in the Quality Manual and/or any Quality Plans? | |
| How is the QMS represented in contract and new product developments? | |
| Who is responsible for identifying requirements and risks that are on the frontiers of company or known technology, how are they controlled and how are new procedures generated if required? |
| Typical auditor's questions (documentation requirements) | Remarks |
|---|---|
| Are written procedures in all areas of the QMS unambiguous, understandable... |
