| ISO9001 and other Quality Systems require that the | | | | Human Resources: |
| organization conduct periodical compliance audits during | | | | - Has your training plan been updated? |
| the course of the year. As the date of the Third Party | | | | - Is there evidence that you measure the |
| audit (Registration or Surveillance) approaches, the | | | | effectiveness of the training? |
| urgency to conduct internal audits to demonstrate | | | | Infrastructure: |
| compliance with this requirement and to detect and | | | | - Are maintenance records up to date? |
| correct any nonconformance increases substantially. A | | | | - Is the workplace clean and orderly? |
| lot of anxiety is experienced before such audits. This is | | | | Design and Product Development (where applicable): |
| particularly true for small companies without prior ISO | | | | - Are all design controls being used? |
| audit experience. Often, your audit team does not | | | | - Is there evidence that formal design reviews have |
| know how to identify the most important things that | | | | taken place? |
| need double-checking before the Registrar visit. Below | | | | Purchasing: |
| is an abbreviated checklist that zeroes in on the most | | | | - Has the approved vendor list been kept up to date? |
| important issues that your internal audit team should | | | | - Are vendor evaluations conducted periodically? |
| review : | | | | - Are all Supplier Corrective Actions closed? |
| General Requirements: | | | | Product realization: |
| - Is the Quality Policy posted at various locations? | | | | - Is there a plan for controlling product Quality? Are |
| - Do employees understand the policy and are they | | | | processes controlled at predetermined points? |
| able to explain it in their own words? | | | | - Is there evidence that product and parts are |
| - Are your Management Review minutes documented | | | | protected from damage throughout? |
| and easily accessible? | | | | - Are products and assemblies identified throughout? |
| - Do employees understand the Company's Quality | | | | Monitoring Measuring Devices: |
| Objectives and how their jobs contribute to them? | | | | - Are all measuring devices calibrated and properly |
| - Can employees explain how they know their jobs | | | | labeled? |
| are being done correctly? | | | | Corrective Actions: |
| Document Controls: | | | | - Are all Corrective Actions closed? |
| - Are prior revisions of all documents (procedures, | | | | - Have you confirmed that the Corrective Actions |
| work instructions, and forms) removed from all work | | | | were effective? |
| stations? | | | | - Are nonconforming products and parts segregated |
| - Are all document revisions properly logged? | | | | and identified? |
| - Are obsolete procedures marked as such and | | | | Once your audit team assures compliance with the |
| stored in an archived file? | | | | above audit points, it can spend any remaining time |
| Records Control: | | | | addressing other details that may come up during the |
| - Are records stored in an orderly manner? | | | | Registrar audit. This list will also assist process owners |
| - Are record files complete and easily accessible to | | | | in sustaining the Quality Management System. |
| the auditor? | | | | |