ISO 9000 Audit Checklist: Section 8 - Internal
| Question | Reference Documents | Notes |
| Does the company perform monitoring, measurement, analysis and improvement processes to ensure conformity of the product? | ||
| Does the company perform monitoring, measurement, analysis and improvement processes to ensure proper operation of the quality system? | ||
| Does the company continuously improve the effectiveness of the quality management system? | ||
| Where does the company use statistical techniques to evaluate the product and quality system? | ||
| 8.2 Monitoring and Measuring | ||
| 8.2.1 Customer Satisfaction | ||
| Is information about customer perception and the ability of the company to meet the customer requirements monitored by the organization? | ||
| What systems is used for obtaining and using information relating to customer satisfaction? | ||
| 8.2.2 Internal Audits | ||
| Are internal audits performed at periodic planned intervals to determine if the quality system conforms to the ISO 9001 requirements? | ||
| Are internal audits performed to determine if the quality system is effectively implemented and maintained? | ||
| Does the internal audits plan take into consideration previous audit results (follow up)? | ||
| Is the audit criteria, scope period and method define in a document? | ||
| Do auditors ever audit their own work? | ||
| How does auditor selection and auditor performance ensure objectivity and impartiality in the audit process? | ||
| What system is in place to ensure that audit non-conformities and their causes are corrected and eliminated without undue delay? | ||
| Do follow-up audit activities include verification of the actions taken and reporting of the results? | ||
| 8.2.3 Monitoring and Measurement of Processes | ||
| Are suitable methods used to assure that the company processes meet the customer requirements? | ||
| Do these methods demonstrate the ability of the processes to fulfill the quality plan? | ||
| Are corrective actions taken when planned results are not achieved? | ||
| 8.2.4 Monitoring and Measure of Product | ||
| Are product characteristics monitored and measured to confirm that the product meets the requirements? | ||
| Is monitoring and measuring the product done at an appropriate stage in the product realization (production process)? | ||
| Is evidence of conformity with the acceptance criteria documented and maintained as a quality record? | ||
| Are records maintained to indicate the person authorizing the release of the product? | ||
| Are all planned activities completed prior to the release of the product (unless otherwise approved by the relevant authority or customer)? | ||
| 8.3 Control of nonconforming Product | ||
| How Is nonconforming product identified and controlled to prevent unintended usage or delivery? | ||
| What documented procedure establishes controls, assigns authority and responsibility for processing of nonconforming materials? | ||
| Are actions taken to eliminate the source of nonconforming products? | ||
| What process is used to authorize use, release or accept nonconforming product with concessions? | ||
| Are records maintained identifying the non conformities and any subsequent actions taken to use the product with concessions? | ||
| When nonconforming product is corrected, is it subject to re-verification or re-test to confirm conformity? | ||
| If nonforming product is detected after delivery or use, is appropriate action taken by the organization to correct the problem? | ||
| 8.4 Analysis of Data | ||
| Is appropriate data collected and analyzed to demonstrate the effective of the quality management system and continuous improvement system? | ||
| Is the data from multiple sources like product, process, quality system, customer or information from other relevant sources? | ||
| Does the analysis of this data provide information about customer satisfaction | ||
| Does the analysis show conformance to the product requirements? | ||
| Does the analysis show trends of process and products including opportunities for continuous improvement (corrective and preventive actions)? | ||
| Does the analysis provide information about the performance and trend for suppliers? | ||
| 8.5 Improvement | ||
| 8.5.1 Continual Improvement | ||
| What systems does the organization use to continually improve the effectiveness of their QMS? | ||
| Are results of audit, management reviews, corrective and preventive actions, and analysis of data used for continuous improvement of the QMS, processes and products? | ||
| 8.5.2 Corrective Actions | ||
| Are corrective actions taken to eliminate the cause of nonconformities and to prevent further nonconformities? | ||
| Are corrective actions appropriate based on the non conformities encounters? | ||
| What is the documented procedure for reviewing nonconformities including customer complaints? | ||
| What is the documented procedure for determining the cause of nonconformities? | ||
| What is the documented procedure ( part of a documented procedure) for determining the implementing actions? | ||
| Are corrective actions recorded and maintained as a quality record? | ||
| Are corrective actions reviewed to confirm that the action was successful? | ||
| 8.5.3 Preventive Actions | ||
| What procedure describes how the organization takes actions to eliminate potential non conformities before they happen? | ||
| What is the documented procedure for determining potential nonconformities? | ||
| What is the documented procedure for determining the cause of nonconformities? | ||
| What is the documented procedure ( part of a documented procedure) for determining and implementing actions? | ||
| Are preventive actions recorded and maintained as a quality record? | ||
| Are preventive actions reviewed to confirm that the action was successful? |
