ISO 9001 audit

ISO 9001 audit Preventive Action Audit Checklist 1. Has the organization determined actions to eliminate the causes of potential nonconformities in order to prevent occurrence? 2. Are preventive actions appropriate to the effects of the potential problems? 3. Has a documented procedure been established to define the requirements for: a) Determining potential nonconformities and their causes? b) Evaluating the need for action to prevent occurrence of nonconformities? c) Determining and implementing actions needed? d) Recording and maintaining the results of action taken? e) Reviewing of preventive action taken?

Corrective Action Audit Checklist 1. How is corrective action taken to eliminate the cause of nonconformities in order to prevent recurrence? 2. How is corrective action appropriate to the impact of the Problems encountered? Is there a documented procedure for corrective action which defines requirements for: a. Identifying nonconformities (including customer complaints)? b. Determining the causes of nonconformity? c. Evaluating the need for actions to ensure that nonconformities do not recur? d. Determining and implementing the corrective action needed? e. Recording results of action taken?

f. Reviewing corrective action taken?

Continual Improvement Audit Checklist 1. Are processes necessary for the continual Improvement of the quality management system planned and managed? 2. How is continual improvement of the quality management system facilitated through the use of: a. Quality policy? b. Quality objectives? c. Audit results? d. Analysis of data? e. Corrective and preventive action ? f. Management review?

Control of Nonconforming Product Checklist 1. Is nonconforming product identified and controlled to prevent unintended use or delivery? 2. Has a documented procedure been established to define controls and related responsibilities and authorities for dealing with nonconforming product? 3. Are nonconforming product dealt with by one or more of the following ways: a) Action taken to eliminate the detected nonconformity?

b) Authorized use, release or acceptance under concession by a relevant authority and, where applicable, by the customer c) Action taken to preclude its original intended use or application 4. Are records maintained identifying the nature of nonconformities and any subsequent actions taken, including any concessions? 5. When nonconforming product is corrected, is it subject to re-verification to demonstrate conformity to the requirements? 6. When nonconforming product is detected after delivery, or use has started, is appropriate action taken by the organization to the effect or potential effect?

Analysis of Data Audit Checklist 1. Is appropriate data determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made? 2. Does this data included data generated from monitoring, measurement and other relevant sources? 3. Does the analysis of this data provide information related to: a) Customer satisfaction? b) Conformance to product requirements? c) Characteristics and trends of processes and products including, opportunities for preventive action? d) Suppliers?

Monitoring and Measurement of Product Checklist 1. Are product characteristics monitored and measured to verify that product requirements are met? 2. Is monitoring and measurement of product characteristics carried out at appropriate stages of the product realization process in accordance with the planned arrangements? 3. Is evidence of conformity with the acceptance criteria documented and maintained? 4. Are records maintained to indicate the person(s) authorizing release of product? 5. Unless otherwise approved by a relevant authority or where applicable, the customer, are all planned arrangements satisfactorily completed prior to proceeding with release?

Monitoring and Measurement of Processes Checklist 1. Are suitable methods applied for monitoring and where applicable, measurement of the quality management system processes necessary to meet customer requirements? 2. Do these methods demonstrate the ability of the processes to achieve planned results? 3. Are correction and corrective actions taken when planned results are not achieved?

Internal Audit Checklist 1. Are periodic internal quality audits conducted to determine whether the quality management system has been effectively implemented and maintained? 2. Are internal quality audits planned, including consideration of the status and importance of the activities and areas to be audited as well as there results of previous audits? 3. Is the audit scope, frequency, and methodologies defined?

4. Are audits conducted by personnel other than those who performed the activity being audited? 5. Are there documented procedures that include the responsibilities and requirements for conducting audits, ensuring their independence, recording results, and reporting to management? 6. Have personnel conducting internal audits been trained? 7. Are records of internal auditor training maintained and available? 8. Does management take timely corrective action on deficiencies found during the audit? 9. Do follow-up actions include the verification of the implementation of corrective action and the reporting of verification results?

Customer Satisfaction Audit Checklist 1. Are measurement and monitoring activities needed to assure conformity and achieve improvement been identified and included in the product quality plan? 2. Does this process include the determination of the need for, and use of, applicable methodologies including statistical techniques?

Audit Checklist of Control of Measuring and Monitoring Devices 1. Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements? 2. Have processes been established to ensure that monitoring and measurement can be carried out in a manner consistent with the monitoring and measurement requirements?

3. Where necessary to ensure valid results, are measuring equipment: a) Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, is the basis used for calibration or verification recorded? b) Adjusted or re-adjusted as necessary? c) Identified to enable the calibration status to be determined? d) Safeguarded from adjustments that would invalidate the measurement result? e) Protected from damage and deterioration during handling, maintenance and storage? 4. Has the organization assessed and recorded the validity of the previous measuring results when the equipment is found not to conform to requirements?, and taken the appropriate action on the equipment and any product affected? 5. Are records of the calibration and verification results maintained? 6. Where computer software is used in the monitoring and measurement of specified requirements, is the ability of the computer software to satisfy the intended application confirmed prior to initial use? 7. Is the ability of computer software to satisfy the intended application reconfirmed as necessary?

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