ISO 9001:2008 Quality Manual (Section 8)
This document includes limited portions of section 8 of our Ultimate Quality Manual product. It is free to use "as is" or you can get the entire solution in Word format, including an installation guide, by purchasing our Quality Manual product.
8 Measurement, analysis and improvement
Planning for monitoring, measurement, analysis and improvement activities occurs at two levels:
The product level—ensuring and demonstrating conformity of the product. Production Management is responsible for determining the appropriate production processes and measuring and monitoring activities used during production and inspection in daily operations and the records thereof. Such activities are reviewed during Management Review meetings, where customer satisfaction is analyzed to determine where improvements at the product level can be made.
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8.2 Monitoring and measurement
8.2.1 Customer satisfaction
Customer satisfaction is considered during Management Review Meetings. Customer satisfaction data is collected and reported using customer feedback data and various satisfaction results. Such data is summarized into reports that are presented to top management for analysis. Top management ensures that data regarding product and process conformance, supplier performance, and customer satisfaction is collected, recorded and analyzed. Although measurements of such performance indicators may be collected as it becomes available, such data is analyzed annually during Management Review Meetings. Customer satisfaction data is a vital tool in driving improvement of the quality management system.
8.2.2 Internal Audits
The company conducts periodic Internal Audits to determine whether or not the quality management system conforms to the requirements of ISO 9001, our internal procedures, and whether or not the system has been effectively implemented and maintained. Such audits are in accordance with the Internal Audit procedure. The procedure defines the requirements for internal auditors, for conducting audits, and for recording the results and reporting them to management.
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8.2.3 Monitoring and measurement of processes
Where applicable, the company has implemented the necessary methods to ensure that our products and services meet the planned results. When the results of the events are not achieved corrective action shall be documented on the applicable Corrective Action Request and actions taken as deemed necessary. Internal audits and management review will be some of the methods used to monitor the processes.
8.2.4 Monitoring and measurement product
According to the associated production procedures, work instructions constitute the quality and inspection plan for each order. Such plans dictate where in the process inspections are to take place as well as the acceptance criteria associated with the inspections. Records of production and inspection activities required by such quality plans remain with documents throughout production and shipping, after which they are maintained according to the Record Retention Form. These indicate the Operator authorizing the release of product to subsequent operations or to Finished Goods Inventory or the customer. These documents also demonstrate conformity with the acceptance criteria. Product is not released to the customer until all planned arrangements have been satisfactorily completed unless otherwise approved by the customer.
8.3 Control of Non-conforming Product
All products found to be non-conforming to specified requirements, are identified by marking the non-conformity and/or segregating the product while awaiting disposition per procedure SQ00xx.
Non-conformities discovered during receiving or receiving inspection are treated according to the non-conforming product procedure contained in the Receiving and Receiving Inspection procedure. Non-conformities discovered during production or inspections are treated according to the non-conforming product procedure contained in the Production procedure.
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8.4 Analysis of data
Data demonstrating the suitability and effectiveness of the quality management system as well as that used to evaluate where continual improvement of the quality management system can be made is presented and analyzed during Management Review meetings. Data presented during the meeting includes data resulting from monitoring and measuring product, process and customer satisfaction and other relevant sources.
Information resulting from these analysis includes customer satisfaction levels, conformity of product to requirements, characteristics and trends of processes and products including opportunities for preventive action, and supplier performance.
8.5.1 Continual improvement
ACME will continually improve the effectiveness of the quality management system through use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. Continual improvement activities will be reviewed during management review meetings and will be documented on the Corrective Action Request form.
8.5.2 Corrective Action
Corrective Actions are undertaken to eliminate the causes of non-conformity in order to prevent their recurrence. Actions taken are appropriate to the impact of the problems encountered. Corrective Actions may be initiated by anyone in the company according to the Corrective and Preventive Actions procedure. Such actions will be recorded and processed using a Corrective Action Request form. Any resulting changes to processes and procedures will be reflected in the appropriate documents.
Corrective Actions may arise from a variety of sources, including Management Review Meetings, Internal Audits, Customer Complaints, and any identification of nonconformity. The Management Representative will review all requests for Corrective Actions to determine the feasibility of the requested actions and to assign responsibilities for determining the problem’s root cause and evaluating the appropriate actions to ensure that the nonconformity does not recur. Corrective action will be determined and implemented accordingly and the results will be recorded in the Quality system database on the vault.
Upon completion of a Corrective Action, the person responsible for the action will record its completion on the Engineering Change Form.
8.5.3 Preventive Action
Proposals for Preventive Actions may arise in the same manner as those for Corrective Actions, although Preventive Actions are undertaken to eliminate causes of potential non-conformities. Such proposals will be processed in a similar manner as Corrective Actions. Also, whenever corrective actions are implemented, consideration is always given to determine steps needed to initiate preventive action to prevent potential non-conformities in similar situations. Preventive actions may be initiated independently of a corrective action in order to prevent potential non-conformities. Preventive actions and their verification are maintained in the quality system database.
Associated documents/records for section 8:
Management Review Meetings procedure, SQ00xx
Management of Non-Conforming Materials, SQ00xx
Internal Audits procedure, SQ00xx
Corrective and Preventive Action procedure-ECR/ECO, SQ00xx