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Continuous Improvement | ISO 9001 Quality Manuals

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What are the requirements of ISO 9001:2008 Clause 5.6 Management Review?
Clause 5.6.1 Management Review General Regular Management reviews should be conducted in order to assess the effectiveness of the Quality Management System and to continually improve. The management review should be a formal analysis and review of the quality policy, quality objectives and quality management system performance which generates plans for corrective action, preventative action or opportunities for improvement all of which should be documented in the management review minutes. Clause 5.6.2 Management Review Input The first item on the management review agenda really should be a review of the Quality Policy to confirm it is pertinent to the quality management system and organisation or if any changes are required. Similarly the Quality Objectives should be reviewed and updated as necessary. There should be a review of the Management Structure and any changes and confirmation that there is adequate quality management system resource. The meeting should cover the minutes and follow-up actions from previous review meetings and confirm actions to improve the quality management system as a result of the review have been completed. Findings of internal and external quality management system audits should be reviewed and outstanding non-conformances as a result of internal and external quality management system audits discussed. The Management Representative should conduct a trends analysis of the results of internal and external audits to present to the meeting. The management review team should also ensure that internal quality management system audits have been carried out as planned. Adverse trends such as an increased number of non-compliances should be identified and corrective action proposed. The results of third-party quality management system audits should be thoroughly scrutinised as these represent and independent view of the organisation. The Quality Manager should present a trend analysis of Customer Complaints. This data should compare year on year performance especially when a product or service is seasonal. Volumes should be factored into the complaints analysis and so complaints should be presented taking this into consideration. Complaints are should also be categorise into critical and non-critical. Non-critical and total complaint analysis is useful for trends. Critical complaints should be closely analysed to determine if there is a common cause and if effective corrective action has been taken. A standard format is to compare complaints per million units sold for each product. Industry standard complaint levels should be used for comparison. Again trends should be identified and if necessary plans for preventative action taken. Complaint analysis should also give an indication of opportunities for improvement of the quality management system. At this stage Safety incidents, recalls or withdrawals should also be reviewed. Corrective Action should have already been taken to deal with the causes of these incidents, the meeting should review the effectiveness of the quality management system in eliminating the cause of the incidents and also consider any common factor to the incidents in order to assess if preventative actions are required to improve the quality management system. The meeting should review the quality management system Approved Supplier Register. A review of annual supplier performance should be presented normally by the Purchasing Manager. The report should include items such as percentage on time deliveries, percentage order completion, any nonconformances such as damaged deliveries or non-conforming products supplied plus any products

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Continuous Improvement | ISO 9001 Quality Manuals

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rejected or accepted under concession. The report should also recognise exceptional supply performance and added value assistance received from suppliers as this should be factored into the quality management system when renegotiating contracts. Corrective Action plans should be formulated to deal with or change poor performing suppliers. Similarly to Customer Complaints, Supplier complaints should be analysed for trends. The management review meeting should discuss quality management system process performance and confirm that the correct performance indicators are being monitored. Review and analysis of the quality management system Key Performance Indicator trends should be conducted to see if there is a visible improvement in performance. Sales levels should be one of the quality management system Key Performance Indicators as this will give an indication of company performance in the market place. Also the number and performance of new products successfully launched into the market place should be discussed. Again corrective action, preventative action and opportunities for improvement of the quality management system should be considered from the key performance indicator trend analysis. The management review should cover the status of corrective and preventive action and compare numbers since the previous review and consider if the quality management system corrective and preventative actions are being completed in a timely fashion. There should conduct a review of changes within the organisation and how this may have affected resource requirements including infrastructure, work environment, personnel and training requirements. At this stage proposed changes should be discussed and again quality management system resource requirements identified. Review should also include Environmental performance and incidents, and Health and Safety performance and accidents Clause 5.6.3 Management Review Output The Management Review outputs should include resource requirements corrective and preventative actions identified as a result of analysis of the quality management system review inputs, all of which should be clearly documented in the minutes. There will also be opportunities for Improvement in quality management system effectiveness including product related customer requirements, change or elimination of non-productive elements, change or elimination of non-productive systems or procedures and supply of resource needed for improvement plans. The results of the Management Review meetings should be documented in the minutes of the meeting and include a summary of all quality management system review inputs and outputs. The Management Representative should ensure the minutes of the Management Review meeting are distributed and effectively cascaded within the organisation.

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12/08/2010

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