ISO 9001 Certification Requirements: Management Review
Regular Management reviews should conducted in order to assess the effectiveness of the Quality Management System and to continually improve the organisation’s effectiveness. The reviews should be conducted at least annually and involve the Senior Management. The Management Representative will normally carry out most of the preparation work for the review but may request that each department representative prepares information for review. The scope of the Quality Management Review should include all quality management system process activities conducted on site and any sub-contracted activities.
Senior management should review the company management systems at a minimum annually. The purpose of the review is to ensure the continuing suitability, adequacy and effectiveness of the quality management system. The review should include assessing opportunity for improvements and the need for amendments to the systems. The proceedings of all reviews should be documented.
The management review meeting is normally chaired by the most Senior Manager such as the Managing Director. Senior Management representing each department in the organisation should be present including the nominated Management Representative.
The quality management system review meeting should have an agenda including all the key items for review and opportunities for input from all the participants.
There should be clear Management Review Objective outlined at the start of the review. A typical objective would be to review and assess the effectiveness of the Quality Management System and to initiate corrective and preventative actions should they deemed to be necessary and to seek potential opportunities to improve the effectiveness of the quality management system and exceed customer requirements.
For each item on the agenda there should be an analysis of performance or review of suitability and comments or details of the findings and plans for corrective action, preventative action or opportunities for improvement all of which should be documented in the management review minutes.
Management Review Topics
The first item really should be a review of the quality management system Policy to confirm it is pertinent 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 management resource.
The meeting should cover the minutes and follow-up actions from previous review meetings and confirm actions as a result of the review have been completed.
Findings of internal and external audits should be reviewed and outstanding non-conformances as a result of internal and external 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 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 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. 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 corrective action in eliminating the cause of the incidents and also consider any common factor to the incidents in order to assess if preventative action is required.
The meeting should review the 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 non-conformances such as damaged deliveries or non-conforming products supplied plus any products 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 in 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 Process performance and product conformity Key Performance Indicators and firstly confirm that the correct performance indicators are being monitored. Review and analysis of the Key Performance Indicator trends should be conducted to see if there is a visible improvement in performance. Sales levels should be one of the 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 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 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 resource requirements identified.
Review should also include Environmental performance and incidents,
and Health and Safety performance and accidents
The Management Review outputs should include Corrective and Preventative Actions identified as a result of analysis of the 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 quality enhancement, 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 review inputs and outputs. The Management Representative should ensure the minutes of the Management Review meeting are distributed and effectively cascaded within the organisation.
In additional to the formal Management Review an organisation should consider other review activities to monitor the effectiveness of the quality management system including a daily management meeting to review recent performance and issues arising by exception, Key Performance Indicator Reviews to review previous performance in quality, wastage and customer service, Environmental performance review, Health & Safety performance review, HACCP review and Quality Review.