The management review shall be What kinds of information are planned and carried out taking into reviewed in management reviews? consideration: These must include: a) the status of actions from actions status of previous reviews; previous management reviews; changes to internal/external issues b) changes in external and internal relevant to the QMS; issues that are relevant to the issues that affect strategy; quality management system KPIs for nonconformities and including its strategic direction; corrective actions; c) information on the quality monitor and measurement of performance, including trends and results; indicators for: audit results; 1) nonconformities and corrective customer satisfaction; actions; issues concerning external 2) monitoring and measurement providers; results; issues concerning other relevant 9.3.1 3) audit results; parties; q2 4) customer satisfaction; adequacy of resources and 5) issues concerning external effectiveness of QMS; providers and other relevant process performance; interested parties; conformity of products and 6) adequacy of resources required services; for maintaining an effective quality actions taken to address risks and management system; opportunities and their 7) process performance and effectiveness; conformity of products and new potential opportunities for services; continual improvement. d) the effectiveness of actions taken to address risks and opportunities (see clause 6.1); e) new potential opportunities for continual improvement. 9.3.2 The outputs of the management Show me that management review shall include decisions and reviews include decisions and actions related to: actions relating to: a) continual improvement Continual improvement 9.3.2 opportunities; opportunities; q1 b) any need for changes to the The need for changes to the QMS quality management system, including resource needs. including resource needs. Show me what The organization shall retain documented Documented information of documented information as information you have as management reviews. evidence of the results of evidence of management reviews. 9.3.2 management reviews. q2 10 Improvement 10.1 General The organization shall determine How do you determine and select and select opportunities for opportunities for improvement? improvement and implement What necessary actions have you necessary actions to meet implemented so that you have met 10.1 customer requirements and customer requirements and q1 enhance customer satisfaction. enhanced customer satisfaction?
9.3.1 q2 The management review shall be planned and carried out taking into consideration: a) the status of actions from previous management reviews; b) changes in external and internal issues that are relevant to the quality management system including its strategic direction; c) information on the quality performance, including trends and indicators for: 1) nonconformities and corrective actions; 2) monitoring and measurement results; 3) audit results; 4) customer satisfaction; 5) issues concerning external providers and other relevant interested parties; 6) adequacy of resources required for maintaining an effective quality management system; 7) process performance and conformity of products and services; d) the effectiveness of actions taken to address risks and opportunities (see clause 6.1); e) new potential opportunities for continual improvement. What kinds of information are reviewed in management reviews? These must include: actions status of previous reviews; changes to internal/external issues relevant to the QMS; issues that affect strategy; KPIs for nonconformities and corrective actions; monitor and measurement of results; audit results; customer satisfaction; issues concerning external providers; issues concerning other relevant parties; adequacy of resources and effectiveness of QMS; process performance; conformity of products and services; actions taken to address risks and opportunities and their effectiveness; new potential opportunities for continual improvement. 9.3.2 9.3.2 q1 The outputs of the management review shall include decisions and actions related to: a) continual improvement opportunities; b) any need for changes to the quality management system, including resource needs. Show me that management reviews include decisions and actions relating to: Continual improvement opportunities; The need for changes to the QMS including resource needs. 9.3.2 q2 The organization shall retain documented information as evidence of the results of management reviews. Show me what documented information you have as evidence of management reviews. Documented information of management reviews. 10 Improvement 10.1 General 10.1 q1 The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction. How do you determine and select opportunities for improvement? What necessary actions have you implemented so that you have met customer requirements and enhanced customer satisfaction?
Portrait-Audit-Checklist.docx