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Quality management system guidance

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Planning 


          
6.0 Quality management system planning

          
Although risks and  opportunities have to be determined and addressed, there is no requirement for  a formal, documented risk management process. Confirm that your organization  has a methodology in place that enables them to effectively identify risks and opportunities  with respect to the planning of its quality management system. 

          
    
            
  • Determine the risks and opportunities relevant to your organization's context 4.1 and interested parties 4.2. Integrate risk-based and opportunity-based thinking into processes 4.4.
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  • Determine, analyse and evaluate risks, then plan actions to address risks in proportion to their potential impact, including risks to conforming products and services during and after a disruption.
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  • Plan actions to address opportunities, such as new practices, products, services, partnerships or technologies; opportunities can be handled through a separate process from risks.
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  • Establish quality management system objectives and targets at each relevant function, level and process, and plan how they will be achieved.
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  • Plan changes to the management system, considering resources and information, how the change will be communicated, and how its effectiveness and results will be monitored and reviewed.
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How to apply the latest quality management principles

          
Apply the quality management principles (QMPs) in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle. The ISO 9000 quality management principles are embodied with in the individual requirements of ISO 9001 and the table below relates these principles to the applicable clauses and requirements:

          

                    
                      

                        ISO 9000 Principles
                        ISO 9001 Base Clauses
                        Action & Compliance Summary
                        ISO 9001 Clauses
                      

                      

                        Evidence-based decision making
                        4.4.1 Risks and opportunities (g)
                        Determine the risks and opportunities that need to be addressed, taking account of your organization's context 4.1 and relevant interested parties 4.2. Integrate risk-based and opportunity-based thinking into processes 4.4.
                        6.1.1 Determining Risks and Opportunities
                      

                      

                        Evidence-based decision making
                        4.4.1 Risks and opportunities (g)
                        Determine, analyse and evaluate risks to conforming products and services and customer satisfaction, including during and after a disruption. Plan proportionate actions, build them into your processes and evaluate their effectiveness.
                        6.1.2 Actions to Address Risks
                      

                      

                        Improvement and evidence-based decision making
                        4.4.1 Risks and opportunities (g)
                        Determine, analyse and evaluate opportunities, such as new practices, products, services, partnerships or technologies, separately from risks if you wish. Plan actions, build them into your processes and evaluate their effectiveness.
                        6.1.3 Actions to Address Opportunities
                      

                      

                        Evidence-based decision making
                        4.4.1 Criteria and methods (d)
                        Establish measurable quality objectives at relevant functions, levels and processes, consistent with the quality policy. Plan what will be done, resources, responsibilities, timescales and how results will be evaluated. 
                        6.2 Quality Objectives and Planning
                      

                      

                        Evidence-based decision making and improvement
                        4.4.1 Evaluate and change (h)
                        Plan changes to the QMS, considering: a) purpose and possible consequences; b) QMS integrity; c) resources and information; d) responsibilities and authorities; e) communication; f) how effectiveness will be monitored and evaluated; g) how results will be reviewed.
                        6.3 Planning of Changes
                      

                    
                  

			
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Free PDCA guidance

          
 ISO Navigator™ is our FREE online training tool that shows you  how to apply the principles of PDCA to your operations. We also offer many  helpful templates  that get you on the road to documenting your management system,  please visit the  download page.