Define the Determine those Processes exist within the organization. They may be formal need for processes that need or informal. There is no catalogue or list of processes that documented to be formally have to be formally defined. The organization should information defined and how they determine which processes need to be documented on the are to be basis of risk-based thinking, including, for example: documented. The size of the organization and its type of activities. The complexity of its processes and their interactions. The criticality of the processes. The need for formally accountability of performance. Processes can be formally documented using a number of methods such as graphical representations, user stories, written instructions, checklists, flow charts, visual media or electronic methods including graphics and systemization. However, the method or the technology chosen are not the goals. They can be used to describe processes, which are the means to achieve the goals. Effective and organized processes can then deliver consistent and accountable operations and the desired objectives and results which can then be improved. Note: For more guidance see the ISO 9000 Introduction and Support Package module Guidance on the Documented Information Requirements of ISO 9001:2015 Define the Determine the Define the required outputs and inputs of the process. interfaces, risks activities needed to Determine the risks to conformity of products, services and and activities achieve the intended customer satisfaction if unintended outputs are delivered. outputs of the Determine the activities, measures and inherent controls within the process and risks of required to transform the inputs into the desired ouputs. process unintended outputs. Determine and define the sequence and interaction of the activities within the process. Determine how each activity will be performed. Ensure that the management system as a whole takes account of all material risks to the organization and users. Note: In some cases the customer may specify requirements not only for the outputs but also for the realization of a process. Define the Determine and Identify the validation necessary to assure effectiveness and monitoring and how monitoring and efficiency of the processes and system. Take into account measurement measuring should be such factors as: requirements applied. This should Monitoring and measuring criteria. be both for control Reviews of performance and improvement of Interested parties’ satisfaction. the processes and the Supplier performance. intended process On time delivery and lead times. outputs. Failure rates and waste. Determine the need Process costs. for recording results. Incident frequency. Other measures of conformity with requirements.
Define the need for documented information Determine those processes that need to be formally defined and how they are to be documented. Processes exist within the organization. They may be formal or informal. There is no catalogue or list of processes that have to be formally defined. The organization should determine which processes need to be documented on the basis of risk-based thinking, including, for example: The size of the organization and its type of activities. The complexity of its processes and their interactions. The criticality of the processes. The need for formally accountability of performance. Processes can be formally documented using a number of methods such as graphical representations, user stories, written instructions, checklists, flow charts, visual media or electronic methods including graphics and systemization. However, the method or the technology chosen are not the goals. They can be used to describe processes, which are the means to achieve the goals. Effective and organized processes can then deliver consistent and accountable operations and the desired objectives and results which can then be improved. Note: For more guidance see the ISO 9000 Introduction and Support Package module Guidance on the Documented Information Requirements of ISO 9001:2015 Define the interfaces, risks and activities within the process Determine the activities needed to achieve the intended outputs of the process and risks of unintended outputs. Define the required outputs and inputs of the process. Determine the risks to conformity of products, services and customer satisfaction if unintended outputs are delivered. Determine the activities, measures and inherent controls required to transform the inputs into the desired ouputs. Determine and define the sequence and interaction of the activities within the process. Determine how each activity will be performed. Ensure that the management system as a whole takes account of all material risks to the organization and users. Note: In some cases the customer may specify requirements not only for the outputs but also for the realization of a process. Define the monitoring and measurement requirements Determine and how monitoring and measuring should be applied. This should be both for control and improvement of the processes and the intended process outputs. Determine the need for recording results. Identify the validation necessary to assure effectiveness and efficiency of the processes and system. Take into account such factors as: Monitoring and measuring criteria. Reviews of performance Interested parties’ satisfaction. Supplier performance. On time delivery and lead times. Failure rates and waste. Process costs. Incident frequency. Other measures of conformity with requirements.
ISO9001Process_Approach-1.docx