| ISO 9001: Systemic Requirements |
| Establishing quality system |
| Develop quality management system |
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Identify the processes that make up our quality system. |
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Describe our quality management processes. |
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Implement our quality management system |
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Use quality system processes. |
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Manage process performance. |
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Improve our quality management system |
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Monitor process performance. |
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Improve process performance. |
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| Document our quality system |
| Develop quality system documents |
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Develop documents to implement our quality system. |
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Develop documents that reflect what our organization does. |
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Prepare quality system manual |
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Document our procedures. |
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Describe how our processes interact. |
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Define the scope of our quality system. |
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Control quality system documents |
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Approve documents before we distribute them. |
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Provide the correct version of documents at points of use. |
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Review and re-approve documents whenever we update them. |
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Specify the current revision status of our documents. |
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Monitor documents that come from external sources. |
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Prevent the accidental use of obsolete documents. |
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Preserve the usability of our quality documents. |
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Maintain quality system records |
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Use our records to prove that requirements have been met. |
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Develop a procedure to control our records. |
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Ensure that our records are useable. |
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| ISO 9001: Management Requirements |
| Support quality |
| Promote the importance of quality |
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Promote the need to meet customer requirements. |
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Promote the need to meet regulatory requirements. |
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Promote the need to meet statutory requirements. |
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Develop a quality management system |
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Support the development of a quality system. |
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Formulate our organization's quality policy. |
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Set our organization's quality objectives. |
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Provide quality resources. |
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Implement our quality management system |
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Provide resources to implement our quality system. |
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Encourage personnel to meet quality system requirements. |
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Improve our quality management system |
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Perform quality management reviews. |
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Provide resources to improve the quality system. |
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| Satisfy your customers |
| Identify customer requirements |
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Expect our organization to identify customer requirements. |
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Meet your customers' requirements |
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Expect our organization to meet customer requirements. |
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Enhance customer satisfaction |
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Expect our organization to enhance customer satisfaction. |
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| Establish a quality policy |
| Define our organization's quality policy |
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Ensure that it serves our organization's purpose. |
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Ensure that it emphasizes the need to meet requirements. |
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Ensure that it facilitates the development of quality objectives. |
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Ensure that it makes a commitment to continuous improvement. |
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Manage our organization's quality policy |
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Communicate our policy to your organization. |
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Review our policy to ensure that it is still suitable. |
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| Carry out quality planning |
| Formulate our quality objectives |
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Ensure that objectives are set at organizational levels. |
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Ensure that objectives facilitate product realization. |
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Ensure that objectives support the quality policy. |
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Ensure that objectives are measurable. |
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Plan our quality management system |
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Plan the development of our quality management system. |
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Plan the implementation of our quality management system. |
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Plan the improvement of our quality management system. |
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Plan the modification of our quality management system. |
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| Control your quality system |
| Define responsibilities and authorities |
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Clarify responsibilities and authorities. |
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Communicate responsibilities and authorities. |
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Appoint management representative |
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Oversee your quality management system. |
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Report on the status of your quality management system. |
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Support the improvement of your quality management system. |
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Support internal communications |
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Ensure that internal communication processes are established. |
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Ensure that communication occurs throughout the organization. |
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| 5.6 Perform management reviews |
| Review quality management system |
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Evaluate the performance of our quality system. |
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Evaluate whether our quality system should be improved. |
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Examine management review inputs |
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Examine audit results. |
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Examine product conformity data. |
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Examine opportunities to improve. |
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Examine feedback from customers. |
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Examine process performance information. |
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Examine corrective and preventive actions. |
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Examine changes that might affect your system. |
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Examine previous quality management reviews. |
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Generate management review outputs |
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Generate actions to improve our quality system. |
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Generate actions to improve our products. |
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Generate actions to address resource needs. |
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| ISO 9001: Resource Requirements |
| Provide quality resources |
| Identify quality resource requirements |
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Identify resources needed to support the quality system. |
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Identify resources needed to improve customer satisfaction. |
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Provide quality system resources |
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Provide resources needed to support the quality system. |
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Provide resources needed to improve customer satisfaction. |
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| Provide quality personnel |
| Use competent personnel |
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Ensure that our personnel have the right experience. |
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Ensure that our personnel have the right education. |
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Ensure that our personnel have the right training. |
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Ensure that our personnel have the right skills. |
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Support competence |
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Define acceptable levels of competence. |
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Identify training and awareness needs. |
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Deliver training and awareness programs. |
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Evaluate effectiveness of training and awareness. |
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Maintain a record of competence. |
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| Provide quality infrastructure |
| Identify infrastructure needs |
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Identify building needs. |
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Identify workspace needs. |
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Identify hardware needs. |
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Identify software needs. |
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Identify utility needs. |
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Identify equipment needs. |
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Identify support service needs. |
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Provide needed infrastructure |
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Provide needed buildings. |
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Provide needed workspaces. |
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Provide needed hardware. |
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Provide needed software. |
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Provide needed utilities. |
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Provide needed equipment. |
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Provide needed support services. |
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Maintain our infrastructure |
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Maintain your buildings. |
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Maintain your workspaces. |
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Maintain our hardware. |
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Maintain our software. |
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Maintain our utilities. |
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Maintain our equipment. |
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Maintain our support services. |
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| Provide quality environment |
| Identify needed work environment |
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Identify factors needed to ensure products meet requirements. |
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Manage needed work environment |
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Manage factors needed to ensure products meet requirements. |
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| ISO 9001: Realization Requirements |
| Control realization planning |
| Plan product realization processes |
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Define product quality objectives and requirements. |
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Identify product realization needs and requirements. |
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Develop product realization processes |
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Develop product realization documents. |
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Develop product realization record keeping systems. |
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Develop methods to control quality during product realization. |
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| Control customer processes |
| Identify customers' product requirements |
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Identify the requirements that customers want us to meet. |
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Identify the requirements that are dictated by the product's use. |
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Identify the requirements that are imposed by external agencies. |
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Identify the requirements that our organization wishes to meet. |
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Review customers' product requirements |
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Review requirements before you accept orders from customers. |
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Maintain a record of our product requirement reviews. |
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Control changes in product requirements. |
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Communicate with your customers |
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Develop a process to control communications with customers. |
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Implement our customer communications process. |
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| Control product development |
| Plan design and development |
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Define our product design and development stages. |
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Clarify design and development responsibilities and authorities. |
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Manage interactions between design and development groups. |
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Update our design and development plans as changes occur. |
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Define design and development inputs |
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Specify product design and development inputs. |
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Record product design and development input definitions. |
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Review product design and development input definitions. |
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Generate design and development outputs |
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Create product design and development outputs. |
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Approve design and development outputs prior to release. |
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Use design and development outputs to control product quality. |
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Carry out design and development reviews |
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Perform product design and development reviews. |
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Record product design and development reviews. |
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Perform design and development verifications |
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Carry out product design and development verifications. |
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Record product design and development verifications. |
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Conduct design and development validations |
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Perform product design and development validations. |
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Record product design and development validations. |
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Manage design and development changes |
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Identify changes in product design and development. |
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Record changes in product design and development. |
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Review changes in product design and development. |
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Verify changes in product design and development. |
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Validate changes in product design and development. |
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Approve changes before they are implemented. |
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| Control purchasing function |
| Control purchasing process |
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Ensure that purchased products meet requirements. |
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Ensure that suppliers meet requirements. |
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Document product purchases |
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Describe the products being purchased. |
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Specify the requirements that must be met. |
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Verify purchased products |
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Verify purchased products at our own premises. |
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Verify purchased products at suppliers' premises (when required). |
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| Control operational activities |
| Control production and service provision |
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Control production and service processes. |
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Control production and service information. |
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Control production and service instructions. |
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Control production and service equipment. |
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Control production and service measurements. |
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Control production and service activities. |
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Validate production and service provision |
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Prove that special processes can produce planned outputs. |
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Prove that process personnel can produce planned results. |
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Prove that process equipment can produce planned results. |
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Identify and track our products |
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Establish the identity of our products (when appropriate). |
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Maintain the identity of our products (when appropriate). |
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Identify the status of our products (when appropriate). |
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Record the identity of our products (when required). |
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Protect property supplied by customers |
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Identify property supplied to you by our customers. |
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Verify property supplied to you by our customers. |
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Safeguard property supplied to you by our customers. |
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Preserve your products and components |
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Preserve products and components during internal processing. |
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Preserve products and components during final delivery. |
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| Control monitoring devices |
| Identify monitoring and measuring needs |
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Identify the monitoring and measuring that should be done. |
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Select monitoring and measuring devices |
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Select devices that meet your monitoring and measuring needs. |
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Calibrate monitoring and measuring devices |
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Perform calibrations. |
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Record calibrations. |
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Protect monitoring and measuring devices |
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Protect our devices from unauthorized adjustment. |
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Protect our devices from damage or deterioration. |
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Validate monitoring and measuring software |
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Validate monitoring and measuring software before we use it. |
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Revalidate monitoring and measuring software when necessary. |
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Use monitoring and measuring devices |
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Use devices to ensure that our products meet requirements. |
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