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This page presents an overview of ISO 9001 2015 and provides a PDF sample of our approach.
Source: http://praxiom.com/iso-9001.htm |
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4.1 Understand your organization and its unique context |
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• Identify and understand your organization’s context. • Identify and understand your organization’s context before • Consider the external issues that are relevant to your organization’s • Consider the internal issues that are relevant to your organization’s • Monitor information about your organization’s context. • Consider the impact changes in context could have on |
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4.2 Clarify the needs and expectations of interested parties |
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• Identify the parties who affect or could affect your QMS. • Consider how interested parties affect or could affect your ability • Consider how interested parties could affect your ability to provide • Clarify and understand their unique needs and expectations. • Monitor and review information about your interested parties. |
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4.3 Define the scope of your quality management system |
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• Clarify boundaries and think about what your QMS should apply to. • Use boundary and applicability information to define your scope. • Consider your organization’s context when you define your scope. • Document the scope of your quality management system (QMS). • Use your scope document to describe the boundaries of • Use your scope document to identify the types of products • Use your scope document to explain that every ISO 9001 requirement • Maintain the document that defines the scope of your QMS. • Control your organization’s QMS scope document. |
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4.4 Develop a QMS and establish documented information |
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4.4.1 Establish a QMS that complies with this standard |
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• Develop a process-based quality management system (QMS). • Determine the processes that your QMS needs. • Determine methods needed to manage processes. • Determine resources needed to support processes. • Determine process responsibilities and authorities. • Determine risks and opportunities for each process. • Determine methods needed to evaluate processes. • Implement your process-based quality management system. • Apply criteria needed to operate and control your processes. • Apply methods needed to operate and control your processes. • Maintain your process-based quality management system. • Improve your process-based quality management system. |
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4.4.2 Maintain QMS documents and retain QMS records |
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• Maintain documents needed to support process operations. • Control documents which support process operations. • Retain records which show that plans are being followed. • Control records which show that plans are being followed. |
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5.1 Provide leadership by focusing on quality and customers |
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5.1.1 Provide leadership by encouraging a focus on quality |
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• Accept responsibility for your QMS. • Demonstrate a commitment to your QMS. • Ensure that a quality policy is developed. • Ensure that quality objectives are established. • Ensure that requirements are built into processes. • Ensure that your QMS achieves all intended results. • Communicate your commitment to the QMS. • Explain why quality management is important. • Expect managers to be accountable for their QMS. • Encourage your personnel to support their QMS. • Promote the use of risk-based thinking. |
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5.1.2 Provide leadership by encouraging a focus on customers |
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• Expect personnel to focus on customers. • Expect personnel to manage all relevant requirements. • Expect personnel to manage relevant risks and opportunities. • Expect personnel to focus on enhancing customer satisfaction. |
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5.2 Provide leadership by establishing a suitable quality policy |
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5.2.1 Provide leadership by formulating your quality policy |
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• Develop an appropriate quality policy. • Make sure that it supports your organization’s purpose. • Make sure that it deals with your organization’s context. • Formulate your organization’s quality policy. • Make a commitment to satisfy applicable requirements. • Make a commitment to continual QMS improvement. • Implement your organization’s quality policy. • Maintain your organization’s quality policy. |
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5.2.2 Provide leadership by implementing your quality policy |
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• Document your organization’s quality policy. • Communicate your organization’s quality policy. • Apply your organization’s quality policy. |
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5.3 Provide leadership by defining roles and responsibilities |
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• Assign QMS roles, responsibilities, and authorities. • Communicate QMS roles, responsibilities, and authorities. |
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6.1 Define actions to manage risks and address opportunities |
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6.1.1 Consider risks and opportunities when you plan your QMS |
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• Plan the development of your organization’s QMS. • Identify the risks and opportunities that could influence the • Consider how your organization’s context could affect • Consider how your organization’s interested parties could • Figure out what you need to do to address the risks and |
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6.1.2 Plan how you’re going to manage risks and opportunities |
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• Consider your organization’s risk treatment options. • Define actions to address risks and opportunities. • Define actions that you can take to address the risks |
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6.2 Set quality objectives and develop plans to achieve them |
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6.2.1 Establish quality objectives for all relevant areas |
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• Clarify criteria for setting quality objectives. • Set quality objectives in all relevant areas. • Communicate your quality objectives. • Document your quality objectives. • Monitor your quality objectives. • Update your quality objectives. |
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6.2.2 Develop plans to achieve objectives and evaluate results |
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• Establish plans to achieve quality objectives. • Plan how you’re going to evaluate your results. |
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6.3 Plan changes to your quality management system |
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• Plan changes to your quality management system. • Consider the purpose of the changes you intend to make. • Consider responsibilities and authorities whenever you make changes. • Consider the consequences that changes could potentially produce. • Consider the availability of resources whenever you make changes. • Consider the integrity of your QMS whenever you make changes. |
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7.1 Support your QMS by providing the necessary resources |
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7.1.1 Provide internal and external resources for your QMS |
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• Determine the resources that your QMS needs. • Provide the resources that your QMS needs. |
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7.1.2 Provide suitable people for your QMS and your processes |
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• Provide the people that your QMS needs to be effective. • Provide the people that you need in order to operate processes. • Provide the people that you need in order to control processes. |
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7.1.3 Provide the infrastructure that your processes must have |
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• Determine the infrastructure that your processes need. • Identify the infrastructure that your organization needs • Provide the infrastructure that your processes need. |
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7.1.4 Provide the appropriate environment for your processes |
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• Determine the environment that your processes need. • Identify the environment that your organization needs • Provide the environment that your processes need. |
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7.1.5 Provide monitoring, measuring, and traceability resources |
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7.1.5.1 Provide suitable monitoring and measuring resources |
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• Determine monitoring and measuring resource requirements. • Identify the monitoring and measuring resources that you • Provide suitable monitoring and measuring resources. |
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7.1.5.2 Provide suitable measurement traceability resources |
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• Determine your measurement traceability requirements. • Provide suitable measurement traceability resources. |
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7.1.6 Provide knowledge to facilitate process operations |
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• Determine the knowledge that your organization needs to have. • Acquire the knowledge that your organization needs to have. • Make organizational knowledge available to the extent necessary. • Monitor relevant trends and changes in knowledge and information. • Maintain the organizational knowledge that has been acquired. |
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7.2 Support your QMS by ensuring that people are competent |
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• Identify those under your control who do work that affects quality. • Clarify your organization’s quality competence requirements. • Acquire competence whenever shortcomings are discovered. • Document the competence of those whose work affects quality. • Evaluate the effectiveness of actions taken to acquire competence. |
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7.3 Support your QMS by explaining how people can help |
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• Make personnel aware of your organization’s QMS. • Share information about your QMS with the people who |
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7.4 Support your QMS by managing your communications |
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• Support your QMS by managing QMS communications. • Figure out how internal communications will be handled. • Figure out how external communications will be handled. |
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7.5 Support your QMS by controlling documented information |
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7.5.1 Include the documented information that your QMS needs |
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• Figure out how extensive documented QMS information should be. • Consider activities when you establish documents and records. • Consider personnel when you establish documents and records. • Consider processes when you establish documents and records. • Consider products when you establish documents and records. • Consider services when you establish documents and records. • Consider size when you establish documents and records. • Select all the documents and records that your QMS needs. • Select all internal documents and records that your QMS needs. • Select all external documents and records that your QMS needs. |
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7.5.2 Manage the creation and revision of documented information |
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• Manage the creation and updating of documented information. • Make sure that your organization’s QMS documents • Make sure that your organization’s QMS documents • Make sure that your organization’s QMS documents |
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7.5.3 Control the management and use of documented information |
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7.5.3.1 Control your organization’s QMS documents and records |
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• Select the QMS documents and records that you need. • Select all the documentation that you need in order to • Select all of the documentation that is required by ISO 9001. • Control the QMS documents and records that you need. • Control all the internal documentation that your QMS needs. • Control all the external documentation that your QMS needs. |
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7.5.3.2 Control how QMS documents and records are controlled |
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• Control how QMS documents and records are controlled. • Control how QMS documents and records are created. • Control how QMS documents and records are identified. • Control how QMS documents and records are distributed. • Control how QMS documents and records are accessed. • Control how QMS documents and records are retrieved. • Control how QMS documents and records are stored. • Control how QMS documents and records are used. • Control how QMS documents and records are changed. • Control how QMS documents and records are protected. • Control how QMS documents and records are preserved. |
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8.1 Develop, implement, and control your operational processes |
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• Plan the implementation and control of operational processes. • Prepare operational process implementation and control plans. • Use your plans to implement and control operational processes. • Control planned operational process changes and modifications. • Retain suitable operational process documents and records. |
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8.2 Determine and document product and service requirements |
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8.2.1 Communicate with customers and manage customer property |
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• Communicate with customers. • Provide information to customers. • Obtain information from customers. • Manage customer property. • Control property supplied by customers. |
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8.2.2 Clarify all product and service requirements and capabilities |
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• Identify requirements for products & services offered to customers. • Verify that you can actually meet product & service requirements. |
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8.2.3 Review product and service requirements and record results |
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8.2.3.1 Verify requirements before you accept orders from customers |
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• Study product & service requirements before accepting order. • Clarify differences between original proposal and final order. • Confirm that you can meet product and service requirements. |
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8.2.3.2 Document your review of product and service requirements |
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• Document results of product and service requirement reviews. • Document new or changed product and service requirements. |
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8.2.4 Amend documents when product and service requirements change |
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• Amend all relevant documented information to reflect • Retain and control documents and records that describe |
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8.3 Establish a process to design and develop products and services |
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8.3.1 Create an appropriate design and development process |
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• Establish an appropriate design and development process. • Implement an appropriate design and development process. |
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8.3.2 Plan product and service design and development activities |
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• Plan your design and development stages and controls. • Consider design and development process complexities. • Consider design and development process requirements. • Consider design and development process expectations. • Consider design and development process participation. • Consider design and development process interfaces. • Consider design and development process responsibilities. • Consider design and development process documentation. • Consider design and development process resources. |
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8.3.3 Determine product and service design and development inputs |
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• Clarify your product and service design and development inputs. • Define product and service design and development resource needs. • Control your design and development input documents and records. |
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8.3.4 Specify how design and development process will be controlled |
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• Control product and service design and development activities. • Control how design and development results are defined. • Control how design and development reviews are carried out. • Control how design and development validations are performed. • Control how design and development verifications are done. • Document product and service design and development activities. |
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8.3.5 Clarify how design and development outputs will be produced |
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• Control product and service design and development outputs. • Ensure that outputs can be compared against input requirements. • Ensure that outputs are capable of supporting product provision. • Ensure that outputs include or refer to acceptance criteria. • Ensure that outputs can be used to validate proposals. • Control design and development output documents and records. |
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8.3.6 Review and control all design and development changes |
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• Identify changes during or subsequent to design and development. • Review changes during or subsequent to design and development. • Control changes during or subsequent to design and development. |
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8.4 Monitor and control external processes, products, and services |
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8.4.1 Confirm that external products and services meet requirements |
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• Establish controls for external processes, products, and services. • Control your externally provided processes, products, and services. • Determine criteria to select, evaluate, & monitor external providers. • Use criteria to select external process, product, and providers. • Use criteria to monitor the performance of your external providers. • Use criteria to evaluate your organization’s external providers. |
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8.4.2 Develop controls for externally provided products and services |
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• Consider controls for external providers, • Consider the potential impact that externally provided processes, • Consider the controls that external process, product, and service • Develop controls for external providers, • Implement controls for external providers, |
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8.4.3 Discuss your organization’s requirements with external providers |
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• Clarify what you expect from external providers. • Clarify your organization’s process requirements. • Clarify your organization’s product requirements. • Clarify your organization’s service requirements. • Clarify your organization’s equipment requirements. • Clarify your organization’s interaction requirements. • Clarify your organization’s competence requirements. • Clarify your organization’s methodological requirements. • Clarify your organization’s monitoring and control requirements. • Clarify your organization’s verification or validation requirements. • Discuss your organization’s requirements with external providers. |
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8.5 Manage and control production and service provision activities |
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8.5.1 Establish controls for production and service provision |
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• Implement controlled conditions. • Implement controlled conditions for production. • Implement controlled conditions for service provision. • Implement controlled conditions for delivery process. • Implement controlled conditions for post-delivery process. |
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8.5.2 Identify your outputs and control their unique identity |
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• Use suitable means to identify outputs. • Identify outputs throughout production. • Identify outputs throughout service provision. • Control the unique identify of your outputs. • Control output identity if traceability is required. |
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8.5.3 Protect property owned by customers and external providers |
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• Identify property belonging to customers and external providers. • Verify property belonging to customers and external providers. • Protect property belonging to customers and external providers. • Monitor property belonging to customers and external providers. • Document property belonging to customers and external providers. |
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8.5.4 Preserve outputs during production and service provision |
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• Preserve outputs during production and service provision. • Consider using identification methods to preserve outputs. • Consider using packaging methods to preserve outputs. • Consider using handling methods to preserve outputs. • Consider using storage methods to preserve outputs. • Consider using transmission methods to preserve outputs. • Consider using transportation methods to preserve outputs. |
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8.5.5 Clarify and comply with all post-delivery requirements |
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• Clarify your organization’s post-delivery requirements. • Identify activities that must be carried out after product delivery. • Identify activities that must be carried out after service delivery. • Comply with your organization’s post-delivery requirements. |
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8.5.6 Control changes for production and service provision |
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• Review changes in production and service provision. • Document review results, actions taken, and authorizations. • Control changes in production and service provision. |
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8.6 Implement arrangements to control product and service release |
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• Establish planned arrangements to verify products at each stage. • Verify that product requirements were met at appropriate stages. • Establish planned arrangements to verify services at each stage. • Verify that service requirements were met at appropriate stages. |
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8.7 Control nonconforming outputs and document actions taken |
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8.7.1 Identify and control nonconforming output to prevent unintended use |
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• Identify outputs that do not conform to their requirements. • Evaluate nonconforming outputs and examine their impact. • Take appropriate action to control nonconforming outputs. • Verify conformity when nonconforming outputs are corrected. |
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8.7.2 Document nonconforming outputs and the actions that are taken |
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• Document your organization’s nonconforming outputs. • Document the actions and decisions taken to prevent |
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9.1 Monitor, measure, analyze, and evaluate QMS performance |
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9.1.1 Plan how to monitor, measure, analyze, and evaluate |
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• Plan how you’re going to monitor, measure, • Monitor, measure, analyze, and evaluate |
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9.1.2 Find out how well customer needs and expectations are being met |
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• Establish methods that can be used to monitor perceptions. • Monitor how well customer needs and expectations are fulfilled. |
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9.1.3 Evaluate performance, effectiveness, conformity, and satisfaction |
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• Analyze your monitoring and measurement results. • Analyze and evaluate appropriate data and information. • Use your analytical results to evaluate performance. • Use your analytical results to evaluate effectiveness. • Use your analytical results to evaluate conformity. • Use your analytical results to evaluate satisfaction. |
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9.2 Use internal audits to examine conformance and performance |
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9.2.1 Audit your quality management system at planned intervals |
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• Conduct internal conformance audits at planned intervals. • Determine if your organization’s QMS meets requirements. • Examine the effectiveness of your organization’s QMS. |
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9.2.2 Develop an internal audit program for your organization |
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• Plan the development of your internal audit program (programme). • Develop a program that can find out if QMS meets requirements. • Develop a program that can determine if your QMS is effective. • Establish your organization’s internal audit program. • Establish internal audit planning requirements. • Establish internal audit reporting requirements. • Establish internal audit responsibilities. • Establish internal audit schedules. • Establish internal audit methods. |
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9.3 Carry out management reviews and document your results |
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9.3.1 Review suitability, adequacy, effectiveness, and direction |
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• Review your organization’s QMS at regular intervals. • Review the suitability of your organization’s QMS. • Review the adequacy of your organization’s QMS. • Review the effectiveness of your organization’s QMS. • Review the direction of your organization’s QMS. |
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9.3.2 Plan and perform management reviews at planned intervals |
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• Plan your organization’s management review activities. • Schedule your organization’s reviews at planned intervals. • Review your organization’s quality management system. |
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9.3.3 Generate management review outputs and document results |
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• Generate suitable management review outputs. • Document the results of your management reviews. |
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10.1 Determine improvement opportunities and make improvements |
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• Consider ways of enhancing customer satisfaction. • Consider opportunities to support innovation. • Consider opportunities to take corrective action. • Consider opportunities to transform your operations. • Consider opportunities to make incremental changes. • Determine and select opportunities for improvement. • Identify opportunities to meet customer requirements. • Consider opportunities to enhance customer satisfaction. • Meet customer requirements and enhance satisfaction. |
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10.2 Control nonconformities and take appropriate corrective action |
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10.2.1 Correct nonconformities and address causes and consequences |
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• React to your organization’s nonconformities. • Control and correct your nonconformities. • Evaluate the need to eliminate causes. • Develop corrective actions to address causes. • Implement corrective actions to address causes. • Review the effectiveness of your corrective actions. |
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10.2.2 Document your nonconformities and the actions that are taken |
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• Document your organization’s nonconformities. • Document the actions taken to address nonconformities. • Document your organization’s corrective action results. |
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10.3 Enhance the suitability, adequacy, and effectiveness of your QMS |
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• Consider evaluation, analytical, and management review outputs. • Use results to confirm that unmet QMS needs must be addressed. • Improve the suitability, adequacy, and effectiveness of your QMS. |
