Iso 9001 2015 Praxiom 3g315r

This web page presents a Plain English overview of the new ISO 9001 2015 quality management standard. For a more detailed version, please see ISO DIS 9001 2015 Translated into Plain English. Part 4. Context asks you to start by understanding your organization and its context before you start to develop its process-based quality management system (QMS). It asks you to consider the external and internal issues that are relevant to your organization's purpose and strategic direction and to think about the influence these issues could have on its QMS and the results it intends to achieve. This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences. Once you’ve considered all of this, you're ready to define the scope of your QMS and to begin its development.

Part 5. Leadership asks your organization's top management to provide leadership for its QMS by showing that they it, by expecting people to focus on quality and on customers, by expecting them to provide compliant products and services, and by expecting them to manage risks and opportunities. Section 5 also expects top management to establish a quality policy and to assign QMS roles, responsibilities, and authorities.

Part 6. Planning asks you to plan the development of your QMS. It asks you to address the risks and opportunities that could influence your organization's QMS or disrupt its operation and to consider how its context and its interested parties could affect its QMS and the results it intends to achieve. Section 6 also asks you to set quality objectives and to develop plans to achieve them. Finally, it asks you to control changes to your QMS.

Part 7. asks you to your QMS by managing

communications and by providing the necessary resources. It asks you to provide competent people, to provide an appropriate infrastructure and environment, to provide suitable monitoring and measuring technologies, to provide the knowledge that is needed to process operations, and to provide documented information. It asks you to start by figuring out how extensive your documented information should be and then asks you to select and include all the documentation your organization needs in order to ensure that its processes are being carried out as planned and all the documentation it needs in order to comply with the ISO 9001 standard. It asks you to manage the creation and modification of this documentation and to control how it is used.

Part 8. Operations asks you to develop, implement, and control the operational processes that your organization needs in order to provide products and services and to manage and control risks and opportunities. It asks you to clarify how product and service requirements will be managed and how communications with customers will be handled. Section 8 also asks you to establish a product and service design and development process (when necessary), to monitor externally provided products and services, to manage production and service provision, to supervise product and service release, and to control nonconforming process outputs, products, and services.

Part 9. Evaluation asks you to monitor, measure, analyze, and evaluate the performance of your organization's QMS. It asks you to monitor customer satisfaction, to evaluate monitoring and measuring results, to audit conformance and performance, and to review the suitability, adequacy, and effectiveness of your QMS.

Part 10. Improvement asks you to identify opportunities to improve

your organization's processes, products and services, and to enhance customer satisfaction. It also asks you to control nonconformities, to take corrective actions, and to enhance the suitability, adequacy, and effectiveness of your QMS.

RELATED RESOURCES

ISO 9001 2015 Introduction Quality Management Principles ISO 19011 Internal Audit Library Outline of ISO 9001 2015 Standard

ISO 9001 2015 versus ISO 9001 2008 Plain English ISO 9000 2015 Definitions ISO's Process Approach in Plain English ISO 9001 2015 Translated into Plain English ISO 9004 2009 Translated into Plain English Plain English Quality Management Checklist

This web page presents a Plain English outline of the new ISO DIS 9001 2015 quality management standard. For a more detailed version, see ISO 9001 2015 Translated into Plain English.

4. Context 4.1 Understand your organization and its unique context. 4.2 Clarify the needs and expectations of interested parties. 4.3 Define the scope of your quality management system. 4.4 Establish a QMS that complies with this standard.

5. Leadership 5.1 Provide leadership by focusing on quality and customers. 5.1.1 Provide leadership by encouraging a focus on quality. 5.1.2 Provide leadership by encouraging a focus on customers. 5.2 Provide leadership by establishing a suitable quality policy. 5.2.1 Provide leadership by formulating your quality policy. 5.2.2 Provide leadership by implementing your quality policy. 5.3 Provide leadership by defining roles and responsibilities.

6. Planning 6.1 Define actions to manage risks and address opportunities. 6.1.1 Consider risks and opportunities when you plan your QMS. 6.1.2 Plan how you’re going to manage risks and opportunities. 6.2 Set quality objectives and develop plans to achieve them. 6.2.1 Establish quality objectives for all relevant areas. 6.2.2 Develop plans to achieve objectives and evaluate results. 6.3 Control changes to your quality management system.

7.

7.1 your QMS by providing the necessary resources. 7.1.1 Provide internal and external resources for your QMS. 7.1.2 Provide suitable people for your QMS and your processes. 7.1.3 Provide the infrastructure that your processes must have. 7.1.4 Provide the appropriate environment for your processes. 7.1.5 Provide suitable monitoring and measuring resources. 7.1.6 Provide knowledge to facilitate process operations. 7.2 your QMS by ensuring that people are competent. 7.3 your QMS by explaining how people can help. 7.4 your QMS by managing your communications. 7.5 your QMS by controlling documented information. 7.5.1 Include the documented information that your QMS needs. 7.5.2 Manage the creation and revision of documented information. 7.5.3 Control the management and use of documented information. 7.5.3.1 Control your organization's QMS documents and records. 7.5.3.2 Control how QMS documents and records are controlled.

8. Operations 8.1 Develop, implement, and control your operational processes. 8.2 Clarify how product and service requirements will be managed. 8.2.1 Clarify how communications with customers will be handled. 8.2.2 Clarify how product and service requirements will be specified. 8.2.3 Clarify how product and service requirements will be reviewed. 8.3 Establish a process to design and develop products and services.

8.3.1 Create a design and development process when necessary. 8.3.2 Plan product and service design and development activities. 8.3.3 Determine product and service design and development inputs. 8.3.4 Specify how design and development process will be controlled. 8.3.5 Clarify how design and development outputs will be produced. 8.3.6 Review and control all design and development changes. 8.4 Monitor and control externally provided products and services. 8.4.1 Confirm that external products and services meet requirements. 8.4.2 Establish controls for externally provided products and services. 8.4.3 Discuss your organization’s requirements with external providers. 8.5 Manage and control production and service provision activities. 8.5.1 Establish controls for production and service provision. 8.5.2 Identify process outputs and control their unique identity. 8.5.3 Protect property owned by customers and external providers. 8.5.4 Preserve outputs during production and service provision. 8.5.5 Clarify and comply with all post-delivery requirements. 8.5.6 Control changes for production and service provision. 8.6 Implement arrangements to control product and service release. 8.7 Control nonconforming process outputs, products, and services.

9. Evaluation 9.1 Monitor, measure, analyze, and evaluate your QMS performance. 9.1.1 Plan how you’re going to monitor, measure, analyze, and evaluate. 9.1.2 Obtain customer information and monitor customer satisfaction.

9.1.3 Analyze and evaluate monitoring and measurement results. 9.2 Use internal audits to examine conformance and performance. 9.2.1 Audit your quality management system at planned intervals. 9.2.2 Develop an internal audit program for your organization. 9.3 Review the suitability, adequacy, and effectiveness of your QMS. 9.3.1 Plan and perform management reviews at planned intervals. 9.3.2 Generate management review outputs and document results.

10. Improvement 10.1 Determine improvement opportunities and make improvements. 10.2 Control nonconformities and take appropriate corrective action. 10.2.1 Correct nonconformities and address causes and consequences. 10.2.2 Document your nonconformities and the actions that are taken. 10.3 Enhance the suitability, adequacy, and effectiveness of your QMS.

If you'd like to see how we've translated each of the above sections into Plain English, please check out our more detailed ISO 9001 webpage.

RELATED RESOURCES

ISO 9001 2015 Introduction Quality Management Principles Overview of ISO 9001 2015 Standard Plain English Internal Audit Standard ISO 9001 2015 versus ISO 9001 2008

Plain English ISO 9000 2015 Definitions ISO's Process Approach in Plain English ISO 9001 2015 Translated into Plain English ISO 9004 2009 Translated into Plain English Plain English Quality Management Checklist

Updated on May 15, 2015. First published on November 25, 2014.