5.0 Leadership 5.0 Management Responsibility Title only Top management is now required to demonstrate leadership and 5.1 Leadership And Commitment 5.1 Management Commitment commitment in regard to the QMS. They should ensure that the quality policy and objectives are compatible with the business’s strategic direction, that the policy is understood and followed, and Leadership And Commitment For The 5.1.1 5.1 Management Commitment that the QMS is integrated into the organization’s business Quality Management System processes. There are also additional requirements based on the need to 5.1.2 Customer Focus 5.2 Customer Focus identify and address any risks to conformity of goods and services provided to customers. 5.2 Quality Policy 5.3 Quality Policy Includes an additional requirement to make the policy available to 5.2.1 Establishing the Quality Policy 5.3 Quality Policy interested parties and being available as documented information. 5.2.2 Communicating the Quality Policy 5.5.3 Internal Communication Amended, no longer requires the specific position of a Quality 5.5.1 Responsibility And Authority Management Representative. Organizations ensure should that Top Organizational Responsibilities And management has taken on or delegated the responsibility for 5.3 Authorities management of the quality management system, and that they have established a means to monitor if processes are delivering their 5.5.2 Management Representative intended outputs. Planning For The Quality Management 6.0 5.4.2 Quality Management System Planning Title only. System This is a new requirement that requires a process to be 5.4.2 Quality Management System Planning implemented to determine and evaluate applicable risks. The Actions To Address Risks And 6.1 organization will be expected to have an understanding of this Opportunities requirement and be prepared to explain how they are managed 8.5.3 Preventive Action within their quality system.
5.0 Leadership 5.0 Management Responsibility Title only 5.1 Leadership And Commitment 5.1 Management Commitment Top management is now required to demonstrate leadership and commitment in regard to the QMS. They should ensure that the quality policy and objectives are compatible with the business’s strategic direction, that the policy is understood and followed, and that the QMS is integrated into the organization’s business processes. There are also additional requirements based on the need to identify and address any risks to conformity of goods and services provided to customers. 5.1.1 Leadership And Commitment For The Quality Management System 5.1 Management Commitment 5.1.2 Customer Focus 5.2 Customer Focus 5.2 Quality Policy 5.3 Quality Policy Includes an additional requirement to make the policy available to interested parties and being available as documented information. 5.2.1 Establishing the Quality Policy 5.3 Quality Policy 5.2.2 Communicating the Quality Policy 5.5.3 Internal Communication 5.3 Organizational Responsibilities And Authorities 5.5.1 Responsibility And Authority Amended, no longer requires the specific position of a Quality Management Representative. Organizations ensure should that Top management has taken on or delegated the responsibility for management of the quality management system, and that they have established a means to monitor if processes are delivering their intended outputs. 5.5.2 Management Representative 6.0 Planning For The Quality Management System 5.4.2 Quality Management System Planning Title only. 6.1 Actions To Address Risks And Opportunities 5.4.2 Quality Management System Planning This is a new requirement that requires a process to be implemented to determine and evaluate applicable risks. The organization will be expected to have an understanding of this requirement and be prepared to explain how they are managed within their quality system. 8.5.3 Preventive Action
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