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
8.4 Externally Provided Products & Services 7.4.1 Purchasing Process Title only. 8.4.1 General 7.4.1 Purchasing Process This requirement is comparable to the requirement from ISO 9001:2008 Clauses 7.4.1. Organizations should ensure that documented information records; not only the criteria by which suppliers were selected, but also the results of the selection activities, and the results from the monitoring of their performance. 8.4.2 Type And Extent Of Control Of External Provision 7.4.1 Purchasing Process This requirement is comparable to the requirements from ISO 9001:2008 Clauses 7.4.1 – Purchasing Process and Clause 7.4.3 - Verification of Purchased Product. Organizations should ensure that the supplied product or service meets the specified requirements by implementing a process of inspection to ensure that purchased products conform. 7.4.3 Verification Of Purchased Product 8.4.3 Information For External Providers 7.4.2 Purchasing Information This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.4.2 – Purchasing Information. Organizations need establish methods for communicating their intentions in terms of controlling and monitoring external provider performance to external providers. 8.5 Production And Service Provision 7.5 Production And Service Provision Title only. 8.5.1 Control Of Production And Service Provision 7.5.1 Control Of Production And Service Provision This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.1 - Control of Production and Service Provision and Clause 7.5.2 Validation of Processes from Production and Service Provision. Organizations must control the conditions by which products or services are provided. 8.5.2 Identification And Traceability 7.5.3 Identification And Traceability This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.3 - Identification and traceability. Where traceability is a requirement, the organization must control and record the unique identification of the product. 8.5.3 Property Belonging To Customers Or External Providers 7.5.4 Customer Property Have controls been established for external provider property ownership does not transfer to the organization?
8.5.4 Preservation 7.5.5 Preservation Of Product This is a new requirement. The auditor will expect to see that adequate measures are taken to protect/preserve the product during internal processing and delivery to the intended destination. 8.5.5 Post-Delivery Activities 7.5.1 Control Of Production And Service Provision This is a new requirement for the organization to have controls for the expanded list of applicable Post Delivery activities. 8.5.6 Control Of Changes 7.3.7 Control Of Design And Development Changes This is a new requirement for the organization to implement a process for responding to unplanned changes in such a way that conformity with requirements is maintained. Changes should be documented and information retained about the changes, including who authorized the change and the actions arising from the change. 8.6 Release Of Products And Services 8.2.4 Monitoring And Measurement Of Processes This requirement is comparable to ISO 9001:2008 Clause 8.2.4 Monitoring and Measurement of Processes. Your organization must show evidence that a process (method, techniques, formats, etc.) is in place to monitor and measure the characteristics of product to verify that requirements are being met. 7.4.3 Verification Of Purchased Product 8.7 Control Of Nonconforming Process Outputs, Products And Services 8.3 Control Of Nonconforming Product This clause now includes as a new requirement, the terms ‘process outputs’ and ‘services’ as well as products. It should be noted that there is no need to maintain a documented procedure but your organization may still chose to operate one. 9.0 Performance Evaluation N/A No ISO 9001:2008 Equivalent Title only. 9.1 Monitoring, Measurement, Analysis And Evaluation 8.0 Measurement, Analysis And Improvement You should note the additional requirement for your organization to evidence evaluation of the results of monitoring and measurement, not just their analysis. 9.1.1 General 8.1 General 9.1.2 Customer Satisfaction 8.2.1 Customer Satisfaction You should note the additional requirement for organizations to implement a consistent and systematic approach when dealing with customer feedback and that they are obtaining information on customer perception.