6.3 Planning of changes Where the organization How are changes to the QMS determines the need for change to planned systematically? the quality management system Demonstrate the purpose and (see 4.4) the change shall be potential consequences of carried out in a planned and changes; systematic manner. Demonstrate the integrity of the The organization shall consider: QMS; 6.3 a) the purpose of the change and Demonstrate how resources are q1 any of its potential consequences; made available? b) the integrity of the quality Demonstrate how responsibility management system; and authority is allocated or c) the availability of resources; reallocated. d) The allocation or reallocation of responsibilities and authorities. 7 Support 7.1 Resources 7.1.1 General The organization shall determine Demonstrate how resources are and provide the resources needed determined for the establishment, for the establishment, implementation, maintenance and implementation, maintenance and continual improvement of the continual improvement of the QMS. quality management system. Show me how the capabilities and 7.1.1 The organization shall consider: constraints on internal resources q1 a) the capabilities of, and are considered. constraints on, existing internal Show me how needs from external resources; providers are considered. b) What needs to be obtained from external providers? 7.1.2 People To ensure that the organization How do you provide persons can consistently meet customer necessary to consistently meet and applicable statutory and customer, applicable statutory and regulatory requirements, the regulatory requirements for the organization shall provide the QMS including the necessary persons necessary for the processes? 7.1.2 effective q1 Operation of the quality management system, including the processes needed. 7.1.3 Infrastructure The organization shall determine, How do you determine, provide provide and maintain the and maintain the infrastructure for infrastructure for the operation of the operation of processes to 7.1.3 its processes to achieve achieve products and service q1 conformity of products and conformity? services. NOTE 1 Any product realization change affecting customer requirements requires notification to agreement from, the customer.
6.3 Planning of changes 6.3 q1 Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner. The organization shall consider: a) the purpose of the change and any of its potential consequences; b) the integrity of the quality management system; c) the availability of resources; d) The allocation or reallocation of responsibilities and authorities. How are changes to the QMS planned systematically? Demonstrate the purpose and potential consequences of changes; Demonstrate the integrity of the QMS; Demonstrate how resources are made available? Demonstrate how responsibility and authority is allocated or reallocated. 7 Support 7.1 Resources 7.1.1 General 7.1.1 q1 The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization shall consider: a) the capabilities of, and constraints on, existing internal resources; b) What needs to be obtained from external providers? Demonstrate how resources are determined for the establishment, implementation, maintenance and continual improvement of the QMS. Show me how the capabilities and constraints on internal resources are considered. Show me how needs from external providers are considered. 7.1.2 People 7.1.2 q1 To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective Operation of the quality management system, including the processes needed. How do you provide persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes? 7.1.3 Infrastructure 7.1.3 q1 The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services. How do you determine, provide and maintain the infrastructure for the operation of processes to achieve products and service conformity? NOTE 1 Any product realization change affecting customer requirements requires notification to agreement from, the customer.