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8.Operation - Coggle Diagram

- - - - a) the nature, duration & complexity of the design & development activities
      - b) the required process stages, including applicable design & development reviews
      - c) the required design & development verification & validation activities
      - d) the responsibilities & authorities involved in the design & development process
      - e) the internal & external resource needs for the design & development of products & services
      - f) the need to control interfaces between persons involved in the design & development process
      - g) the need for involvement of customers & users in the design & development process
      - h) the requirements for subsequent provision of products & services
      - i) the level of control expected for the design & development process by customers & other relevant interested parties
      - j) the documented information needed to demonstrate that design & development requirements have been met
  - - - a) functional & performance requirements
      - b) information derived from previous similar design & development activities
      - c) statutory & regulatory requirements
      - d) standards or codes of practice that the organization has committed to implement
      - e) potential consequences of failure due to the nature of the products & services
  - - - a) the results to be achieved are defined
      - b) reviews are conducted to evaluate the ability of the results of design & development to meet requirements
      - c) verification activities are conducted to ensure that the design & development outputs meet the input requirements
      - d) validation activities are conducted to ensure that the resulting products & services meet the requirements for the specified application or intended use
      - e) any necessary actions are taken on problems determined during the reviews, or verification & validation activities
      - f) documented information of these activities is retained
  - - - a) meet the input requirements
      - b) are adequate for the subsequent processes for the provision of products & services
      - c) include or reference monitoring & measuring requirements, as appropriate, & acceptance criteria
      - d) specify the characteristics of the products & services that are essential for their intended purpose & their safe & proper provision
  - - - a) design & development changes
      - b) the results of reviews
      - c) the authorization of the changes
      - d) the actions taken to prevent adverse impacts
- - - - a) the availability of documented information that defines:
        
        1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed
        
        2) the results to be achieved
      - b) the availability & use of suitable monitoring & measuring resources
      - c) the implementation of monitoring & measurement activities at appropriate stages to verify that criteria for control of processes or outputs, & acceptance criteria for products & services, have been met
      - d) the use of suitable infrastructure & environment for the operation of processes
      - e) the appointment of competent persons, including any required qualification
      - f) the validation, & periodic revalidation, of the ability to achieve planned results of the processes for production & service provision, where the resulting output cannot be verified by subsequent monitoring or measurement
      - g) the implementation of actions to prevent human error
      - h) the implementation of release, delivery & post-delivery activities
  - - - Identification
      - Handling
      - Contamination control
      - Packaging
      - Storage
      - Transmission / Transportation
      - Protection
  - - - a) statutory & regulatory requirements
      - b) the potential undesired consequences associated with its products & services
      - c) the nature, use & intended lifetime of its products & services
      - d) customer requirements
- - - - a) the requirements for the products & services are defined, including:
        
        1) any applicable statutory & regulatory requirements
        
        2) those considered necessary by the organization
      - b) the organization can meet the claims for the products & services it offers
  - - - a) providing information relating to products & services
      - b) handling enquiries, contracts or orders, including changes
      - c) obtaining feedback & complaints
      - d) handling or controlling customer property
      - e) establishing contingency actions
  - - - a) requirements specified by the customer, including the requirements for delivery & post- delivery activities
      - b) requirements not stated by the customer, but necessary for the specified or intended use, when known
      - c) requirements specified by the organization
      - d) statutory & regulatory requirements applicable to the products & services
      - e) contract or order requirements differing from those previously expressed
    - - a) on the results of the review
      - b) on any new requirements for the products & services
- - - - 1) the processes
      - 2) the acceptance of products & services
    - - 1) to have confidence that the processes have been carried out as planned
      - 2) to demonstrate the conformity of products & services to their requirements
- - - - a) Products & services for incorporation.
      - b)Direct provision to customers.
      - c) Processes provided by external decision.
  - - - a) Maintain control over externally provided processes within the QMS.
      - b) Define controls for providers and resulting output.
      - c) Take consideration:
        
        1) Consider impact on meeting customer and regulatory requirements.
        
        2) The effectiveness of the controls applied by the external provider
      - d) Determine verification activities for compliance.
  - - - a) the processes, products & services to be provided
      - b) the approval of:
        
        1) products & services
        
        2) methods, processes & equipment
        
        3) the release of products & services
      - c) competence, including any required qualification of persons
      - d) the external providers’ interactions with the organization
      - e) control & monitoring of the external performance
      - f) verification or validation activities
- - - - a) correction
      - b) segregation, containment, return or suspension of provision of products & services
      - c) informing the customer
      - d) obtaining authorization for acceptance under concession