7. Product realization

7.1 Production Planning

The organization plans and develops the processes needed for production of products. Production planning is consistent with the requirements of the other processes of the quality management system (see 4.1). In production planning, the organization determines the following, as appropriate:

• quality objectives and requirements for the product,
• the need to establish processes, documents, and provide resources specific to the product,
• required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance, and
• records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
• The identification of resources to support operation and maintenance of the product.

The output of the planning is in a form suitable for the organizations method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, is referred to as the quality plan.

NOTE 2 The organization also applies the requirements given in 7.3 to the development of product realization processes.

Supporting Documentation

• Production Overview Flowchart

7.2 Customer- related processes

7.2.1 Determination of requirements related to the product

The organization determines:

• requirements specified by the customer, including the requirements for delivery and post-delivery activities,
• requirements not stated by the customer but necessary for specified or intended use, where known,
• statutory and regulatory requirements related to the product, and
• any additional requirements determined by the organization.

Supporting Documentation

• Quote Process Flowchart
• Order Processing/Contract Review
• Order Change Process Flowchart

  7.2.2 Review of requirements related to the product

  The organization reviews the requirements related to the product. This review is conducted prior to the organizations commitment to supply a product to the customer (e.g. acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that:

• product requirements are defined,
• contract or order requirements differing from those previously expressed are resolved, and
• the organization has the ability to meet the defined requirements.
• risks, such as new technology or short delivery time scale, have been evaluated.

  Records of the results of the review and actions arising from the review are maintained (see 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements are confirmed by the organization before acceptance. Where product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

Supporting Documentation:

• Order Processing/Contract Review
• Order Change Process Flowchart

  7.2.3 Customer communication

  The organization determines and implements effective arrangements for communicating with customers in relation to:

• product information,
• enquiries, contracts or order handling, including amendments, and
• customer feedback, including customer complaints.

Supporting Documentation

• Order Processing/Contract Review
• Order Change Process Flowchart

7.3 Design and development

The organization has no design and development activities and has excluded these requirements from its Quality System determines.

7.4 Purchasing

7.4.1 Purchasing process

The organization ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization evaluates and selects suppliers based on their ability to supply product in accordance