ISO 9001:2008 Quality Manual (Section 7)
The following document includes a portion of section 7 of our Ultimate Quality Manual. It is free to use "as is" or you can purchase this document with our implementation guide and top-level procedures in Microsoft Word format by visiting our Quality Manual information page.This document covers sections 7 only.
7 Product realization
7.1 Planning of product realization
In general, the company’s realization process planning is consistent with our normal methods of operation covered by existing procedures. In planning the processes for realization of products falling outside our normal methods, the following is considered:
- Quality objectives for products, projects or contracts, as applicable,
- The need for process documentation, e.g., a separate quality plan, and any necessary resources specific to the product,
7.2 Customer –related processes
7.2.1 Determination of requirements related to the product
Customer requirements are determined by Sales personnel during the inquiry, quotation, and order acceptance stages of customer contact. Personnel determine customer requirements as described below, including product requirements specified by the customer, including availability, delivery and post-delivery activities, product requirements that are not specified by the customer but are necessary for the intended use, and any obligations related to the product, including regulatory requirements.
7.2.2 Review of requirements related to the product
Prior to submission of a quotation or acceptance of an order, the Sales and Order Entry procedure requires that formal reviews take place to ensure that the customer’s requirements for the product have been clearly defined and documented. Such reviews also ensure that the company has the ability to meet those requirements. If a received order or contract differs from the associated quotation, the differences are resolved before accepting and processing the order.
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7.2.3 Customer communication
Any other communications by customers will be routed to Sales personnel who will respond appropriately according to the Sales and Order Processing procedure and/or the Corrective and Preventive Action procedure. Where appropriate, Sales personnel may authorize other personnel to serve as liaison to the customer for technical questions or other specific reasons. Sales personnel will also solicit customer feedback through appropriate means.
7.3 Design and development
The company maintains documented procedures to control and verify the processes of product design and development in order to ensure that the regulatory, market, safety, customer, and internal requirements are satisfied. Customer safety and appropriate regulatory requirements are clearly identified, defined, reviewed, recorded and retained in the Design Files. Incomplete, conflicting, and ambiguous requirements are corrected and clarified before further design activities are carried-out.
All design activities are planned and provided sufficient resources to perform design-related tasks. We review, verify, and validate all design projects to ensure that the project is on target with stated goals and expectations and to ensure that the end product meets the requirements and needs of the customer.
7.4.1 Purchasing process
The company’s purchasing processes, including supplier evaluation and selection, are controlled according to the Procurement and Supplier Management procedure, which ensures that purchased product conforms to the applicable requirements. The type and extent of control exerted over such suppliers and their product, or service, depends on the products’ impact on the realization process and/or the quality of the final product. Criteria for selection, evaluation and re-evaluation of suppliers are described in the Procurement and Supplier Management procedure.
7.4.2 Purchasing information
Designated employees are authorized to identify resource or purchasing requirements. As appropriate, a Purchase Order is initiated to procure the needed items. The Purchase Order details all necessary information and pertinent specifications including, where applicable, the requirements for qualification of the product, or any quality management system requirements. All purchasing documents are reviewed by Purchasing personnel for accuracy and completeness prior to release.
7.4.3 Verification of purchased product
Purchased products are verified upon receipt according to the Receiving and Receiving Inspection procedure. When requested, all purchased products are to be supplied with appropriate product certification. If our customers should decide to verify products at our suppliers’ premises prior to delivery, the arrangements, verification and release of such products will be determined by Purchasing personnel, and will be recorded on or referenced by the Purchase Order.
7.5 Production and service provision
7.5.1 Control of production and service provision
Production operations are planned and controlled by production management, who are responsible for providing suitable production equipment and a suitable working environment. Production equipment is appropriately maintained, as are the records of such maintenance.
The Production Manager is responsible for providing appropriate information to Operators that specifies product characteristics, processing requirements, and verification criteria, as appropriate. Production management also ensures that work instructions are available to Operators as necessary to ensure product conformity. Production operations are conducted in accordance with the Production procedure.
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When nonconforming product is encountered during production and inspection, the Production procedure prescribes the proper course of action for the person discovering the nonconformity. Nonconforming product is corrected when practical and is re-inspected against the criteria against which it originally failed. Nonconforming product is not sent to customers, unless the customer approves otherwise through a concession negotiated by Sales personnel or the President.
Any post-delivery agreements will be honored in accordance with company policy. Alternative agreements may be negotiated, reviewed, and approved during contract review activities.
7.5.2 Validation of processes for production and service provision
Production processes are qualified by a history of successful use. Should new or changed production processes become part of the quality management system, such processes will be qualified by top management prior to their implementation. Such planning will be conducted in accordance with the Management Review procedure.
7.5.3 Identification and Traceability
Where applicable, all received materials are identified by packing documents, tags and/or stamps. Once received items are accepted in accordance with the Receiving procedure, they are moved to the appropriate storage location or recipient as appropriate, ensuring that product identification is maintained.
Identification of product throughout production is ensured through segregation, physical appearance, location in production, accompanying work instructions and labeling, markings, stamps, etc. The Production procedure further describes product identification techniques. A product’s inspection status can also be determined by it physical appearance, its location in production, marks, or tags. Product is uniquely identified where traceability is a requirement. Such unique identification is affixed to the product and recorded on its accompanying paperwork.
7.5.4 Customer property
Some customers will supply us with materials to be incorporated into their products. Such items will be handled with care while under our control. Such customer-supplied materials are received in a manner similar to any other materials purchased by the company that are to be incorporated into products sold. Such materials are verified to ensure that they are in good condition upon receipt and are handled and stored to protect them from damage and deterioration.
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7.5.5 Preservation of product
All materials and products under our control are stored and handled in such a way as to preserve conformity of the product, including any constituent parts. Such protection is also extended to product being delivered, which is packaged appropriately to preserve conformity during delivery. At all times employees handle items in such a manner as to ensure their own safety and the safety of others. All employees involved in the handling of products take care to handle and store them in such a manner as to prevent damage and deterioration and to maintain product identification. Appropriate handling and transport equipment is used at all times.
7.6 Control of measuring and monitoring devices
Measuring and monitoring devices that are used to demonstrate the conformance of a product to specified requirements are controlled according to the Calibration procedure. Each such device will have a corresponding Calibration Record that maintains the device’s calibration data and history.
All personnel who use measuring and monitoring devices are trained in their selection and use as well as their proper handling and storage, and personnel understand that they are not to adjust these instruments. Work instructions and associated drawings prescribe which measurements are to be made, as well as the associated tolerances. If measuring and monitoring devices are not specified by the work instructions, personnel responsible for determining conformity will select and use measuring and monitoring equipment with the appropriate capability for the measurement requirements.
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Associated documents/records for section 7:
Design Control, SQ00xx
Sales and Order Processing procedure, SQ00xx
Procurement and Supplier Management procedure, SQ00xx
Inventory Control - Receiving, Inspection and Stocking procedure, SQ00xx
Management of Non-Conforming Materials, SQ00xx
Equipment Calibration and Maintenance procedure, SQ00xx
Calibration and Maintenance Records, Quality System database