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IsO9001:2000E) 7.5 Production and service provision 7.5.1 Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable a)the availability of information that describes the characteristics of the product, b)the availability of work instructions, as necessary, c)the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e)the implementation of monitoring and measurement, and f the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a)defined criteria for review and approval of the processes, b)approval of equipment and qualification of personnel, c)use of specific methods and procedure d)requirements for records(see 4.2. 4)and e)revalidation. 7.5.3 Identification and traceability Where appropriate the organization shall identify the product by suitable means throughout product ealization The organization shall identify the product status with respect to monitoring and measurement ts Where traceability is a requirement, the organization shall control and record the unique identification of the product(see 4.2.4) NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained 7.5.4 Customer property The organization shall exercise care with customer property while it is under the organization's control being used by the or ation. The organization shall identify, verify, protect ad safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use this shall be reported to the customer and records maintained (see 4.2. 4) NOTE Customer property can include intellectual property OISO2000-All rights reservedISO 9001: 2000(E) ©ISO2000 – All rights reserved 10 7.5 Production and service provision 7.5.1 Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4) and e) revalidation. 7.5.3 Identification and traceability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4) NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. 7.5.4 Customer property The organization shall exercise care with customer property while it is under the organization’s control being used by the organization. The organization shall identify, verify, protect ad safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4) NOTE Customer property can include intellectual property
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