8.5 Production and service Provision (8.5.1)

8. OPERATION

8.5 Production and service Provision

8.5.1 Control of production and service provision

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

• a) the availability of documented information that defines: (via 8.1 & 8.2.2)
• 1) the characteristics of the products to be produced, the services to be provided, or the activities
• 2) be performed;
• 3) the results to be achieved;
• b) the availability and use of suitable monitoring and measuring resources (via 7.1.5);
• c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; (via 8.2.3)
• d) the use of suitable infrastructure (via 7.1.3) and environment for the operation of processes via 7.1.4);
• e) the appointment of competent persons (via 7.2), including any required qualification;
• f) the validation , and periodic revalidation, of the ability to achieve planned results of the processes for production and 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 (via 8.6), delivery and post-delivery activities (via 8.5.5).

Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 9.1.3 (Performance analysis and evaluation)
Clause 10.1 (Improvement)

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8.4 Control of externally provided processes, products and services (8.4.3)

8. OPERATION

8.4 Control of externally provided processes, products and services

8.4.3 Information for external providers

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.

The organization shall communicate to external providers its requirements for:

• a) the processes, products and services to be provided;
• b) the approval of:
• 1) products and services;
• 2) methods, processes and equipment;
• 3) the release of products and services;
• c) competence, including any required qualification of persons;
• d) the external providers’ interactions with the organization;
• e) control and monitoring of the external providers’ performance to be applied by the organization;
• f) verification and validation activities that the organization, or its customer, intends to perform at the external providers’ premises.

Cross reference
Clause 9.1.3 (Performance analysis and evaluation) 

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8.3 Design and development of products and services (8.3.4)

8. OPERATION

8.3 Design and development of products and services

8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:

• a) the results to be achieved are defined;
• b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
• c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;
• d) validation  activities are conducted to ensure that the resulting products and 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 and validation  activities;
• f) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation  have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

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8.3 Design and development of products and services (8.3.2)

8. OPERATION

8.3 Design and development of products and services

8.3.2 Design and development planning

In determining the stages and controls for design and development , the organization shall consider:

• a) the nature, duration and complexity of the design and development activities;
• b) the required process stages, including applicable design and development reviews;
• c) the required design and development verification and validation activities;
• d) the responsibilities and authorities involved in the design and development process;
• e) the internal and external resource needs for the design and development of products and services
• f) the need to control interfaces between persons involved in the design and development process;
• g) the need for involvement of customers and users in the design and development process;
• h) the requirements for subsequent provision of products and services;
• i) the level of control expected for the design and development process by customers and other relevant interested parties;
• j) the documented information needed to demonstrate that design and development requirements have been met.

Cross reference
Clause 9.1.3 (Performance analysis and evaluation)

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