Specification Requirements

8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, 
taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

8.2.2 Determining the requirements for products and services

When determining the requirements for the products and services to be offered to customers, the 
organization shall ensure that:

8.2.3 Review of the requirements for products and services

8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and 
services to be offered to customers. The organization shall conduct a review before committing to supply 
products and services to a customer, to include:

The organization shall ensure that contract or order requirements differing from those previously 
defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the 
customer does not provide a documented statement of their requirements

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the 
review can cover relevant product information, such as catalogues.

8.2.3.2 The organization shall retain documented information, as applicable:

8.3 Design and development of products and services

8.3.1 General

The organization shall establish, implement and maintain a design and development process that is 
appropriate to ensure the subsequent provision 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:

8.3.3 Design and development inputs

The organization shall determine the requirements essential for the specific types of products and 
services to be designed and developed. The organization shall consider:

Inputs shall be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs shall be resolved.

The organization shall retain documented information on design and development inputs.

8.3.4 Design and development controls

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

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

8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:

8.3.6 Design and development changes

The organization shall identify, review and control changes made during, or subsequent to, the design 
and development of products and services, to the extent necessary to ensure that there is no adverse 
impact on conformity to requirements.

The organization shall retain documented information on:

8.4     Control of externally provided processes, products and services

8.4.1 General

The organization shall ensure that externally provided processes, products and services conform to 
requirements.

The organization shall determine the controls to be applied to externally provided processes, products 
and services when:

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations

8.4.2 Type and extent of control

The organization shall ensure that externally provided processes, products and services do not 
adversely affect the organization’s ability to consistently deliver conforming products and services to 
its customers.

The organization shall:

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:

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:

8.5.2     Identification and traceability

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

8.5.3 Property belonging to customers or external providers

The organization shall exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization.

The organization shall identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services.

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.

NOTE A customer’s or external provider’s property can include materials, components, tools and equipment, 
premises, intellectual property and personal data.

8.5.4 Preservation

The organization shall preserve the outputs during production and service provision, to the extent 
necessary to ensure conformity to requirements.

NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

8.5.5 Post-delivery activities

The organization shall meet requirements for post-delivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, the organization shall consider:

NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such 
as maintenance services, and supplementary services such as recycling or final disposal

8.5.6 Control of changes

The organization shall review and control changes for production or service provision, to the extent 
necessary to ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, 
the person(s) authorizing the change, and any necessary actions arising from the review.

8.6 Release of products and services

The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.

The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer

The organization shall retain documented information on the release of products and services. The 
documented information shall include:

8.7 Control of nonconforming outputs

8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.

The organization shall deal with nonconforming outputs in one or more of the following ways:

8.7.2 The organization shall retain documented information that:

Revision #1
Created 3 May 2023 03:33:52 by Admin
Updated 3 May 2023 10:38:42 by Admin