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Clause 8 Operation

8.1 Operational planning and control

The intent of the clause on Operational planning and control is to specify the requirements that need to be implemented within the organization’s operations to make sure the Management Systems Standard requirements are fulfilled, and the priority risks and opportunities are being addressed.

8.2.1 Customer communication

When comparing this clause to the corresponding Clause 7.2.3 of ISO 9001:2008, the key criteria remains, with a couple of additions. It has been expanded to include new requirements to obtain ‘customer views and perceptions’ instead of ‘customer feedback’.

8.2.2 Determining the requirements for products and services

An organization must define the requirements (Inputs) into its operations for effective product and service provision. This may also include the requirements from interested parties relating to the product.

8.2.3 Review of requirements for products and services (ISO 9001)

The primary objective of the criteria in Clause 8.2.3 is to ensure that the organization effectively reviews the requirements for delivery of products and services, prior to delivery. In the main, the requirements extend beyond that of the immediate customer and organizational needs, to that of other interested parties including regulators.

8.2.4 Changes to requirements for products and services

When we compare this with to ISO 9001:2008, this criteria is new to the quality management Standard.

8.3.1 Design and development - General

The primary requirement of this criteria is for the organization to establish a formal set of criteria, or 'code of practice', for their design and development process.

8.3.2 Design and development planning

The organization is required to describe how it provides for the planning and control of its design and development processes. Consider the nature and complexity of the work, compliance obligations, control of unintended consequences, etc.

8.3.3 Design and development inputs

Documenting the inputs into the design and development process is the main requirement of this criteria. The text provides an explicit set of requirements which an organization must consider, and address where applicable.

8.3.4 Design and development controls

This set of criteria requires an organization to document the expect outcomes of the design and development process, and review those outcomes or results against the specified requirements, relevant to intended use.

8.3.5 Design and development outputs

The organization must ensure that design and development output; is a clear description of the product, containing detailed information for those carrying out operations activities.

8.3.6 Design and development changes

It is important that the organization provides for formal control of changes to design specifications, throughout the design and development process.

8.4.1 Control of externally provided processes, products and services - General

The opening sentence of this clause contains the primary criteria for an organization to ensure that inputs into its operations, and product and service delivery, conform to established requirements. It then sets out a number of specific criteria, addressing a few critical aspects of supply chain management.

8.4.2 Type and extent of control

The primary objective of the criteria of this clause is to ensure that the organization has determined the necessary controls required to manage its supply chain effectively.

8.4.3 Information for external providers

This clause of the Standard provides a set of criteria which can be used as an excellent framework for effective supply chain management.

8.5.1 Control of product and service provision

This clause of ISO 9001 is specific to controlling the working environment, ensuring that product and service provision is done so under "controlled conditions".

8.5.2 Identification and traceability

This criteria requires an organization to have an established process for the identification and traceability of outputs, in terms of the monitoring and measurement requirements at all stages of production, to enable the organization to demonstrate conformance to requirements, e.g.;
physical part marking,
labeling, tags, bar codes,
signage, visual indicators,
part segregation,
lay down areas,
storage racks.

8.5.3 Customer property

This criteria is very specific to customer owned property, where it is being handled through operations, and by extension, through subcontractors where they act on behalf of the organization.

8.5.4 Preservation

This criteria was introduced as a new ISO 9001 requirement in 2015. The focus here is on identifying and managing the preservation of specified product and service elements throughout operations.

8.5.5 Post-delivery activities

This criteria requires the organization to provide for the effective management of its post delivery activities and processes, with due consideration for the aspects documented in points a) to e), above.

8.5.6 Control of Changes

Refer to clause 6.3, where planning of changes is discussed in detail. At clause 8.5.6, we are looking at changes during the production and delivery of products and services, whether planned or not.

8.6 Release of products and services

The simplicity of this criteria is that the organization needs to respond formally, in a level of detail proportionate to the complexity of the process activities.

8.7 Control of nonconforming outputs

Controlling of nonconforming product throughout operations is critical to maintaining ISO 9001. The organization is expected to be able to demonstrate effective management of this aspect to ensure demonstrable control with regard to preventing unintended use of nonconforming products and services.

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