ISO 9001:2015—A Complete Guide to Quality Management Systems by Itay Abuhav

Author:Itay Abuhav
Language: eng
Format: azw3
Published: 2016-12-31T08:15:29+00:00

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ISO 9001:2015—A Complete Guide to Quality Management Systems

8.2.3 Review of Requirements for Products and Services

After determining the requirements for the product or the service, the organization is required to develop a method to review customers’ requirements. The review of the requirements for products and services refers to the examination of the operational conditions that may affect the ability of the organization to provide a product according to the requirements specified by the customer and determined by the organization. The ISO 9001 Standard requirements are as follows: 8.2.3.1

• The organization shall review with the goal of ensuring its ability to meet the requirements for products and services to be offered to customers.

• The review of requirements shall be performed prior to the engagement by the organization to provide the product to the customer.

• The organization shall review product requirements specified by the customer. The determination shall refer to delivery and post-delivery activities as well.

• The organization shall review product requirements that are necessary for the realization of the product.

• The organization shall review a product’s requirements that are not expressed or forwarded by the customer, but are required for obtaining the intended use of the product.

• The organization shall review regulatory or statutory requirements applicable to the product and service.

• The organization shall ensure that differences between the specifications conveyed by the customer and the actual requirements submitted to the customer are settled.

• The organization shall ensure that a product’s requirements are defined, clear, and understood, including the delivery and post-delivery requirements.

• When the customer does not provide documented requirements or specifications, the organization must obtain an approval prior to acceptance (forwarding for realization).

• In case the customer does not deliver its specific requirements, the review will be based on the product or service information available to customer.

• Note—in case the review is not practicable, the organization shall inform the customers of the product’s specification prior to acceptance of order (like product catalogs in Internet sales).

8.2.3.2

• The results of the review shall be maintained as documented information.

• Where and when new requirements arise from the review, they shall be maintained as documented information.

The objective of these requirements is to provide an internal approval that the organization can realize and supply the product according to the requirements and expectations of the customer. The review will be conducted before the submission of a commitment to the customer. In other words, it must be clear before

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receiving the approval of the order what is to be done, by whom and when and whether the organization is capable.

Accepting a Request from the Customer

Review of requirements related to the product begins with a method for receiving the requirements and coordinating them with your organization. The objectives of the review are as follows:

• Capturing the requirements of the customer

• Translating the needs into organizational terms—product specifications, processes and activities, risks or opportunities, and regulations

• Reviewing, ensuring, and approving the ability of the organization to realize and deliver the product or to provide the service

The organization is required to incorporate these steps in its process of managing customers’ requests or orders.

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