Clause 8 Operation
8.2.3 Review of requirements for products and services (ISO 9001)
Clause Criteria
There are 2 sub-clauses, as follows:
Clause 8.2.3.1 - (Organizational capabilities)
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:
a) requirements specified by the customer, including the requirements for delivery and postdelivery activities;
b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and services;
e) contract or order requirements differing from those previously expressed.
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.
Clause 8.2.3.2 - (Documented information)
The organization shall retain documented information, as applicable:
a) on the results of the review;
b) on any new requirements for the products and services.
Explanation
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.
The important point is that an organization is required to be able to demonstrate that this review is carried out, where applicable. This may require a formal "production planning" procedure to be established, which will provide for documented recording of these considerations.
A couple of straightforward examples:
Our own Sales Process, at Enable ISO, includes a peer review of proposals prior to sending to our prospect customers, so that our ability to deliver to all relevant requirements has been appropriately considered.
This allows for effective delivery upon receipt of customer acceptance, as the "production planning" has been addressed at proposal and peer review stage.
Another, from the print sector, is a sub-process between the design and production operations.
Once a design has been confirmed by the customer, it is sent to operations for printing.
The "Pre-press" or production planning phase will confirm the availability of materials, machinery, manpower, etc., prior to sending the job onto the production floor.
Importantly, compliance with legislation and industry regulation governing the delivery of products and services is the responsibility of the organization, not the customer.
Note: If you have any specific questions about your own organization and how you are to address production planning, please contact us via the chat box or email.
Chief Explainer:
Phil Byrne