ISO 9001 Standards Requirement – Product Realization

ISO 9001 Standards Requirement – Product Realization

Planning of Product Realization
Plan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the:
Quality objectives and product requirements
Need for processes, documents, and resources
Verification, validation, monitoring, measurement, inspection, and test activities
Criteria for product acceptance
Records as evidence the processes and resulting product meet requirements

Customer-Related Processes

Determination of Requirements Related to the Product
Determine customer requirements:
Specified for the product (including delivery and post-delivery activities)
Not specified for the product (but needed for specified or intended use, where known)
Determine:
Statutory and regulatory requirements applicable to the product
Any additional requirements considered necessary by the organization

Review of Requirements Related to the Product
Review the product requirements before committing to supply the product to the customer in order to:
Ensure product requirements are defined
Resolve any requirements differing from those previously expressed
Ensure its ability to meet the requirements
Maintain the results of the review, and any subsequent follow-up actions. When the requirements are not documented, they must be confirmed before acceptance.
If product requirements are changed, ensure relevant documents are amended and relevant personnel are made aware of the changed 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 catalogs or advertising material.

Customer Communication
Determine and implement effective arrangements for communicating with customers on:
Product information
Inquiries, contracts, or order handling (including amendments)
Customer feedback (including customer complaints)