ISO 9001 Standards Requirement – Product Realization

ISO 9001 Standards Requirement – Product Realization
Planning of Product RealizationPlan 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 requirementsNeed for processes, documents, and resourcesVerification, validation, monitoring, measurement, inspection, and test activitiesCriteria for product acceptanceRecords as evidence the processes and resulting product meet requirements
Customer-Related Processes
Determination of Requirements Related to the ProductDetermine 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 productAny additional requirements considered necessary by the organization
Review of Requirements Related to the ProductReview the product requirements before committing to supply the product to the customer in order to:Ensure product requirements are definedResolve any requirements differing from those previously expressedEnsure its ability to meet the requirementsMaintain 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 CommunicationDetermine and implement effective arrangements for communicating with customers on:Product informationInquiries, contracts, or order handling (including amendments)Customer feedback (including customer complaints)