ISO 9001: Clauses 7 through 8

Section 7: Product Realization

  • Planning
    • The organization needs to plan the activities leading to your product.
  • Customer
    • The organization must determine customer requirements including those product requirements not specified by the customer but necessary for intended product use and regulatory and legal requirements.
    • You must determine and keep records of the review of contracts or orders.
    • The organization must plan and implement customer communications processes including product information, inquiries, order handling/contracts and amendments and customer feedback.
  • Design and Development
    • There are very specific requirements and records required for design and development planning, inputs, outputs, review, verification, validation and changes.
  • Purchasing
    • The organization must determine criteria for evaluation, selection and re-evaluation of suppliers.
    • There are requirements for purchasing information and requirements for verification of purchased product.
  • Production and Service Provision
    • Determine the controls necessary to provide your product including any process validation, identification and traceability, customer property, and preservation of product.
  • Control of measuring devices
    • Determine measuring devices and calibrate according to the standard requirements.

Section 8: Measurement, Analysis and Improvement

  • Collect data to provide information on customer satisfaction and dissatisfaction and conformance to customer requirements. These methods shall confirm the continuing ability of each process to satisfy its intended purpose.
  • Audit your quality management system according to the requirements.
  • Monitor your processes to ensure they are operating effectively.
  • At appropriate stages of the product realization process, the organization must measure and monitor the characteristics of the product to verify that requirements are met.
  • Control your nonconforming product, the “bad stuff”.
  • Collect and analyze data in order to provide a consistent product and improve the effectiveness of your quality management system.
  • The organization must facilitate the continuous improvement of the quality management system through the use of the quality policies, objectives, audit results, data analysis, corrective and preventive actions, and management review.
  • Fix your problems. Establish corrective and preventive action processes to determine and fix problems and potential problems. Determine root cause, fix the problem and check that the fix was appropriate and successful.

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