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4.16. Control of Quality Records |
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You must retain records that verify product compliance to requirements. Your records must also demonstrate the verified effectiveness of your operations through internal audits, corrective actions, senior management reviews, assessment of suppliers, calibration, training, customer contracts, design reviews, product nonconformances, inspection and testing, and product identification. Records should be defined, filed, and maintained to allow for easy access. They should identify the process and products involved. Record retention procedures must be documented and support customer agreements. Quality records must be stored for minimum deterioration, easy retrieval, and for a reasonable period of time (e.g., warranty period). If you reference records outside of your organization, you must maintain documented procedures supporting their maintenance. The control of quality records requires that:
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