This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
Don't use supplies until you know they are good and correct for this use. Verification of supplies must be guided by a plan or documented procedure.
The intent of this section is to reduce the costly effects of damaged product by discovering problems as early in the operation as possible and taking action to eliminate further damage. The scope of this section includes design and development activities, as well as production and installation. Be sure you know that incoming materials are as specified in the purchase order. The method used to carry out this verification will vary depending on the importance of the supplies to the performance of the end product. It is permissible to allow qualified operators to inspect their own work. Materials from approved suppliers may not need to undergo incoming inspection prior to use. Procedures should specify what corrective actions are to be taken in the event a faulty product is received.
Keep especially good records on supplies that are used before proper verification has been completed so they can be recalled if found faulty.
Use of supplies prior to their verification is strongly discouraged. However, if verification is not yet complete, the Standard requires total traceability (see 4.8). Use of a quarantine area for such products is common but optional. If this procedure is ever used, take corrective action (see Section 4.14).
Inspect, test and identify the product during its manufacture in accordance with documented procedures. Determine whether the product is conforming to specifications. Hold the product until required inspections and tests have been performed. Clearly identify any failed or nonconforming product.
Perform tests or other verifications on subassemblies of the product while it is undergoing production. The location and frequency of checks will depend on the importance of the examined characteristics to the end product. Document action to be taken in the event of failure of critical inspection equipment.
Carry out final inspection and testing in accordance with documented procedures. When doing the final inspection, check that all required previous tests (e.g., incoming inspection and in-process tests) have been performed and passed. Don't ship the product until all the steps in the final inspection procedures have been completed and the documentation is in order.
Be sure to provide a specific inspection of the finished product just prior to shipment, even if many in-process inspections have already been performed. If the in-process inspections are adequate, the final inspection may consist only of verifying that all planned in-process tests were performed and passed. This final inspection is the basis for deciding whether to ship or hold the product.
Records of test results and acceptance criteria used in the final testing must be kept.
Records must be kept to show that the needed inspections have been carried out throughout the manufacture and installation of the product. As with all Quality Records, it must be stipulated how long such records are to be retained. The length of this time period will depend on the service life and critical nature of the product and on specific legal requirements.
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