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.


4.8 Product Identification and Traceability

Know How to Identify Products

Where appropriate, establish procedures to identify a product and determine what drawings, or other specifications, are used as it moves through manufacturing, delivery and installation. Individual products or batches of products must also have unique serial identifications if assuring product quality necessitates this. This identification must be recorded as a Quality Record.

Discussion:

Product identification makes it possible to distinguish one product type from another so that production personnel can determine which of several similar products they are working on. Traceability produces a record of one unit's manufacturing history. For sensitive products, the traceability may need to begin with the receipt of raw materials and identify all intermediate stages in production. If a critical test component is found to be faulty or out of calibration, it must be possible to determine which products (either in-house or shipped) are at risk from previous use of uncalibrated equipment.

Since this paragraph begins with the phrase "where appropriate", requirements will differ by industry. Traceability of items through a delivery service may also be required. Such examples include identification tags on airline baggage or identifications on packages to be delivered.


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