Simplified Overview of ISO 9001 Clause 8.5.2 Requirements
Clause 8.5.2 comprises several specific components organizations must meet:
Identification Procedures: Using serial numbers, batch codes, or barcodes to ensure product identity.
Traceability System Implementation: Choosing appropriate methods (barcoding, RFID) depending on industry needs.
Record-Keeping: Documenting key process stages: dates, materials, supplier details, and batch numbers.
Change Control: Evaluating impact of changes on traceability, getting approvals, and properly documenting.
Employee Training: Ensuring team understanding of processes for reliable adherence.
Complex traceability systems are made manageable through diligent following of each required ISO step, reducing risk and raising compliance confidence.