The International Organization for Standardization is an international standard-setting body. ISO gives this explanation of the name: 'Because 'International Organization for. Main page Contents Featured content Current events Random article Donate to. Create a book Download as PDF Printable version. ISO 9001:2008. Buy the official quality management systems standard from ASQ.org. The current version of ISO 9001 was released in September 2015.
The quality management system of the International Organization for Standardization (ISO) is generally called the ISO 9000 series or ISO 9000 family and ISO 9001 is the most important standard in this family. A quality management system (QMS) is defined as 'part of a management system intended to lead and manage an organization regarding quality.'
ISO 9001 is an international standard based on the essence extracted from many successful cases regarding business improvement. Its purpose is to maximize profits by promoting business based on consistent rules concerning not only manufacturing processes or products, but also throughout the business from purchase to manufacturing, shipment, and service. We can say that it is the best guideline for improving routine work by eliminating problems such as inefficient procedures or repeated mistakes. By obtaining ISO 9001 certification, the company can also achieve social credibility and increase the trust of customers.
Two Concepts of Traceability
ISO 9001 specifies traceability in two sections: Measurement traceability and Identification and traceability. Since the topic of this page is traceability in the entire supply chain, this section describes identification and traceability.
Overview of Identification and Traceability
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ISO 9001 states the following requirements regarding identification and traceability:
- Use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
- Identify the status of outputs with respect to monitoring and measuring requirements throughout production and service provision.
- Control the unique identification of the outputs when traceability is a requirement, and retain documented information to enable traceability.
These can be summarized as follows:
Select suitable means for identification (representation format and representation method) throughout the processes from production to retail to allow identification of outputs such as finished products and information in every process. Record and store the information properly.
Identification is an especially important concept in these requirements. This identification means a common recognition shared among the entire production processes or the entire supply chain. Assume that you have a chip used for manufacturing a TV, for instance. The basics of identification are to ensure that this chip is recognized as the same one whether it exists by itself or is built in a product, and to allow everyone to know the current status of the chip, whether it has passed inspection or is under inspection, or in what process it is being worked on.
For that purpose, a traceability system identifies objects by using a representation format such as serial numbers or lot numbers, as well as the transfer medium such as labels and RF tags.
When all people related to the supply chain, including consumers, can recognize the status of the product and objects and information has been linked, tracing forward/back can be done easily. This ensures the quality and safety of the product.