ISO9001 And The Requirements For Identification and Traceability
Clause 8.5.2 of ISO9001:2015 is a very brief section which outlines the need for the organisation to (it's got that Shall word in it again meaning you must) be able to identify and trace their products and services, it's brief but important, here's why.
Let's start with identification since you would find it tricky to trace anything that isn't easily identifiable right? The standard says that you need to use a suitable means for identifying the outputs to ensure conformity of the products and services (we have talked previously about what a conforming product would be). Like many things in the standard it doesn't prescribe how you identify things it leaves that up to you, it just says you must. So it could be part numbers, barcodes, I once worked with a client who gave every product a name (they still used part numbers for the component parts, however). A document traveller is also perfectly acceptable, it's up to you how you manage it.
The next part of this section says that the organisation shall identify the status of outputs with respect to monitoring and measurement requirements throughout the product or service. So this is about having a process to do this and making sure that everyone understands what the process is and actually follows through on that process rather than it be a few pages in a manual on the shelf. Having things like signatures, initialling the document traveller or even an approval stamp are acceptable ways of saying that the product or service has reached a point where it's status has been judged as acceptable. So, for example, it may have passed some form of test, you should be able to indicate this easily so everyone can see this. In a previous electronics company I worked at we put different coloured paint pen marks on the edge of the circuit boards to indicate what type of test it had passed, visual inspection, In-circuit test, functional test or final QC for example.
Finally, in this section ISO9001:2015 requires the organisation controls the unique identification of the outputs when traceability is a requirement and that they retain documented information necessary to enable traceability.
So, what does this mean?
- Firstly, you don't have to have any traceability to meet ISO9001:2015 if no customer or government agency or other agency doesn't require you to have it, the only reason you must have traceability is
because ofyour products end destination to an extent. For example, if you are making hip joints or parts going into cars or aircraft you can pretty much guarantee you need to be able to trace every single one, if you are making metal coasters then possibly not.
- Secondly, the level of traceability may vary, for example you probably need to be able to trace not only the batch that was made together but possibly the raw materials used to make the final product, you may have to be able to trace the test equipment used to approve the product or the people who manufactured it.
- Thirdly, to be traceable you need to be using part numbers or some unique identification (hence that's the 1st part of this requirement) you may use a dated batch number or individual serial numbers, if you work on the belief that at some point you are going to have a complete recall of the product then start there and work back on how you would track everything as you build your process.
If you do require to have traceability then you need to keep all of the evidence and information required to prove that traceability so that may be employee records in terms of who has worked on a product (and in some cases training records) for materials it may be certificates of conformity from the suppliers to original purchase information, this is something that would be discussed between you and the client to enable the level of traceability you need
Identification and traceability as required by ISO9001:2015 clause 8.5.2 isn't overly complicated but it does need to be documented in a way that everyone is going to understand it and be able to keep track of your products and services. You need to structure things in such a way as to be able to clearly identify at what stage things are and if they have passed a test on conformity or not, finally, if your customer requires it you need to be able to fully track the product and trace all the parts that have gone into it's creation and other products created in the same batch.
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