ISO9001 and The Release of Products & Services
What is the signal within your organisation that your product or service is ready to be handed over to the customer? That is essentially the question that ISO9001:2015 is asking in Clause 8.6 – Release of Products and Services.
Previously we have talked about verification and validation of your product or service to ensure that it meets the end user requirements, this is applicable again here as the processes you designed back then are what need to be in place here. Think about the quality steps you have implemented, is there an inspection check, a buddy check, do you use automated test equipment to show that the product meets a set standard or test customers to ensure your service is right?
These are the things that determine that you are ready to hand over your product or service to the customer, somewhere along the line it has passed some form or test or verification.
The standard talks about the need to implement planned arrangements, this is simply what we have talked about previously. What are the quality plans you have in place to ensure that the product meets specification and is fit for purpose. The planned arrangements are planned since you wrote them down in your documentation, incidentally, not writing anything down doesn't mean you can skip this clause! It sounds obvious but I have had this question asked so just to be clear not writing it down is a bad thing.
As an organisation you will determine the point in your processes that these checks or inspections happen to your product or process. It may be that you can leave it all to the end just prior to shipping, it's unlikely and unwise but you could do that or you can break your process into stages and have some form of check at the end of each stage which is far more likely and of course you need to check against an agreed standard of what is and isn't acceptable.
Evidence of Conformity
Clause 8.6 of the ISO9001:2015 standard needs you to be able to provide evidence with the acceptance criteria that you have set. This means then that there will need to be some form of documented record kept showing that it met the criteria. This can take any form you want it to take as an organisation as long as you are able to demonstrate that you have met the requirement. This could then be a test record showing the results of the product testing, if it did then you also need to show that the test system was within calibration or fit for purpose as essentially a gold standard. If you used say a measuring gauge to check something then you would want to show that it was in calibration but also that the user was trained correctly to use that equipment.
If it was a manual inspection process then what was the criteria for inspection, what tools were sued and again was the person trained.
The final part of Clause 8.6 is the need to be able to trace the decision to release the product or service back to the individual who made that decision. This could be as simple as a signature on the inspection or test report for example. You will need to demonstrate that the person making the decision to supply is authorised to do this, this could be due to position in the organisation, training or any number of reasons that the organisation deems appropriate.
Where you do release product that isn't up to the required specification then this needs to be again fully authorised and documented as to why this has happened. For example, you may have had a concession from the end customer to ship as is, in which case a copy of the at authorisation should be easily available within the records of this product shipment.
ISO9001:2015 Clause 8.6 is all about how you ensure that you don't provide products or services that are not fit for purpose, they must meet the required spec. The clause is looking for evidence that you have tested that you meet the specification and that you are able to show who made that decision and that they are authorised to do so.
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