The release of products and services to the customer is a critical stage of production. This is the time to check and ensure that your product or service is meeting the requirements of the customer and is created or delivered as per the acceptance criteria set by the client. Clause 8.6 Release of product and services of ISO 9001:2015 requires that an organization defines planned arrangements at suitable stages to verify that the product and service requirements have been met. The clause also requires that the evidence of conformity with acceptance criteria is retained by the organization. The release of products and service should not be done until verification of conformity to the specified requirements has been satisfactorily completed unless otherwise approved by a relevant authority and, as applicable, by the customer.
Why is it important?
The quality of a product or service is an important criteria that influences customer satisfaction greatly. A product or service should be made as per the requirements defined by the customer and should meet the customer’s acceptance criteria. When a product does not meet the customer’s acceptance criteria and is released prior to verification by the organization, it can lead to customer dissatisfaction and in turn lead to the organization losing its credibility and finally losing its customer base including returning customers.
A pre-determined set of verification steps at different stages of product or service can considerably reduce the chances of bad deliveries and that is what makes this clause an important clause where documented evidence of such verification activities should also be retained by the organization.
This clause requires that an organization decide the verification activities, or simply put, inspection and testing methods that you will put in place to ensure that the product or service is what the customer needs.
While determining the adequate level of inspection or testing, you need to look at your complete production process or service delivery process and decide on the stages or points at which verification activities should take place. Such activities may be planned in your quality plan or project programmes.
The organization needs to identify, monitor and measure key characteristics of the product or service to verify their conformance to requirements and agreed acceptance criteria. All the planned verification activities should be carried out before the release is made to the customer. In case there is a need to release any intermediate/final product or service to the customer before all planned verifications to that stage have been completed, prior written approval should be obtained from relevant internal authority and/or customer.
Planned arrangements for verification can include activities like simulations, trials, functional testing, system testing, performance or load testing, prototypes, inspection which may include in-process or final article inspection, user acceptance testing, product qualification/ certification, third party testing or qualification by a regulator, etc.
While planning for these verification activities, an organization should also ensure that they determine the documentation necessary to demonstrate compliance with this clause. Another important aspect is to also determine who is responsible for these activities. In other words, who decides if all product or service characteristics are met. Also, identify what equipment is required for such activities as this equipment may also need to undergo calibrations.
Let’s take an example of a software development firm. Verification activities may start at the very beginning of the software development with a detailed requirements review. This may be followed by design reviews and verification, code reviews, system and integration testing. At the end of the project, there may be user acceptance testing which will validate that the product meets the acceptance criteria set by the customer. At each stage of the software development, review and test records are maintained to show compliance. A final inspection may be performed before the final release to ensure that all the test results are passed using sample data. All these are planned arrangements that are substantiated with evidence of conformity at every point.
Clause 8.6 of the ISO9001:2015 standard requires that documented evidence is available with respect to the acceptance criteria set. This clause requires that documentation is maintained to provide evidence of conformity which should also indicate the person(s) authorizing the release of the product. The extent of documentation may be based on the risk involved in the process and complexity of the product or service provided.
It could just include a test report which shows the results of the product testing. If the equipment was used for testing or measurements, you may also need records to show equipment or test system used was within the calibration range. You may also need supporting evidence to show that the person who used the calibrated equipment was trained to use that equipment.
Other records that provide evidence that acceptance criteria have been met may include release notes or certificates, certificate of conformity, regulatory certificate, etc.
The final requirement of Clause 8.6 is the traceability of the person authorizing the release of the product or service. You will need to show that the personnel making the decision to release the product or service has the authority to do so. This could be due to his/her role or position in the organisation, appropriate competency and training or other reason deemed appropriate by the organisation. The information that may be included in verification records can be as simple as a signature on the test report or can include the name of the personnel authorizing the release of the product or service, authorized signatories, stamp impression, their authority status, etc.
There may be conditions where a product is released without it meeting the requirements or specification provided by the customer/regulatory body. This also needs to be authorised by a relevant authority and reasons for doing so should also be documented. For example, there may be a case where the customer requests to ship a product early without certain inspection or testing being completed. A copy of such approvals should be maintained within the records of this product shipment.