Mark Hammar With the release of ISO 9001:2015, there are specific requirements for you to include in your Quality Management System (QMS) about what you need to do when you accept your products and services for delivery to your customers. At first glance, there seems to be more requirements for the release of products and services, but this is not necessarily the case and many companies will already have many of the required records in place.
So, what is required, and how is it different than before?
What has changed in ISO 9001:2015?
In the previous version of ISO 9001, product release was included in section 7.5.1, which covered the controls to be in place for provision of products and services. This section required that you plan and carry out the provision of your products and services under controlled conditions, which could include (if applicable) the implementation of product release controls. There were no further requirements within this section on what those controls needed to entail, and as seen above, this control was only there if it was determined to be applicable; therefore, it could easily have been avoided if there was not a specific customer requirement. This has changed in ISO 9001:2015.
What is now required in ISO 9001:2015?
In ISO 9001:2015, section 8.6 details the requirements for release of products and services. The first thing to note is that this section does not include an “as applicable” clause, so it is necessary to consider it within your QMS. As you read through the requirements of ISO 9001:2015, it can be seen that many of them are similar to the requirements from throughout ISO 9001:2008, but collected into one section. So, what does ISO 9001:2015 require?
- Planned arrangement to verify requirements: The first required action is that you have planned when you will verify that you meet the requirements for the products and services at appropriate stages. This does not need to be all at the end, but can be split up as is reasonable to ensure that when you deliver your products and services, all requirements have been verified.
- Do not deliver unless you have finished everything: There is a reason that you have identified the planned arrangements that are needed to complete the preparation of your products and services for delivery, and these requirements need to be completed before you deliver. This only makes sense, for why else would you identify something as required unless it needed to be done? There is, however, a statement included that you can deliver with open action if this is appropriately approved; an example would be if your customer is to perform a final test for you after you deliver.
- You need documented information for the release: As with many requirements of ISO 9001:2015, you need to be able to prove that you did what you planned to do, and records of your release of products and services are one of these requirements. In addition, your records need to contain two specific pieces of information: evidence that you met the acceptance criteria, and identification of the person or persons who authorized the release. Remember that this does not need to be all on one documented record, so long as it can be proven that you met the requirements for the products and services when delivered.
It is important to note that like many other requirements in the ISO 9001:2015 standard, this applies to all of the products and services you provide to your customer, much like the design and development requirements that I mentioned in the article on Specific use of ISO 9001 design and development in the machining process. So, for a service you provide, such as delivery of your products, how will you prove that this service meets the acceptance criteria and is approved by the appropriate person?
Do what makes sense for you and your customer
It is important that your efforts to meet these requirements do not make your Quality Management System overly complicated. In many cases, you will already have in place records that demonstrate that all requirements for your products and services are met and who approved them, so you will just need to identify where these are located and align them with your listing of applicable products and services.
The important thing in a Quality Management System is to do what is necessary to meet the needs of yourself and your customer in order to improve customer satisfaction, not to find a way to satisfy the whims of a certification body auditor. Do what makes sense for you and your customer with regards to the release of products and services, and you will find that the improvements will help you to improve customer satisfaction, which is the reason for having a Quality Management System in the first place.
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