Issue 59 – Clause 8.6: Release of Products and Services
Clause 8.6: Release of Products and Services
What’s the intent of Clause 8.6?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 58) we discussed the topic of “providing products and services”, and now here in Clause 8.6 we address the area of “releasing products and services”. The intent of this Clause is to take those products we’ve produced and those services we can now supply and “release” to the Customer who has ordered them.
Note A: This Clause DOES include requirements for “documented information”.
Note B: As some of you already know, the content for these Newsletters comes from working in the field with my Clients, and with their ISO Certification Bodies. I gain a lot of hands-on experience from conducting training workshops, gap audits and internal audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. A popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit. On that note, some organizations are opting to use an outside resource to assist with their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions we offer, can be found below).
The new numbering format…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Clause 8.6 Release of Products and Services consists of zero (0) Sub-Clauses.
For many companies, the only thing new in Clause 8.6 is that it now applies to “and services”. This Clause is asking organizations to implement planned arrangements (at appropriate points along the process), to ensure that either the Product or the Service has been verified as having met acceptance criteria BEFORE releasing that Product or that Service to the Customer. Theoretically this means that your organization will never deliver a defective Product or a defective Service to your Customers.
This Clause also contains strong requirements for “documented information”, including actually identifying those specific individuals who said it was okay to “release” your products and services into the hands of the Customer. In the case of “services”, once again you need to look at your Scope Statement covered way back in Clause 4.3 to see what services you said will be provided to your Customers. The main intent behind this Clause is that the Customer expects you to thoroughly check your own work (your Products and your Services) before providing it to them, which just makes good business sense.
Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…
PS: Don’t forget to look at the Q&A section below for some final thoughts…
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For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
Q: How do you perform an audit for Clause 8.6 of ISO 9001:2015?
A: For Clause 8.6, an Audit Checklist should cover these areas:
– Has the organization implemented planned arrangements to verify that product and service requirements have been met? Has this been done at appropriate stages along the production and service delivery processes? How?
– Is there evidence to show that past products and services that have been released did not proceed until all of these planned arrangements had been carried out?
– Has the organization ever needed to supply a product or a service that did not meet requirements? Did a relevant authority approve it? Was the Customer involved?
– Does the organization retain documented information showing evidence of conformity for past product and service provision? Can the identity of the person (or persons) be traced to determine who authorized the release of the product or service?
(Make sure to interview more than one person and obtain examples for the items listed above)
Until next time…
Helping Business Professionals Reduce Risk and Remove Waste!