Issue 31 – Clause 8.6: Release of Products and Services
Clause 8.6: Release of products and services
What’s new in Clause 8.6?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 30) we discussed the topic of “providing products and services”, and now here in Clause 8.6 we address the area dealing with “releasing products and services”. At this point within Element 8.0 (Operation), you’ve covered all of the steps necessary to “release” your products, and “release” your services, to your Customers.
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 and gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. Combining an on-site Gap Audit with ISO 9001:2015 Essentials Training, has become our most popular request for proposal from our Newsletter readers. The second most popular request is our on-site Document Development Training Workshop (…more details on these training sessions, as well as other training that 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.
Let me begin by saying that 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…
To view all of our past Newsletters or to sign up to receive them… click here
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, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements in the ISO Standards.
This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator. This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame. If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part). Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it. A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant. As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.
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.
This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed. PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event. This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.
Q: How do you perform a gap audit for Clause 8.6 of ISO 9001:2015?
A: For Clause 8.6, a Gap Audit checklist should cover these areas:
– Has the organization implemented planned arrangements to verify that service requirements have been met? Has this been done at appropriate stages along the service delivery processes? How?
– Is there evidence to show that past 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 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 service provision? Can the identity of the person (or persons) be traced to determine who authorized the release of the 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!