Issue 28 – Clause 8.3: Design and Development of Products and Services
Clause 8.3: Design and Development of Products and Services
What’s new in Clause 8.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 27) we discussed the topic of “product and service requirements”, and now here in Clause 8.3 we address the area dealing with “design and development”. Since the previous Clause required you to know all of your “product and service requirements”, now you can begin the process of “designing” them to meet those requirements, if necessary.
Note A: This Clause DOES include requirements for “documented information”.
Note B: In case you were curious, 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 gap audits (as well as training seminars), 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 Essentials Training, has become our most popular request for proposal from our Newsletter readers (…more details on this, 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 8.3 Design and Development of Products and Services consists of six (6) Sub-Clauses as listed below:
8.3.2 Design and Development Planning
8.3.3 Design and Development Inputs
8.3.4 Design and Development Controls
8.3.5 Design and Development Outputs
8.3.6 Design and Development Changes
Sub-Clause 8.3.1 General – The new requirements within this sub-clause are the result of the use of the words “and services”. As I have mentioned in previous Newsletters, “services” were always included in the old 2008 version, as outlined up in Section 3.0 (Terms and definitions). In any event, this new revision makes sure we address “services” by inserting it throughout the whole document.
Let’s begin by discussing the fact that the majority of companies currently registered/certified to ISO 9001:2008 take a “Not Applicable” on Clause 7.3 (Design and Development), and that is because in most cases companies have a pre-existing menu of product offerings that have already been “designed” for all Customers, which they simply produce based on demand. If however they bring on-board a completely new product and they begin doing “design” activities, then this Clause (8.3) would become applicable to them. Actually in many cases, companies simply acquire new products that have already been “designed” by another organization, and they begin to produce them… which means “design” still does not apply. In those instances, Clause 8.1 (Operational planning and control) would be the mechanism for ensuring the organization has “plans” and “controls” in place to produce these new products, to meet the stated requirements.
The exact same logic or approach holds true for any “services” offered by the organization to their Customers (as outlined in their Scope statement). If you have a pre-existing menu of services that have already been “designed” for all Customers, then how these services are “planned and controlled” would be addressed within Clause 8.1 (Operational planning and control).
So here are the critical questions you need to ask:
Does your company initiate product design activities specifically for any Customer Orders that are received? OR
Does your company initiate product design activities in order to offer any new products to your Customers?
If the answer to either question is “yes” then that was the primary reason Clause 8.3 was included in the ISO 9001:2015 Standard… and “yes”, product design is applicable to you, and all of the “shall” requirements within this Clause apply.
If the answer to both questions is “no”, then product design is not applicable to you.
Go through these same questions again but now change the word “product” into the word “service”… by doing so you will be able to determine if “design of services” is applicable to you or not.
Keep in mind that even if you decide that “design” is not applicable to you (for either products or services), you still need to implement controlled processes for consistently providing those products and services (listed within your Scope) to your Customers… and you need to do it to their satisfaction.
If “design” is applicable then sub-clause 8.3.1 is asking organizations to implement and control an overall process that will generate a “designed product” and/or a “designed service” that meet of all of the necessary requirements.
Sub-Clause 8.3.2 Design and Development Planning – What’s new in this sub-clause is first found in 8.3.2 a) where your organization is asked to consider the “nature, duration and complexity” of their designs when deciding design stages and design controls. 8.3.2 e) asks you to consider what “external” resources (in addition to internal) will be needed to perform the design activities. 8.3.2 g) wants you to consider involving Customers (and users) within the design process/stages. 8.3.2 i) is asking organizations to think about what level of control is “expected” by either Customers and/or other interested parties. Finally, 8.3.2 j) is asking you to decide what documented information will demonstrate that design requirements have been met. This by the way, could be a simple “Design Checksheet” which flows alongside the stages of design and confirms all the necessary activities were completed.
Sub-Clause 8.3.3 Design and Development Inputs – The biggest change is found in 8.3.3 e) which asks organizations to consider the “potential consequences of failure” from their designs. A good tool that can be used here would be a FMEA (failure mode and effects analysis).
Sub-Clause 8.3.4 Design and Development Controls – This sub-clause combines a number of the design sections from the old 2008 version, namely design review, design verification and design validation. Essentially all of the requirements here are similar to 2008.
Sub-Clause 8.3.5 Design and Development Outputs – This sub-clause carries over all of the previous 2008 requirements with additions in 8.3.5 c) asking you to identify what the monitoring and measuring requirements are during subsequent processing, and 8.3.5 d) which requires you to specify what characteristics are essential for the intended purpose of the final design.
Sub-Clause 8.3.6 Design and Development Changes – This sub-clause is similar to the previous 2008 requirements with new requirements found in 8.3.6 c) asking you to document who authorized the design changes and 8.3.6 d) which requires you to document actions you take to prevent adverse impacts from your “changed” design.
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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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 8.3 of ISO 9001:2015?
A: For Clause 8.3, a Gap Audit checklist should cover these areas:
– Is Clause 8.3 applicable to the organization? If not, what is the justification for the products listed in the Scope? For the services listed in the Scope?
– What initiates “design” activities within the organization?
– Does design planning consider the nature, duration and complexity of the design activities? How?
– Does design planning consider the need to involve Customers and Users as part of the design activities? How?
– Does design planning consider the level of control expected by Customers and other interested parties within the design activities? How?
– Does the organization consider, as part of the design inputs, the potential consequences of failure? How?
– Does the organization include, as part of the design outputs, the monitoring and measuring requirements as part of the final design? How?
– Does the organization include, as part of the design outputs, the characteristics essential for the intended purpose of the final design? How?
– Does the organization retain documented information on who authorized the design changes?
– Does the organization retain documented information on the actions taken to prevent adverse impacts from the design changes?
(Make sure to interview more than one person and obtain examples for the items listed above)
Until next time…
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