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ISO9001 and Design & Development Inputs
In this second part of the discussion about ISO9001:2015 Section 8.3 we are going to look at section 8.3.3 of ISO9001:2015 which is all about the Design & Development Inputs to your product or service. The aim of this clause is simple,
8.3.3 Design & Development Inputs
The inputs that impact the design and development of any product or service can be pretty large and will obviously vary from industry to industry as well as product to product. ISO9001:2015 recognises this fact and provides some help here with clause 8.3.3. This clause has that all important SHALL word in it again so it's not an optional element if you carry out any design or development of products but when you look at the clause why wouldn't you be doing this anyway? Here's what it says:
"The organisation SHALL determine the requirements essential for the specific types of products and services designed & developed."
ISO9001:2015 Section 8.3.3
It then gives you 5 points to consider:
1. Functional & Performance Requirements
This section is to make you think about exactly how your product or service is going to function when it's used in the big wide world by your customers. What are the performance requirements, what things must it do (and do well) and what things should it most definitely not do? Think about what the specifications should be, what materials should be used, what standards or expectations it needs to meet.
2. Information derived from previous similar designs and development activities
When you think about it this is a little bit of the PDCA (Plan Do Check Act) thinking right here. You may have similar designs or developments previously, what can you learn from that, what would you repeat or not repeat, are there sections of those designs or activities you would reuse? What experience did you gain from these other activities either directly or indirectly through for example customer feedback that you can apply to the new design or development activity.
3. Statutory & Regulatory Requirements
For the product or service, you are working on, are there any statutory or regulatory requirements that it must meet? If so what are they, how will you meet them with this product. Do you need to get external help to understand the requirements or carry out testing and validation to ensure you comply?
4. Standards or codes of practice that the organisation has committed to implement
In the same way that you will need to meet the legal elements (Statutory & regulatory requirements), there are most likely industry standards, customer standards or codes of practice that your product or service needs to meet. For example, from my background in Electronics Manufacturing, a question that is always asked is does this product need to meet IPC610 class 2 or class3 quality levels, class 3 being much higher and so sometimes costlier to meet and the specifying or parts is different.
5. Potential Consequences of failure due to the nature of the products or services
Some form of risk assessment or FMEA (Failure Modes & Effects Analysis) process is a good way of dealing with this requirement. Think about your products and services. How could they fail, if they do fail what is likely to happen, what is the worst possible thing that could happen and how likely are they to happen. How can you avoid these failures?
Fitting to your organisation
The extent that you carry out these input reviews will depend on both the size of your organisation and the products or services you provide. If you are GE and providing aircraft engines for example it'll be full on, if however, you are making say paper hats for parties it will be a lot smaller exercise but it is left to the organisation to determine what will be adequate for them in determining what they feel are the complete list of inputs and also that these inputs are unambiguous, i.e. you shouldn't really have to guess what they mean!
Conflicting Inputs
With any product or service design and development process there are going to come points where there is conflict in the design and development requirements. The organisation must close out all of these conflicting inputs before moving on. When you think about it this makes sense, why would you not want to get total clarity on what you were providing before you start, think of the wasted costs and resources if you don't.
Retention of Records
Clause 8.3.3 of ISO9001:2015 - Design and Development inputs has a final statement in it, "The Organisation SHALL retain documented information on design and development inputs". It's that word shall again, remember this means you must do it. How you do it is completely up to you as an organisation how you achieve this.
Summary
The Design and Development inputs clause of ISO9001:2015 isn't written to be a barrier, rather it provides a great framework to utilise to ensure that you have really considered all the inputs you need to for your specific organisation and your product or service, that you have considered previous designs or services and took learnings from them and that you have considered the environment your product or service will operate in prior to moving into full on design. Get the ground rules set out before you move on.
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