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ISO9001 and The Design & Development Clauses – Part 1

ISO9001:2015 Clause 8.3 is all about how your organisation carries out it's design and development of products and services. Now obviously if you do not actually carry out any design or development work then this section is not applicable to you and you are allowed to exclude it from your ISO9001:2015 system, however your request for exclusion will have to pass the sniff test, assuming it does you can skip this section, if not, read on!

In this post we are going to cover the first 2 sections of clause 8.3 : 8.3.1- General and 8.3.2 Design & Development Planning of the Design & Development of Products and Services for ISO9001:2015.

Clause 8.3.1 – General

 This section of the clause is a single sentence, not that big a deal, 24 words in total, can't be that big a deal, right? Wrong, like most initial elements to a clause this sets the scene of what is to come, and it contains one of the mightiest words in the IOS9001:2015 lexicon... "SHALL". Remember shall is ISO9001 speak for you must do it or we won't give you a certification.

So in this single statement ISO9001 requires that you create, implement and maintain a proper process that means you will be able to provide products and services from a design & development point of view. So that's all of the documentation, processes, testing, compliance work, training, communication etc that you need to do to develop your products or services... no so small now is it?

Clause 8.3.2 – Design & Development Planning

Thankfully the ISO9001:2015 authors aren't that mean, they are going to give you a framework to develop your systems around and it starts as usual with planning (remember that underpinning Plan, Do Check Act principle way back at the beginning of the standard, well it's at play here as well).

In this section, the standard says that you SHALL consider at least the following 10 things when you are figuring out what the stages and controls are. It doesn't say you must have all of them only that you should consider them. Now it's a good idea here to document how you are proceeding with this part of the process, i.e. take each of the 10 things on a list and not what you did to consider them with respect to your products or services design & development. If you decided that they were not applicable, then state that and why you decided that it wasn't applicable. Your auditor can obviously debate if something is or isn't applicable to you but it's your choice and if you can show you considered it then you are compliant. 
Here is a breakdown of the list:
​ What the standard says ​ What it means
The nature, duration & complexity of the design & development processes ​ Understand how big the design & development task is! What processes will you need to ensure a successful outcome!
The requirements that specify particular process stages, including applicable design and development reviews ​ What factors would drive a particular stage of the design, is it a customer requirements, regulatory, do you need for example EMC testing and how will you review these stages and will they be in sequential stage & gate, will it be an agile / scrum approach ​ 
​The required design and development verification and validation activitiesUnderstand what they verification (conformance to requirements i.e. does your design do what it should) and validation (compatible with the intended use or application) requirements of the product/service are.
​The responsibilities and authorities involved in the design and development process ​ Who gets to decide what the product will / wont do, who decides if it's met a requirement and moves forward etc.
​The internal & External Resource needs for the design & development of the products and services ​What people, skills, resources, equipment, buildings, patents and so many more things will you need to realise this product or service. Remember you should also consider the resources that you are buying in
​The need to control interfaces between individuals and parties involved in the design and development process ​ How will you ensure everyone is talking the same language when it comes to your product or service? How will you make sure that everyone is working on the current version?
​The need for involvement of customer and user groups in the design and development process ​ Does the end customer need to have input into your design and development process? Are they a on of the sign off authorities? What about product testing groups?
​The requirement for subsequent provision of products and services ​ How will you support your product or service on an on going basis, will it be something that people need to maintain or will it be a closed unit? Will it continually evolve or is it a one time design and that's it done?
​ The level of control expected for the design and development process by customers and other relevant interested parties How much input will your end customer have in the design process, will they specify what you are doing 100%, if you are a contracted design house the answer here is probably! what about those other Interested Parties, who are they? When they could be regulatory bodies for example, again think about our EMC testing example the testing lab and the regulatory body would be interested parties in the design and development of the product.
​The necessary documented information to confirm that design and development requirements have been met. How will you prove that you have actually met what the requirements were of the product or service? So again, if it needs to comply to EMC requirements then a testing certificate would be useful. If the customer wants it to have a blue flashing light, can you show documentation proving it has a working blue flashing light that will work for the expected duration. This documentation should be retained for future records.

As we mentioned, for all these areas you need to be able to consider how it would impact your process. There isn't a requirement in the standard to document any processes or procedures you come up with as a result only that you can prove that you considered at least these elements. However, lets be honest, you would be a bit remiss as an organisation not to develop the associated procedures to ensure consistency of approach.

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Monday, 20 May 2019

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