ISO9001 and The Requirements for Products and Services

How often have you got into the manufacture or design of a product and realise that you really don't either understand exactly what you should be making or that you are not capable of making it? ISO9001:2015 clause 8.2 Requirements for Products and Services is really aimed at avoiding this situation from happening. It's important then, that you do take time to carefully think about this section and how you will implement it into your organisation.

The Structure of ISO9001:2015 Clause 8.2 

It's pretty easy to think about the 4 sub-sections of this clause as a feedback loop within the organisation and to the customer as we have shown below, lets walk through each of the sub-sections to explain further.

Clause 8.2.1 - Communicate With Your Customer 

The whole idea that you have to communicate with your customer seems completely obvious, yet some organisations really do struggle. This section really will help you think carefully about how and what you should be communicating which should include things like:

• Exactly what products & Services you provide - think about this as basically pitching your stall so people know what you do. Drag in your marketing people to this conversation!
  
• How you handle enquiries, orders, contracts and any changes within your organisation
• How you will get customer feedback (including complaints - which are really just opportunities to improve) about your products and services
• How you will handle any customer-owned property, this could be hardware, software or Intellectual property for example
• What specific actions you would take as contingency actions should they become relevant, this is akin to your Disaster Recovery Plan for example.

When you are thinking about how you are going to communicate you need to think carefully about the audience that you are communicating with. Do they have a preference? Is it lots of words they need to read, is it online / in brochures, if so which ones? is it in videos or interactive elements on your website or downloads? the choice is yours but you should be putting yourself in the shoes of your customers when deciding,

Clause 8.2.2 Determining The Requirements For Products & Services 

This section has 2 requirements for you to think about:

• You must ensure that the requirements for the products or services you are going to supply are actually defined, these may include
  
  • Any statutory or regulatory requirements that the products or services should meet
  • Anything else that your organisation determines that it should meet, for example perhaps you want it to be waterproof or be visually appealing
• That you can actually meet the specifications or claims you have made about your products or services either in your literature/website/spec documents or agreements with customers to name but a few examples.

Again how you choose to do this is up to you but it's probably a good idea to have some form of document to outline the specification and be able to back it up with supporting evidence of it meeting those requirements.

Clause 8.2.3 Review the Requirements For Products & Services 

ISO9001:2015 Clause 8.2.3 is all about reviewing your customer requirements before you agree to supply anything to them, after all, how happy will the customer be if you agree to supply something that you can't possibly make? This section requires you to conduct a review before you sign on the dotted line that must include:

• The requirements as specified by the customer, including any delivery requirements and post-delivery requirements e.g. warranty or spare parts holding
  
• Any requirements that the customer hasn't stated directly but you know are necessary for the specified or intended use of your product or service to be successful
• Any requirements that you as an organisation have set yourselves
• Any statutory or regulatory requirements that your product or service needs to comply with
• The contract or order from the customer to ensure that it doesn't differ from what was previously expressed if they do you need to ensure that these variations are discussed with the customer in advance of progressing and clarified so everyone is clear about the requirements.

If the customer hasn't provided a clear documented outline of their requirements then you are required to confirm back to them what you will be provided based on the above points. It's a good idea to actually do this even if you have a documented outline of requirements from the customer so you are all 100% clear. Now obviously in some instances, this isn't possible, internet sales is the example given int he standard. In this case, you should do what it is practicable to do in terms of your organisation and your customers. A confirmation email or a catalogue reference would work for example.

As an organisation, you are required to retain relevant documentation on both the results of the review and any new requirements for the products and services, it's up to you how you meet this requirement.

Clause 8.2.4 Changes to requirements for Products & Services 

Over time technology and the market will move on and so your products and services will change, customer requirements will change. The standard requires you to keep documented information updated with these changes to ensure it is still current. Furthermore it requires you to ensure that all 'relevant' persons are made aware of these changes, so these could be internal and external customers, they could be regulatory bodies or suppliers, in fact it's anyone who would be impacted by a change to your product or service. Again how you do this is up to you and you should be able to demonstrate that you have done this step.

Summary 

ISO9001:2015 Section 8.2 then is all about how you specify, manage and communicate the requirements for your products and services. You need to take account of your customers needs, ensuring that what you are offering them meets their requirements, what you can supply and any legal requirements as well. Before you sign on the dotted line of the contract to supply ensure that you are clear what is being asked of you and what you can actually deliver and of course what is required after you deliver. ensure that you and your customer are completely in lock step about the final product or service being delivered and ensure you have a way of letting everyone know if something in the product or service has or is changing.