Oct 05, 2017

Making Sure your Design Process is ISO 9001 Compliant

If you have designed a product, but are not convinced that the processes are in accordance with the requirements listed in ISO 9001, read on.

A good design process is critical for any manufacturing company unless manufacturing is only done according to customer drawings.

You are using a design process if you take requirements from a third party and then want to create products that should meet the requirements specified. If you are certified to the ISO9001 standard, your design activities need to comply with specific requirements. You do however have some discretion in deciding how you will meet them.

Process Flow

The ISO requirements specify that the design process flow is done along the following lines:

  • Gather design inputs
  • Review Inputs and make sure they are adequate
  • Create outputs
  • Verify or Review that the outputs meet the input requirements
  • Build a validation product (prototype) and test
  • Validate or Review that the product meets all the requirements
  • Control and Approve any changes in the design

Where any element of the process is reviewed, records must be kept so that these can be checked later if anything goes wrong. Continual improvement is a cornerstone of ISO 9001. In the context of design, this means that records must be reviewed when something goes wrong so that ways can be found to ultimately improve the process. This step is a crucial method by which process improvement can be implemented.

The 5 components of design

The ISO 9001standard only specifies what you need to include in your process. The five parts of the requirements mention few things that you need to include in your process.

D & D Planning

This section simply specifies that you should have a plan according to which you design. A simple flow diagram may be all that is required. You may want to include the name of the person responsible for each step to make sure that handovers between different people or departments are managed. Although controls are a separate section of this clause, these can be implemented at any stage where you decide they are required. It might be useful to include the controls in the diagram.

D & D Inputs

This is the first real step of the D & D process and it requires that you make sure that you have all the requirements for your design. When determining the requirements, make sure you look at customer requirements, comply with industry or government regulations, and review previous designs to check if there were any inputs discovered there. Once you have all these inputs, review them to make sure they are adequate and record them.

D & D Controls

The D & D control section mentions 3 types of controls which need to be implemented in the D & D process. The section does not specify where they need to be implemented and also notes that they can be done in any combination, or separately.

  1. Review

Review steps need to be included in the process to make sure it works properly. Will the design meet the requirements, will any problems be pointed out and will required changes be made? The Review(s) should answer these questions. You also need to involve people from all departments of the organization that are involved in whichever way in the design and decides if the reviewed results and actions have to be recorded.

  1. Verification

Verification is the process of taking the design outputs (build instructions, drawings, test instructions, etc.) and ensuring that all requirements obtained from design inputs are catered for.

  1. Validation

Validation happens after you have actually built the first product (prototype) and test it to ensure it meets all the requirements. You also need to check if it is suitable for its intended use. Whenever possible, validation should take place before the first product is shipped or installed for use by the customer.

D & D Outputs

D & D Outputs are typically things like written assembly instructions, drawings, electronic machining files, or any other document that you need. The outputs do however need to include anything required in the inputs, be able to be used by departments such as production and purchasing, contain the acceptance criteria for the product, and ascertain the characteristics for proper use.

Control of D & D Changes

This clause specifies how any change to an output of a design process should be handled. The purpose is to ensure that not just anyone can make a change without first making sure that the change is good and has been approved for implementation.

The D & D Process made Easy

When using MyEasyISO, you can always be sure that your D & D process meets the ISO 9001 requirements. The Design and Development module in MyEasyISO defines all the required steps and all you need to do is fill in the relevant screens. You can define exactly which controls you need at what stage of the process. Any changes that are required to the process need to be reviewed and authorized before they can be implemented.

A design/review cycle that is implemented properly will save money and time by removing problems before they occur.

Sree vidhya

You may also like...

Most Popular

Digitize Your Calibration Management with Effivity Pro

Unlock efficiency in your calibration processes with Effivity's calibration management software.

Why Industry Leaders Choose Effivity for their EHS Software

Learn how Effivity's Environment Management Systems software offers innovative, user-friendly solutions.


Talked About

Effivity is Proud to Be A Part of Idea Pattarai

Effivity, with its user-friendly and scalable software solutions, is glad to be a part of Idea Pattarai.

Global Giants of Chemical Industry joins with Effivity Pro to enhance QHSE Compliance

Discover how Global Giants of Chemical Industry partnered with Effivity PRO to revolutionise QHSE.


Effivity is a leading QMS software for Quality Management System automation as per ISO 9001 standard, HSE software for Health – Safety - Environment Management System as per ISO 14001 & ISO 45001 standards and FSMS – HACCP software for food safety management system automation as per ISO 22000 / FSSC 22000 standards.