What is ISO 9001 Design and Development of Products and Services? The Design and Development clause within the ISO 9001 regulations is meant to give companies a specific process for how their product should be designed and developed. From the time the idea of a product is strategized to when it is actually created and implemented requires a very specific process, especially when it comes to meeting ISO 9001 requirements.
Within the recent version of ISO 9001 requirements, the Design and Development clause is one of the most vital for any type of business. However, the specific contents of this section are not as specific as most of us would prefer them to be. Instead of trying to read between the lines, this guide will explain everything you need to know.
|ISO 9001:2015||ISO 9001:2008||Summary of Changes|
|8.3||Design And Development Of Products And Services||7.3||Design and Development||Title only.|
|8.3.1||General||N/A||No ISO 9001:2008 Equivalent||This is a new requirement that mandates the introduction of a design and development process where this activity is required.|
|8.3.2||Design And Development Planning||7.3.1||Design And Development Planning||This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.1 – Design and Development Planning. It is likely that organizations complying with ISO 9001:2008 will already be undertaking the activities required by this clause|
|8.3.3||Design And Development Inputs||7.3.2||Design And Development Inputs||Organizations should note the additional requirements to ensure that when design and development is undertaken that the design inputs include standards, and relevant codes of practice that the organization is committed to implementing.
Where the organization is responsible for the design of its products, the organization must consider the potential consequences of failure due to the nature of the products or services.
|8.3.4||Design And Development Controls||7.3.4||Design And Development Review||These requirements are comparable to the requirements from ISO 9001:2008. It is likely that organizations complying with ISO 9001:2008 will already be undertaking the activities required by this clause|
|7.3.5||Design And Development Verification|
|7.3.6||Design And Development Validation|
|8.3.5||Design And Development Outputs||7.3.3||Design And Development Outputs|
|8.3.6||Design And Development Changes||7.3.7||Design & Development Changes|
When it comes to the ISO 9001 Design and Development Process, there is a set of steps that are outlined for the most effective results. Since the standards themselves are not specifically explained in too much detail within ISO 9001, I have put together a breakdown of what this process really entails.
Design and Development Steps:
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From start to finish, these procedures serve to guide a company in the right direction when they are planning and developing their product.
To summarize these steps, they will begin with a concrete idea for the product, accompanied by a solid plan of action, followed by more detailed planning, trial and error with a physical prototype, and changes to improve these areas.
Throughout each of the design and development stages, it is important to keep accurate and organized documentation for every event that occurs for the highest possible level of accuracy.
In the next sections, I have separated the stages of design and development into two broad categories: the initial and final stages. For the purposes of a clear explanation, each of these sections will describe the first steps that include planning and evaluation, as well as the last steps where the product is very close to completion.
The initial stages of the design and development process will include planning the product, deciding what functions or purpose it will carry out, perfecting the design, and reviewing it to make sure everything is correct before creating the first prototype.
These are among the most important steps in the design and development process, because without careful planning in the beginning, there is room for a lot of mistakes along the way to coming out with a successful product.
The main ideas to keep in mind during these initial stages is that the product in question must be effective and useful to the consumer, and the customers must be able to easily assemble or use the product for the purpose that will be outlined in the planning process.
The first step of the design and development process is the initial planning stage. This section of the ISO guidelines states that the design of the product in question must be carefully planned before any actions can be completed.
The planning stage should not only define what processes will be completed in order to carry out the product, but also which person will be responsible for each specific task. In order to avoid any hiccups along the way, each individual should be aware of their contribution to the plan of action that is being created.
While it is not required that the planning process be documented and written down on paper, the best practice would be to keep some kind of record. This way, the company will be able to keep track of the steps that they have planned to follow without anything becoming lost or confused.
The next step of the design and development procedure is the design inputs. Since the last stage was for planning, this is the actual first step toward the direction of creating and implementing the product that is in question.
In other words, the company will take their very first actions during the design input stage in correlation with the plan that they put into place in the beginning of the process.
The main points of the design input process are to make sure that the requirements of the customer are being met by the product as well as the regulations of the government or industry that the product falls under. This step should be documented and recorded, ensuring that this information is correct.
Following the design input, the company will move on to design and development outputs. Contrary to the input stage, this process will include creating an actually definition of the product’s design. The ISO 9001 guidelines do not give any specific requirements for how this design should be documented.
Some ideas for product design and development output documentation can be drawings of the model, written instructions for assembling the product, or something similar.
The design and development review process will consist of going over the past and future steps of product development in order to ensure everything is running smoothly. During this step, the company should be able to identify and confirm that their product design meets all necessary requirements.
In the event that there are any problems with the product itself or the compliance with the regulations in question, actions must be taken to change them and get the process back onto the right track. The end of the design and development stage will include the review of company personnel and the documentation of their progress.
The final steps of the design and development process include the confirmation that the actual physical prototype is in good standing, as well as the implementation of changes and solutions for any problems that might arise.
These are defined as the final stages due to the fact that the product will be fully completed once these actions are taken by the company. These steps will essentially include a lot of trial and error, depending on how well the initial planning stages were followed.
After the design and development process has been thoroughly reviewed, the company will move on to design and development validation. This is where the very first prototype of the product is built and tested for quality and competency with all requirements.
This prototype of the product should also meet the requirements for the intended use that were defined in the planning step. In other words, the test product should work efficiently for the actions it is supposed to carry out or the problem it should solve for the consumer.
The control of design and development changes area is the last step of the development process. If there is anything wrong with the test product that was created in the previous validation procedure, this will be where the changes take place.
These changes can be anything from edits to previous product sketches or a revision to the instructions of use or assembly that were also defined in the planning stage. To avoid any detrimental mistakes, these changes should be thoroughly researched and discussed before they are implemented.
If anyone in the company is able to make changes to the product design or assembly without the assurance that it will make it more successful, the process can become misconstrued and confusing. Any changes that are made during this stage should be properly documented for future reference.
This is a new requirement that mandates the introduction of a design and development process where this activity is required. You should seek and record evidence that, where applicable, your organization has implemented a design and development process to allow effective product or service provision, where the requirements for products and services are not defined by the customer or interested parties.
This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.1 – Design and Development Planning. It is likely that if your organization already complies with ISO 9001:2008, you will already be undertaking the activities required by this clause.
You should seek and record evidence that your organization has considered the explicitly referenced considerations relating to the design and development process set out above. You should also ensure that your organization has retained documented information to confirm the identified design and development requirements were met and that design reviews were undertaken.
This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.2 - Design and Development Inputs 7.3.1. You should seek and record evidence that your organization has documented and retained information concerning the need for internal and external resources and the potential consequences of design or development failure.
This requirement is comparable to the requirements from ISO 9001:2008 Clauses 7.3.3, 7.3.4, 7.3.5 and 7.3.6. You should seek and record evidence that your organization has applied the necessary controls to its design and development process in order to ensure that:
1. The results from undertaking the design and development process are clearly defined;
2. The design and development reviews take place in accordance with planned arrangements;
3. The design and development outputs meet the design and development inputs (verification);
4. The resulting products and services are fit for their intended use or specified application where this is known to the organization (validation).
This requirement is comparable to the requirement from ISO 9001:2008 Clauses 7.3.3 – Design Development Outputs. You should seek and record evidence that the additional requirement to retain documented information concerning design outputs. You should also check the need for design outputs to reference monitoring and measuring requirements.
This requirement is directly comparable to ISO 9001:2008 Clause 7.3.7 - Control of Design and Development Changes. It is important to control design changes throughout the design and development process and it should be clear how these changes are handled and what affects they have on the product.
You should seek and record evidence that your organization has retained documented information concerning:
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As you can see, the product design and development process is a thorough one, but it is ultimately very beneficial to the businesses who follow through with it carefully.
Just like the process that was outlined for design and development, the customer satisfaction procedure gives companies a guideline for how they can make sure their customers are happy with the service and products they are receiving. This also includes close monitoring and a lot of documentation for efficiency.
For ISO 9001 certification, all companies must have possession of a quality manual, quality policy, quality objectives, quality records, as well as six more specific procedures. These procedures are control of documents, control of records, internal audit, control of nonconforming product, corrective action, and preventative action.
Written: 3rd May 2019
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
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Control of Design & Development Procedure
The purpose of this procedure is to ensure that all design and development interfaces among different organizational functions and groups are defined and properly managed to ensure effective communication and clear assignment of responsibility.
When the design and development process is outsourced, the supplier will meet the requirements of this procedure and provide objective evidence that the requirements were met.
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