Following the Design and Development clause within ISO will give companies a specific process for how their product or Service should be designed and developed to meet customer expectations.
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The purpose of the Design and Development 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.
If your design and development is outsourced, the supplier will meet the requirements of this procedure and provide objective evidence that the requirements were met.
Our Design & Development Procedure is proven to work.
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.
From start to finish, these steps and their procedure serve to guide a company in the right direction when they are planning and developing their product.
To summarize these steps, you will begin with a concrete idea for a product, accompanied by a solid plan of action, followed by more detailed planning, a physical prototype, and changes to improve these areas.
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.
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.
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.
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.
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).
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.
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.
Our Design & Development Procedure is proven to work.
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.
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 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.
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:
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.
Our Design & Development Procedure is proven to work.
Updated: 23rd March 2023
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.
Learn more about Richard
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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. Forms & Reports also included:
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