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.
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.
The objective of the Design and Development Process 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.
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.
8.3.2 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.
8.3.3 Design and Development Inputs
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.
8.3.4 Design and Development Controls
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:
The results from undertaking the design and development process are clearly defined;
The design and development reviews take place in accordance with planned arrangements;
The design and development outputs meet the design and development inputs (verification);
The resulting products and services are fit for their intended use or specified application where this is known to the organization (validation).
8.3.5 Design and Development Outputs
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.
8.3.6 Design and Development Changes
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:
Design and development changes;
The results of reviews;
The authorization of changes;
Actions taken to prevent adverse impacts.
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.
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