In the previous post we touched upon the inputs for the Design and Development Clause of the ISO 9001 standard. The outputs are closely related to the inputs of course, but they have some twists to them. The four outputs that need to be covered are:
- Meet the input requirements.
- Be suitable for subsequent processes for the provision of products and services.
- Include, or refer to, appropriate monitoring and measuring requirements and their acceptance criteria.
- Define the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
All the information of the Design and Development outputs needs to be documented either through a register or some other form.
Meet the Input Requirements
This one is pretty straight forward. The product should meet the input requirements. If the product or service doesn’t meet the requirements, it isn’t only useless, but we have also failed to fulfill our customer’s needs—a pretty important part of doing business. To meet the requirements, it is critical that these requirements were very clear in the first place. The clarity of the requirements should be well thought of during the input phase of the design and development process.
Be Suitable for Subsequent Processes for the Provision of Products and Services
The company should be able to have processes in place to realize the product or service according to the specs of the customer. These processes are part of the QMS and should lead to a desired output. It should be very clear that the QMS of the company is able to produce the product within specs and rules and regulations.
Include, or Refer to, Appropriate Monitoring and Measuring Requirements and Their Acceptance Criteria
The company needs to have a strong plan to monitor if the product is designed as expected. This can, of course, be accomplished by very close communication with the customers and other stakeholders in the process. The way the company communicates and how it documents this information should be clearly defined to make it unambiguous.
Define the Characteristics of the Products and Services That Are Essential for Their Intended Purpose and Their Safe and Proper Provision
The products or services should function as intended—this is also closely related to the input requirements. When these are pretty clear, it gets a lot easier to make the product or service function as intended. However, even if the requirements are clear, the company should fully understand if the product or service is safe and properly functioning. The customer can request a car without a steering wheel, but even if the company built such a car, it is mostly likely not safe and not intended to operate like this, except for a self driving car maybe. So even if the specs are clear, the company has the duty to judge if the functions are really what some can expect from the product or service.
Documented Information on Design and Development Outputs Must Also Be Retained—IE: Records
Lastly, it is crucial to have all the information created during the processes documented in some way. This can be in Word/Excel documents or in specialized platforms. It should be retrievable whenever asked for by someone.
The 8.3.5 isn’t all that hard in essence, it just requires the company to make sure that the product is developed as intended by the stakeholders. The information that is created during the process should be registered in a system as per the company’s choice.