Understanding Section 8.3
Design and development of products and services
This is an educational article on Section 8.3 of ISO 9001, entitled “Design and development of products and services”.
The purpose of this article is to give you an understanding of what Section 8.3 requires.
This article is directed towards:
- Those responsible for compliance to section 8.3.
- Those responsible for the design and development of products or services.
- Others interested in understanding section 8.3.
Section 8.3 is entitled “design and development of products and services”.
This section requires you to establish, implement, and maintain a design and development process.
The first step is Design and Development Planning.
You are required to determine the appropriate stages and controls to ensure quality outputs.
This can be represented in a design and development flowchart or diagram, or it can be defined in a formal Design and Development Plan.
Such a plan often includes such things as:
- Scope
- Goals & objectives
- Assumptions & constraints
- Resources
- Test methods
- Acceptance criteria
- Verification and validation protocols
- Deliverables
- Approval requirements
- And so forth
When performing design and development planning, and deciding the appropriate stages and controls for your design and development process, you are required to consider:
- The level of complexity of your design and development activities
- The reviews necessary to ensure quality outputs
- The verification and validation activities necessary to ensure quality outputs
- The roles and responsibilities involved in the process
- The resources needed for the process
- Communications involved in the process
- The level of involvement of customers in the process
- Production requirements of the products or services being designed
- Stakeholder requirements for design and development control
- Records necessary to demonstrate conformity with requirements
The next step is to determine Design and Development Inputs for the specific types of products and services being designed and developed.
One form of design and development inputs is design requirements.
To determine the design and development inputs for the specific types of products and services that you are developing, you are required to consider:
- Functional and performance requirements
- Previous similar design and development information
- Statutory and regulatory requirements
- Standards or codes of practice that your organization has committed to implement
- Potential consequences of failure due to the nature of the products and services
You are required to ensure that design inputs and requirements are:
- Complete and unambiguous
- Without conflict
- Retained as a record
Section 8.3.4 is entitled “Design and Development Control”, and it requires you to apply controls to ensure that:
- Desired results are defined
- Reviews are conducted
- Verification is conducted
- Validation is conducted
- Problems are acted upon
- Control activities are documented
Review, verification, and validation activities can often occur simultaneously, but they have distinct purposes.
Reviews are periodic, planned activities (often meetings) undertaken during the design process to identify and remove barriers to a successful design. Often technical problems are solved, new product requirements are identified, and existing product requirements become more well-defined. Reviews may involve a certain degree of verification or validation activities as well.
Verification is strictly a paper exercise in which the design requirements, or inputs, are compared against the design outputs, to make sure the final design has addressed all requirements. An output of this process might be some kind of a requirements compliance statement.
Validation is actually building a version of the product, or service, and proving that the design can meet the requirements set out for it. The built version can be an engineering model, a part or portion of the product or service, or the first full prototype. In some industries validation is referred to as a First Article Inspection (FAI), a first off, or Production Part Approval Process (PPAP).
This slide is a copy of a previous slide we looked at. To reiterate, ISO 9001 requires that all of these activities be undertaken, that associated problems are resolved, and that the activities and their results are documented.
Though not mentioned here in section 8.3.4, Section 8.3.3 required you to consider potential consequences of failure — a type of risk assessment activity. The results of risk assessment activities — such as risk analysis, Failure Modes Effects Analysis, Fault Tree Analysis, etc. — often provide high-risk design characteristics and issues that warrant the need for design verification and validation efforts. Where appropriate, be sure to incorporate high-risk issues into design input requirements, design reviews, and design verification and validation activities.
Section 8.3.5 is entitled Design and Development Outputs, and it requires you to ensure that design outputs:
- Meet the input requirements
- Meet requirements for subsequent provision
- Provide requirements for monitoring and measuring
- Provide acceptance criteria
- Specify the essential characteristics of the product or service
- Are retained as a record
These requirements are a bit redundant as earlier sections said essentially the same things, but remember to keep outputs as a record.
Section 8.3.6 it entitled “Design and Development Changes” and it requires you to:
- Identify,
- Review, and
- Control
Changes made:
- During, and
- Subsequent to
Design and development. Basically, any design change, any time — identify, review and control it.
The purpose of design and development change control is to ensure that changes have no adverse impact on conformity to requirements.
When changes are made, you are required to retain records of the following:
- Design and development changes
- The results of reviews
- The authorization of changes
- The actions taken to prevent adverse impacts
For more information on how to implement this section, watch our implementation videos for section 8.3, and review our template library for examples.