AS/NZS ISO 9001 Design and Development Procedure

AS/NZS ISO 9001 Design and Development Procedure

This design and development procedure can assist your business comply with AS/NZS ISO 9001, Quality Management Systems clauses:

  • 8.3. Design and Development of Products and Services.
  • 8.3.1. General.
  • 8.3.2. Design and Development Planning.
  • 8.3.3. Design and Development Inputs.
  • 8.3.4. Design and Development Controls.
  • 8.3.5. Design and Development Outputs.
  • 8.3.6. Design and Development Changes.
$35.00 - Includes 10% Tax

Design and Development of Products and Services?

Design and development is a term used to describe the process of creating a product or service. It involves taking an idea or concept and turning it into a reality. This can be done through research, planning, and execution.

The end goal is to create something that is both functional and appealing to the user. Having unique designs can be what will attract customers to your business and make them want to learn more about what you have to offer.

Having quality development processes to support your design is essential because it is the intellect behind your business. The two aspects of design and development work hand-in-hand for a business that wants to succeed in any industry.

When your business has a strong foundation in both design and development, you will be able to adapt and change with the times.

What is a Design and Development Procedure?

A design and development procedure outlines the steps to follow to create a new product or service. There can be varied types of design and development procedures however, they all share some common steps. First, a company will identify a need or opportunity for a new product or service.

They will then research the market to see the nature of the products or similar products or services that currently exist and what consumers want. Next, they will develop a concept for the new product or service and create prototypes. Finally, they will evaluate the product or service to make sure it meets all the necessary requirements and make any necessary changes.

Note: Following a design and development procedure can ensure compliance with all essential aspects and this will result in successful outcomes.

The Design and Development Process

The design and development process includes the stages of research, ideation, planning, prototyping, testing and outcome. The product development process is iterative, meaning that it goes back and forth between these stages until the product or service is ready for launch.

Relative to AS/NZS ISO 9001, Quality Management Systems clause 8.3. Design and Development of Products and Services the process follows a system as outlined below.

AS/NZS ISO 9001 Design and Development Process

Design and Development Planning

At the start of the design process, a business should review all specific requirements and identify the key stages of the design process. These design and development stages include, for example:

  • The organization of planning and strategy.
  • Task sequencing.
  • The compulsory steps of design.
  • Any significant stages and methods of configuration.

The following activities (where applicable) should be included in a design plan.

  • Identifying internal and external resources.
  • Assigning the responsibilities for the design and development process.
  • Determining the nature, duration and complexity of the design.
  • Verification and validation of activities with each stage.
  • Determining the required documented information.
  • Determining the need for the involvement of customers or users in the process.
  • Determining and scheduling design reviews.

Design and Development Inputs

Design inputs such as customer data, drawings, specifications, standards, regulations, etc should be checked to confirm they are adequate and explicit.

Identified design and development inputs should be assessed for:

  • Any functional and performance requirements.
  • Any lessons learned and information from previous design and development projects.
  • The applicable statutory and legislative requirements.
  • What the potential consequences are for failure.

Note: Documented information of all inputs included should be maintained, including any corrective or preventative actions.

Design and Development Controls

Design and development controls are essential for ensuring that a product or service meets the quality requirements set forth by the developer, customer or client. These controls of the design help to ensure that the product or service is designed correctly and that any changes made during the development process are properly documented and approved.

Design and development controls should have defined criteria, and may include specification reviews, verifications and validation tasks.

Design and Development Outputs

Design and development outputs refer to the various deliverables that result from the design and development process of a product or service. These outputs can take many different forms, depending on the nature of the project. For example, a small project might result in only a few deliverables, while a large project could produce hundreds of deliverables.

Some common types of design and development outputs include:

  • Design documentation requirements.
  • Functional specifications.
  • Requirements for calculations or analysis.
  • Configuration and acceptance criteria.
  • Supplier or customer feedback.
  • Formal verification that the product or service meets the input requirements.
  • Capabilities to be used in subsequent processes.
  • Instructions for safe and proper use.
  • Statutory and regulatory requirements.

Design and development outputs should always be reviewed and approved before product or service release and list all acceptance criteria.

Note: All records of design outputs should be retained as ‘documented information’ for auditing purposes.

Design and Development Changes

The design and development process can easily evolve over the design and development lifecycle. Improvements are often identified to enhance the outcome of a product or service and make it more user-friendly.

Changes to a design or development thereof should be identified, recorded and then be subjected to justification and a review. Any approved changes should then undergo a verification and validation process and the results should be retained by the responsible person(s) as ‘documented information.’

Design and development changes may include:

  • The details and specifics of the design and development changes.
  • The results of the validation reviews.
  • Any corrective or preventative actions taken to address issues and prevent adverse impacts.
  • The authorization and approval of changes.

Note: The end result of any design and development process should a product or service that is user-friendly, appealing, highly functional and have a fantastic performance.

Contents of this AS/NZS ISO 9001 Design and Development Procedure

  • Approval.
  • Purpose.
  • Scope.
  • Terms and Definitions.
  • Roles and Responsibilities.
  • Procedures.
  • Design and Development Overview.
  • Design and Development Process Activity Map.
  • Design and Development Process.
  • Inputs.
  • Activities.
  • Design and Development Changes.
  • Tools and Techniques.
  • Design and Development Outputs.
  • Design and Development Review.
  • Related Procedures, Forms and Documents.
  • Review Criteria.
  • Record Management.
  • References.

Why Choose to Buy this AS/NZS ISO 9001 Design and Development Procedure

  • This 10-page design and development procedure can enable you to ensure that design and development interfaces within your business are defined and professionally managed.
  • This includes enabling effective communication and the clear assignment of responsibility for design and development.
  • This procedure can be applied to meet the requirements of all the design and development processes that can be undertaken by any ‘typical’ business under controlled conditions.

Note: This procedure and its processes can also be applied to outsourced designers too.

After purchasing this AS/NZS ISO 9001 design and development procedure you will be able to:

  • Very easily edit and customize the template to create your own design and development procedure.
  • Apply your own style, format and brand to the procedure.
  • Use it in any industry or sector regardless of the size or type of organization.

Availability and Use of this AS/NZS ISO 9001 Design and Development Procedure

  • This procedure is accessible to you right now by clicking the ‘Buy Now’ button.
  • The procedure will be delivered to you in fully editable Microsoft Word format for immediate and full use in your business.
  • There are no subscriptions, contracts or ongoing costs.

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