This is a sample QA policy created with MAUS Quality Assurance for ISO 9001 : 2008. More info on MAUS Quality Assurance available here.
Policy
Product Design and Development
Description
COMPANYNAME has guidelines for all employees regarding Product Design and Development
Purpose
The purpose of this policy is to explain the general procedures relating to Product Design and Development
Scope
The following guidelines are to be adhered to by all managers, supervisors and employees.
Procedure
Our design process will be checked at various stages by suitably qualified staff to ensure that the design will result in a product that meets our customer’s specification. These stages will include:
7.3.1 DESIGN AND DEVELOPMENT PLANNING
The design and development plan will outline the steps in the process, specify who is responsible for each part of the design/development process and outline all the inputs to the process. It will also outline what is the validation activity mandatory to be conducted at the end of each stage to ensure success. The design and development plan may alter as the design progresses.
7.3.2 DESIGN AND DEVELOPMENT INPUTS
.
During the design process, inputs to the design process will be determined, clearly defined and records maintained. Inputs will include:
Functional and performance requirements
Statutory and regulatory requirements as applicable
Information from previous designs where applicable;
Other essential requirements
7.3.3 DESIGN AND DEVELOPMENT OUTPUTS
During the design/development process, we will regularly check that the outcomes are according to specification and that all departments that will be involved in implementing the design are consulted. We will ensure that the design and development outcomes meet all statutory safety and environmental requirements.
7.3.4DESIGN AND DEVELOPMENT REVIEW
At relevant stages during the design or development process, COMPANYNAME will review progress against planned requirements.
Any problems identified will have actions planned and implemented to correct the problem.
Records of reviews and any actions will be maintained. Participants in the review will include representatives of staff involved in the design and development process.
7.3.5 DESIGN AND DEVELOPMENT VERIFICATION
COMPANYNAME will plan verification for designs to verify that design and development outputs meet input requirements. Records of verification activities and any actions required will be maintained.
7.3.6 . DESIGN AND DEVELOPMENT VALIDATION
During design and upon completion, the product or service will be tested to ensure that it performs as expected at the commencement of the design process and to verify that the performance is in line with the customer’s specifications.
7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Any changes or modifications to the design after implementation will also be reviewed, documented and approved before they are implemented.
Refer Procedure: QP 3.7 Design and Development Management
