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Sample ISO 9000 Quality Policy Manual: Sec. 4.4 Design Control

by Ron Kurtus (14 March 2001)

The following material is section 4.4 of a Quality Policy Manual, used to satisfy the ISO 9001 standard. This material follows the rationale approach to stating company policies and is intended as an example of this approach as well as a sample of a Quality Manual.

For other sections, refer to the Manual Table of Contents



4.4 Design Control

In our company, we design the product according to the contracted requirements or specification. That design sometimes may change due to evolving technical improvements and/or revised design requirements.

Rationale

We believe it is important for us to maintain control over how our products are being designed and over the possible changes in the design. This is to make sure the product not only fulfills customer requirements but also stays within contracted features.

We believe that effective design control will result in reduced costs by helping eliminate wasted effort and material due to incorrect or unauthorized design changes. It will also ultimately result in increased business due to customer satisfaction from getting expected goods and services.

Policy

Thus, it is the policy of this company to adhere to the ISO 9001 section 4.4 standard on Design Control, as follows.

4.4.1 General

To ensure that the contracted requirements are met, it is our policy to always maintain control of the design of the products we make and to verify that design.

It is also our policy to use and maintain Procedure 4.4 to control and verify the design of our product.

4.4.2 Design and Development Planning

To effectively coordinate the design effort and avoid misdirection or areas of work not covered, it is our policy to always have plans that identify the responsibility for each design and development activity.

To maintain the management of the project, it is also our policy to always use these plans to describe or reference these activities. These plans are always updated as the design evolves.

4.4.2.1 Activity Assignment

To ensure the design and verification activities are done correctly, those activities are planned and assigned to qualified staff equipped with adequate resources. Details are provided in Procedure 4.4.

4.4.2.2 Organizational and Technical Interfaces

To avoid poor or incomplete communications that could result in lack of design coordination and even cause mistakes, it is our policy to always identify the organizational and technical interfaces between different involved groups and to document, transmit, and regularly review the necessary information concerning these interfaces.

The identification and documentation details are provided in Procedure 4.4.

4.4.3 Design Input

To avoid confusion about the inputs to the design and to ensure complete understanding of what the customer wants, it is our policy to always identify, document and review the selection by our engineering staff for adequacy of the design input requirements relating to the product.

It is also our policy to always resolve incomplete, ambiguous, or conflicting requirements with those responsible for drawing up these requirements. This is done during the design review, as per Policy paragraph 4.3.

4.4.4 Design Output

To ensure the design conforms to the goal of satisfying customer requirements, it is our policy to always document our design output and express it in terms of requirements, calculations, and analyses.

It is also our policy that our design output always:

  1. Meets the design input requirements;
  2. Contains or references acceptance criteria;
  3. Conforms to appropriate regulatory requirements whether or not these have been stated in the input information;
  4. Identifies those characteristics of the design that are crucial to the safe and proper functioning of the product.

4.4.5 Design Verification

To avoid careless or incomplete verification of our design, it is our policy to always plan, establish, document, and assign to competent personnel functions for verifying that design.

By design verification we mean the activity that establishes that design output meets the design-input requirement (see 4.4.4) by means of design control measures such as:

  1. Holding and recording design reviews (see section 4.16);
  2. Undertaking qualification tests and demonstrations;
  3. Carrying out alternative calculations; and
  4. Comparing the new design with a similar proven design, if available.

It is our policy to always follow Procedure 4.4 for verification of our design.

4.4.6 Design Changes

To avoid unauthorized, unnecessary, or incorrect changes and modifications to the design of our product, as well as to avoid the risk of losing track and control of changes, it is our policy to always have design changes and modifications identified, documented, and reviewed and approved

It is also our policy to maintain Procedure 4.4 for the identification, documentation, and appropriate review and approval of design changes and modifications.


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