ISO 9000-4 Guidelines Translated into Plain English

Guidelines for Designing and Managing Product Dependability Programs

De Biasi & Associates

This section summarizes ISO 9000-4. It highlights the main points. It does not present detail.
If you need a detailed and complete interpretation of the ISO 9000-4 standard,
please consider purchasing our hardcopy version.

ISO 9000-4 explains what a Product Dependability Program is and how it should be managed. The purpose of a Product Dependability Program is to produce products that are reliable and maintainable. Your organization should consider the ISO 9000-4 program if dependability
is an important aspect of product quality.

• Define a Product Dependability Policy. Start by defining a policy that explains your attitude towards product dependability and which specifies dependability characteristics.

• Define functions and provide resources. Define the organizational functions that you will need in order to manage and maintain your product dependability program and ensure that this program has the resources it needs to carry out these functions.

• Product dependability requirements should be defined by researching customer needs. Therefore, market research procedures are needed.

• Program review procedures should be developed. Make sure your Product Dependability Program is reviewed regularly by:
  • Senior management, and
  • An independent person.

• Document every aspect of your product dependability program including the procedures used to control and evaluate product dependability.

• Quantitative and qualitative tools, to analyze and estimate the dependability of products, should be made available to your staff. Also, make sure that these people know how to use these tools.

• Documents and records should be maintained. These documents and records should include:
  • Product dependability plans.
  • Dependability test instructions and data.
  • Results of dependability analyses and predictions.

• Set up an information system to track and store product dependability data. Use this data to design and redesign your products and to plan your maintenance activities.

• Maintain a master list of program dependability documents and make sure that only current versions are in circulation.

• Develop a product dependability plan. This plan should specify your dependability activities, practices, and resources.

• Develop contract review procedures. These procedures must ensure that you and your customers explicitly agree on product dependability expectations and requirements.

• Prepare product specifications which list availability, reliability, and maintainability performance requirements.

• Clarify product dependability requirements. Before you design products, make sure that all product dependability requirements are clarified and that the design will meet these requirements.

• Develop product design and maintenance guidelines to ensure that product dependability requirements are met.

• Purchased products must meet dependability requirements. Develop procedures to ensure that all products provided by outsiders meet your dependability requirements.

• Analyze dependability. Develop procedures to analyze, predict, and review the dependability of all of your products.

• Verify dependability. Develop procedures to verify and validate product dependability requirements.

• Calculate costs. Develop procedures to calculate product life-cycle costs.

• Provide customer support. Make sure that your customers know how to operate and maintain your products.

• Improve product dependability. Develop procedures to improve the dependability of your products.

• Develop a feedback system. Develop procedures to collect product dependability data and gather customer feedback.

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