ISO 9000-4 1993 in Plain English

Guidelines for Managing Product Dependability Programs

Also see ISO 9001 2008 in Plain English and ISO 9004 2009 in Plain English

This web page is based on the ISO 9000-4:1993 Quality Standard 
published by the International Organization for Standardization
It presents an interpretation of this standard using language 
that is simple and easy to understand.

ISO 9000-4 explains what a Product Dependability Program is and 
how it should be managed. Your organization should consider such 
a Program if dependability is an important aspect of product quality.

>>>  ISO 9000-4 1993 is now OBSOLETE <<<

Product dependability policy and objectives 

  • Define and document your product dependability 
    policy and your product dependability objectives.

    • Define a policy that explains your attitude towards
      product dependability and which specifies
      dependability characteristics.

    • List the product dependability objectives
      you want to achieve.

Functions and resources 

  • Define functions and provide resources.

    • Define the organizational functions and services that 
      you will need in order to manage and maintain your 
      Product Dependability Program.

    • Ensure that your Product Dependability Program has 
      all the resources it needs to carry out these functions 
      and perform these services.

Dependability requirements and customer needs 

  • Product dependability requirements should be defined
    by researching customer needs and expectations.

    • Therefore market research procedures are needed.

Program review

  • Develop Program evaluation procedures.

    • Develop and document procedures that senior
      managers can use to evaluate the performance
      of your Product Dependability Program.

    • Develop and document procedures that independent
      groups can use to review product dependability
      performance, processes, procedures, tools,
      tasks, results, and costs.

Program documentation 

  • Document your Product Dependability Program.

    • Document the methods and procedures 
      used to define dependability characteristics.

    • Document the methods and procedures 
      used to control dependability characteristics.

    • Document the methods and procedures 
      used to evaluate dependability characteristics.

Dependability measurement

  • Identify quantitative and qualitative tools to estimate
    and analyze the dependability of your products.

    • Ensure that these tools are made available to staff.

    • Ensure that they know how to use these tools.

Information system 

  • 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.

Documents
and records 

  • Product dependability documents and records should
    be maintained. These documents and records should
    include product dependability:

    • Plans 

    • Test data

    • Field data

    • Analyses

    • Predictions

    • Instructions

    • Requirements

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

Planning 

  • Develop a product dependability plan. It should:

    • Explain how you intend to meet product 
      dependability requirements and objectives.

    • Describe the resources you will use to meet 
      your dependability requirements and objectives.

    • Define the steps you will take to meet your 
      dependability requirements and objectives.

Contract review 

  • Develop procedures to coordinate and control the
    review of customer contracts. Your contract review
    procedures should make sure that:

    • Dependability requirements are defined.

    • Operational expectations are clarified.

    • Maintenance obligations are specified.

    • Acceptance tests are described and explained.

    • Dependability differences, between the original 
      tender and the final contract, have been resolved.

    • Management representatives are appointed to 
      supervise and discuss contracts with customers.

    • Records are kept which describe review decisions.

Dependability requirements 

  • Define detailed product dependability requirements.

    • Define product availability requirements.

    • Define product reliability requirements.

    • Define product maintainability requirements.

  • Clarify your maintenance support assumptions.

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

Design and maintenance 

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

    • Address product reliability, maintainability,
      and testability issues.

    • Address the human factors that could
      affect product dependability.

External products 

  • Develop procedures to define dependability
    requirements for products provided by outsiders.

    • Make sure that products provided by subcontractors
      (suppliers) clearly meet your product dependability
      requirements.

    • Make sure that products provided by your customers
      clearly meet your product dependability requirements.

Analysis and review 

  • Evaluate product dependability. Analyze, predict, and
    review the dependability of your products. Consider using
    the following kinds of tools and techniques:

    • Human factors analysis

    • Fault tree analysis

    • Tradeoff analysis

    • Stress analysis

    • Risk analysis

Verification and validation 

  • Verify and validate product dependability. Develop procedures
    to verify and validate product dependability requirements.
    Consider using the following kinds of:

    • Planning procedures

      • Verification planning

      • Validation planning

      • Test planning

    • Testing procedures

      • Reliability tests

      • Production tests

      • Acceptance tests

      • Dependability tests

Life-cycle costs 

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

Customer support 

  • Support your products. Make sure your
    customers know how to:

    • Operate your products.

    • Maintain your products.

      • In order to ensure that your customers
        properly maintain your products, make
        sure they know what kinds of:

        • Spare parts should be used.

        • Test equipment should be used.

        • Maintenance tools should be applied.

        • Skills their maintenance people should have.

Dependability improvement 

  • Develop procedures to improve the dependability of
    your products. Your procedures should ensure that
    dependability improvement opportunities are identified 
    and exploited. Your procedures should try to:

    • Improve product reliability

    • Improve product availability

    • Improve product maintainability

  • Develop procedures to control the product dependability
    improvement process. Your procedures should ensure that:

    • Changes are reviewed.

    • Previous analyses are repeated.

    • Prior predictions are reconsidered.

    • Old data and documents are re-examined.

Dependability feedback 

  • Develop a product dependability feedback system.

    • Develop procedures to collect product
      dependability data during:

      • Testing

      • Manufacturing

      • Field use

    • Develop procedures to handle, store, 
      and analyze product dependability data.

    • Develop procedures that customers can use
      to collect product dependability data and to
      report their experience back to you.

Also see ISO 9001 2008 in Plain English and ISO 9004 2009 in Plain English

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First published on June 6, 1997. Updated on December 10, 2011.

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