ISO 9000-4 1993 in Plain English

Guidelines for Managing Product Dependability Programs

ISO 9000-4 is OBSOLETE.  See ISO 9001 2015 and ISO 9004 2009.

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 suppliers 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 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.

ISO 9001 2015 in Plain English - ISO 9004 2009 in Plain English