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ISO.2.2 ISO 9001 Conformity on the Basis of the V-Model  

  ISO.2.2 ISO 9001-Konformitšt auf der Basis des V-Modells

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  • ISO.2.2 ISO 9001 Conformity on the Basis of the V-Model
  • Links to the V-Model Mailinglist
  • ISO.2.2 ISO 9001 Conformity on the Basis of the V-Model

    Contractors who want to get a certificate according to DIN/ISO 9001 or EN 29001 (in the following referred to as ISO 9001) must operate and maintain a quality management system. In this connection it must be observed that such a certificate can also be given to individual corporation departments. Therefore, if an order requires a certificate, it must be guaranteed that all corporate departments/groups in the contractor company can obtain such a certificate.

    In order to obtain an ISO 9001 certificate, all processes in the certification range have to be regulated by process rules. The V-Model is such a process rule according to ISO 9001 (interpreted by ISO 9000, part 3) for the process "Software Development". Contrary to other process regulations, the V-Model contains very substantial process regulations integrating many subprocesses. Therefore, in the QA manual of the contractor, the V-Model must be embedded bindingly as process regulations (at least for orders from the defense area). The necessity of the project-specific operationalization of the V-Model in the form of a Project Manual corresponds with this and remains valid.

    The V-Model meets the requirements of the ISO 9001 for the technical process of the software development. The organizational requirements of the ISO 9001 go beyond this and must be met by the contractor in addition to this. Thus the V-Model is a building block helping to meet the ISO 9001 standard that essentially simplifies the procedure to get a certificate; however, it must be supplemented by organizational, contractor-specific regulations and embedded in the contractor context (cf. allocation of roles, etc.).

    Since its objective is the functional description of the procedure, the V-Model does not contain any information about the appropriate corporate or departmental problems. Everything in connection with the embedding in the corporation or with a project-specific context has been left out on purpose.

    Based on the structural items of the ISO 9000, part 3 (instruction for the use of the ISO 9001), the following table includes the allocation of V-Model regulations (activities and products) for the ISO requirements. The table is to

    In this connection it is differentiated between meeting the ISO requirements directly and indirectly with the help of the V-Model. "Directly" means that the V-Model refers to documents (e. g. Project Manual, QA Plan) in which the appropriations demanded by ISO 9001 have been specified.

    The following explains which organizational requirements have to be additionally met in order to get an ISO 9001 certification:

    1. The management of the contractor has to specify and to document its business strategies and goals as well as its commitment with regard to quality. It must be guaranteed that these strategies are understood, realized and observed on all levels of the organization (ISO 9000, part 3, chapter 4.1.1.1).
    2. The responsibilities, authorizations and relationships between staff members holding management posts, executive posts, and controlling posts, that might possibly have an impact on quality, have to be specified and documented (ISO 9000, part 3, chapter 4.1.1.2.1).
    3. The contractor has to specify the requirements for the internal verification, to make available appropriate resources, and to hire qualified staff for the tasks of verification (ISO 9000, part 3, chapter 4.1.1.2.2).
    4. The contractor has to appoint a representative agent from management who must have the authority and responsibility to guarantee that the requirements of the ISO 9001 will be met and observed at all times (ISO 9000, part 3, chapter 4.1.1.2.3).
    5. The QA system must be evaluated by top management at appropriate intervals, in order to guarantee that the system is always up to date and effective. Any documents about such reviews have to be safely stored and maintained (ISO 9000, part 3, chapter 4.1.1.3).
    6. All elements, requirements and preparations for the QA system have to be systematically and orderly documented in a QA manual (ISO 9000, part 3, chap 4.2.2).
    7. In order to verify that all activities relevant for quality correspond with the planned steps, the contractor has to introduce a planned, comprehensive, and documented internal quality audit system and also to guarantee the efficiency of the QA system (ISO 9000, part 3, chapter 4.3).
    8. The contractor has to introduce, document and maintain procedures for a general improvement that goes beyond the improvement of the project itself (correction measures) (ISO 9000, part 3, chapter 4.4).
    9. The contractor should introduce and maintain procedures for the audit of contracts and for the coordination of these activities (ISO 9000, part 3, chapter 5.2).
    10. The contractor should introduce and maintain procedures for the realization of maintenance tasks (ISO 9000, part 3, chapter 5.10).
    11. The contractor should apply quantitative measurement methods for the quality of the development and delivery process (ISO 9000, part 3, chapter 6.4.2).
    12. The contractor should introduce and maintain procedures for the investigation of the training requirements for staff members and personnel in charge of quality-relevant activities (ISO 9000, part 3, chapter 6.9).
    If the customer demands a QA system according to ISO 9001, the contractor can prove this with the appropriate certificate of an accredited certification agent.

    ISO 9000, Part 3 V-Model
    direct indirect
    Rule/Activity Product Rule/Activity Product
    4 Quality Assurance System-Scope
    4.1 Responsibilities of Management        
    4.1.1 Responsibilities of Management of the Supplier        
    4.1.1.1 Quality Strategy       QA Plan
    4.1.1.2 Organization     Roles/Activities
    Allocations
    Project Manual 7.1, 7.2
    4.1.1.3 Review of Quality Assurance System by Management        
    4.1.2 Responsibility of Management of the Customer        
    4.1.3 Joint Reviews PM6 Report Documents   Project Plan 3.1.5
    4.2 Quality Assurance System        
    4.2.1 General Information        
    4.2.2 Documentation of the Quality Assurance System       V-Model as one of
    the Process Instructions
    4.2.3 Quality Assurance Plan QA1 QA Plan,
    Assessment Plan
       
    4.3 Internal Quality Audits     QA5  
    4.4 Correction Measures PM6      
    a) Investigation of the Cause PM7 Report Documents CM4.7 Project History
    b) Analysis of Processes   QA Plan QA3  
    c) Error Prevention Measures CM3      
    d) Control Measures CM3,
    V-Model Change Procedures
         
    e) Procedural Changes V-Model Change Procedures      
    ISO 9000, Part 3 V-Model
    direct indirect
    Rule/Activity Product Rule/Activity Product
    5 Quality Assurance System - Lifecycle Activities
    5.1 General Information V-Model      
    5.2 Contract Review        
    5.2.1 General Information PM2   PM1 Project Manual,
    included in Contract
    5.2.2 Contract Items relevant for Quality CM3 Project Manual    
    5.3 Specification of Contractor        
    5.3.1 General Information SD1.2
    SD1.3
    SD1.4
    SD1.5
    SD1.6
    User Requirements QA1.1 QA Plan
    5.3.2 Cooperation SD1.7 Protocol   Project Manual 7.4
    5.4 Development Plan        
    5.4.1 General Information PM1.1,
    PM1.2,
    PM1.3,
    PM1.5
    Project Manual,
    Project Plan
       
    5.4.2 Development Plan        
    5.4.2.1 Phases SD, QA Project Manual    
    5.4.2.2 Management PM Project Manual,
    Project Plan
       
    5.4.2.3 Development Methods and Tools PM1.4 Project Manual 6    
    5.4.3 Direction of Development PM6,
    PM8,
    QA1.2
    Assessment Plan    
    5.4.4 Specification for Development Phases PM4 Project Manual    
    5.4.5 Results of Development Phases QA2,
    QA4
    Project Manual,
    Assessment Specification
    (Verification)
       
    5.4.6 Verification of Each Phase PM6 Project Plan (for Time Schedule)    
    ISO 9000, Part 3 V-Model
    direct indirect
    Rule/Activity Product Rule/Activity Product
    5.5 Planning of Quality Assurance        
    5.5.1 General Information QA1.1,
    QA1.2
    QA Plan,
    Assessment Plan
       
    5.5.2 Content of Quality Assurance Plan        
    a) Quality Goals QA1.1 QA Plan    
    b) Criteria QA2.1,
    QA2.2
    QA Plan    
    c) Types QA1.1 QA Plan    
    d) Planning QA2 Assessment Plan    
    e) Responsibilities QA1.1 QA Plan    
    5.6 Design and Implementation        
    5.6.1 General Information        
    5.6.2 Design        
    a) Design Aspects PM1.3,
    SD1 to
    SD5-SW
    Project Manual    
    b) Design Methods PM1.4,
    SD1 to
    SD5-SW
    Project Manual 6    
    c) Design Experience CM4.5      
    d) Following Processes   Technical Requirements    
    5.6.3 Implementation        
    a) Rules SD6-SW Project Manual 8    
    b) Implementation Methods   Project Manual 6    
    5.6.4 Reviews QA4,
    PM6,
    Product Flow according to V-Model
    Assessment Protocol -> CM    
    ISO 9000, Part 3 V-Model
    direct indirect
    Rule/Activity Product Rule/Activity Product
    5.7 Testing and Validation        
    5.7.1 General Information        
    5.7.2 Test Planning        
    a) Test Plans QA2 Assessment Plan    
    b) Test Cases QA2.3 Assessment Specification    
    c) Test Types QA1.1,
    QA2.1
    QA Plan 5    
    d) Test Environment QA2.2 Assessment Plan 5.1    
    e) Criteria   Assessment Specification    
    f) User Documentation        
    g) Staff/Personnel PM1.1,
    QA1.2
    Project Manual 7,
    Assessment Plan 3
       
    5.7.3 Testing        
    a) Test Results   Assessment Report    
    b) Problems QA5      
    c) Based on Changes in Participating Dpmts. CM3      
    d) Adequacy QA4 Assessment Plan 2    
    e) HW and SW Config. CM2 CID    
    5.7.4 Validation QA4
    (for the System)
         
    5.7.5 Field Test QA4
    (with special Assmt. Criteria)
         
    5.8 Acceptance        
    5.8.1 General Information QA4     Project Manual
    5.8.2 Planning of Acceptance Tests QA2     Contract
    5.9 Reproduction, Delivery and Installation        
    5.9.1 Reproduction     Contract  
    a) Copies   Project Manual    
    b) Type of Data Volume   Project Manual    
    c) Documentation   Project Manual    
    d) Copyright        
    e) Storage CM4.4      
    f) Obligation to Deliver        
    5.9.2 Delivery SD8.3 QA Plan 5.3    
    5.9.3 Installation SD9.2   Contract  
    ISO 9000, Part 3 V-Model
    direct indirect
    Rule/Activity Product Rule/Activity Product
    5.10 Maintenance        
    5.10.1 General Information CM3      
    5.10.2 Maintenance Plan SD1.8 SWMM Concept    
    5.10.3 Identification of Initial State of Product CM4.4      
    5.10.4 Supporting Organization SD1.8 SWMM Concept Contract  
    5.10.5 Different Maintenance Activities   CM Plan    
    5.10.6 Maintenance Notes and Reports CM3      
    5.10.7 Release Procedure acc. to Product Flow V-Model CM Plan    
    a) Release     Part 1, Chapter 2.3  
    b) Release Types        
    c) Future Changes     CM  
    d) Change Procedures        
    e) Change Notes CM3      
    6 Quality Assurance System-Supporting Activities (not phase-dependent)
    6.1 Configuration Management        
    6.1.1 General Information CM      
    6.1.2 Configuration Management Plan CM1, PM1 CM Plan    
    a) Organization   Project Plan    
    b) Activities   Project Manual 5    
    c) Tools   Project Manual 6    
    d) State of Elements   CM Plan 3    
    6.1.3 Configuration Management Activities        
    6.1.3.1 Identification and Traceability of Configuration CM2 CM Plan,
    CID
       
    6.1.3.2 Management of Changes CM3      
    6.1.3.3 Configuration Status Report CM2 CID    
    ISO 9000, Part 3 V-Model
    direct indirect
    Rule/Activity Product Rule/Activity Product
    6.2 Document Management        
    6.2.1 General Information Product Flows acc. to V-Model      
    a) Documents        
    b) Approval V-Model Change Procedure      
    c) Change Procedures PM1
    (Tailoring)
         
    6.2.2 Document Types        
    a) Procedural Instructions        
    b) Planning Documents Product Flows acc. to V-Model      
    c) Product Documents Product Flows acc. to V-Model      
    6.2.3 Approval and Release of Documents        
    a) Availability     CM  
    b) Updated Documents     V-Model Release  
    6.2.4 Document Change   CM Plan CM2 Project Manual 4.3
    6.3 Quality Protocol   QA Plan 5.2 V-Model (CM)  
    6.4 Measurements        
    6.4.1 Measurements at Product QA5      
    6.4.2 Process Measurement     QA3,
    PM8,
    CM4.7
     
    6.5 Rules, Practices and Agreements        
    6.6 Tools and Techniques     Project Manual 6  
    6.7 Procurement        
    6.7.1 General Information PM2;
    SD1,
    SD2
    Assessment Specification    
    6.7.2 Assessment of Subsuppliers       QA Plan 5.2
    6.7.3 Validation of Procured Products QA2,
    QA4
    Assessment Specification    
    6.8 Added Software Product PM2,
    QA2,
    QA4
    Assessment Specification    
    6.9 Training PM10      

    Table ISO.1: How the ISO 9001 is covered by the V-Model

    Links to the V-Model Mailinglist

    Mail 0407- Re: Auswirkungen der Revision zur ISO 9000ff
    Mail 0249 - V-Modell und ISO-9000-3 (249)

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