Pyxis Systems International, Inc.
 

ISO Fundamentals for Software (ISO1.1) - Lesson Plan

 

Session 1 

Module 1: An explanation of how ISO 9001, ISO 9000-3, TickIT, and other certification methods apply to software is discussed. This is a high level overview to set the stage for the remainder of the course. The emphasis is on demands for ISO and its impact on software worldwide. 

Module 2: In this module the first 8 elements of ISO 9001 are covered, emphasizing their relationship to ISO 9000-3 and hence, to software. Those elements of ISO 9001 are: 

    4.1 MANAGEMENT RESPONSIBILITY 
    4.2 QUALITY SYSTEM 
    4.3 CONTRACT REVIEW 
    4.4 DESIGN CONTROL 
    4.5 DOCUMENT AND DATA CONTROL 
    4.6 PURCHASING 
    4.7 CONTROL OF CUSTOMER-SUPPLIED PRODUCT 
    4.8 PRODUCT IDENTIFICATION AND TRACEABILITY

There is often confusion as to what constitutes a quality system and who has management review and responsibility in relation to software. An exercise is given in this module that brings that issue in focus for your company. 
 

Session 2 

Module 3: The next 8 elements of ISO 9001 are covered in this module: 

    4.9 PROCESS CONTROL 
    4.10 INSPECTION AND TESTING 
    4.11 CONTROL OF INSPECTION, MEASURING, AND TEST EQUIPMENT 
    4.12 INSPECTION AND TEST STATUS 
    4.13 CONTROL OF NON-CONFORMING PRODUCT 
    4.14 CORRECTIVE AND PREVENTIVE ACTION 
    4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION, AND DELIVERY 
    4.16 CONTROL OF QUALITY RECORDS 

This area focuses on inspection and testing, but directed from the manufacturing point of view. How this is applied to software is provided in this module. Process control and non-conforming products are elements of this area of ISO 9001. The application of these elements to your software environment are discussed through a class exercise. 

Module 4: The final 4 elements of ISO 9001 are addressed: 

    4.17 INTERNAL QUALITY AUDITS 
    4.18 TRAINING 
    4.19 SERVICING (maintenance) 
    4.20 STATISTICAL TECHNIQUES (measurements) 

Each of these as applied to software is covered. A perspective is provided of what an ISO audit involves with emphasis on sample questions and answers, quality manuals, objective evidence, findings and deficiencies. This course concludes with an exercise that summarizes all the ISO elements with a mock audit performed by the class. 

 

 

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Baltimore, MD 21240

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