Reference framework of ISO 9000 standards

Reference framework of ISO 9000 standards

1. Historical development of the quality management concept

   • Movements that are considered more important:
     • * Quality control by inspection * Zero defects quality *Statistical quality control *Total quality control *Quality assurance *Quality circles

2. Origins of ISO9000 Standards

   • Initially, the ISO9000 Standards included, in addition to the process control, quality control of the products. To achieve this, 20 countries with active participation and 10 countries as observers created by consensus a series of norms oriented to the administration of the quality that they called ISO9000, whose final emission is made in 1987.
     • The ISO standard can, conceptually, be divided into three large groups
       • first of all what refers to the concepts, principles, fundamentals and vocabulary of the quality management system; the rule ISO-9001 that establishes the requirements to be met, and the standard ISO-9004 which provides guidance to improve the performance of the quality management system.
   • Regulations used for the quality management and quality assurance –Guidelines for their selection and use–, whose fundamental purpose is to normalize terms and concepts that are used and applied to the field of quality management.

3. Structure of the ISO-9001 Standard

   • Structure of ISO 9001: 2008 (ICONTEC, 2008)
     • 1. Purpose and field of application 2. Normative references 3. Terms and definitions 4. Quality management system 5. Managemet responsabilities 6. Resource Management 7. Product realization 8. Measurement, analysis and improvement
   • Structure of the ISO-9001: 2015 standard
     • presents several important changes and new items within its structure with respect to the norm ISO-9001 version 2008, which are specified and mentioned below (ICONTEC, 2015):
       • 1. reach 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement
     • The concept of Action is annulled preventive
       • the concepts document and record are replaced by the term documented information
         • the global term of stakeholders within from the approach to total quality.
           • Continuous improvement: and organizations do not may limit the development of cycles of NC / AC
             • The Deming Cycle The known methodology as PDCA (Plan-Do-Check-Act) or Deming cycle,

4. certification under ISO-9001 Standards

   • It is possible to divide the development of the process of certification based on ISO-9001 Standards: quality engineering, quality system design, documentation, implementation, internal audit, quality manual and certification itself bliss.