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ISO 9001 2015


For organizations asking how to improve the quality of their products and services and consistently meet their customers' expectations, ISO has an answer. Addressing various aspects of quality management and containing some of ISO's best-known standards, there's the ISO 9000 family.

ISO 9001:2015 Quality management systems – Requirements is the latest revision of the standard.

ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO's quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings y business benefits.

For "documentation information" click on : Documented Information ISO 9001 2015
For "Audit check-list" click on : Audit Check-list ISO 9001 2015
The seven quality management principles are:

  • 1. Customer focus

  • 2. Leadership

  • 3. Engagement of people

  • 4. Process approach

  • 5. Improvement

  • 6. Evidence-based decision making

  • 7. Relationship management

For details click : quality management principles
The contents of ISO 9001:2015 standard are:

Introduction
  • 1 Scope

  • 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

Annex A Clarification of new structure
Annex B Other international on quality management and quality management systems developed by ISO/TC 176
Core concepts of ISO 9001:2015 are :

  • Process approach – Enables organization to plan its processes and interaction

  • Plan-Do-Check-Act (PDCA) cycle – Ensures processes are adequately resourced and managed

  • Risk-based thinking – Enables organization to:

    - determine factors that could cause its processes and its quality management system to deviate from its planned results
    - to put in place preventive controls to minimize negative effects, and
    - to make use of opportunities as they arise
  • Improvement - correction, continual improvement, breakthrough change, innovation & re-organization

Major changes (from ISO 9001:2008 to ISO 9001:2015)

  • High Level Structure (HLS)

  • Changes in terminology

  • No requirement for management representative

  • No requirements for quality manual and six mandatory procedures

  • Risk-based thinking

  • Context of the organization

  • Organizational knowledge

  • No separate clause for "preventive action"