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THE NEW STRUCTURE OF ISO 9001:2015

Over the last 25 years many standards related to management systems have been introduced, among which the most common are those relating to Quality, Safety and Environment. As a matter of fact, enterprises find themselves more and more often to apply simultaneously multiple standards that adopt different formats and heterogeneous terminologies. To overcome this kind of problems, ISO has established a High Level Structure (Annex SL) that will standardize the setting of all standards.

QSA.net has been developed taking into account this kind of approach and allows a management simplified by the fact of focusing on the organization itself.

The new structure (*) is divided into 10 chapters:

1. Scope and application field
2. Normative references
3. Terms and definitions
4. Organization Context
    4.1 Understanding the organization and its context (#)
    4.2 Understanding the needs and expectations of interested parties (#)
    4.3 Determining the scope and application field of QMS (Quality Management System)
    4.4 Quality Management System and its processes
5. Leadership
    5.1 Leadership and commitment
    5.2 Focus on customer
    5.3 Quality policy
    5.4 Organizational roles, responsibilities and authorities
6. Planning
    6.1 Actions to address risks and opportunities (#)
    6.2 Quality and planning objectives to achieve them
    6.3 Changes Planning
7. Support
    7.1 Resources
         7.1.1 General
         7.1.2 People
         7.1.3 Infrastructure
         7.1.4 Environment for the processes operation
         7.1.5 Monitoring and measuring resources
         7.1.6 Organizational knowledge
    7.2 Competence
    7.3 Awareness
    7.4 Communication
    7.5 Documented information
         7.5.1 General
         7.5.2 Creating and updating
         7.5.3 Documented information control
8. Operation
    8.1 Operational planning and control
    8.2 Determination of requirements for products and services
         8.2.1 Communication with customer
         8.2.2 Determination of requirements related to products and services
         8.2.3 Review of requirements related to products and services
    8.3 Design and development of products and services
         8.3.1 General
         8.3.2 Design and development planning
         8.3.3 Design and development inputs
         8.3.4 Design and development controls
         8.3.5 Design and development outputs
         8.3.6 Design and development changes
    8.4 Control of external supply
         8.4.1 General
         8.4.2 Type and control extent of external supplies
         8.4.3 Information for external suppliers
    8.5 Production and service delivery
         8.5.1 Control of production and service delivery
         8.5.2 Identification and traceability
         8.5.3 Property belonging to customers or external suppliers
         8.5.4 Preservation
         8.5.5 Post-delivery activities
         8.5.6 Changes Control
    8.6 Release of products and services
    8.7 Control of nonconforming outputs
9. Performance evaluation
    9.1 Monitoring, measurement, analysis and evaluation
         9.1.1 General
         9.1.2 Customer satisfaction
         9.1.3 Analysis and evaluation
    9.2 Internal audit
    9.3 Management review
10. Improvement
    10.1 General
    10.2 Nonconformity and corrective action
    10.3 Continual Improvement

(*) Unofficial translation

(#) functionality in the implementation phase

This structure is currently the most recent draft that will lead to the publication of the FDIS, but should not be considered as an official document or in any way formally approved.