ISO 9001:2015, MAIN CHANGES

The new ISO 9001: 2015 introduces three new requirements: the organization context, the interested parties and the risk. Regarding the purpose of the rule, it is unchanged: product compliance and customer satisfaction.

There are many changes that characterize the new ISO 9001: 2015, a key objective is to have a simpler, more applicable standard, a common format and language even for small enterprises.

The main changes of the new ISO 9001:2015 are summarized as follows:

  • Greater focus on the customer
  • policies and objectives aligned with the strategies of the organization
  • Risk-based thinking
  • Greater flexibility in regards with documentation

One of the innovative aspects that the new ISO 9001:2015 has developed is the expansion of the concept from customer to "interested parties". In particular, new points are introduced, which require the Organization to understand their external and internal environment, in order to examine needs and expectations of stakeholders that may impact on the quality management system (QMS). On this basis the Organization will have to develop policies and objectives in line with the strategies of the organization.

With "risk-based approach" it is meant the will to determine and assess opportunities and risks to be addressed in order to ensure the efficiency of the quality management system (QMS), by preventing and reducing the undesirable effects, in favor of a continuous improvement. The concept of "preventive action" is then turned into a risk-based approach.

QSA.net is introducing new features able to provide methodological and operational support in the implementation of these important changes.

The increased flexibility regarding the documentation can be summarized in a "bureaucratic" simplification of the system documentation. It is provided a greater flexibility for enterprises, which are free to choose depth and detail they wish to use for their written documentation, a choice that can be made based on various factors, such as the complexity of the processes and the expertise of staff.

This simplification will allow a real computerization of processes for a more efficient and effective management system.

The new ISO 9001:2015 will ask all certified organizations to review its quality management system in order to introduce new requirements and improve the management of organizational processes, ensuring effectiveness, efficiency and control capabilities.

What would be the best time to think about the future of your System Management with QSA.net?

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.

ISO 9001:2015, elaboration process

The ISO standards are reviewed every five years in order to ensure an upgrade. In the year 2012 a formal review of the ISO 9001 standard was completed and led to the decision of proceeding with a revision of the standard.

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 defined a High Level Structure that will standardize the setting of all the rules.

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 ISOs are developed by Technical Committee (TC) and Sub-Committees (SC). ISO/TC176/SC2 is responsible for the ISO 9001. At present, the ISO 9001:2015 is developed, in SC2, by a specific working group, that is WG24.

The ISO 9001:2015 development process has been structured in several stages: the first step was the agreement on the need of a revision of the standard, which was followed by the agreement on the application field and the objectives. The third step was the Working Drafts (WD) that preceded the Committee Draft (CD) that in the case of ISO 9001:2015 was very troubled (ISO/CD 6/2013).

The Draft International Standard (DIS) was approved in May 2014 (5/2014 DIS) and precedes the Final Draft International Standard (FDIS) that, for ISO 9001:2015, is planned for July 2015 (FDIS 7/2015). The final release of the new ISO 9001:2015 is expected for the month of September.

QSA.net software is evolving on the basis of the changes introduced by the new rules or the revision of existing standards, on the experience gained in the field by its users and on the application of techniques, tools and methods of business organization.

The technical staff of QSA.net is working to include all the changes introduced by the new ISO 9001:2015, and in particular the practical application of the Risk Based Thinking.