STRUCTURE OF THE ISO 9001:2015 STANDARD
STRUCTURE OF THE ISO 9001:2015 STANDARD
The structure of the ISO 9001: 2015 quality standard does not vary much from the 2008 version, however, it does emphasize certain aspects that were not previously established with such importance. The 2015 version is the latest update of ISO 9001 and was published on September 23, 2015. As of this date, the IAF (International Accreditation Forum) defined a period of “coexistence” of the two versions, until September 2018.
Main differences between the 2008 and 2015 versions of ISO 9001:
ISO 9001:2008
- Purpose and scope of application
- Rules for consultation
- Terms and definitions
- Quality Management System
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
ISO 9001:2015
- Scope
- Normative references
- Terms and definitions
- Organizational context
- Leadership
- Planning
- Operations
- Performance evaluation
- Improvement
The main difference is that in the current version, the first 3 sections consist of an introduction, terms and scope of the standard, while sections 4 to 10 establish the requirements of the standard.
ISO 9001:2015 CURRENT VERSION STRUCTURE
4.Context of the organization
It deals with the establishment of the external and internal factors that impact, in some way, the processes that the company performs, its objectives, its strategic direction and its results. Since these are issues considered in the quality management system (QMS), the organization is obliged to follow up and review the information regarding them.
5. Leadership
The standard talks about the commitment and leadership that top management must adopt with respect to the quality management system, in a list of general actions and with a customer focus:
Take responsibility and be accountable for the effectiveness of the system.
Establish and communicate the quality policy and objectives for the QMS.
Ensure the integration of the system requirements into the company’s processes.
Promote the process-based approach.
Ensure the availability of the necessary resources for the QMS.
Engage, direct and support the people involved in the processes.
Promote improvement.
6.Planning
The International Organization for Standardization (ISO) states that when changes to a quality management system are necessary, they should be carried out in a planned manner and with certain considerations:
The purpose of the changes and their potential consequences.
The integrity of the quality management system.
The availability of resources.
The assignment of roles and responsibilities.
7.Support
This section discusses the form and requirements for resources, competence, awareness, communication and documented information.
8.Operation
This section deals with the importance of planning and control of the processes necessary to comply with the requirements established for the provision of products and services. For this, it is necessary to determine the criteria to be considered for the processes and the resources necessary to obtain compliance.
9. Performance evaluation
Within the generalities of this chapter, it is established that the organization should consider the need to carry out periodic measurements and follow-ups; to this end, it should determine the appropriate follow-up, analysis and evaluation methods. It is important that documented information is kept as evidence.
10.Improvement
It has to do with the opportunities for improvement and the actions taken to increase customer satisfaction. To achieve this, the improvement of products and services should be considered, considering the needs and expectations; correcting, preventing and reducing the effects; as well as improving the performance and efficiency of the quality management system.
As can be seen, the new version of ISO 9001 emphasizes aspects that are important for risk management and exceeding customer expectations. In requirements for certification you can see that it is basically about these new changes in the structure of ISO 9001.
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