THE QUALITY MANAGEMENT SYSTEM: ISO 9001
The ISO 9000 family of standards identifies a set of standards and guidelines developed by ISO (International Organization for Standardization).
The three main standards of the ISO 9000 family are:
- ISO 9000 "Quality management systems - Fundamentals and terminology"
The applicability of the ISO 9001 standard is independent of the size or sector of the company. The standard defines principles and a methodology that the organization must apply in order to guarantee more effective processes to achieve its business goals and be efficient in terms of customer satisfaction.
The standard specifies the requirements that a quality management system must have to provide evidence of an organization's ability to guarantee its stakeholders and customers efficient business processes in full compliance with the applicable contractual provisions and regulations, with the aim of increase customer satisfaction.
The ISO 9001 standard is based on a "process structure" : the process approach to quality management consists in the ability to manage the activities of a specific organization through the identification and control of the relative processes and interactions in a systematic and organic way.
The model adopted provides an approach based on the concept of continuous improvement according to the "Plan, Do, Check, Act" scheme:
The objectives and advantages in the application of a quality management system can be found in the overall satisfaction of all the interested parties, whether they are customers, employees, suppliers, owners or the company itself, through:
- Definition of roles and responsibilities within the company
Over the years there have been several updates and revisions and the current version of the standard is now represented by ISO 9001: 2015 . In this latest revision the ISO High Level Structure (HLS) scheme has been adopted, which represents the basic structure of all ISO standards.
The ISO High Level Structure (HLS) provides that the standard is defined in 10 chapters, according to the following subdivision:
What's new compared to the previous 2008 version is the 4 - Organization context chapter. The Organization must determine which interested parties can influence its ability to provide products and services on an ongoing basis that comply with the implicit, explicit and mandatory requirements.
Consideration of the needs of the interested parties must be functional to customer satisfaction.
The requirements or expectations of the interested parties must be inputs for the planning of the quality management system and the management review.
Another new feature is represented by the figure of the Management Representative , now no longer envisaged, which centralized all the responsibilities related to the management of the quality management system: however, the rule provides that these responsibilities and authorities are always assigned.
Although the standard does not expressly speak of "risk analysis", a risk-based approach (Risk Based Thinking) is fundamental, in the new edition of ISO 9001: 2015, to plan the system of quality management, considering that one of the aims of the system is to provide a prevention tool for the organization that adopts it.
The terms registration and documented procedure, typical of the ISO standard, have been replaced by the expression documented information . This concept is one of the main innovations of the new edition of the standard, making a decisive contribution to simplifying document requirements.