MANAGEMENT & PROTECTION SYSTEMS

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).
These standards offer a quality management system, designed for monitor business processes so that they are directed to improving the effectiveness and efficiency of the organization as well as customer satisfaction.

The three main standards of the ISO 9000 family are:

- ISO 9000 "Quality management systems - Fundamentals and terminology"
- ISO 9001 "Quality Management Systems - Requirements"
- ISO 9004 "Quality Management Systems - Guidelines for Performance Improvement"

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
- Definition of operating methods within the company
- Compliance with contracts
- Compliance with the laws
- Staff motivation
- Optimization of time and use of resources with consequent increase in productivity
- Increased business efficiency
- Achievement of business objectives
- Continuous improvement of business performance
- Improving the corporate image

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.
The expectations of the interested parties that may influence the quality management system.

Consideration of the needs of the interested parties must be functional to customer satisfaction.
Examples of interested parties can be:

The requirements or expectations of the interested parties must be inputs for the planning of the quality management system and the management review.
Again with reference to the requirement of Chapter 4, the contents of the policy must be consistent with the results of the context analysis, with the needs of customers, other interested parties and applicable mandatory requirements. The continuous changes in the Organization and in the context in which it operates impose a periodic revision of the policy.

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.
With the term "risk", although normally associated with a negative value, a positive or negative connotation is to be understood.
In fact they can be considered as an opportunity, for example. the launch of new products, the opening of new markets or the introduction of new technologies, all of which can also be considered potential risks.
It is the organization that has to evaluate these aspects with reference to its business and consider the different actions to be taken to deal with such situations.

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.
The norm punctually indicates for which requirements it is necessary to keep a record or maintain a management document, but now it is up to the Organization to determine which documents are necessary for the management and effectiveness of the system, and how these must be managed.