“The ability to meet moral and material, social and economic needs of civil and productive life, appropriately identified and translated into specific, concrete and measurable requirements through suitable standardisation and regulation processes.”
Quality requirements are more complete and effective the wider the satisfaction they deliver, and the greater the number of stakeholders whose expectations are taken into account and met through compliance with those requirements.
QUALITY must be a conscious choice and commitment for everyone who has the duty to provide quality and the right to receive it.
In social and economic life, every organisation producing goods and services is expected to deliver and guarantee quality to the market, in proportion to the needs it is required or committed to meet.
Who is involved in a company quality system?
The people involved in managing and complying with a company quality system can be internal or external to the business. In simple terms, they can be described as follows:
- Management, that is, the business itself. No quality system can be guaranteed unless management clearly intends to step up its commitment to processes, premises and products of increasing and certifiable quality, investing further in property, equipment and people.
- The Quality Manager: the link between management and operations, this is the reference figure who designs, manages and organises the company quality system, making sure that processes and documentation are in line with what management has decided and therefore with the reference standards.
- Quality Control: all the people, inside and outside the company, with specific tasks in checking the established procedures form the quality control team, ensuring with suitable continuity and frequency that every process complies with the adopted standards and procedures.
- The Control Body: an independent third party whose task is to verify, with the help of qualified experts (auditors), that documentation is consistent with the chosen standards and that processes are carried out in line with them, issuing documents that certify conformity.
What needs must quality meet?
Essentially, there are mandatory needs and voluntary needs.
First of all, basic and binding needs must be met. These are protected by national law through technical regulations (mandatory), which set out the essential requirements for protecting general public interests such as safety, hygiene and health. Public authorities use their own tools to authorise the marketing and use of products, processes and services.
The ministries responsible for each sector grant authorisations or notifications to the bodies in charge of conformity assessment, to certify that producers place on the market goods and services that meet legal requirements.
“Additional” needs are covered by voluntary technical standards, which set out the production, performance and function requirements of the subject of the standard, based on the quality standards and product specifications the business chooses to adopt.
How is conformity assessed?
There can be different approaches, depending on the organisation and the standard concerned:
- First-party approach, where the main role is played by the manufacturer of the product or the provider of the service, who guarantees the quality delivered;
- Second-party approach, where responsibility for building and assuring quality lies mainly with the user;
- Third-party approach, where all the main functions of verifying and certifying quality, along with some supporting functions, are carried out by independent control bodies. The third-party approach has become established because public and private organisations providing goods and services need independent, impartial assessments to show their ability to meet the needs associated with their products and services, with the added benefit of reducing the related technical, economic, administrative and legal risks.
Quality tools
Quality assurance, carried out by accredited operators, relies on several complementary tools, depending on the needs it must guarantee.
CERTIFICATION is a third-party attestation of conformity of products, processes, people and systems with specified requirements.
Product certification (governed by sector, general and product-specific standards or equivalent references) is a form of direct assurance that confirms whether a tangible or intangible product (a service), seen as the result of a process, meets the applicable requirements.
The output of certification is the CERTIFICATE or declaration of conformity, which refers only to the subject of the certification (the scope of the standard) and is issued on the basis of sample checks. It confirms that the organisation is able to meet and maintain the requirements over time and to take effective corrective and preventive action.
- Certification is therefore valid for a set period, and the certificate issued by the competent certification body is seen in a “diachronic perspective”, over time.
- An inspection, carried out by auditors, consists of examining a design, product, service, process or facility and determining its conformity with specific requirements or, on the basis of “professional judgement”, with general requirements.
- Inspection reports state whether, at that given moment, the product, process and so on meets the applicable requirements or not. The report issued by the inspection body is independent of the inspected organisation’s ability to implement corrective action to remove any non-conformities.
- The inspection report is therefore a kind of snapshot, showing the subject (design, process and so on) at a precise, identified moment, in a “synchronic dimension”.
