QUALITY MANAGEMENT SYSTEMS

What is ISO 9000?

ISO 9000 is a family of internationally recognized standards related to quality management systems. These standards define the organizational structures and practices that both public and private companies should adopt in order to improve their processes and achieve results that meet market expectations and customer needs.

What does implementing ISO 9001 in a company mean?

Implementing ISO 9001 means establishing an internal organizational system that complies with the requirements defined by the ISO 9001 standard.

The standard applies to all company processes, including sales, purchasing, production, and other operational activities. These processes must be properly documented through dedicated documentation such as:

• Quality manual

• Procedures

• Work instructions

In addition, all activities related to quality management must be recorded using specific forms and documents, known as quality records.

How can a company obtain UNI EN ISO 9001 certification?

Below is a summary of the main steps required to achieve ISO 9001 certification:

• Study the requirements of the ISO 9001 standard or engage a specialized consulting firm.

• Define the company organizational structure and appoint a Quality System Manager and a Management Representative.

• Analyze all company processes, including sales, purchasing, production, design, maintenance, and equipment calibration.

• Ensure that all processes comply with the requirements of the standard.

• Develop procedures and work instructions that clearly describe company processes.

• Prepare all the necessary documentation and operational forms.

• Develop the Quality Manual, which summarizes all procedures and work instructions.

• Conduct internal audits to verify that procedures and work instructions accurately reflect the company’s actual operations.

• Select an accredited certification body (such as DNV, IMQ, etc.) and schedule the certification audit.

• If the certification audit is successful, the company will be awarded ISO 9001 certification. The certification is valid for three years, with annual surveillance audits carried out by the certification body.

Costs and time required to obtain UNI EN ISO 9001 certification

On average, a medium-sized company requires approximately six months to achieve ISO 9001 certification with the support of an external consulting firm.

The main costs involved are related to:

• Consultancy services

• Certification body fees

Additional internal costs may arise from the involvement of company staff during the implementation process.

What is the objective of an ISO 9001 quality management system?

The main objective of an ISO 9001 quality management system is to ensure that the products or services provided by the company meet specified requirements.

According to the standard, these requirements correspond to the explicit and implicit expectations of customers.

What does “UNI EN ISO 9001 certification” mean?

Certification confirms that a product, process, or service complies with a specific standard or regulatory document.

It is issued by an independent certification body, which acts as a third party with respect to both the certified company and any consulting organizations involved in the implementation process.

What does it mean that the quality system is monitored by an accredited certification body?

Certification verifies that a company’s management system complies with the requirements defined in ISO standards.

Accreditation, on the other hand, ensures that the certification body itself meets national and international criteria.

An accredited certification body can issue certifications that are internationally recognized by organizations belonging to EA – European Cooperation for Accreditation.

The added value of accredited certification lies in the guarantee provided by an independent third party that the certification body thoroughly evaluates:

• company activities

• customer needs (both explicit and implicit)

• the expectations of stakeholders

In other words, an accredited certification body is expected to perform an in-depth evaluation of the company’s quality management system, rather than limiting its assessment to a purely formal compliance check.

In Italy, the official body responsible for accrediting certification bodies is ACCREDIA.