ISO 9001

ISO 9001 was developed by the International Organization for Standardization (ISO) and is an international standard outlining the general requirements for a quality management system. Businesses wishing to demonstrate their ability to provide products and/or services that meet both customer and legal requirements must comply with these requirements.

ISO 9001 can be applied to all companies and organizations (private or public), regardless of type, size, or activity. Its purpose is to help them enhance customer satisfaction for their products or services through the implementation of a quality management system.

The quality management system under ISO 9001 is developed through the following phases:

• Identifying legal and regulatory requirements for the provided products/services
• Evaluating existing management processes and records to ensure their compliance with the standard
• Reviewing and updating existing processes and records where there are deviations from the standard’s requirements, and creating new processes and records where there is a complete absence
• Training personnel on the system’s requirements
• Implementing the system
• Reviewing and modifying the system if necessary
• Conducting an internal audit

Several factors may affect the level of difficulty in implementing the system, such as the company’s type and size, the complexity of its processes, and how familiar the staff is with working under a management system. In particular, any business that produces or distributes a product subject to CE marking requirements must either have the product certified with a CE mark or ensure the products it distributes are already certified.

Working with a specialized consultant is useful to develop a functional and effective system tailored to the company’s needs and in line with the standard’s requirements. ISO 9001 can also be combined with other standards that a company currently applies or plans to apply, so as to establish a unified management system.

Several certification bodies in Greece are accredited by the Hellenic Accreditation System (ESYD) or by equivalent organizations to issue relevant certificates, depending on the company’s activity.

The certification process involves evaluating the company’s compliance with its operations and the products/services it offers, assessing the management system against the standard’s requirements, and reviewing the system’s implementation.

Upon successful completion of the assessment, the Certification Body issues a three-year Certificate of Conformity. In the event of significant deviations, the company must complete corrective actions before the certificate can be issued, while minor deviations must be resolved by the next assessment.

The certificate remains valid as long as scheduled periodic assessments by the Certification Body, at least annually, confirm ongoing compliance with the defined requirements.

Key reasons businesses seek ISO 9001 certification include:

• Competition and customer demands
• Organizing company departments and standardizing processes to minimize errors and failures
• Improving staff performance
• Strengthening efforts to achieve customer satisfaction
• Developing business relationships with customers and suppliers who prefer to work with ISO 9001-certified companies
• Complying with legal requirements on implementing a quality management system (depending on the company’s activity)
• Gaining eligibility to participate in public tenders where an ISO 9001 Certificate is part of the required documentation