Kiwa Cermet ISO 9001-2015

ISO 9001:2015 is the international standard for Quality Management Systems (QMS), published by ISO — International Organization for Standardization. It is the world’s most widely used reference standard in quality: it has more than one million active certificates in more than 170 countries, and applies to organizations of all sizes and product sectors.

The 2015 version — currently in force — has introduced a substantial revision from the previous 2008 edition, adopting the structure common to all ISO management system standards (High Level Structure). This makes ISO 9001:2015 directly integrable with other standards such as ISO 14001 (environmental management) and ISO 45001 (occupational health and safety), reducing complexity for organizations operating multiple certified systems in parallel.

The basic principles

The standard is based on seven quality management principles that guide organizational and operational choices: customer focus, leadership, people involvement, process approach, continuous improvement, evidence-based decision-making, and stakeholder relationship management. These are not abstract principles: the standard translates them into requirements that can be verified by an accredited certification body.

One of the distinctive elements of the 2015 version is the concept of risk-based thinking-risk — based thinking. The organization is required to identify internal and external factors that may affect the achievement of its quality objectives, and to define proportionate preventive actions. It is no longer sufficient to document procedures: it is necessary to demonstrate that it has reasoned about risks and made informed decisions in response to them.

The relationship with ISO 22000 and FSSC 22000

In the food and nutraceutical sector, ISO 9001:2015 often coexists with more specific food safety standards — particularly ISO 22000:2018 and FSSC 22000. The relationship between these standards is not one of overlap but complementarity: ISO 9001 certifies the quality management system in its broadest sense — processes, customer satisfaction, continuous improvement; ISO 22000 and FSSC 22000 focus specifically on food hazard management and product safety throughout the supply chain.

Thanks to the adoption of the common High Level Structure, the requirements of the two families of standards complement each other without duplication: those operating an ISO 22000:2018-compliant system have already met most of the structural requirements of ISO 9001:2015, and vice versa. For an organization operating in co-packing or nutraceutical formulation, having both levels of certification-system quality and food safety — represents a comprehensive assurance framework recognizable by buyers in any market.

The certification body: Kiwa Cermet Italy

Kiwa Cermet Italia S.p.A. is one of the most well-established management system certification bodies in Italy, operating under the umbrella of the international Kiwa Group, present in more than 40 countries. It is ACCREDIA — accredited — the Italian accreditation body-and is a member of IAF (International Accreditation Forum), which guarantees multilateral recognition of the certificate in all member countries. Verification of the validity of the certificate is available on the body’s own public register.

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