MANAGEMENT SYSTEMS

Set of flexible and tailored solutions to address the development, certification and maintenance of the system and obtain results of improvement for the management, operation, productivity and the protection of people and resources. The goal is to offer an analysis and assistance to the development of the management system, also integrated, targeted to the organization's processes.

UNI EN ISO 9001:2008

Title: Quality Management Systems - Requirements
The standard specifies requirements for a quality management system for an organization that: a) have the need to demonstrate its ability to consistently provide product that meets customer requirements and applicable regulatory requirements; b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement in the system and ensure compliance with customer requirements and applicable regulatory requirements. All requirements are of a general nature and intended to be applicable to all organizations, regardless of type, size and product provided. The standard can be used by internal and external parties to the organization, including certification bodies, to assess the organization's ability to meet the requirements of the customer, statutory and regulatory requirements applicable to the product and the requirements established by the organization itself.

UNI EN 9100:2009

Title: Quality Management Systems - Requirements for Aviation, Space and Defense Organizations.
The standard is the official version of the European standard EN 9100 (edition August 2009) and takes into account the corrections introduced on September 9, 2009. The standard includes the requirements of the management system for the quality of the UNI EN ISO 9001: 2008 specifies requirements info for the aviation industry, space and defense.

AQAP/AER-Q

The AQAP (Allied Quality Assurance Publications) are regulations issued by the Agency for standardization within NATO (NSA) with the aim of defining the basic requirements of quality specific to organizations providing products to any entity or organization belonging to the military NATO. These standards are recognized as standard contractual requirements by all the NATO countries, in order to allow the management and monitoring of the selection process on the quality of the supplier in the military. The rules contain additional specific requirements, such as to fully satisfy the demands of the defense sector, in addition to those already present in the standard civil correspondent.
Of particular importance is the AQAP 2110 which defines the requirements for quality assurance for an organization that designs, develops and manufactures. The rule is essentially structured according to ISO 9001, it calls calls paragraphs paragraphs counterparts counterparts and, when appropriate, defines additional requirements NATO.

UNI ISO/TS 16949:2009

Title: Quality management systems - Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations.
The standard, together with the UNI EN ISO 9001: 2008, defines the requirements of the Quality Management System for the design and development, production and, when relevant, installation and service of products related to the automotive sector. It is applicable to sites of organizations to which they are manufactured production parts and / or parts specified by the customer. Support functions, both internal and remote (such as design centers, central offices and distribution centers) that support the site are part of the audit of the site, but can not obtain certification of its own according to the technical specification . The technical specification can be applied to the entire automotive supply chain.

UNI CEI EN ISO 13485:2012

Titolo: Medical devices - Quality Management Systems - Requirements for regulatory purposes.
The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.