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Indenture level

Level of subdivision of an item from the point of view of a maintenance action.


Innovation

Innovation can be described as "a new idea, creative thoughts, new imaginations in form of device or method". Innovation is often understood as the application of better and more effective solutions that meet new requirements, unarticulated needs, or existing market needs.
Innovation involves deliberate application of information, imagination and initiative in deriving greater or different values from resources, and includes all processes by which new ideas are generated and converted into useful products or processes. For businesses, innovation can increase the likelihood of your business succeeding.


Integrated Management System

Integrated Management System (IMS) consists on the integration of all organization’s systems and processes in a smart way into one complete framework, enabling an organization to work as a single unit with unified objectives.


ISO 13485

ISO 13485 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 and applicable regulatory requirements. 
Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.


ISO 55000

The ISO 55000 consists of three standards that represent a global consensus on asset management and what it can do to increase value generated in all type of organizations:

  • ISO 55000 Asset Management - Overview, principles and terminology
  • ISO 55001 Asset Management – Requirements
  • ISO 55002 Asset Management - Guidelines on the application of ISO 55001

ISO 55000 series provides terminology, requirements and guidance for implementing, maintaining and improving an effective asset management system, that can be applied to all types of assets and by all types and sizes of organizations.


ISO 9000

ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size.
The ISO 9000 family contains these standards:

  • ISO 9001:2015: Quality Management Systems - Requirements
  • ISO 9000:2015: Quality Management Systems - Fundamentals and Vocabulary (definitions)
  • ISO 9004:2018: Quality Management - Quality of an Organization - Guidance to Achieve Sustained Success (continuous improvement)
  • ISO 19011:2018: Guidelines for Auditing Management Systems

ISO TS 16949

ISO/TS 16949 in conjunction with ISO 9001, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
ISO/TS 16949 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.


Item

Any part, component, device, subsystem, functional unit, equipment or system that can be individually considered.


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