A Quality Management System standard based on a number of quality management principles including
a strong customer focus, the process approach, and continual improvement. Using ISO 9001:2008 helps ensure that customers
get consistent, good quality products and services, which in turn brings many business benefits.
– A Quality Management System standard for the medical device industry 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.
AS9100 – A Quality Management System standard for
the aerospace industry. The standard incorporates all of ISO9001 and includes specific requirements relating to aviation,
space and defense, as well as land- and sea-based systems for defense applications.
A standard that specifies the requirements for the application of risk management to medical devices and applies to all stages
of the life-cycle of a medical device.
ISO17025 – A standard that
specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers
testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
ISO/TS 16949 – A standard used in conjunction with ISO 9001:2008, which defines the quality management system
requirements for the design and development, production, and installation and service of automotive-related products.
ISO14001 – An Environmental System Standard that specifies requirements for an environmental management system to enable an
organization to develop and implement a policy and objectives which take into account legal requirements and other requirements
to which the organization subscribes, and information about significant environmental aspects.
approach to ISO is to implement a "Quality Management" leadership culture that meets the customer's quality
requirements and applicable regulatory requirements, while aiming to enhance customer satisfaction, and pursue continual improvement
of its performance in pursuit of these objectives. The International Organization for Standardization (ISO 9001-2008)
introduced a revised Quality Management standard based on an emphasis on measuring customer satisfaction along with a compatibility
with ISO 14001 - Environmental Management Systems. Leanovations has been teaching, coaching and guiding companies through
our “Lean to Green (L2G) Process” helping companies with implementing business sustainability that has a positive
impact on 3-P's; the People, Planet and Profits.